Jama Gandhi 2022 SC 220007 1669761091.38561 PDF

Clinical Review & Education
JAMA | Special Communication
Antiretroviral Drugs for Treatment and Prevention

of HIV Infection in Adults
2022 Recommendations of the International Antiviral Society–USA Panel
Rajesh T. Gandhi, MD; Roger Bedimo, MD; Jennifer F. Hoy, MBBS; Raphael J. Landovitz, MD; Davey M. Smith, MD;
Ellen F. Eaton, MD; Clara Lehmann, MD; Sandra A. Springer, MD; Paul E. Sax, MD; Melanie A. Thompson, MD;
Constance A. Benson, MD; Susan P. Buchbinder, MD; Carlos del Rio, MD; Joseph J. Eron Jr, MD;
Huldrych F. Günthard, MD; Jean-Michel Molina, MD; Donna M. Jacobsen, BS; Michael S. Saag, MD
Multimedia
IMPORTANCE Recent advances in treatment and prevention of HIV warrant updated Supplemental content
recommendations to guide optimal practice.
OBJECTIVE Based on a critical evaluation of new data, to provide clinicians with

recommendations on use of antiretroviral drugs for the treatment and prevention of HIV,
laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and
new challenges in people with HIV, including COVID-19 and monkeypox virus infection.
EVIDENCE REVIEW A panel of volunteer expert physician scientists were appointed to update
the 2020 consensus recommendations. Relevant evidence in the literature (PubMed and
Embase searches, which initially yielded 7891 unique citations, of which 834 were considered
relevant) and studies presented at peer-reviewed scientific conferences between January
2020 and October 2022 were considered.
FINDINGS Initiation of antiretroviral therapy (ART) is recommended as soon as possible after

diagnosis of HIV. Barriers to care should be addressed, including ensuring access to ART and
adherence support. Integrase strand transfer inhibitor–containing regimens remain the
mainstay of initial therapy. For people who have achieved viral suppression with a daily oral
regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently
as every 2 months is now an option. Weight gain and metabolic complications have been
linked to certain antiretroviral medications; novel strategies to ameliorate these
complications are needed. Management of comorbidities throughout the life span is
increasingly important, because people with HIV are living longer and confronting the health
challenges of aging. In addition, management of substance use disorder in people with HIV
requires an evidence-based, integrated approach. Options for preexposure prophylaxis
include oral medications (tenofovir disoproxil fumarate or tenofovir alafenamide plus
emtricitabine) and, for the first time, a long-acting injectable agent, cabotegravir. Recent
global health emergencies, like the SARS-CoV-2 pandemic and monkeypox virus outbreak,
continue to have a major effect on people with HIV and the delivery of services. To address
these and other challenges, an equity-based approach is essential.
CONCLUSIONS AND RELEVANCE Advances in treatment and prevention of HIV continue to

improve outcomes, but challenges and opportunities remain.
Author Affiliations: Author

affiliations are listed at the end of this
article.
Corresponding Author: Rajesh T.
Gandhi, MD, Cox 548, Infectious
Diseases Division, Massachusetts
General Hospital, 55 Fruit St,
JAMA. doi:10.1001/jama.2022.22246 Boston, MA 02114 (RGANDHI@mgh.
Published online December 1, 2022. harvard.edu).
(Reprinted) E1
© 2022 American Medical Association. All rights reserved.
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Clinical Review & Education Special Communication Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults
F
our decades after the initial cases of HIV were reported, tions or abstracts presented at peer-reviewed conferences were
strategies for treating and preventing HIV infection con- identified by the panel, and published and presented citations were
tinue to advance. People with HIV should be treated as soon obtained from drug manufacturers.
as possible after diagnosis. If they have an opportunistic infection,
antiretroviral therapy (ART) should be started shortly after initia- Process
tion of treatment of the infection. Initial ART options include daily The updated recommendations focus on adults with or at risk for
oral therapy, usually with a combination containing an integrase HIV infection in settings in which most antiretroviral drugs are avail-
strand transfer inhibitor (InSTI). For patients who have achieved vi- able. Each recommendation is rated for the strength of the recom-
ral suppression, a long-acting injectable regimen (cabotegravir and mendation and the quality of the supporting evidence (Table 1).
rilpivirine [RPV]), which can be dosed every 2 months, is an option. For recommendations that have not changed substantially or for
In addition to treatment improvements, there have been ma- which few new data have become available since 2020, the previ-
jor advances in HIV prevention through preexposure prophylaxis ous iterations of the recommendations provide background infor-
(PrEP), including daily oral options and, for the first time, a long- mation and relevant evidence.1 Key recommendations for each sec-
acting injectable option, cabotegravir. tion are listed in a Box or Table. ART drug combinations that are
As treatment and prevention of HIV improve, new challenges co-formulated are noted with slashes (eg, drug A/drug B/drug C).
and opportunities arise. As people with HIV live longer, there are im- Detailed tables and further details about the process, panel, evi-
portant considerations related to aging that require an integrated dence identification, and the IAS–USA and its policies are available
approach. Multidisciplinary and holistic care of people with sub- in the Supplement.
stance use and substance use disorder is required to achieve opti-
mal outcomes in treating and preventing HIV. Other infectious dis-
ease outbreaks, such as COVID-19 and now monkeypox virus
Initiation of ART
infection, also present rapidly evolving challenges for clinicians and
people with HIV. To effectively address these and other challenges, Recommendations for when to start ART are reported in Box 1. Ini-
as well as to realize the opportunity to end the HIV epidemic, ef- tiating ART as soon as possible after an HIV diagnosis is a high pri-
forts must be redoubled, with equity being the guiding principle. ority to improve the health and life expectancy of people with HIV
This updated article provides current recommendations for and to eliminate HIV transmission to sexual and injection drug use
treatment and prevention of HIV as well as an up-to-date discus- partners, as well as to infants.1 Rapid ART initiation (within 7 days
sion of important comorbidities and coinfections in people with HIV of diagnosis), including same-day initiation of ART on the day of di-
as they relate to the use of ART. agnosis or the first clinic visit, improves the likelihood of persons link-
ing to HIV care and the likelihood of and time to viral suppression.3-5
In resource-limited settings, rapid ART initiation improved survival
and longitudinal engagement in care.6 In highly resourced set-
Methods
tings, there are limited clinical and long-term outcomes from ran-
Appointment of the Panel domized clinical trials of rapid ART initiation. Based on the totality
A volunteer international panel of experts in HIV research and clini- of evidence, ART initiation is recommended within 7 days of diag-
cal care, and the panel leadership, was appointed by International nosis, including on the day of diagnosis or the first clinic visit, if the
Antiviral (formerly AIDS) Society–USA (IAS-USA). Members were patient is ready and there is no evidence of a co-occurring oppor-
screened for expertise, involvement in research and care, financial tunistic infection that might affect the timing of initiation of treat-
relationships, and ability to work toward consensus. New mem- ment (evidence rating: AIII). Timing and choice of initial therapy in
bers were added since the panel’s last report to contribute addi- the presence of an acute opportunistic infection is discussed in the
tional expertise, particularly in substance use disorders and antiret- Initiating ART in the Setting of Active Opportunistic Infections and
roviral drugs. The panel convened in person and by conference calls Cancer section below.
from October 2021 to October 2022. Teams were appointed for each The success of ART depends on addressing barriers to care and
primary section, which evaluated relevant evidence and drafted rec- on reliable ART access and adherence support. Identification and
ommendations for review by the full panel. elimination of barriers is especially crucial to the success of rapid ART
initiation programs. Barriers often include lack of transportation,
Identification of the Evidence housing instability,7 food insecurity, racism,8 out-of-pocket drug
New evidence on antiretroviral drugs was identified in the pub- costs, pharmacy availability, restrictive clinic hours, stigma, and dis-
lished literature, major scientific conference presentations, or safety crimination. Barriers that impair care engagement and ART access
reports.1 Literature searches were conducted by a panel member and adherence should be identified and addressed using evidence-
(C.d.R.) in PubMed and Embase for the period January 2020 to informed methods (evidence rating: AIIa). These include individual-
October 2022, and the panel monitored for new evidence thereaf- level interventions such as case management and patient/peer navi-
ter. The 7891 unique citations were reviewed by a member (M.S.S.) gation to initiate linkage to care and social services; transportation
who identified 834 possibly relevant publications. The substance use and accompaniment to visits; appointment reminders; and psycho-
disorder team identified and reviewed additional evidence to de- social support.9 Evidence-based structural interventions include
velop this newly added section. Abstracts presented at scientific con- “data to care” (using data systems to identify people who are out of
ferences between July 2020 and October 2022 were identified by care, to provide services), mobile clinics, telehealth, street medi-
panel members and teams. Additional relevant scientific publica- cine, use of visiting nurses, expanded clinic hours, pharmacy delivery,
E2 JAMA Published online December 1, 2022 (Reprinted) jama.com

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults Special Communication Clinical Review & Education
Table 1. Strength of Recommendation and Quality of Evidence

Rating Scalea Box 1. Key Recommendations for When to Start
Antiretroviral Therapy (ART)
Category, rating Definition
Strength of recommendation • Initiation of ART is recommended as soon as possible after
diagnosis, ideally within 7 days, including on the same day as
A Strong panel support for the recommendation
diagnosis or at the first clinic visit if the patient is ready and there
B Moderate panel support for the recommendation is no suspicion for a concurrent opportunistic infection
C Limited or weak panel support for the recommendation (evidence rating: AIII)
Quality of evidence • Structural barriers that could delay receipt of ART (including
Ia Evidence from 1 or more randomized clinical trials same-day), and impede care engagement, continuous ART
published in the peer-reviewed literature access, and ART adherence should be identified and addressed
Ib Evidence from 1 or more randomized clinical trials using evidence-informed strategies (evidence rating: AIIa)
presented in abstract form at peer-reviewed scientific • Initiation of ART at the time of diagnosis of acute HIV infection is
meetings recommended (evidence rating: AIIa)
IIa Evidence from nonrandomized clinical trials or cohort or • Initiation of ART is recommended within 2 weeks of initiation of
case-control studies published in the peer-reviewed
literature treatment for most opportunistic infections
IIb Evidence from nonrandomized clinical trials or cohort or • For persons with active tuberculosis without evidence of
case-control studies presented in abstract form at tuberculous meningitis, ART should be initiated within 2
peer-reviewed scientific meetings weeks after initiation of tuberculosis treatment,
III Recommendation based on the panel’s analysis of the especially for those with CD4 cell count less than 50/μL
accumulated available evidence
(evidence rating: AIa)
a
Adapted in part from Canadian Task Force on Periodic Health Examination.2 • For those with tuberculous meningitis, high-dose steroids
should be initiated along with tuberculosis treatment and ART
should be initiated within 2 weeks after starting tuberculosis
treatment and steroids (evidence rating: BIa)
use of community health workers, and use of strategies to elimi- • For individuals with cryptococcal meningitis with access to
nate health care–related stigma and discrimination.10 close monitoring and supportive care for adverse events,
The panel recommends initiating ART at the time of diagnosis ART should be initiated 2 to 4 weeks after starting
for persons with acute HIV infection (evidence rating: AIIa). Imme- antifungal therapy (evidence rating: BIIb); ART-naive
diate ART initiation leads to rapid viral suppression, thus decreas- individuals who have asymptomatic cryptococcal antigenemia
ing the risk of transmission to others, and preserves immune and a negative lumbar puncture result with no evidence of
cryptococcal meningitis should start ART immediately
responses.4,11,12 Additionally, early ART initiation is associated with
(evidence rating: BIII)
a lower viral reservoir.13 People with HIV who have low or undetect- • Initiation of ART is recommended immediately in the setting
able HIV RNA levels without taking ART (“elite controllers”) have el- of a new diagnosis of cancer with attention to drug-drug
evated levels of inflammation that are reduced after ART is interactions (evidence rating: BIIa)
initiated.14,15 In addition, even those who manifest low viral loads ini-
tially often do not maintain control over time.16 Based on the theo-
retical benefits of reducing inflammation in people with HIV, treat- DTG/3TC is the only 2-drug regimen currently recommended for
ing elite controllers is reasonable. initial therapy, but it should only be used when HIV RNA level is less
than 500 000 copies/mL and neither hepatitis B coinfection nor la-
mivudine resistance is present (evidence rating: AIa). Accordingly,
DTG/3TC should not be used for rapid ART initiation when these labo-
Initial ART Regimens for Individuals With HIV
ratory results are not yet available. Long-acting cabotegravir with
Recommended initial ART regimens for individuals with HIV are re- rilpivirine is not recommended for initial ART, although its use has
ported in Box 2. Regimens containing the InSTIs bictegravir (BIC) or been explored in a small demonstration project (see Switches to
dolutegravir (DTG) are recommended as initial treatment for most Long-acting Cabotegravir and Rilpivirine section below).19
individuals owing to their high efficacy, tolerability, safety, and high Although InSTIs and tenofovir alafenamide have been impli-
barrier to resistance; low pill burden; and low potential for drug- cated in weight gain for some individuals and preliminary data raise
drug interactions (evidence rating: AIa). InSTI-based regimens also concern about metabolic adverse effects with InSTIs, such con-
result in faster viral suppression than regimens containing a prote- cerns do not override the potential benefit of these drugs. Clini-
ase inhibitor (PI) (eg, boosted darunavir ) or nonnucleoside reverse cians should provide resources and counsel patients regarding life-
transcriptase inhibitor (NNRTI).17 style changes that may ameliorate weight gain and other metabolic
Tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate concerns (evidence rating: AIII) (see Weight Gain and Metabolic Com-
(TDF) (herein TXF)/emtricitabine (FTC) or lamivudine (3TC) (herein plications With ART section below).
XTC) are recommended as nucleoside reverse transcriptase inhibi-
tor (nRTI) components of initial ART regimens (when DTG/3TC is not Initiation of ART in the Setting of PrEP Failure
used) (evidence rating: AIa). Abacavir is no longer recommended as InSTI resistance has been observed in people who acquire HIV in the
initial therapy in most people with HIV owing to concerns about its setting of cabotegravir PrEP.20,21 A pharmacokinetic study pre-
association with cardiovascular disease,1,18 the risk of abacavir hy- dicted that concentrations of cabotegravir may persist for up to 2.5
persensitivity, the burden of HLA B*5701 testing, and no substan- or 4 years in some persons assigned male or female at birth,
tial advantage over DTG/3TC alone. respectively.22 If HIV is acquired in the setting of prior cabotegravir
jama.com (Reprinted) JAMA Published online December 1, 2022 E3

Box 2. Recommended Initial Antiretroviral Therapy (ART) Regimens
Recommended for Most People With HIV • Cabotegravir

• The following are recommended (in alphabetical order) for most • DTG/3TC
people with HIV: • DTG/RPV
• BIC/TAF/FTC (evidence rating: AIa) If patient is already taking, and stable while taking, bictegravir- or
• Dolutegravir plus TXF/XTC (evidence rating: AIa) doravirine-containing regimens or the 2-drug regimens DTG/3TC
• DTG/3TC (only if HIV RNA <500 000 copies/mL and HBV or DTG/RPV and wishes to continue, counsel patient about
coinfection not present). This regimen should not be used for uncertainties regarding safety during pregnancy and monitor HIV
rapid initiation when genotype, HIV RNA, and HBV serology RNA more frequently
results are not yet available (evidence rating: AIa)
Should Not Be Used During Pregnancy Because of
• Persons who acquired HIV while receiving preexposure prophylaxis
Inadequate Drug Levels
with tenofovir alafenamide or tenofovir disoproxil fumarate with
• Cobicistat-containing regimens (evidence rating: AIIb)
emtricitabine should have a blood sample for genotyping drawn
prior to initiating therapy and a 3-drug regimen, preferably Recommended During Tuberculosis Treatment
dolutegravir or bictegravir plus TXF/XTC, should be initiated (in Alphabetical Order by Anchor Drug)
if ART is to be started before genotype results are available • TXF/XTC is recommended with 1 of the followinga:
(evidence rating: AIII) • Dolutegravir (50 mg twice daily) (evidence rating: BIa)
• Persons who acquired HIV after exposure to cabotegravir for • Efavirenz (600 mg) (evidence rating: AIa)
preexposure prophylaxis should have a blood sample for InSTI • Raltegravir (800 mg twice daily) (evidence rating: BIa)
genotyping drawn prior to beginning therapy with an InSTI-based • A ritonavir-boosted PI regimen with TXF/XTC may be used only
regimen (evidence rating: AIII) if it is not possible to use any of the above regimens. In that
• If therapy is desired before genotype results are available or if case, rifabutin (150 mg) should be substituted for rifampin
InSTI-resistance is present, a boosted PI regimen containing (evidence rating: BIII)
darunavir and TXF/XTC should be used (evidence rating: AIII) • Bictegravir, darunavir boosted with ritonavir or cobicistat,
doravirine, EVG/COBI, long-acting cabotegravir plus rilpivirine,
Recommended During Pregnancy
etravirine, and rilpivirine are not recommended with rifampin
• TAF/XTC plus dolutegravir (evidence rating: AIa), withTDF/XTC
because of drug-drug interactions (evidence rating: AIIa)
plus dolutegravir a suitable alternative if tenofovir alafenamide is
• DTG/3TC is not recommended with rifampin because of drug-drug
not available (evidence rating: AIa)
interactions and inadequate data (evidence rating: BIII)
• The following drugs may be used if dolutegravir is not an option:
• Raltegravir (400 mg twice daily) (evidence rating: AIIa) Abbreviations: BIC, bictegravir; COBI, cobicistat; DTG, dolutegravir;
• Atazanavir plus ritonavir (evidence rating: BIIa) EVG, elvitegravir; FTC, emtricitabine; HBV, hepatitis B virus; InSTI, integrase
• Darunavir plus ritonavir (evidence rating: BIIa) strand transfer inhibitor; PI, protease inhibitor; RPV, rilpivirine; TAF, tenofovir
• Rilpivirine (evidence rating: BIIa) alafenamide; TDF, tenofovir disoproxil fumarate; 3TC, lamivudine;
TXF, tenofovir alafenamide or tenofovir disoproxil fumarate; XTC, emtricitabine
Not Recommended to Initiate During Pregnancy Because of or lamivudine.
Inadequate Data to Support Use (Evidence Rating: AIII for All) a
There is a pharmacokinetic interaction between rifampin and tenofovir
• Bictegravir
alafenamide; clinical data with coadministration are limited.
• Doravirine
PrEP, the results of an InSTI genotype test should be available be- to low drug levels that can impair efficacy (evidence rating: AIIb).
fore starting an InSTI-based regimen (evidence rating: AIII). If ART At present, there are insufficient data to recommend initiation with
is to be started before resistance testing results are available, or such bictegravir, doravirine, cabotegravir, and DTG/3TC during preg-
testing is not available (owing to resource constraints or inability to nancy (evidence rating: AIII). Although bictegravir, doravirine,
amplify with a low viral load), a boosted darunavir regimen with DTG/3TC, or DTG/RPV should not be initiated during pregnancy,
TXF/XTC should be started (evidence rating: AIII). if patients are already stable with these regimens and choose to
In persons diagnosed with HIV while receiving TXF-based PrEP, continue after being informed about the insufficient data, they
resistance testing should be performed but initiation of ART need should be followed up with more frequent HIV RNA monitoring
not be delayed while awaiting genotype results. A 3-drug regimen, (evidence rating: CIII).23
preferably dolutegravir or bictegravir with TXF/XTC, is recom- Although preliminary data from the Tsepamo study initially
mended until genotype results are available (evidence rating: AIII); suggested an association between neural tube defects and dolute-
in the rare but most extreme case of TXF/XTC-induced resistance gravir exposure at the time of conception, updated results now
associated with K65R and M184V mutations, TXF/XTC plus dolute- show no statistically significant difference in the incidence of
gravir or bictegravir would still be expected to be active. neural tube defects between regimens with and without dolute-
gravir when taken at the time of conception. 24 Dolutegravir,
ART and Pregnancy therefore, is a recommended agent for most people with HIV,
All persons with HIV who are pregnant should be receiving ART for including during pregnancy. The IMPAACT 2010 trial found dolute-
their own health and to prevent transmission of HIV to the fetus.1 gravir regimens to be virologically superior to efavirenz (EFV)/
Those diagnosed with HIV during pregnancy should begin ART TDF/FTC and demonstrated that dolutegravir plus TAF/FTC was
immediately with a recommended 3-drug regimen (evidence rat- associated with lower rates of adverse events and improved infant
ing: AIa). Cobicistat should not be used during pregnancy owing outcomes. Therefore, the recommended regimen for pregnancy is

TAF/XTC plus dolutegravir (evidence rating: AIa), with TDF/XTC Table 2. Other Recommended Initial Antiretroviral Therapy (ART)
plus dolutegravir a suitable alternative if tenofovir alafenamide is Regimens
not available (evidence rating: AIa). In the same study, efavirenz
Regimena,b Potential uses and cautions
was associated with higher levels of infant growth stunting than
DRV/COBI/TAF/FTCc Preferred for patients with prior cabotegravir PrEP
dolutegravir.25,26 An analysis from the Pediatric HIV/AIDS Cohort exposure when an InSTI genotype is not available
and the Swiss Mother and Child HIV Cohort also supports the use Darunavir plus cobicistat Potential use for known or suspected pretherapy
of dolutegravir in pregnancy, finding that rates of viral suppression or ritonavir plus multidrug resistance or InSTI resistance or in
TXF/XTC people with HIV at high risk of poor adherence
with ritonavir-boosted atazanavir or raltegravir were lower than DOR/TDF/3TCc May be useful in people with HIV who have
with dolutegravir.27 or doravirine plus intolerance to InSTIs
TXF/XTC
EFV (600 or Potential use for treatment of HIV/tuberculosis
Initiating ART in the Setting of Active Opportunistic 400 mg)/TDF/FTC coinfection; pregnancy or pregnancy intention
Infections and Cancer or 3TCc
For persons with a concurrent opportunistic infection, initiation Raltegravir plus Potential use for treatment of HIV/tuberculosis;
TXF/XTC pregnancy or pregnancy intention; when there is
of ART within 2 weeks of initiation of treatment for the opportu- high risk of drug-drug interactions
nistic infection is recommended, except where evidence supports RPV/TAF/FTCc Small pill size; use only if pretreatment HIV RNA
level is <100 000 copies/mL and CD4 cell count is
delaying ART because of increased risk of morbidity or mortality >200/μL
from immune reconstitution inflammatory syndrome. With the Rilpivirine plus Use only if pretreatment HIV RNA level is <100 000
availability of InSTIs and the use of adjunctive corticosteroid TDF/3TCd copies/mL and CD4 cell count is >200/μL
therapy, earlier recommendations for delaying Mycobacterium Abbreviations: COBI, cobicistat; DOR, doravirine; DRV, darunavir;
tuberculosis treatment have been reconsidered. For persons with EFV, efavirenz; FTC, emtricitabine; InSTI, integrase strand transfer inhibitor;
PrEP, preexposure prohylaxis; RPV, rilpivirine; TAF, tenofovir alafenamide;
active tuberculosis, ART should be initiated within 2 weeks after
TDF, tenofovir disoproxil fumarate; 3TC, lamivudine; TXF, tenofovir alafenamide
starting treatment for tuberculosis, particularly if the CD4 cell or tenofovir disoproxil fumarate; XTC, emtricitabine or lamivudine.
count is less than 50/μL (evidence rating: AIa). For those with a
The recommended initial ART regimens are reported in Box 2.
tuberculous meningitis, high-dose steroids along with tuberculo- b
Regimens are listed in alphabetical order. Drug components separated with
sis treatment is recommended, with ART initiation within 2 weeks a virgule (/) indicate that these are available as coformulations.
thereafter (evidence rating: BIa).28 c
Available as a single-tablet coformulation.
For persons with cryptococcal meningitis and with access to d
Available in generic formulations in many countries.
close monitoring and supportive care for adverse events, ART
should be initiated 2 to 4 weeks after starting antifungal therapy
(evidence rating: BIIb). The data supporting a delay in ART initia-
tion for persons with cryptococcal meningitis were largely gener- Other Recommended Regimens
ated in resource-constrained settings where access to close moni- Other recommended regimens appear in Table 2. Although InSTI-
toring and supportive care may not be as readily available and in based regimens are recommended for most persons, there
persons who were not being treated with InSTI-based ART. are special circumstances in which other regimens may be consid-
A cohort study that did not show an increase in adverse outcomes ered as initial ART. A boosted darunavir regimen may be used
with earlier initiation of ART29 coupled with the availability of ART when InSTI or multidrug resistance is a consideration, including
regimens with lower rates of adverse effects and drug interac- when there has been prior exposure to cabotegravir as PrEP
tions support earlier ART initiation. ART-naive individuals who (evidence rating: AIIb).
have asymptomatic cryptococcal antigenemia and a negative
lumbar puncture result should start ART immediately30 (evidence
rating: BIII), as should patients with cancer and untreated HIV
When and How to Switch ART Regimens
(evidence rating: BIIa).
Drug-drug interactions must be considered for all patients, Regimen switches can be broadly categorized into those for pa-
but particularly for those with a diagnosis of HIV and tuberculosis. tients with and for patients without viral suppression. Both indica-
The only regimens that may be safely used with rifampin include tions for switching treatment require careful review of a patient’s
dolutegravir (50 mg twice daily31) (evidence rating: BIa), efavirenz ART regimen history, medication tolerability, concomitant medica-
(600 mg once daily) (evidence rating: AIa), or raltegravir (800 mg tions, food requirements, reproductive plans, potential issues with
twice daily) (evidence rating: BIa) (but not raltegravir [400 mg twice insurance and coverage, and results from all prior resistance test-
daily32] [evidence rating: AIa]), each given with TXF/XTC.31-33 ing before switching (evidence rating: AIII).
(There is a pharmacokinetic interaction between rifampin and Regimen changes should also prompt more frequent clinical
tenofovir alafenamide; clinical data with coadministration are lim- and laboratory follow-up until it is established that the regimen
ited.) There are inadequate data to support use of DTG/3TC in this is well tolerated, not associated with toxicity, and is effective
setting (evidence rating: BIII). Poorer adherence with twice-daily (evidence rating: AIII), with the first assessment of HIV RNA and
raltegravir contributed to increased virologic failure in 1 study, un- safety laboratory assays at approximately 1 month after changing
derscoring the need for adherence support when twice-daily regi- therapy. For patients who switched owing to virologic failure, the
mens are used.34 If none of these regimens can be used, ritonavir- viral load test should be repeated monthly until suppression to
boosted atazanavir or lopinavir with TXF/XTC may be used with undetectable is documented and then every 6 months thereafter
rifabutin (150 mg daily). (evidence rating: AIa).

Switching in the Setting of Viral Suppression avoid drug interactions or to maximize treatment simplicity to
Persons with suppressed virus and no history of transmitted or ac- enhance adherence.
quired HIV drug resistance can generally switch therapy to any of
the recommended initial regimens and maintain viral suppression. Switches to Long-acting Cabotegravir and Rilpivirine
Recently, there has been increased interest in 2-drug strategies as a In persons with no history of treatment failure and no known or sus-
way of reducing drug exposure. Most data supporting this strategy pected resistance to either drug, injectable cabotegravir and rilpi-
come from prospective randomized trials of persons with no his- virine, given either every 1 or 2 months, was noninferior to contin-
tory of treatment failure switching to DTG/3TC35,36 or DTG/RPV.37 ued oral ART.48,49 Those interested in non-oral options for ART
These studies demonstrated ongoing viral suppression compa- because of privacy, stigma, or convenience reasons will usually have
rable to continued 3-drug treatment, without evidence of loss of vi- greater satisfaction with cabotegravir and rilpivirine than contin-
rologic control.38 In addition, InSTI resistance was not observed in ued oral ART.50 One recent report described use of this regimen in
these studies, although NNRTI resistance occurred in 1% of partici- 15 people with viremia not receiving oral ART.19 Despite the short-
pants receiving DTG/RPV. Furthermore, retrospective studies of term success of this approach in this study, cabotegravir plus rilpi-
baseline samples in the trials of DTG/3TC showed no adverse effect virine is not recommended in the setting of viremia outside of a re-
from archived resistance mutations, including M184V.39,40 Thus, un- search setting and should be started only after viral suppression has
less there is documented or suspected history of treatment failure, been achieved with oral ART.
proviral resistance testing is not required prior to switching to 2-drug Cabotegravir plus rilpivirine injections can be started after an
therapy, even if there is no available pretreatment resistance test re- oral lead-in to ensure tolerability or, alternatively, without an oral
sult (evidence rating: BII). cabotegravir plus rilpivirine lead-in based on patient preference.51
An important limitation of both 2-drug regimens is that they pro- Since the regimen is administered by clinic staff, cabotegravir plus
vide insufficient treatment for people with concomitant chronic rilpivirine requires more clinical resources than oral ART. Staff must
hepatitis B who should, therefore, continue 3-drug regimens that be trained in proper administration techniques; in addition, the pre-
include TXF/XTC. Furthermore, all people with HIV who lack immu- scribing clinician will need to ensure that pharmacy, insurance, and
nity to hepatitis B should undergo immunization. Recent data show scheduling logistics are in place prior to offering this therapy. More-
that hepatitis B CpG oligodeoxynucleotide vaccine (which is being over, patients need to travel to and from sites of administration,
investigated and compared with other vaccines in an ongoing clini- which may pose a barrier for some individuals.
cal trial) is highly immunogenic in people with HIV who have high Even among patients who receive all of the scheduled injec-
CD4 cell counts and suppressed virus while receiving ART.41 Docu- tions in a timely fashion, there is a risk of treatment failure with
menting a seropositive response to the vaccine is recommended emergent resistance, including both InSTI and NNRTI mutations
prior to switching from a TXF-based 3-drug regimen to a 2-drug regi- in some. Although this risk is small (approximately 1%-2% in
men that does not include TXF. clinical trials), it is higher than for continued oral ART with
Recent clinical trials in persons with viral suppression have dolutegravir- or bictegravir-based regimens, and patients should
demonstrated the safety of switching to dolutegravir plus 2 nRTIs be informed of this risk prior to switching to long-acting injectable
or BIC/FTC/TAF, even in the setting of likely or proven nRTI resis- ART. The risk appears to be higher when giving cabotegravir plus
tance. In the 2SD study conducted in Kenya, participants receiving rilpivirine every 8 weeks than every 4 weeks. Treatment options
second-line regimens consisting of a boosted PI plus nRTIs were for those who experience treatment failure with long-acting cabo-
randomly assigned to continue their current treatment or switch to tegravir plus rilpivirine and develop resistance will be limited,
dolutegravir plus 2 nRTIs.42 At 48 weeks, dolutegravir plus 2 nRTIs because neither NNRTI-based nor InSTI-based regimens are opti-
was noninferior to the continued therapy. Although no prior resis- mal choices.
tance assessments were performed in that trial, other studies of If scheduled doses of cabotegravir plus rilpivirine are missed,
second-line boosted PI regimens in Africa have shown extensive resumption of therapy should follow redosing guidance as out-
nRTI resistance, including high rates of M184V and K65R muta- lined in the product prescribing information. For patients who have
tions, and such resistance would be expected in the population maintained viral suppression, switching from long-acting inject-
enrolled in the 2SD trial. able cabotegravir plus rilpivirine back to daily oral therapy can be
Similar results have been seen with switches to BIC/FTC/TAF done without the need for proviral DNA resistance testing (evi-
in people with resistant virus.43,44 Preexisting M184V/I mutations dence rating: BIII).
had no effect on efficacy in this setting.45 In addition, prospective
studies of people with treatment failure show high rates of viral Switching for Virologic Failure
suppression with dolutegravir plus 2 nRTIs,46,47 implying that this Virologic failure (defined as HIV RNA level >200 copies/mL) should
regimen would maintain suppression regardless of nRTI resis- be confirmed by repeating a viral load measurement as soon as pos-
tance. By contrast, switches to first-generation InSTIs (raltegravir sible. If virologic failure is confirmed, genotype resistance testing
or elvitegravir) or NNRTIs from high resistance–barrier regimens should be performed, preferably while patients are taking the fail-
containing a boosted PI are not recommended (evidence rating: ing therapy. Resistance testing is still recommended even if a regi-
AIa). The use of dolutegravir plus TXF/XTC or BIC/FTC/TAF in men has been discontinued or a person acknowledges poor medi-
patients with current viral suppression and a documented history cation adherence (evidence rating: AIII).
of M184V and K65R mutations is supported by the existing data Proviral DNA resistance testing can identify resistance even if
from switch and failure studies. Situations where such regimens HIV RNA level is less than 500 copies/mL (including undetectable
might be chosen include limited other treatment options, to levels), but results of such testing do not correlate reliably with

Table 3. Recommendations for Laboratory Monitoring for Persons With HIV
Description of monitoring At HIV diagnosis and start of ART During ART At virologic failure
HIV RNA level Yes (evidence rating: AIII) Every 3 mo until suppressed and then every 6 Yes (evidence rating: AIa)
mo (evidence rating: AIa)
CD4 cell count Yes (evidence rating: AIII) Every 6 mo until >250 cells/uL for 1 y, then Yes (evidence rating: AIII)
stop provided viral suppression is maintained
HIV RT-pro genotype test Yes (evidence rating: AIII) If switching to injectable ART when patient has Yes (evidence rating: AIa)
viral suppression, proviral RT-pro genotype
can be collected for those who do not have
a documented pre-ART RT-pro genotype
HIV integrase genotype test If a patient’s partner is known to have a If failing ART regimen included an
failing ART regimen that includes an InSTI InSTI (evidence rating: AIII)
or individual has received cabotegravir for
PrEP (evidence rating: BIII)
Viral tropism test Before start of maraviroc
HLA B*5701 test Before start of abacavir
Cryptococcal antigen test if Yes (evidence rating: AIa)
CD4 cell count <100 cells/μL
Safety laboratory and Yes (evidence rating: AIa) Yes (evidence rating: AIII) Yes (evidence rating: AIII)
coinfection screening
(eg, STIs, viral hepatitis)
Abbreviations: ART, antiretroviral therapy; InSTI, integrase strand transfer inhibitor; PrEP, preexposure prophylaxis; RT-pro, reverse transcriptase–protease;
STI, sexually transmitted infection.
standard genotypes and may miss important mutations, so results gest that this subtype has naturally occurring resistance to
should be interpreted with caution.52 fostemsavir),54 lenacapavir (currently approved in the European
The most common reason for virologic failure is poor medica- Union and under US Food and Drug Administration [FDA] review),
tion adherence. Additional potential causes such as food effects, maraviroc (if the patient’s virus is documented to be R5 tropic
drug interactions, and pharmacy dispensing errors should be inves- when tested), ibalizumab, or enfuvirtide. Recycling of nRTIs with
tigated. If no resistance mutations are found, clinicians should offer partial antiretroviral activity may also be warranted.
tools to improve adherence and regimen change to improve sim- If there is both high-level InSTI resistance and decreased PI
plicity or tolerability, if indicated. Based on the results of prospec- susceptibility, then a multidrug regimen with at least 2 fully active
tive clinical trials, dolutegravir plus 2 nRTIs (with at least 1 active agents from these novel drug classes should be used, along with
nRTI as determined by genotypic testing) is recommended after recycled nRTIs because of their ongoing partial antiviral activity
treatment failure with an NNRTI plus 2 nRTIs (evidence rating: (evidence rating: AIII).
AIa).1 Although not studied in virologic failure, BIC/FTC/TAF should
have similar activity to dolutegravir plus TXF/XTC. If no active nRTIs
are present after virologic failure and a boosted PI and an InSTI
Laboratory Monitoring in Individuals With
remain fully active, then treatment choices include boosted
darunavir plus TXF/XTC (evidence rating: AIa) or dolutegravir plus a Established HIV at HIV Diagnosis and Starting ART
boosted PI with or without additional agent(s) (evidence rating: Recommendations are summarized in Table 3. Recommended
BIII). Dolutegravir plus TXF/XTC (evidence rating: AIa) is an alterna- laboratory monitoring before ART is started (evidence rating: AIII)
tive option to avoid drug interactions and maximize treatment sim- should characterize (1) HIV stage (HIV RNA level, CD4 cell count),
plicity, although this regimen has an approximate 4% risk of emer- (2) general health (kidney and liver function, lipid levels, complete
gence of dolutegravir resistance.47 blood cell count, glucose level, and pregnancy), (3) ART resistance
Management of InSTI resistance can be difficult. Owing to the (reverse transcriptase–protease [RT-pro] genotype), and (4) pres-
rarity of such resistance, the common presence of extensive resis- ence of coinfections (viral hepatitis A, B, and C; tuberculosis; and
tance to other drug classes, and relative paucity of prospective stud- sexually transmitted infections [STIs]). Unless there is a history of
ies evaluating treatment outcomes in this population, guidance from preexisting kidney or liver injury or a high likelihood of transmitted
an expert in HIV drug resistance is recommended for selection of an drug resistance, the results of these laboratory tests should not
optimal regimen (evidence rating: AIII). delay starting ART (evidence rating: BIII), but follow-up of these
If InSTI resistance is relatively limited (as commonly occurs results should occur quickly to maximize safety. Given the low
after treatment failure with raltegravir or elvitegravir) and a new prevalence of transmitted InSTI resistance,55 InSTI genotyping prior
ART regimen is to include an InSTI, dolutegravir should be adminis- to ART initiation is not recommended unless there is suspicion that
tered twice daily.53 This regimen should also include at least 1 and infection was transmitted from a partner with InSTI failure or if the
preferably 2 other fully active drugs, optimally from drug classes patient previously received PrEP with cabotegravir (evidence rat-
not previously used. These might include fostemsavir (except for ing: BIII).1,56 An assessment for latent tuberculosis (initially, after
treatment of HIV subtype CRF01_AE, because available data sug- immune reconstitution, and then if there is exposure) and, if the

tuberculosis, and viral hepatitis; cancer screening (including for cer-

Box 3. Weight Gain and Metabolic Complications While Receiving vical and anal cancer); general health maintenance assessments; vac-
Antiretroviral Therapy (ART) cinations; and evaluation for medication toxicity at each visit.65
• Documentation of weight and BMI at baseline and every 6
months is recommended for people with HIV initiating or At the Time of Virologic Failure and Before Starting
switching regimens to identify those with excessive weight gain New ART Regimen
(evidence rating: AIIa) If an HIV RNA level greater than 20 to 50 copies/mL is detected
• Counseling regarding possibility of weight gain and potential
during ART after previous viral suppression, then an early repeat
cardiometabolic complications is recommended for people with
HIV RNA level and assessment of medication adherence, drug-drug
HIV initiating or switching ART (evidence rating: AIII)
• Yearly diabetes screening and assessment of cardiovascular risk interactions, and tolerability is recommended (evidence rating:
score of patients receiving InSTI-based ART is recommended AIa).1 If HIV RNA level is greater than 200 copies/mL on 2 consecu-
(evidence rating: BIII) tive measurements, then HIV RT-pro genotype and InSTI genotype
• Lifestyle changes (exercise and diet) are recommended to (if the patient was receiving an InSTI) testing are recommended
support people with HIV who gain greater than 5% body weight (evidence rating: AIII).1 For patients with intermittent or persistent
(evidence rating: AIII)
low-level viremia between 50 and 200 copies/mL, assessments for
Abbreviations: BMI, body mass index; InSTI, integrase strand transfer ART adherence, tolerability, and toxic effects are recommended
inhibitor. (evidence rating: CI), but changing ART regimens is not recom-
mended unless ART toxicity or intolerability are identified
(evidence rating: AIII). Of note, a common cause of low-level vire-
CD4 cell count is less than 100 cells/μL, cryptococcal antigen test- mia in patients receiving an InSTI are interactions with multivalent
ing at presentation should be performed. cations (Ca2+, Fe3+, Mg2+, Al3+, Zn2+), such as those in mineral
supplements and antacids.1 Before starting maraviroc, testing for
During ART viral CCR5 tropism is recommended each time (unless X4 virus was
Within 6 weeks of starting ART, assessment of treatment adher- previously detected), in which case maraviroc should not be used
ence and tolerability is recommended, along with the measure- (evidence rating: AIa).
ment of HIV RNA level (evidence rating: BIII). Although suppres-
sion of HIV RNA levels to undetectable may occur faster with InSTI-
based regimens, it may take up to 24 weeks of continuous
therapy.57,58 If the HIV RNA level has not declined by 2 log10 cop-
Weight Gain and Metabolic Complications
ies/mL within 12 weeks of therapy and adherence appears to be suf- With ART
ficient, then a genotype based on the patient’s regimen is recom- Recommendations are summarized in Box 3. Weight gain is gener-
mended (evidence rating: AIII).1 ally observed within the first year following initiation of most ART
If the patient remains virally suppressed, clinically stable, and regimens, but treatment with InSTI- and tenofovir alafenamide–
adherent to medications, then HIV RNA levels should be moni- based regimens is associated with greater weight gain than regi-
tored every 3 months until virally suppressed for at least 1 year. Af- mens containing tenofovir disoproxil fumarate, efavirenz, or a
terward, the frequency of viral monitoring can be changed to every boosted PI. Weight gain can occur with (1) initiation of InSTI- or
6 months (evidence rating: AIII). tenofovir alafenamide–containing ART in previously ART-naive
Before starting an injectable ART regimen for a patient with vi- individuals 66 ; (2) switch to InSTI- or tenofovir alafenamide–
ral suppression, proviral RT-pro genotype should be collected for containing ART in individuals with viral suppression67; or (3) initia-
those who do not have a documented pre-ART RT-pro genotype tion of tenofovir alafenamide or InSTI for PrEP.68 This weight gain
(evidence rating: BIII). Of note, NNRTI resistance may not always be with ART is more likely to occur in women and Black and Hispanic
detected by a proviral genotype, and proviral genotyping has not yet individuals and appears to occur mostly within the first year of ART
been validated as a method to decide whether it is safe to switch to initiation69 or switch.70 In the ADVANCE trial, most of the weight
injectable cabotegravir plus rilpivirine. If a patient has rilpivirine- gain in dolutegravir groups was fat gain in trunk and limbs, and it
associated mutations on genotypic testing or a history of virologic was higher with concomitant tenofovir alafenamide use.71
failure while receiving an NNRTI, injectable cabotegravir plus rilpi- Exposure to efavirenz or tenofovir disoproxil fumarate for ART
virine should be avoided (evidence rating: BIa).48,59 or PrEP is associated with weight suppression, compared with
Once viral suppression occurs with ART, CD4 cell counts should other antiretroviral drugs or no ART exposure.72 This might compli-
be measured every 6 months until they are greater than 250 cells/μL cate assessment of weight gain after switching from tenofovir diso-
for at least 1 year (evidence rating: AIII).1 Afterward, CD4 cell counts proxil fumarate to tenofovir alafenamide or after changing efavi-
do not need to be measured unless ART failure is identified or the renz to an InSTI.
patient experiences an immunosuppressive condition (evidence rat- Weight gain while receiving an InSTI is likely mediated by adi-
ing: AIII). Patients receiving tenofovir disoproxil fumarate should also pocyte dysfunction, inducing adipogenesis, lipogenesis, oxidative
have urinary glucose and protein monitoring when starting tenofo- stress, fibrosis, and insulin resistance.73,74 CYP2B6 genotypes
vir disoproxil fumarate and at least every year thereafter (evidence have been associated with greater weight gain after switch from
rating: BIII).60-64 efavirenz to InSTI-based ART. 75 Mechanism(s) of tenofovir
Patients should have regular age- and risk-appropriate screen- alafenamide–associated weight gain remain incompletely eluci-
ing for coinfections such as STIs (at all exposed mucosal sites), dated. A switch from tenofovir disoproxil fumarate to tenofovir

alafenamide is associated with increases in lipid levels and cardio-

vascular risk score, perhaps because tenofovir disoproxil fuma- Box 4. Recommendations for Older People With HIV
rate lowers lipid levels.76 • Screening for HIV is recommended in older individuals to prevent
Although decreased in the general population, the risk of car- late diagnosis with advanced disease (evidence rating: AIIa)
diovascular disease has not declined among people with HIV.77 • Initiation of ART is recommended as soon as possible after
In addition to traditional risk factors and the chronic inflammation diagnosis, either the same day of diagnosis, first clinic visit,
associated with HIV itself, some ART regimens may contribute to or within 7 days. Assessment of comorbidities, kidney
function, and medications will influence the choice of ART
this risk, but more research is needed. Recent cohort studies
suggest that InSTI-based ART may be associated with an
• Assessment of polypharmacy and simplification of complex
increased risk of incident cardiovascular disease, new-onset dia- regimens, both ART and comorbidity treatments, is
betes, hyperglycemia,78-80 elevated blood pressure,80 and de recommended to improve adherence, prevent adverse
novo hepatic steatosis. These cardiometabolic effects were not drug-drug interactions, reduce falls risk, and reduce costs
observed in other studies, and it remains unclear whether they (evidence rating: AIIb)
are transient or sustained or whether InSTI exposure is causative. • Screening for comorbidities, impaired cognitive and function,
poor mobility, frailty, and falls risk is recommended for older
The retrospective nature and lack of availability of weight mea-
people with HIV, using validated tools. The frequency of
surements in most data make it difficult to ascertain whether this assessment is determined by the baseline assessment
risk (if confirmed) is a direct InSTI toxic effect or the result of (evidence rating: BIII)1
InSTI-related weight gain. In one study, the InSTI-diabetes asso- • Consideration of integrated care models and Antiretroviral
ciation was attenuated when accounting for 12-month weight Stewardship models is recommended to improve outcomes and
change. 81 Nonetheless, data suggest that diabetes risk with quality of life for people aging with HIV (evidence rating: BIII)
weight gain at ART initiation is significant.82 Further research Abbreviation: ART, antiretroviral therapy.
is needed to evaluate the role of appetite, caloric intake, and
energy expenditure in InSTI- and tenofovir alafenamide–related
weight gain.
Whether weight gain is reversible with switch to non-InSTI or cally relevant pharmacokinetic changes and potential increased tox-
non–tenofovir alafenamide regimens is unclear and under investi- icity associated with aging require dose adjustment in older people
gation (ClinicalTrials.gov Identifier: NCT04636437). Data from the with HIV remains unclear and is currently not warranted (evidence
SALSA83 and TANGO39 studies suggest that switching off of teno- rating: AIII).90
fovir alafenamide does not lead to weight loss. Until there are data Polypharmacy occurs more frequently in older people with
proving benefit, switching regimens because of weight gain is not HIV and is associated with increased risk of adverse health out-
recommended (evidence rating: BIIa); instead, lifestyle modifica- comes such as falls, frailty, hospitalization and mortality, and
tions, like exercise and diet intervention, are recommended drug-drug interactions.91 Management of polypharmacy includes
(evidence rating: AIII). Semaglutide and other glucagon-like pep- (1) optimization of ART, including simplification of ART when pos-
tide 1 analogues that decrease weight in people without HIV are being sible (see When and How to Switch ART Regimens section), and
studied in people with HIV.84,85 (2) regular medication review with “pruning” of nonessential
medications.92,93 Antiretroviral stewardship programs effectively
reduce medication errors, dose antiretroviral drugs appropriately
for kidney and liver dysfunction, manage drug-drug interactions,
HIV and Aging and offer an opportunity to assess and deprescribe potentially
Recommendations for older people with established HIV are sum- inappropriate medication.94
marized in Box 4. Not only is the prevalence of HIV and diagnoses There is an ongoing growing burden of neurocognitive dys-
of new infections in people older than 50 years increasing, but more function and frailty in people aging with HIV, which results in
than half of older people with HIV are diagnosed at a late stage of decreased quality of life, greater health care utilization, and higher
disease (ie, CD4 cell count <350/μL).86,87 Delayed diagnosis is a lost mortality.95,96 Recommendations for screening and management
opportunity to initiate ART early for maximal health benefits and for of comorbidities in older people with HIV, assessment of functional
prevention of transmission. impairment and frailty, and evaluation of neurocognitive impair-
Early diagnosis and initiation of ART is particularly important in ment are unchanged since the previous report.1 Recent studies
older persons because they are more likely to have a blunted im- have shown that accumulation of comorbidities had greater nega-
mune response following ART initiation88 and have a higher risk of tive effect on neurocognitive performance than did HIV disease
serious non-AIDS complications. Choice of initial ART requires con- parameters.97,98 Intensification of ART with either dolutegravir or
sideration of the background risk and burden of non-AIDS comor- maraviroc did not improve cognitive impairment, despite lower
bidity, drug-drug interactions, and polypharmacy to manage mul- cerebrospinal fluid HIV viral loads in the intensified group. 99
timorbidity in older people with HIV (evidence rating: BIII). Aggressive management of comorbidities, rather than ART modifi-
Recommended initial ART includes InSTI-based regimens with cation, may be the most beneficial strategy for improving neuro-
TAF/FTC or DTG/3TC (see Initiation of ART section). Caution should cognitive function.
be exercised in the use of tenofovir disoproxil fumarate because of By the end of this decade, the proportion of people with HIV who
its associated kidney and bone toxicity.89 Studies of pharmacoki- will be older than 65 years is projected to be almost 25%.100 The ag-
netics of ART are limited in older people with HIV. Whether clini- ing of people with HIV has highlighted the need for integrated care

models, including multidisciplinary teams of geriatricians, HIV spe- likely required to reach maximal protection and is recommended
cialists, pharmacists, and allied health practitioners (such as physio- for at least 7 days after last risk activity.1 This daily regimen is also
therapists) offering holistic patient-centered care.101-103 recommended for people who are pregnant or breastfeeding
(evidence rating: AIIa).
On-demand (2-1-1) oral dosing is recommended for cisgender
men of any sexual orientation, but there are insufficient data to
Prevention of HIV Infection
support its use to prevent HIV acquisition via receptive vaginal
Recommendations for HIV prevention are summarized in Table 4. sex (including neovaginal sex) or injection drug use. TDF/FTC 2-1-1
Tools to prevent the acquisition of HIV infection are highly effec- dosing is initiated with a double dose 2 to 24 hours before
tive and continue to increase in breadth. Strategies to test, iden- planned sexual activity and single additional doses 24 and 48
tify, link to care, and quickly treat and virally suppress individuals hours subsequent to the first dose; if additional sexual activity
with HIV are crucial to prevention efforts (evidence rating: AIa); occurs within 7 days of the initial planned activity, daily single
such efforts have health benefit for the individual and eliminate dosing should be continued until 2 doses after the last planned
sexual transmission of HIV. Use of condoms continues to be rec- activity. The 2-1-1 regimen should be used with caution in trans-
ommended as the cornerstone of STI prevention efforts for all gender women receiving gender-affirming hormone therapy, par-
penetrative sex acts (evidence rating: AIIa). Medical circumcision ticularly with first use, or reinitiation of TDF/FTC after prolonged
for heterosexual males and harm reduction interventions (includ- hiatus, because rectal tissue concentrations may be somewhat
ing but not limited to medication treatment for opioid use disor- lower early after starting 2-1-1 regimens and may have reduced
der and syringe access) are effective prevention strategies for efficacy.106,107
applicable populations. Daily oral TAF/FTC is preferred over TDF/FTC for individuals
PrEP should be discussed with all sexually active adolescents with creatinine clearance between 30 and 60 mL/min or when
and adults and anyone who injects nonprescription drugs (eg, opi- there is known osteopenia or osteoporosis. (Bone density scans are
oids, methamphetamine) or who has a substance use disorder, with- not necessary before starting TDF/FTC.) Further, TAF/FTC use
out specific criteria for risk behaviors or screening tools (evidence should be limited to cisgender men of any sexual orientation and
rating: AIII).105 Populations with disproportionately high HIV inci- anyone whose risks do not include receptive vaginal sex (including
dence rates should be particularly encouraged to consider PrEP as neovaginal sex) or those whose risk is exclusively posed by injec-
part of their HIV prevention plans; these include cisgender men and tion drug use. Data on efficacy of TAF/FTC for preventing HIV
transgender individuals who have sex with men; young adults and acquisition through receptive vaginal sex are not available.
adolescents; people whose sexual partners are from regions of gen- Prescribing for all oral PrEP regimens (including the 2-1-1 regi-
eralized HIV epidemic; persons who use nonprescription drugs and men) should be for no more than 1 month initially and 3 months
alcohol; individuals who exchange sex for money, goods, or ser- thereafter to ensure appropriate HIV testing intervals. Tenofovir-
vices; partners of incarcerated individuals; and anyone with a re- based oral PrEP regimens have extremely low failure rates when
cent bacterial STI. Prescription of PrEP for adolescents should be taken as prescribed.
done with specific attention to their additional support and adher-
ence needs (evidence rating: AIa) and with care around potential dis- Same-Day or Rapid PrEP Start
closure of sexual behaviors and gender identity to parents or guard- Delaying PrEP is not recommended for individuals at risk. If HIV
ians (evidence rating: AIII). test results are available from samples drawn within 7 days of ini-
tiation or if the result of a rapid (point-of-care) HIV antibody test
Choosing the PrEP Regimen is negative, then PrEP should be initiated while awaiting the
The optimal PrEP regimen for a given person is the one most results of HIV, hepatitis B, and kidney function testing, as long as
acceptable to that person and congruent with their sexual behav- the patient is willing to take such an approach. Clinicians should
ior, ability to take medications reliably, likelihood of anticipating follow up on test results and make adjustments as needed. If a
sexual activity, and adverse effect profile. The choice of PrEP regi- high-risk encounter occurred within the past 72 hours, then a
men made initially may need to be reconsidered over time. For 3-drug postexposure prophylaxis (PEP) regimen is recommended
example, someone challenged by taking daily oral tablets is likely to (evidence rating: AIa) (see below), which can be changed to PrEP
have better prevention effectiveness from an injectable regimen; on PEP completion.
for someone who prefers to take an oral medication, that prefer-
ence should be respected. Injectable PrEP Regimen
Long-acting injectable cabotegravir was approved by the FDA for
Oral PrEP Regimens the prevention of sexual acquisition of HIV infection in December
Daily oral TDF/FTC (including generic tenofovir formulations) 2021 and is recommended for prevention of sexual transmission of
remains a recommended PrEP regimen for all populations at risk HIV across populations (evidence rating: AIa).20,108 There are insuf-
(evidence rating: AIa). For cisgender males, oral dosing should be ficient data to recommend its use for injection drug exposures, but
initiated with a double dose of TDF/FTC for the first day, followed if a person who injects drugs is also at risk for acquiring HIV through
by daily single tablets, and should not be discontinued until at sex, cabotegravir is a recommended option (evidence rating: AIII).
least 2 doses after last sexual activity1; this approach is antici- An oral lead-in of cabotegravir of approximately 1 month duration
pated to provide protection within 24 hours of initial dosing. should be limited to those with severe atopic histories or concerns,
For non–cisgender male populations, 7 days of daily dosing is because potential nonadherence to oral dosing may create a period

Table 4. Recommendations for Biomedical HIV Prevention by Population and Transmission Risk Behaviora
TDF/FTC (evidence rating)b

Daily oral TAF/FTC Intramuscular cabotegravir
Daily oral On-demand oral (evidence rating) (evidence rating)
Cisgender men/women
Insertive sex (vaginal/anal) Yes (AIa) Yes (BIa) Yes (AIa) Yes (AIa)
Receptive vaginal sex Yes (AIa) Insufficient data Insufficient data Yes (AIa)
Receptive anal sex Yes (AIa) Yes (AIa) Yes (AIa) Yes (AIa)
Injection drug use Yes (AIa) Insufficient data Insufficient data Insufficient data
(if sexual risk as well, apply
appropriate category above)c
Transgender women
Insertive sex (vaginal/anal) Yes (AIa) Yes (AIII/CIII)d Yes (AIa) Yes (AIa)
Receptive (neo) vaginal sex Yes (BIII) Insufficient data Insufficient data Yes (BIII)
Receptive anal sex Yes (AIa) Yes (AIII/CIII)d Yes (BIa) Yes (AIa)
Injection drug use Yes (AIa) Insufficient data Insufficient data Insufficient data
Transgender men
Receptive vaginal Yes (AIII) Insufficient data Insufficient data Yes (AIII)
(“front-hole”) sex
Receptive anal sex Yes (AIII) Yes (AIII) Yes (AIII) Yes (AIII)
Injection drug use Yes (AIII) Insufficient data Insufficient data Insufficient data
Prerequisites and safety considerations
Creatinine clearance, mL/min >60 >60 >30 No restrictions; caution with
end-stage kidney disease
not yet receiving dialysis
Drug-drug interactions NA NA NA Do not use with certain
anticonvulsants and
antimycobacterialse
Adjust dosing if using with
rifabutinf
Other Avoid use if individual has Avoid use if individual has Not applicable Use caution if gluteal fillers
known osteopenia or known osteopenia or or implants are present or if
osteoporosis osteoporosis; caution patient is using
during first use for anticoagulants or has
transgender woman who bleeding diathesis or
uses exogenous estrogens thrombocytopenia
or androgen blockers
Prescribing
Initial 30-d supply 30-d supply 30-d supply 30 d of oral (optional)
First and second injections
separated by 4 wk
Follow-up 90-d supply 90-d supply 90-d supply One injection every 8 wkg
Dosing TDF (300 mg)/FTC TDF (300 mg)/FTC TAF (25 mg)/FTC Oral: 30 mg
(200 mg) (200 mg) (200 mg)
Injection: 600 mg (3 mL)
Laboratory tests
Initiationh HIV Ag/Abi HIV Ag/Abi HIV Ag/Abi HIV Ag/Abi
HIV RNAj HIV RNAj HIV RNAj HIV RNAj
Creatinine Creatinine Creatinine HAV IgGk
HAV IgGk HAV IgGk HAV IgGk HBsAg
HBsAg HBsAg HBsAg HBsAb
HBsAb HBsAb HBsAb HCV IgG
HCV IgG HCV IgG HCV IgG Gonorrhea/chlamydia NAATl
Gonorrhea/chlamydia Gonorrhea/chlamydia Gonorrhea/chlamydia NAATl Syphilis test
NAATl NAATl Syphilis test Pregnancy testm
Syphilis test Syphilis test Pregnancy testm
Pregnancy testm Pregnancy testm
After 1 mo HIV Ag/Ab HIV Ag/Ab HIV Ag/Ab HIV Ag/Ab
HIV RNAj,n
Every 2 mo HIV Ag/Ab
HIV RNA
(continued)

Table 4. Recommendations for Biomedical HIV Prevention by Population and Transmission Risk Behaviora (continued)
TDF/FTC (evidence rating)b

Daily oral TAF/FTC Intramuscular cabotegravir
Daily oral On-demand oral (evidence rating) (evidence rating)
o
Every 3-4 mo HIV Ag/Ab HIV Ag/Ab HIV Ag/Ab HIV Ag/Ab
Creatininep Creatininep Creatininep HIV RNA
Gonorrhea/chlamydia Gonorrhea/chlamydia Gonorrhea/chlamydia NAATl Gonorrhea/chlamydia
NAATl NAATl Syphilisq NAAT1
Syphilisq Syphilisq Pregnancy testm Syphilisq
Pregnancy testm Pregnancy testm Pregnancy testm
Annually Creatinine Creatinine Creatinine HCV IgGr
HCV IgGr HCV IgGr HCV IgGr
HIV testing considerations If discordant or If discordant or If discordant or Results of HIV Ag/Ab test
difficult-to-interpret HIV difficult-to-interpret HIV difficult-to-interpret HIV test and HIV RNA are not needed
test results, call CDC test results, call CDC results, call CDC before administering
(800-232-4636) for (800-232-4636) for (800-232-4636) for additional follow-up injections
additional guidance additional guidance guidance If discordant or
difficult-to-interpret HIV
test results, call CDC
(800-232-4636) for
additional guidance
Other considerations
Late or missed doses When starting or after 7 or NA Resume with single-tablet daily If any injection is more than
more consecutive missed dosing 7 d late, consider oral
doses, restart with double “bridging” with daily oral
dose of TDF/FTC and TDF/FTC or TAF/FTC as
resume 1 tablet daily appropriate for sexual risk
factors until injections can
be resumed
If any injection is ≥8 wk
late, reload with 4-wk
interval before resuming
with 8-wk interval
injections
ART regimen in the event of HIV Bictegravir or Bictegravir or Bictegravir or TXF/XTC/RTV/DRV (or
acquisition dolutegravir + TXF/XTC dolutegravir + TXF/XTC dolutegravir + TXF/XTC COBI/DRV) unless a
genotype exonerates NNRTI
resistance, in which case
TXF/XTC/EFV, rilpivirine, or
doravirine can be
considered
Abbreviations: Ab, antibody; Ag, antigen; ART, antiretroviral therapy; prophylaxis initiation should not be delayed: creatinine, HAV IgG, HBsAg,
BIC, bictegravir; CDC, Centers for Disease Control and Prevention; HBsAb, HCV IgG, GC/CT NAAT, and syphilis.
COBI, cobicistat; DRV, darunavir; EFV, efavirenz; FTC, emtricitabine; i
Within 7 days of preexposure prophylaxis initiation or if not available, rapid
HAV, hepatitis A virus; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B test on site and blood drawn for a fourth-generation assay the same day.
surface antigen; HCV, hepatitis C virus; NA, not applicable; NAAT, nucleic acid j
When initiating oral preexposure prophylaxis regimens, HIV RNA testing is
amplification testing; NNRTI, nonnucleoside reverse transcriptase inhibitor;
recommended if high-risk exposure in last 4 weeks or signs and symptoms of
RTV, ritonavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil
HIV infection. When initiating cabotegravir, HIV RNA testing is recommended
fumarate; 3TC, lamivudine; TXF, tenofovir alafenamide or tenofovir disoproxil
in all cases. If HIV RNA not available, use the most sensitive assay that is
fumarate; XTC, emtricitabine or lamivudine.
implementable and feasible.
a
Recommendations in this table are based on currently available data. k
For men who have sex with men and persons who inject drugs (if not known
b
This applies equally to generic tenofovir disoproxil formulations. to be immune).
c
Consider individual balance of risk behaviors—persons who inject drugs are 1
Test all sites used for sexual activity (vaginal, rectal, urethral (via urine testing),
frequently also sexually active within the same networks; therefore, the and pharyngeal).
absence of data for an agent’s protective efficacy in the setting of parenteral m
For individuals of childbearing potential.
exposures should not preclude the agent’s use if demonstrated to have
n
efficacy for that individual’s predominant route of sexual exposure. In such After 1 month of oral (if oral lead-in is used, before first injection) and 4 weeks
cases, refer to the relevant sexual risk category after first injection.
o
d
Evidence rating AIII if patient is using no gender-affirming hormone therapy, Laboratory testing conducted every 3 months for oral tenofovir disoproxil
CIII if using therapy. fumarate–based preexposure prophylaxis and every 4 months for injectable
e cabotegravir.
Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin,
p
rifapentine, and St. John’s Wort. Estimated creatinine clearance rate at first quarterly visit and annually
f thereafter; every 3 to 6 months for patients with or at risk for kidney injury
When rifabutin is started before or concomitantly with the first initiation
(>50 y and/or estimated glomerular filtration rate <90 mL/min/1.73 m2).
injection, the recommended dosing is one 600-mg (3-mL) injection, followed
q
2 weeks later by a second 600-mg (3-mL) initiation injection and monthly Syphilis screening per CDC guidelines with consideration of both conventional
thereafter while receiving rifabutin. When rifabutin is started at the time of the and “reverse” screening algorithms.104
second initiation injection or later, the recommended dosing schedule is r
Every 3 to 6 months for men who have sex with men and persons who inject
600 mg (3 mL) monthly while receiving rifabutin. drugs who use recreational drugs and alcohol at the time of sex or if liver
g
The first 2 injections on injection initiation are separated by 4 weeks. function test results are incidentally found to be abnormal (assays are not part
h of routine monitoring).
If results for the following tests have not been received, preexposure

of vulnerability to HIV acquisition (evidence rating: AIII). Injections Warmline at the National Clinician Consultation Center, available
should be administered gluteally at a dose of 600 mg (3 mL). The at (855) HIV-PrEP.111
first 2 injections should be separated by 4 weeks, and subsequent
injections by 8 weeks. Because the timing of onset of protection is Adherence to PrEP and Persistence/Retention
unknown but is likely to be approximately 7 days after first injec- Individuals most at risk for acquiring HIV are often challenged by ad-
tion, barrier protection is recommended in the first week of the hering to and persisting with oral PrEP medication and services, with
first injection cycle. If an individual is more than 7 days late for any high rates of loss to follow-up.112,113 Numerous structural barriers con-
injection, it is recommended to “bridge” the period from that 7-day tribute to this and are also likely to be applicable to long-acting cabo-
delay until the next injection can be given with an oral PrEP regi- tegravir PrEP.22 Strategies to enhance adherence and persistence
men (see Oral PrEP Regimens section above) (evidence rating: BIII). include PrEP navigators, telehealth or telephone check-ins, smart-
If a resumed injection schedule is 8 or more weeks late (that is, 12 phone reminders, mobile service delivery, and pillboxes.
or more weeks from previous for injection 2, or 16 or more weeks
from previous for injections 3 and beyond), a “reloading” dose ART Choice for PrEP Breakthrough Infections
should be given with a 4-week interval between the 2 injections In instances of breakthrough infections, which can occur rarely with
after the hiatus, before returning to every-8-weeks dosing oral or injectable PrEP, see the Initiation of ART in the Setting of PrEP
(evidence rating: AIa). The recommended HIV testing algorithm at Failure section above.
dispensation of oral bridging and at the time of injection resump-
tion includes both antigen/antibody and HIV RNA testing (evidence
rating: AIII).
Postexposure Prophylaxis for HIV
Because of the prolonged pharmacologic “tail” phase after dis-
continuation of cabotegravir injections (median 43.7 weeks for males, and Bacterial STIs
67.3 weeks for females),109 there has been concern for InSTI resis- A 3-drug fully suppressive ART regimen for 28 days is recom-
tance should infection occur during this period. Individuals who are mended to be administered as rapidly as possible but within 72 hours
stopping injectable cabotegravir but who remain at risk for HIV ac- of a percutaneous, mucous membrane, or sexual exposure to known
quisition should be transitioned to an oral PrEP regimen (see Oral or suspected HIV-positive blood, genital secretions, or visibly bloody
PrEP Regimens section above), and that regimen should be contin- secretions. The recommended regimen is TXF/XTC plus dolutegra-
ued during the period of ongoing risk (evidence rating: AIa). Inject- vir or bictegravir (evidence rating: AIII). PEP should be initiated even
able cabotegravir should be dose-adjusted for coadministration with if awaiting results of HIV testing on the source person (evidence rat-
rifabutin and should not be used with potent inducers of ing: BIII). If there is concern for drug-resistant HIV or in the setting
UDP-glucuronosyltransferase 1A1. It should be used with particular of pregnancy or breastfeeding, expert consultation is advised
caution in individuals with gluteal implants or fillers. Strategies to (evidence rating: AIII) (for example, through the National Clinician
optimize on-time injections should be implemented and may in- Consultation Center).111
clude reminder communications, clinic transportation support, or Randomized studies suggest benefit of postexposure doxycy-
home visiting nursing services (evidence rating: AIII). cline (200 mg once after condomless intercourse) to prevent ac-
quisition of gonorrhea, chlamydia, and syphilis in men who have sex
Laboratory Testing in People Receiving PrEP with men (MSM) and in transgender women.114,115 Importantly, data
Recommendations on frequency and type of laboratory testing on its use for cisgender women and its effects on antimicrobial re-
are reported in Table 4. In patients initiating an oral TXF-based sistance and the microbiome are still pending. Until more informa-
regimen, recommended HIV screening includes a fourth- or fifth- tion is available, this strategy should be considered only on a case-
generation laboratory-based, antigen-antibody assay. For by-case basis for individuals at high risk for acquiring syphilis,
cabotegravir-based regimens, HIV testing at initiation and at all chlamydia, or gonorrhea.
visits should ideally include an HIV RNA test with a lower limit of
quantification of 50 copies/mL or lower AND a laboratory-based
antigen-antibody test (evidence rating: AIa). If RNA testing is not
available, cabotegravir PrEP can still be considered using antigen/ Substance Use in Persons at Risk for and With HIV
antibody screening only (evidence rating: BIa). Results of such Recommendations for persons at risk for and with HIV who use sub-
testing do not need to be available to provide injections. Inject- stances and who have substance use disorders (SUDs) are summa-
able cabotegravir may “mask” or delay the reactivity/positivity of rized in Box 5. Substance use (eg, opioids, stimulants, alcohol) and
conventional HIV testing owing to its high potency and prolonged SUD can interfere with all stages of the HIV prevention and treat-
pharmacokinetics, making breakthrough infections (ie, PrEP fail- ment care continuum.116 Substance use increases the risk of acquir-
ures) challenging to identify. Such failures are often asymptom- ing HIV through sharing injection drug use equipment and condom-
atic and characterized by inconsistent HIV assay results with very less sexual intercourse and may adversely affect HIV outcomes by
low levels of HIV RNA.110 A high degree of suspicion for HIV infec- interfering with ART adherence and the ability to achieve or main-
tion should be maintained for any reactive/detectable HIV testing tain HIV suppression.117-119
results in the setting of a recent HIV exposure or when there are Substance use and SUDs are more common among people with
delays in dosing. HIV than among the general population. Despite the high preva-
Discordant or difficult-to-interpret combinations of HIV test lence of SUDs, only a small number of people with HIV are linked to
results should be discussed with experts, including the PrEP or initiate treatment for SUD. To increase diagnosis and treatment

Among persons engaged in HIV prevention or treatment ser-

Box 5. Recommendations for Persons at Risk for and With HIV vices, SUD can create an additional hurdle for retention in care. Struc-
Who Use Substances and Who Have Substance Use Disorders tural barriers to retention, including lack of transportation, insur-
• Provide screening and treatment for substance use disorders to ance, and housing, as well as criminal legal barriers, poverty, mental
all persons at risk for and living with HIV (evidence rating: AIa) illness, racism, and stigma should be evaluated and addressed.141
• Substance use treatment should be integrated into HIV Innovative service delivery options, including telehealth, extended
prevention and treatment services (evidence rating: AIa) hours, mobile clinics, walk-in clinics, and staff who are peers or near-
• Persons with substance use disorders and HIV infection or risk
peers with lived experience with addiction, are recommended as
for HIV should receive integrated addiction treatment with:
ways to improve access for patients (evidence rating: AIIb).9,142,143
• Pharmacotherapy for opioid and alcohol use disorders
(evidence rating: AIa) Rapid HIV testing combined with rapid ART or PrEP provision among
• Contingency management for stimulant use disorders persons at risk should be available to persons who use substances
(evidence rating: AIII) and who have SUDs (see above).
• Persons with opioid use and alcohol use disorders should be
offered timely initiation of medications for substance use COVID-19 and HIV
disorder regardless of HIV and HCV treatment plans Recommendations are summarized in Box 6. The COVID-19 pan-
demic disrupted access to and delivery of HIV care and services.144-147
• Peer/patient support staff, telehealth, extended hours, mobile
clinics, and walk-in clinic options should be available to persons An extended review is beyond the scope of this document, but sev-
with substance use disorders who are receiving HIV treatment or eral key points should be considered.148,149 Recent studies indicate
prevention (evidence rating: AIIb) that people with HIV are not at increased risk of acquisition of
• Peer/patient support staff, mobile health units, and pharmacy SARS-CoV-2 compared with people without HIV after controlling for
delivery services should be available to persons with substance underlying immunosuppression, viral suppression while receiving
use disorders who are receiving HIV treatment or prevention
ART, and comorbidities.149,150 Data are conflicting and influenced by
(evidence rating: AIIb)
regional heterogeneity about the independent contribution of
Abbreviation: HCV, hepatitis C virus. HIV to higher risk of severe disease and mortality due to COVID-19.151
The preponderance of data suggests that people with HIV who are
of SUDs, screening for and linkage to SUD treatment should be in- receiving effective ART, virally suppressed with a CD4 cell count
tegrated into HIV prevention and treatment services (evidence rat- greater than 200/μL (or in some studies >350 cells/μL), and with-
ing: AIa) (eTable 4 in the Supplement).120,121 Reducing substance use out key comorbidities do not appear to be at substantially in-
(even if abstinence is not achieved) is associated with improved HIV creased risk for severe disease or death compared with people with-
outcomes.122 Therefore, offering addiction treatment, including out HIV.152 There are 3 potential explanations for some of the
pharmacotherapy and behavioral-based therapies, is recom- contradictory findings. First, published reports did not control for
mended for all people with HIV with SUDs (evidence rating: AIa).118 (or may have been confounded by) higher prevalence among people
Medication treatments for opioid use disorder (OUD), includ- with HIV of underlying comorbidities such as cardiovascular dis-
ing buprenorphine, methadone, and extended-release naltrexone, ease, diabetes, chronic kidney disease, chronic pulmonary disease,
reduce nonmedical opioid use and reduce risk for HIV and hepatitis and obesity, all of which are associated with increased risk of se-
C virus (eTable 5 in the Supplement).123-125 For persons with alco- vere COVID-19 and mortality.153-155 Second, published reports had
hol use disorder (AUD), medications (extended-release naltrex- not accounted for HIV RNA, residual HIV-associated inflammation,
one, oral naltrexone) reduce alcohol use, thereby reducing HIV risk or incomplete CD4 cell reconstitution in some people with HIV de-
(eTable 6 in the Supplement).126 For those with HIV, medication treat- spite receiving ART. Third, social determinants of poor COVID-19 out-
ment of OUD and AUD improves ART adherence and viral suppres- comes also intersect with higher prevalence of HIV among racial and
sion and thus is recommended with ART (eFigure in the Supple- ethnic minority populations.
ment) (evidence rating: AIa).127-130 Clinically significant drug-drug Primary COVID-19 vaccination and vaccine boosting is recom-
interactions between ART or hepatitis C virus direct-acting antiviral mended for all people with HIV (evidence rating: AIa). For those who
medications and medications used to treat SUDs are infrequent131,132; have untreated HIV infection or a CD4 cell count less than 200/μL,
neither ART nor medication treatments for SUDs should be with- the primary vaccination series should include at least 3 primary vac-
held (evidence rating: AIII). Although there are as yet no FDA- cine doses, and vaccine booster doses are recommended regard-
approved medications to treat stimulant use disorders (eg, meth- less of age (evidence rating: AIIa). For persons with HIV with viral
amphetamine, cocaine), there are data supporting the use of suppression while receiving ART and with CD4 cell counts greater
contingency management to promote reduced stimulant use.133-136 than 350/μL, antibody responses to SARS-CoV-2 infection or vac-
Interventions that reduce substance use, including medica- cines are not substantially different than among those without HIV.
tion treatments for OUD and AUD, may also improve PrEP out- People with HIV also do not have higher rates of adverse events re-
comes for HIV prevention. Although oral PrEP is approved for related to SARS-CoV-2 vaccines.156-158 However, some studies sug-
ducing HIV transmission via injection drug use, TAF/FTC and gest that vaccine efficacy, as measured by reduction in hospitaliza-
injectable cabotegravir have not yet been evaluated for injection drug tions and mortality, and antibody response rates are lower for people
use–related risk among persons who inject drugs.137 However, per- with HIV with advanced immunosuppression, especially those with
sons who use drugs may acquire HIV via condomless sexual inter- CD4 cell counts less than 200/μL or without viral suppression, than
course; therefore, if they are at sexual risk of HIV acquisition, they those without HIV.159-162 Many of the large phase 3 vaccine trials ex-
should be offered PrEP (evidence rating: AIa).138-140 cluded people with HIV or enrolled numbers too small to draw firm

conclusions. Again, some published data on vaccine immunogenic-

ity in people with HIV are conflicting, possibly owing to small num- Box 6. Recommendations for COVID-19 and People With HIV
bers, insufficient controls for underlying age, comorbidities, HIV RNA • Primary COVID-19 vaccination and vaccine boosting is
levels, or other factors that may affect antibody responses.163,164 recommended for all people with HIV (evidence rating: AIa).
People with HIV who have CD4 cell counts less than 200/μL or un- For those who have untreated HIV infection or a CD4 cell count
treated HIV may benefit from PrEP with tixagevimab plus cil- less than 200/μL, the primary vaccination series should include
gavimab, but only if the circulating SARS-CoV-2 variants are suscep- at least 3 vaccine doses, and vaccine booster doses are
recommended regardless of age (evidence rating: AIIa)
tible (evidence rating: BIII). People with HIV, particularly those with
• If circulating SARS-CoV-2 variants anticipated to be susceptible,
CD4 cell counts less than 200/μL, do appear to be at increased risk
preexposure prophylaxis for susceptible subvariants with
of vaccine breakthrough infections.165 This risk was lower for those tixagevimab (300 mg) plus cilgavimab (300 mg) to prevent
with CD4 cell counts greater than 500/μL. COVID-19 is recommended for adults and adolescents
Current COVID-19 treatment guidelines do not recommend that (aged ⱖ12 years and weighing ⱖ40 kg) with HIV who have
treatment be intensified, withheld, or altered based on HIV-related untreated HIV infection or a CD4 cell count less than 200/μL or
immunosuppression or ART.166-168 One emerging issue is whether those not able to be fully vaccinated owing to a history of severe
adverse reactions to a COVID-19 vaccine or its components
postacute sequelae of COVID-19 (“long COVID”) is more prevalent
among people with HIV. Risk factors for postacute sequelae in people • Postexposure prophylaxis is not recommended for people with
with HIV appear to be the same as for people without HIV.169 The HIV (evidence rating: AIII). Currently available monoclonal
degree to which underlying immunosuppression, viral suppression antibody agents have not been shown to be sufficiently effective
while receiving ART, or other factors affect the risk of postacute against the predominant circulating Omicron variants and
sequealae remains to be determined. subvariants
• People with HIV who develop COVID-19 should be treated
according to current guidelines for management of COVID-19,
Monkeypox Virus Infection
regardless of CD4 cell count or viral suppression
A global surge in monkeypox virus infections, primarily among (evidence rating: AIa)
MSM and with up to 50% occurring among people with HIV, was • People with HIV with CD4 cell counts less than 200/μL or with-
first identified in 2022. Most cases are related to skin-to-skin out viral suppression who develop mild-moderate COVID-19 in-
transmission during sexual encounters. Although the infection can fection should be treated with ritonavir-boosted nirmatrelvir
be asymptomatic,170 the predominant symptoms are skin lesions (evidence rating: AIIa). With the exception of maraviroc,
ART can be co-administered with ritonavir-boosted nirmatrelvir
that progress from papules to pustules and ulcers, often associ-
without dose adjustment (except as needed for estimated
ated with fever, lymphadenopathy, myalgias, headache, or
glomerular filtration rate <60 mL/min), but people with HIV
fatigue.171,172 Skin lesions are typically painful and can coalesce. should be monitored closely for adverse effects while receiving
Patients also often have anogenital or oral lesions, although this treatment. Drug-drug interactions may still limit the use
lesions may exist without any symptoms. People with HIV and low of this treatment if medications used for underlying
CD4 cell counts or with no viral suppression may experience more comorbidities or opportunistic infections are contraindicated
severe disease.173 Coinfection with other STIs is frequent and with ritonavir-boosted nirmatrelvir
• People with HIV who recover from severe COVID-19 should be
should be screened for when monkeypox is first recognized or sus-
monitored for postacute sequelae of SARS-CoV-2 (long COVID)
pected (evidence rating: AIII). and HIV treatment should be optimized to the extent possible to
Diagnosis of monkeypox currently requires nucleic acid ampli- further reduce inflammatory responses to COVID-19 and HIV
fication testing of lesions. Treatment recommendations are evolv- (evidence rating: AIII)
ing, but those patients who are immunosuppressed or otherwise at
Abbreviation: ART, antiretroviral therapy.
high risk for progression or those with severe disease should re-
ceive oral or intravenous tecovirimat (evidence rating: BIII), an in-
vestigational agent with activity against smallpox and monkeypox
viruses. Oral dosing is every 8 or 12 hours (depending on weight) for Promoting Equity in HIV Treatment and Prevention
14 days, administered within 30 minutes of a full fatty meal. Poten- Despite advances in HIV treatment and prevention, large dispari-
tial drug interactions exist between tecovirimat and rilpivirine, dora- ties exist in the global HIV epidemic. The 2021 Global AIDS
virine, and maraviroc, but dose adjustment is not required.174 Update titled “Confronting Inequalities” describes the inequity
The incubation time for monkeypox virus is approximately that continues to drive the HIV epidemic in all regions of the
12 days. For individuals with a known exposure, the JYNNEOS vac- world, with a focus on low- and middle-income countries.175 How-
cine (smallpox and monkeypox vaccine, live, nonreplicating ever, HIV epidemics in high-income countries also are character-
[Bavarian Nordic]) should be administered to asymptomatic con- ized by ongoing disparities. The US epidemic is a prime example:
tacts ideally within 4 days but up to 14 days (evidence rating: AIII). HIV disproportionately affects people who are Black or Hispanic,
Primary JYNNEOS vaccination with 2 doses given at least 28 days those who live in the US South, MSM, transgender individuals,
apart is recommended for individuals at high risk (evidence rating: and people who use drugs, compared with the general
AIII) (eg, MSM with multiple sexual partners). It is crucial that population.176 In 2020, HIV testing and services were disrupted
health messaging center on an equity approach to ensure that edu- by the COVID-19 pandemic in the US, particularly among priority
cation and services reach the most affected populations while populations including men who have sex with men, transgender
simultaneously fighting the stigma increasingly directed toward persons, and Black or African American and Hispanic persons.177
these communities. In addition, Black/African American people were furthest from the

Ending the HIV Epidemic Initiative targets for linkage to care ethnicity, disability, age, income level, education, occupation, geo-
(80%), viral suppression (60%), and PrEP coverage (9%).178 graphic disparities, migratory status, and incarceration.184 Ending
Among Black people with HIV in the US, 52% reside in geographic the HIV epidemic will require an equity approach that focuses re-
areas with high social vulnerability index scores.179 The greatest sources on addressing societal disparities (for example, tackling pov-
burden of HIV in the US is in the South, driven by structural factors erty as an HIV prevention strategy), addressing stigma as a root cause
including long-standing inequitable policies based in racism, and of HIV risk, eliminating laws that target people with HIV, and ensur-
resulting in high levels of poverty, failure to expand health care ing access to care for all.
access through Medicaid expansion, low educational attainment,
intersectional stigma and discrimination, and clinician shortages Limitations
that result in inequitable access to HIV prevention and treatment First, this article is meant to provide general recommendations and
services. Striking disparities also exist across other high-income is not designed as mandates or to replace clinical judgment. Sec-
settings. For example, in the European Union and European Eco- ond, the recommendations are based on the body of evidence that
nomic Area, 44% of new diagnoses in 2019 were among the was available at the time of preparation and may change as new data
migrant populations.180 become available. Third, the recommendations were developed for
Global disparities in PrEP utilization limit its ability to reduce high- and medium-income settings, for which most of the drugs and
HIV transmission,181,182 and there is serious concern that, although tools are available. The specific recommendations may not be ap-
long-acting cabotegravir for PrEP has the potential for consider- plicable in all resource-limited settings.
able benefit,183 its cost and implementation complexity will only
widen disparities.
The United Nations General Assembly Political Declaration on
Conclusions
HIV and AIDS, titled “Ending Inequalities and Getting on Track to End
AIDS by 2030,” offers roadmaps to address global health dispari- Advances in treatment and prevention of HIV continue to improve
ties, including those associated with HIV status, sex, gender, race, outcomes, but challenges and opportunities remain.
ARTICLE INFORMATION Acquisition, analysis, or interpretation of data: National Institute on Drug Abuse, National Center
Accepted for Publication: November 13, 2022. Gandhi, Bedimo, Hoy, Landovitz, Smith, Eaton, for Advancing Translational Science, and Veterans
Lehmann, Springer, Thompson, Benson, Affairs Cooperative Studies Program; receiving
Published Online: December 1, 2022. Buchbinder, del Rio, Eron, Günthard, Molina, Saag. consulting fees from Alkermes Inc; and receiving
doi:10.1001/jama.2022.22246 Drafting of the manuscript: Gandhi, Bedimo, Hoy, in-kind drug donation from Alkermes Inc (Vivitrol)
Author Affiliations: Massachusetts General Landovitz, Smith, Eaton, Lehmann, Springer, Sax, and Indivior (Sublocade) for NIH-sponsored
Hospital and Harvard Medical School, Boston Thompson, Benson, del Rio, Jacobsen, Saag. research. Dr Sax reported receiving grants from
(Gandhi); University of Texas Southwestern Medical Critical revision of the manuscript for important Gilead and ViiV and receiving personal fees from
Center, Dallas (Bedimo); The Alfred Hospital and intellectual content: Gandhi, Bedimo, Hoy, Gilead, Janssen, Merck, and ViiV. Dr Thompson
Monash University, Melbourne, Australia (Hoy); Landovitz, Smith, Eaton, Lehmann, Springer, reported receiving research funding to the AIDS
University of California Los Angeles (Landovitz); Thompson, Benson, Buchbinder, del Rio, Eron, Research Consortium of Atlanta from Bristol Myers
University of California San Diego School of Günthard, Molina, Saag. Squibb, Cepheid Inc, Cytodyne Inc, Frontier
Medicine (Smith, Benson); University of Alabama at Obtained funding: Jacobsen. Biotechnologies, Gilead Sciences, GlaxoSmithKline,
Birmingham (Eaton, Saag); University of Cologne Administrative, technical, or material support: Merck Sharp & Dohme, and ViiV and serving as
and German Center for Infection Research (DZIF), Landovitz, Smith, Eaton, Lehmann, Jacobsen, Saag. chair of an independent data monitoring committee
Bonn-Cologne (Lehmann); Yale University School of Supervision: Gandhi, Sax, Benson, Jacobsen, Saag. for Excision Biotherapeutics. Dr Benson reported
Medicine, New Haven, Connecticut (Springer); The Conflict of Interest Disclosures: Dr Gandhi receiving grants from NIH/National Institute of
Veterans Administration Connecticut Healthcare reported receiving grants from the National Allergy and Infectious Diseases (NIAID), National
System, West Haven (Springer); Brigham and Institutes of Health (NIH). Dr Bedimo reported Institute of Mental Health; receiving grants to her
Women’s Hospital, Harvard Medical School, Boston, receiving grants from Merck and ViiV Healthcare institution from Fogarty, Gilead, and DNAe;
Massachusetts (Sax); Thacker & Thompson, and serving on the scientific advisory board of receiving lecture/symposia honoraria from
Atlanta, Georgia (Thompson); Department of Public Merck, ViiV Healthcare, Gilead Sciences, International Antiviral Society–USA; serving as
Health, San Francisco, California (Buchbinder); Theratechnologies, and Janssen Scientific. Dr Hoy deputy editor of Clinical Infectious Diseases; and
Emory University School of Medicine and Grady reported serving on the advisory board of ViiV receiving consulting fees from NDA Partners.
Health System, Atlanta, Georgia (del Rio); The Healthcare and Gilead Sciences. Dr Landovitz Dr Buchbinder reported receiving grants from
University of North Carolina School of Medicine at reported serving on the scientific advisory board of Gilead Sciences and ViiV Healthcare. Dr del Rio
Chapel Hill (Eron); University Hospital Zurich and Gilead Sciences and Merck; receiving consulting reported receiving grants from the NIH/NIAID
Institute of Medical Virology, University of Zurich, fees from Cepheid; and receiving grants from the Emory Center for AIDS Research and receiving
Zurich, Switzerland (Günthard); University of Paris NIH and ViiV Healthcare. Dr Smith reported consulting fees from Resverlogix. Dr Eron reported
Cité, Saint-Louis and Lariboisière Hospitals, receiving grants from the NIH San Diego Center for receiving personal fees from Merck, ViiV
Assistance Publique Hopitaux de Paris, France AIDS Research and receiving personal fees from Healthcare, and Gilead Sciences and receiving
(Molina); International Antiviral Society–USA, Linear Therapies, Model Medicines, Pharma grants from ViiV Healthcare, Gilead Sciences, and
San Francisco, California (Jacobsen). Holdings, Bayer Pharmaceuticals, and Evidera. Janssen. Dr Günthard reported receiving grants
Author Contributions: Dr Gandhi had full access to Dr Eaton reported receiving grants paid to her from the Swiss National Science Foundation, NIH,
all of the data in the study and takes responsibility institution from NIH and Bristol Myers Squibb and Yvonne Jacob Foundation, Gilead, the Swiss HIV
for the integrity of the data and the accuracy of the receiving consulting fees from Gilead Sciences. Cohort Study, and advisory board, consulting, and
data analysis. Dr Lehmann reported receiving personal fees from data and safety monitoring board fees from Merck,
Concept and design: Gandhi, Bedimo, Hoy, VIIV Healthcare, Gilead, Pfizer, Janssen, Novartis, Gilead Sciences, ViiV Healthcare, GlaxoSmithKline,
Landovitz, Eaton, Lehmann, Sax, Thompson, BioNTech, and Merck Sharp & Dohme and receiving Janssen, Johnson & Johnson, and Novartis.
Benson, Buchbinder, del Rio, Eron, Günthard, grants from the German Center of Infection Dr Molina reported receiving grants from Gilead
Jacobsen, Saag. Research and the German Ministry of Research. and serving on the advisory board for Gilead,
Dr Springer reported receiving grants from the Merck, and ViiV. Dr Saag reported receiving grants

to his institution from ViiV Healthcare and Gilead 7. Stanic A, Rybin D, Cannata F, et al. The impact of Published online August 1, 2022. doi:10.1093/cid/
Sciences and receiving consulting fees from TFF the housing status on clinical outcomes and health ciac631
Pharmaceuticals and American Gene Technologies. care utilization among individuals living with HIV. 20. Landovitz RJ, Donnell D, Clement ME, et al;
No other disclosures were reported. AIDS Care. 2021;33(1):1-9. doi:10.1080/09540121. HPTN 083 Study Team. Cabotegravir for HIV
Funding/Support: This work was sponsored and 2019.1695728 prevention in cisgender men and transgender
funded by the International Antiviral Society–USA 8. Maragh-Bass AC, Gamble T, El-Sadr WM, women. N Engl J Med. 2021;385(7):595-608. doi:
(IAS-USA). IAS-USA is a mission-based, Hanscom B, Tolley EE. Exploring individual-level 10.1056/NEJMoa2101016
nonmembership, 501(c)(3) not-for-profit barriers to HIV medication adherence among men 21. Eshleman SH, Fogel JM, Piwowar-Manning E,
organization. No private sector or government who have sex with men in the HIV Prevention Trials et al. Characterization of human immunodeficiency
funding was used to support the effort. Panel Network (HPTN 065) study. AIDS Care. 2021;33(11): virus (HIV) infections in women who received
members are not compensated for participation in 1404-1413. doi:10.1080/09540121.2020.1828799 injectable cabotegravir or tenofovir disoproxil
the effort. 9. Higa DH, Crepaz N, Mullins MM, et al. Strategies fumarate/emtricitabine for HIV prevention: HPTN
Role of the Funder/Sponsor: The IAS-USA to improve HIV care outcomes for people with HIV 084. J Infect Dis. 2022;225(10):1741-1749. doi:10.
determined the need to update recommendations, who are out of care. AIDS. 2022;36(6):853-862. 1093/infdis/jiab576
vetted and selected the panel members, and doi:10.1097/QAD.0000000000003172 22. Landovitz R, Donnell D, Tran H, et al. Updated
provided administrative support and oversight. The 10. National Academies of Sciences Engineering efficacy, safety, and case studies in HPTN 083:
panel had a role in the design and conduct of the and Medicine. Opportunities to Improve Opioid Use CAB-LA vs TDF/FTC for PrEP [Abstract 96] in
study; collection, management, analysis, and Disorder and Infectious Disease Services. National special issue: Abstracts From the 2022 Conference
interpretation of the data; preparation, review, or Academies Press; 2020. on Retroviruses and Opportunistic Infections. Top
approval of the manuscript; and decision to submit Antiv Med. 2022;30(1 suppl):37.
the manuscript for publication. 11. Martin TCS, Abrams M, Anderson C, Little SJ.
Rapid antiretroviral therapy among individuals with 23. Department of Health and Human Services.
Additional Contributions: We thank Paul A. acute and early HIV. Clin Infect Dis. 2021;73(1):130-133. Recommendations for the use of antiretroviral
Volberding, MD, who initiated the volunteer panel doi:10.1093/cid/ciaa1174 drugs during pregnancy and interventions to
in 1995 and helped guide the committee for 25 reduce perinatal HIV transmission in the United
years. We also thank Michelle Valderama, BS, 12. Chéret A, Bauer R, Meiffrédy V, et al. Once-daily
dolutegravir versus darunavir plus cobicistat in States. ClinicalInfo. Updated March 17, 2022.
production and web manager from the IAS-USA, for Accessed November 9, 2022. https://clinicalinfo.
assistance in managing the manuscript versions; adults at the time of primary HIV-1 infection: the
OPTIPRIM2-ANRS 169 randomized, open-label, hiv.gov/en/guidelines/perinatal/whats-new-
Sherry Wu, BS, for administrative support; and guidelines?view=full
Kimberly R. Powell, MIS, a research impact phase 3 trial. J Antimicrob Chemother. 2022;77(9):
informationist from Emory University for 2506-2515. doi:10.1093/jac/dkac207 24. Zash R, Holmes LB, Diseko M, et al. Update on
conducting the PubMed and Embase literature 13. Rasmussen TA, Ahuja SK, Kuwanda L, et al. neural tube defects with antiretroviral exposure in
searches. Dr Volberding and Ms Powell received no Antiretroviral initiation at ⱖ800 CD4+ cells/mm3 the Tsepamo study, Botswana. Poster presented at:
financial compensation from the sponsor for this associated with lower human immunodeficiency 11th IAS Conference on HIV Science; July 18-21,
article. Ms Valderama and Ms Wu are salaried virus reservoir size. Clin Infect Dis. 2022;75(10): 2022.
employees of the sponsor of this article. 1781-1791. doi:10.1093/cid/ciac249 25. Lockman S, Brummel SS, Ziemba L, et al;
Additional Information: This article is dedicated to 14. Hunt PW, Brenchley J, Sinclair E, et al. IMPAACT 2010/VESTED Study Team and
the memory of Scott M. Hammer, MD, founding Relationship between T cell activation and CD4+ T Investigators. Efficacy and safety of dolutegravir
member of the panel and former panel chair. cell count in HIV-seropositive individuals with with emtricitabine and tenofovir alafenamide
undetectable plasma HIV RNA levels in the absence fumarate or tenofovir disoproxil fumarate, and
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Clinical Review & Education

JAMA | Special Communication

Antiretroviral Drugs for Treatment and Prevention

OBJECTIVE Based on a critical evaluation of new data, to provide clinicians with

FINDINGS Initiation of antiretroviral therapy (ART) is recommended as soon as possible after

CONCLUSIONS AND RELEVANCE Advances in treatment and prevention of HIV continue to

Author Affiliations: Author

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Table 1. Strength of Recommendation and Quality of Evidence

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Box 2. Recommended Initial Antiretroviral Therapy (ART) Regimens

Recommended for Most People With HIV • Cabotegravir

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Table 3. Recommendations for Laboratory Monitoring for Persons With HIV

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tuberculosis, and viral hepatitis; cancer screening (including for cer-

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alafenamide is associated with increases in lipid levels and cardio-

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TDF/FTC (evidence rating)b

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TDF/FTC (evidence rating)b

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Among persons engaged in HIV prevention or treatment ser-

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conclusions. Again, some published data on vaccine immunogenic-

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