Professional Statements and Societal Positions Guidelines
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Updated September 12, 2024. Accessed 11/21/2024.
- ART is recommended for all individuals with HIV, regardless of CD4 T lymphocyte cell count, to reduce the morbidity and mortality associated with HIV infection.
- ART is also recommended for individuals with HIV to prevent HIV transmission.
- Starting therapies for an antiretroviral (ARV) regimen for a treatment-naïve patient generally consists of two (2) nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third active ARV drug from one (1) of three (3) classes:
- An integrase strand inhibitor (INSTI)
- A non-nucleoside reverse transcriptase inhibitor (NNRTI)
- Or a protease inhibitor (PI) with a pharmacokinetic (PK) enhancer (booster) such as cobicistat or ritonavir.
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The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) classifies the following regimens as recommended initial regimens for most people with HIV:
- Bictegravir (BIC)/ tenofovir alafenamide (TAF)/ emtricitabine (FTC)
- Dolutegravir (DTG) plus TAF or tenofovir disoproxil fumarate (TDF) plus FTC or lamivudine (3TC)
- DTG/3TC, except for individuals with HIV RNA >500,000 copies/mL, hepatitis B virus (HBV) coinfection, or in whom ART is to be started before the results of HIV genotypic resistance testing for reverse transcriptase or HBV testing are available
- For people who do not have a history of using long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP), one of the following regimens is recommended:
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For people who have a history of CAB-LA use as PrEP, INSTI genotype resistance testing should be performed before starting ART. If ART is to be started before results of genotypic testing results, the following regimen is recommended:
Darunavir/cobicistat (DRV/c) or darunavir/ritonavir (DRV/r) with TAF or TDF plus FTC or 3TC-pending the results of the genotype test
- The fundamental principle of regimen switching is to maintain viral suppression without jeopardizing future treatment options.
- It is critical to review a patient's full ARV history, including virologic responses, past ARV-associated toxicities, and cumulative resistance test results (if available) before selecting a new ART regimen.
- Adverse events, the availability of ARVs with an improved safety profile, or the desire to simplify a regimen may prompt a regimen switch. Within-class and between-class switches can usually maintain viral suppression, provided that there is no viral resistance to the ARV agents in the new regimen.
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Monotherapy with either a boosted protease inhibitor (PI) or an integrase strand transfer inhibitor (INSTI) has been explored in several trials or cohort studies, and has been associated with an unacceptable rate of virologic failure and the development of resistance; therefore, monotherapy as a switching strategy is
not recommended
.
- Consultation with an HIV specialist should be considered when planning a regimen switch for a patient with a history of resistance to one or more drug classes.
- More intensive monitoring to assess tolerability, viral suppression, adherence, and laboratory changes is recommended during the first 3 months after a regimen switch.
- Drug-resistance testing should be performed while the patient is taking the failing antiretroviral (ARV) regimen or within 4 weeks of treatment discontinuation. Even if more than 4 weeks have elapsed since ARVs were discontinued, resistance testing can still provide useful information to guide therapy, although it may not detect previously selected resistance mutations.
- A new regimen should include at least two, and preferably three, fully active agents. A fully active agent is one that is expected to have uncompromised activity on the basis of the patient's ART history and his or her current and past drug-resistance testing results. A fully active agent may also have a novel mechanism of action.
- In general, adding a single ARV agent to a virologically failing regimen is not recommended because this may risk the development of resistance to all drugs in the regimen.
For some highly ART-experienced individuals with extensive drug resistance, maximal virologic suppression may not be possible. In this case, ART should be continued with regimens designed to minimize toxicity, preserve CD4 cell counts, and delay clinical progression.
Panel on Treatment of Pregnant Women with HIV infection and Prevention of Perinatal Transmission. Department of Health and Human Services. Updated. Accessed 11/21/2024.
Data are limited regarding use of ibalizumab during pregnancy; therefore, ibalizumab-containing regimens cannot be recommended for use in pregnant women, except in special circumstances.