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 December 18, 2019. Accessed 10/9/2020.
- On October 17 2017, DHHS updated the treatment guidelines for initiation of antiretroviral therapy (ART). This includes the following:
- 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-naive 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.
- The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) classifies the following regimens as recommended initial regimens for most people with HIV:
- Dolutegravir/abacavir/lamivudine-only for patients who are HLA-B*5701 negative
- Dolutegravir plus tenofovir/emtricitabine
- Raltegravir plus tenofovir/emtricitabine
- 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.
- 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 isnot 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) regimenor 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 patients 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 April 14, 2020. Accessed 10/9/2020.
Data are limited regarding use of ibalizumab during pregnancy; therefore, ibalizumab-containing regimens cannot be recommended for use in pregnant women.