Panel issues updated guidance on ART for HIV treatment, prevention

Antiretroviral therapy (ART) should be started as soon as possible after HIV diagnosis, and clinicians should address barriers to care, including ensuring ART access and supporting adherence, according to updated recommendations from the International Antiviral Society-USA.

The recommendations update the panel's guidance from 2020 and were developed after a review of the literature through October 2022. They were published Dec. 1 by JAMA.

Regimens containing integrase strand transfer inhibitors remain the mainstay of initial therapy, the panel said. For most people with HIV, bictegravir/tenofovir disoproxil fumarate/emtricitabine, dolutegravir (DTG) plus tenofovir alafenamide or tenofovir disoproxil fumarate/emtricitabine or lamivudine, or DTG/lamivudine is recommended. The panel noted that DTG/lamivudine should only be used as initial therapy if the patient's HIV RNA level is below 500,000 copies/mL and there is no co-infection with hepatitis B virus (HBV); this regimen should not be used for rapid initiation of therapy when genotype, HIV RNA, and HBV serology results are not yet available, the panel said.

Regimen switches for patients with and without viral suppression first require careful review of a patient's ART regimen history, medication tolerability, concomitant medications, food requirements, reproductive plans, insurance coverage, and results from all prior resistance testing, the panel said. More frequent clinical and laboratory follow-up should be done until it is established that the regimen is effective, well tolerated, and not associated with toxicity; HIV RNA and safety laboratory assays should first be conducted approximately one month after changing therapy, according to the panel. Patients who switched regimens because of virologic failure should have a viral load test repeated monthly until suppression to undetectable levels is documented, then every six months thereafter.

Older patients should be screened for HIV to prevent late diagnosis with advanced disease, the panel advised. In addition, assessment of polypharmacy and simplification of complex regimens, both ART and treatments for comorbid conditions, is recommended to improve adherence, prevent adverse drug-drug interactions, reduce fall risk, and limit costs, the panel said. Older patients should also be screened for comorbid conditions, impaired cognition and function, poor mobility, frailty, and fall risk.

Among other recommendations regarding COVID-19, the panel said that all patients with HIV should receive primary COVID-19 vaccination and boosting, and in those who have untreated HIV infection or a CD4 cell count less than 200/µL, the primary vaccination series should include at least three vaccine doses, with vaccine booster doses recommended regardless of age. Preexposure prophylaxis (PrEP) for susceptible COVID-19 subvariants with tixagevimab (300 mg) plus cilgavimab (300 mg) is recommended in adults and adolescents (ages ≥12 years and weighing ≥40 kg) who have untreated HIV infection or a CD4 cell count below less than 200/µL or are unable to be fully vaccinated because of a history of severe adverse reactions to a COVID-19 vaccine or its components, the panel noted. The panel said that postexposure COVID-19 prophylaxis is not recommended for people with HIV, since currently available monoclonal antibody agents are not sufficiently effective against the predominantly circulating omicron variants and subvariants.

The recommendations provide additional advice on the topics above, as well as on laboratory monitoring, weight gain and metabolic complications with ART, selection of a PrEP regimen, postexposure prophylaxis for HIV and bacterial sexually transmitted infections, and treatment in patients with substance use disorders.

The panel also stressed the importance of health equity in HIV care and prevention, pointing out that there are global disparities in use of PrEP and that HIV in the U.S. disproportionately affects people who are Black or Hispanic, those who live in the South, men who have sex with men, transgender individuals, and people who use drugs. “Ending the HIV epidemic will require an equity approach that focuses resources on addressing societal disparities (for example, tackling poverty as an HIV prevention strategy), addressing stigma as a root cause of HIV risk, eliminating laws that target people with HIV, and ensuring access to care for all,” the panel authors wrote.

A Viewpoint also published Dec. 1 by JAMA said that evidence-based tools and intervention to end the HIV epidemic are available, but progress is hampered by an “increasingly hostile and politicized” environment. “This World AIDS Day, what we need to do is clear. We must cultivate a diverse clinical workforce. We must include affected communities at the table. We must advocate for policies to ensure that medicine can be practiced without interference. We must confront stigma and discrimination and focus on health equity at every turn,” the authors wrote. “If we do this, indeed the HIV epidemic could be ended.”