The Department of Health and Human Services (DHHS) this month released revised guidelines for the use of antiretroviral therapy and prevention and treatment of opportunistic infections. The updates reflect the effectiveness of modern treatment but acknowledge that challenges remain for some people living with HIV.
Key changes to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV include the following.
First-line treatment. The guidelines now recommend that dolutegravir (marketed alone as Tivicay and a component of the Triumeq, Dovato and Juluca combination pills) can be prescribed for people of childbearing potential. A few years ago, researchers raised concerns that use of the drug around the time of conception might be linked to a higher risk of neural tube birth defects. But further analysis showed that the risk is low and similar to that of other antiretrovirals. This change was also included in a recent update to the DHHS recommendations for pregnant women.
Optimizing treatment. Some people on suppressive treatment wish to switch regimens—for example, to improve convenience or manage specific side effects. The updated guidelines include information on the new long-acting injectable regimen Cabenuva (cabotegravir/rilpivirine). The Food and Drug Administration recently approved a once-monthly regimen, and an every-other-month schedule is under consideration.
Virological failure. For people who are unable to maintain an undetectable viral load on their current treatment, the guidelines say that a new regimen should include two fully active drugs, including one with a high barrier to resistance, such as dolutegravir or boosted darunavir (Prezista, Prezcobix or Symtuza). Previously, the guidelines called for at least two, preferably three, fully active agents.
Poor CD4 recovery. Some people with HIV have persistent immune activation and do not experience adequate CD4 T-cell recovery despite being on treatment that suppresses their viral load. The revision includes information from new studies of the reasons for declining CD4 counts despite suppressive therapy, reviews experimental strategies to reduce persistent inflammation and explains why monitoring inflammation levels is not currently recommended in clinical practice.
Special populations. The revised guidelines include new information for specific groups of people living with HIV, including women, adolescents and young adults, people with substance use disorders and people with tuberculosis. The section on women features information on weight gain after starting or switching therapy and antiretroviral drug interactions with hormone therapy as well as a new subsection on menopause.
Cost considerations. The update features a discussion of the cost and cost effectiveness of comprehensive HIV care, including the cost of newer antiretrovirals, such as Trogarzo (ibalizumab).
Drug interactions. The drug interaction tables in the guidelines have been updated with new information about Cabenuva and Rukobia (fostemsavir).
Opportunistic infections. The DHHS Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV features new information about coccidioidomycosis, bartonellosis and immunizations for people living with HIV, including an updated recommendation for shingles, or herpes zoster, vaccination.
DHHS welcomes feedback on the revised recommendations. Comments can be sent to ContactUs@hivinfo.nih.gov. The deadline for feedback is June 21 for the antiretroviral therapy guidelines and June 28 for the opportunistic infection guidelines.