On December 18, the federal government announced a new update to its antiretroviral treatment guidelines. The changes include a greater emphasis on HIV treatment as a way to prevent transmission, a new two-drug option for initial treatment and more information about HIV and aging.
The Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents regularly revises the guidelines based on the latest research in the field. The full Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV are available for free at AIDSinfo.nih.gov.
Below are some of the key changes in the new update:
Treatment as Prevention
The new guidelines reflect the growing understanding that people on effective antiretroviral treatment who have an undetectable viral load (under 200) do not transmit the virus to their sex partners. This awareness of treatment as prevention (TasP) gave rise to the campaign to promote the concept of Undetectable Equals Untransmittable, or U=U. The guidelines have added a new section to help providers integrate TasP into their practice. The section includes a review of the major studies supporting U=U, including HPTN 052, PARTNER 1, PARTNER 2 and Opposites Attract. The panel recommends that people starting treatment should use another form of prevention—for example, condoms or PrEP for a partner—for at least the first six months and until they receive an undetectable viral load test result.
First Two-Drug Initial Regimen
For the first time, the guidelines include a two-drug combination to the list of recommended regimens for starting treatment; such recommendations were previously limited to three-drug regimens. Dovato is a combination pill that contains the integrase inhibitor dolutegravir and the nucleoside reverse transcriptase inhibitor lamivudine. Studies have shown that it suppresses HIV as well as a standard three-drug combo. However, it is not recommended for people with a high pretreatment viral load (above 500,000), those with hepatitis B virus (lamivudine is active against hep B but often not strong enough to keep it under control) and those who are starting treatment right away, before the results of HIV resistance testing or hepatitis B testing are available. The other approved two-drug single-tablet regimen, Juluca (dolutegravir/rilpivirine), is only for people who switch treatment with an undetectable viral load, not for initial therapy.
Dolutegravir During Pregnancy
The previous version of the guidelines did not recommend dolutegravir (sold as Tivicay and included in the Triumeq, combination pill as well as Dovato and Juluca) for people who are pregnant, planning to conceive or sexually active and able to conceive but not using effective contraception. This was based on studies showing that infants born to women who took dolutegravir around the time of conception had a higher risk of neural tube birth defects. However, more recent research shows that the risk of such defects is lower than initially reported. The updated guidelines recommend that providers should discuss the benefits and potential risks of dolutegravir and people living with HIV should make their own informed decision about whether to use it.
Rapid Treatment Initiation
The guidelines recommend that antiretroviral therapy should be started immediately or as soon as possible after HIV diagnosis. Starting treatment at the time of diagnosis helps prevent people falling through the cracks on the way to being linked to care. What’s more, rapid treatment cuts the amount of time people spend with a detectable viral load, which improves their own health and reduces the risk of HIV transmission. For those with acute or recent infection, the panel added Biktarvy (bictegravir/tenofovir alafenamide/emtricitabine) as a recommended option for those who will start treatment before resistance test results are available.
The section on optimizing antiretroviral therapy for people with viral suppression has been updated based on new clinical trial data from switch studies that have been reported since the last revision. The panel emphasizes the importance of reviewing an individual’s entire HIV treatment history and any past treatment failures or drug resistance to inform the selection of a new regimen. As with initial therapy, two-drug regimens containing lamivudine are not recommended for people with active hepatitis B.
HIV and Aging
The section on older people living with HIV has also been updated with new data from recent studies. The updates focus on the need to identify older individuals who are at risk for HIV, the need for early diagnosis, the impact of aging on HIV disease progression and age-related comorbidities, and the complexities of managing HIV treatment and drug interactions when people are taking multiple drugs for various conditions. The revision addresses the importance of recognizing HIV-associated neurocognitive problems—which may lead to reduced treatment adherence and poorer overall health—as well as the need to screen for and manage depression.
The tuberculosis section has been updated with new data on short-course regimens for the treatment of latent tuberculosis and new data on drug interactions between antiretrovirals and the TB drugs rifampin and rifapentine.
Finally, the guidelines have an updated section on cost considerations related to antiretroviral treatment, including an overview of the individual and societal costs of HIV care in the United States. A new subsection on cost sharing looks at how cost-containment practices may affect out-of-pocket payments for people with Medicaid, Medicare and AIDS Drug Assistance Program (ADAP) coverage. The section also features a revised discussion about the increased cost of brand-name antiretrovirals and the expected impact of generic regimens as these drugs go off patent.