5 developments to watch for in HIV/AIDS treatment and prevention in 2021

2021 stands to be pivotal year for HIV/AIDS prevention and treatment. Many researchers and advocacy groups are heartened by President-elect Joe Biden’s selection of Rochelle Walensky, M.D., M.P.H., to be the CDC director of the new administration. Walensky, chief of infectious diseases at Massachusetts General Hospital and a professor at Harvard Medical School, is a well-known HIV/AIDS researcher. The CDC director does not require Senate confirmation so there’s no reason to believe that Walensky won’t heading up the federal government’s prime infectious disease agency.

Walensky will be taking the reins at the CDC at a crucial time in the course of the HIV/AIDS epidemic. Many people infected with HIV don’t have a diagnosis, so diagnosed cases don't tell the full story by any means, Even so, it's notable that the number of diagnosed cases has been declining. In 2018, the latest year for which a tally is available, 37,968 new cases were diagnosed, which is 2,868 fewer cases than the 40,836 diagnosed in 2014. In 2018, 5,425 Americans died from the AIDS.

Two years ago, the Trump administration promulgated a 10-year plan to end to end the HIV epidemic. The plan largely hinges on the availability and uptake of medications to both prevent and treat HIV, so medical innovation and ways to disseminate such innovation are crucial.

Here are five developments to look out for in 2021 that may have a major effect on HIV/AIDS treatment and prevention:

1a. Awaiting a decision from the FDA on long-acting injectable Cabenuva

So far, treatment for HIV involves taking pills that need to be taken daily. That may change this year with the advent of treatments that can be injected and don’t need to be taken daily. The implications of long-acting injectable treatment are great, as they will likely improve adherence to treatment and eliminate the daily reminder of treatment.

The FDA is expected to issue its decision on ViiV Healthcare’s injectable Cabenuva—a combination of cabotegravir and rilpivirine—sometime in the next few months.

[Updated: The FDA approved Cabenuva on Jan. 21 along with an oral version of cabotegravir, which is supposed to be taken with an oral version of rilpivirine for a month before starting treatment Cabenuva to test how patients will react to the two-medication combination.]

ViiV Healthcare, a joint venture by GlaxoSmithKline and Pfizer, is marketing Cabenuva.

In phase 2 and 3 clinical trials, the treatment combination, given as two injections — one of cabotegravir and the other, rilpivirine — once a month by a healthcare provider, was shown to be equally as effective as traditional oral options. While it did cause injection-site reactions, patients still preferred Cabenuva over the alternative daily oral option.

1b. Inching closer to a twice-yearly injectable for treatment-resistant patients

Gilead is expected to complete regulatory filings this year for their long-acting self-injectable HIV treatment lenacapavir. Gilead’s long-acting injectable only has to be injected once every six months, a far cry from the daily oral treatments.

If approved, the HIV-1 capsid inhibitor will be the first approved treatment of its kind and is meant for heavily treated patients who have become resistant to multiple drugs—a particularly difficult-to-treat group of patients—in combination with other treatments.

The anticipated regulatory filings will come on the heels of Gilead releasing topline results from the phase 2/3 CAPELLA trial of 36 patients. The data showed that patients receiving lenacapavir were significantly more likely to meet the study’s primary endpoint of a 0.5 log10 or greater reduction in viral load—a marker chosen to measure a relevant change in the amount of virus a patient has—compared with placebo.

2. How might solo cabotegravir play out

Excitement is also mounting for the very real possibility that a long-acting injectable to prevent HIV will soon be approved. As 2020 came to a close, the FDA granted breakthrough designation to ViiV Healthcare’s cabotegravir—one of the two drugs in HIV treatment candidate Cabenuva—for the prevention of HIV. Cabotegravir is administered once every 2 months.

The treatment has demonstrated its ability to effectively prevent HIV infection in men who have sex with men and transgender women in a phase 2b/3 trial comparing the vaccine with Truvada, an FDA-approved HIV prevention oral option taken daily. The study, HPTN 083, was actually halted early because an interim analysis indicated that it was effective. The data showed that cabotegravir injection was 66% more effective at preventing HIV infection than Truvada.

3. Continuing the quest for an HIV vaccine

Despite all the progress in HIV treatment, development of an effective HIV vaccine has proved to be elusive. But vaccine research continues. Janssen’s late-stage, mosaic-based vaccine candidate, which is expected to see initial results from the phase 2b Imbokodo study as early as this year. As of July last year, all 2,600 patients in the study have been fully vaccinated.

4. Gaining more coverage for HIV prevention medication

As the HIV community awaits for the approval of long-acting injectable cabotegravir, a new rule will make current HIV prevention treatments more accessible. Private insurers are now gearing up to offer full coverage for these treatments, also known as PrEP, including Gilead’s Truvada and Descovy, as well as Teva’s newly available generic version of Truvada, for patients at high risk of acquiring HIV.

Coverage of PrEP, which reduces the risk of acquiring by HIV by more than 90%, will likely have significant implications for many patients at risk of HIV, as out-of-pocket costs for the treatments can run patients $1,000 each year even with insurance because insurance does not always cover the full price of the treatment.

The move follows the U.S. Preventive Services Task Force—an independent panel that reviews the effectiveness of and provides recommendations for preventive services—giving PrEP for HIV prevention an “A” recommendation back in 2019. Under the ACA, most insurers must cover preventive services that receive an “A” or “B” rating from the group.