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

Injectable treatments can begin to replace daily pills.

2021 will be a pivotal year for the prevention and treatment of HIV / AIDS. Many researchers and advocacy groups are encouraged by President-elect Joe Biden’s selection of Rochelle Walensky, MD, MPH, to be the CDC director of the new administration. Walensky, chief of infectious diseases at Massachusetts General Hospital and professor at Harvard Medical School, is a well-known HIV / AIDS researcher. The CDC director does not need confirmation from the Senate, so there is no reason to believe that Walensky will not head the leading federal infectious disease agency.

Walensky will take the reins of the CDC at a crucial time in the HIV / AIDS epidemic. Many people infected with HIV do not have a diagnosis, so diagnosed cases by no means tell the whole story. Nevertheless, it should be noted that the number of diagnosed cases has decreased. In 2018, the latest year for which a tally is available, 37,968 new cases were diagnosed, 2,868 fewer than the 40,836 diagnosed in 2014. In 2018, 5,425 Americans died of AIDS.

Two years ago, the Trump administration enacted a 10-year plan to end ending the HIV epidemic. Much of the plan relies on the availability and use of drugs to prevent and treat HIV. Medical innovation and the means to disseminate such innovation are therefore crucial.

Here are five developments to watch for in 2021 that could have a major impact on the treatment and prevention of HIV / AIDS:

1a. Awaiting FDA Decision on Long-Acting Injectable Cabenuva

So far, treatment for HIV has consisted of taking pills which must be taken daily. That could change this year with the advent of treatments that can be injected and do not need to be taken daily. The implications of long-acting injectable therapy are important, as they will likely improve treatment adherence and eliminate the daily treatment booster.

The FDA is expected to make its decision on ViiV Healthcare’s injectable Cabenuva, a combination of cabotegravir and rilpivirine, in the coming 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 of GlaxoSmithKline and Pfizer, markets Cabenuva.

In phase 2 and 3 clinical trials, the treatment combination, given as two injections – one of cabotegravir and the other of rilpivirine – once a month by a healthcare professional was also found to be effective. than traditional oral options. Although it caused reactions at the injection site, patients always prefer Cabenuva on the alternative daily oral option.

1b. A little closer to a semi-annual injectable for treatment-resistant patients

Gilead is expected to complete regulatory submissions this year for its long-acting, self-injecting anti-HIV treatment, lenacapavir. Gilead’s long-acting injectable should only be injected once every six months, away from daily oral treatments.

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

Expected regulatory filings will follow Gilead reports first results of the phase 2/3 CAPELLA trial of 36 patients. Data showed that patients receiving lenacapavir were significantly more likely to achieve the study’s primary endpoint of a 0.5 log10 or greater reduction in viral load, a marker chosen to measure change relevant to the amount of virus in a patient, compared to placebo.

2. How could 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. At the end of 2020, the FDA granted a breakthrough designation to cabotegravir from ViiV Healthcare, one of two drugs from the HIV treatment candidate, Cabenuva, for HIV prevention. Cabotegravir is given once every 2 months.

The treatment 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 oral HIV prevention option approved by the FDA and taken daily. The study, HPTN 083, was actually terminated prematurely because an interim analysis indicated that it was effective. Data showed that injecting cabotegravir was 66% more effective in preventing HIV infection than Truvada.

3. Continue the quest for an HIV vaccine

Despite all the advances in the treatment of HIV, the development of an effective HIV vaccine has proved elusive. But vaccine research continues. The late Janssen stadium, mosaic based vaccine candidate, which should see the first results of the phase 2b Imbokodo study as early as this year. In July of last year, the 2,600 patients in the study have been fully vaccinated.

4. Obtain more coverage for HIV prevention drugs

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

PrEP coverage, which reduces the risk of contracting HIV by more than 90%, is likely to have significant implications for many patients at risk of contracting HIV, as out-of-pocket costs for treatment can cost patients $ 1,000. every year. even with confidence because the insurance does not always cover the full price of the treatment.

The move follows the US Task Force on Preventive Services, an independent expert group that reviews the effectiveness of preventive services and makes recommendations, giving PrEP for HIV prevention an “A” recommendation in 2019. Under the ACA, most receive an “A” or “B” grade from the group.

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