GSK and ViiV score breakthrough therapy designation in HIV prevention, as Truvada showdown draws nearer

A little less than a week after beefing up the data package it plans to take to the FDA for the experimental HIV drug cabotegravir, GSK-owned ViiV Healthcare has received good news on the medicine’s prospects.

Regulators designated cabotegravir as a breakthrough therapy for preventative HIV treatment, the company announced Tuesday afternoon, setting up a showdown with Gilead’s Truvada. ViiV R&D chief Kimberly Smith said it likely sets up an NDA submission in the first half of next year, with the hope of launching the drug in early 2022.

“It just further validates how important this product is,” Smith told Endpoints News. “Even in the United States, even with the presence of daily oral therapy, there’s still 38,000 to 40,000 cases of HIV diagnosed every year. If we continue to have cases at that rate, we won’t get to the end of the epidemic in the US.”

The BTD comes off the results of two trials, both of which reported results earlier this year.

In the former, examining men and transgender women who have sex with men, researchers compared the effects of cabotegravir against the daily oral pills. There, with a 0.41% incidence rate in the injection group and 1.22% in the pill group, cabotegravir proved 66% more effective in a final analysis in July.

The latter study, in sub-Saharan African cisgender women, was stopped by the DSMB earlier this month after an interim analysis that showed it had already met its primary endpoint. ViiV’s results here showed cabotegravir to be 89% more effective than Truvada in both the 200 mg and 300 mg doses. Among the 38 women who contracted HIV, 34 came from the Truvada arm, translating to incidence rates of 1.79% and 0.21% in the Truvada and cabotegravir arms, respectively.

Whereas Truvada is a once-daily pill, cabotegravir is a long-lasting injectable taken every eight weeks for prevention. ViiV and GSK are hoping to capitalize on the idea that patients are less likely to forget to take their medicine, as opposed to the risk of missing a Truvada dose.

“Many people have a tough time taking it consistently every day,” Smith said. “As long as you get your shot, in the interim you don’t have to worry about taking a pill every day.”

Truvada has long been the champion in preventative HIV treatment, reducing the risk of contracting the virus by more than 99%. But generics for the drug launched this year, with Israeli drugmaker Teva launching its own versions of Truvada and another Gilead HIV drug Atripla.

ViiV is hoping to take a bite out of that pie as well, in both the prevention and treatment areas. Smith said that on the treatment side, cabotegravir in combination with J&J’s rilpivirine is currently being evaluated as a monthly regimen by the FDA, with an expected PDUFA date of next Jan. 28. The original NDA there was submitted back in early 2019, but the FDA shot it down with a CRL last December, citing CMC issues.

The combo has also been approved in other countries, such as Canada, and is marketed as Cabenuva.

Gilead has essentially owned the HIV market since Truvada’s approval in 2012, with the drug netting $2.8 billion in sales for both prevention and treatment in 2019. The company also scored an approval for Descovy in HIV pre-exposure prophylaxis late last year.

Click to view original post