GSK, still early in US launch, licenses long-acting HIV PrEP drug Apretude to patent pool for poorer nations

Antivirals have historically made up the bulk of licenses that allow generic companies to copy innovative drugs for poorer countries. Now, GSK’s ViiV Healthcare is adding the world’s first long-acting HIV prevention med to a patent-sharing program merely seven months into an FDA approval.

GSK has signed a licensing deal with the United Nations-backed Medicines Patent Pool (MPP) for its long-acting HIV PrEP drug Apretude, or cabotegravir, the two parties unveiled during the 24th International AIDS Conference. The arrangement gives selected generics manufacturers rights to make and supply copycats of Apretude for 90 poorer countries.

“If you think about the HIV pandemic, the biggest burden is in sub-Saharan Africa,” ViiV’s head of R&D, Kimberly Smith, M.D., said during an interview with Fierce Pharma. “So if we really want to change the trajectory of the epidemic, we have to make this remarkable prevention tool available in the places that need it the most.”

ViiV currently charges Apretude at a list price of $3,700 per vial, or $22,200 per year. Research by the Clinton Health Access Initiative has found that generics manufacturers could make cabotegravir at $2.60 per vial, according to Doctors Without Borders.

Simultaneously at AIDS 2022, the World Health Organization unveiled new guidelines recommending the use of cabotegravir as PrEP for HIV prevention. Also at the HIV conference of the year, ViiV, HIV prevention-focused nonprofit AVAC, the Bill & Melinda Gates Foundation, the Children’s Investment Fund Foundation, MedAccess and Unitaid joined hands in a strategic collaboration to speed equitable access to Apretude in PrEP. The consortium will facilitate pricing discussions for potential government purchases.

The announcements come as Apretude is still early in its U.S. launch after an FDA nod in December as a bimonthly PrEP option to prevent HIV in at-risk people, or over two years after the drug got its global-first nod in Canada as part of an HIV treatment combination alongside Johnson & Johnson’s rilpivirine. It also follows ViiV’s statement in May that it was negotiating licensing terms with MPP.

Gilead Sciences’ oral drugs have been dominating the PrEP market. Through long-acting options, GSK hopes to overcome challenges with adherence related to taking daily pills.

In the HPTN 083 trial conducted in men and transgender women, Apretude takers had 69% less risk of getting infected with HIV compared to individuals on Gilead’s Truvada.

The HPTN 084 study showed Apretude was 89% more effective than Truvada at preventing HIV in women. In an updated analysis GSK’s ViiV just presented at AIDS 2022, the risk reduction remained at 89% after a year of an unblinded phase of the study where participants were made known of which regimen they were taking.

Unblinding the trial works in Truvada’s favor, because women on the daily pill now know that they need to be more adherent to ensure protection, Smith explained.

With the MPP arrangement, GSK hopes to enable broader access to its long-acting PrEP drug. But while GSK could make a case for Apretude’s convenience edge in well-off countries, having an injection that’s administered by a healthcare professional regularly may face some logistical challenges in low-income regions.

The fact that HPTN 084 was conducted in sub-Saharan Africa despite COVID speaks to the motivation women have in coming to the clinic and getting the doses, Smith said. But before the success can be translated to a broader population in the real world, some implementation studies that examine the best way to deliver the drugs in different settings are needed, she added.

“But you can’t learn [the best way to implement Apretude] unless we have a plan to make the medicines available, and that’s what the MPP announcement is,” Smith said.

MPP made headlines during the COVID-19 pandemic with licensing deals such as that of Pfizer’s Paxlovid. But the initiative was originally established in response to the HIV epidemic. As a firm solely focused on HIV, ViiV has contributed to MPP before, including with its current cornerstone drug Tivicay (dolutegravir).

Meanwhile, in the U.S., GSK is projecting a slow sales ramp for Apretude, similar to what its long-acting treatment Cabenuva has experienced. In the second quarter, Apretude delivered sales of 8 million pounds sterling as Cabenuva registered 72 million pounds.

Doctors prescribing HIV meds aren’t familiar with administering injectables. Since Cabenuva’s go-ahead, HIV-treating doctors were largely busy setting up infrastructure and processes for its administration, including potentially hiring a team to manage reimbursement and the actual injection, Smith said. Now, with Apretude’s launch, doctors that prescribe PrEP but don’t treat HIV will have to go through the same learning curve, she said.

Apretude is also launching about the same time as generic Truvada. Reimbursement requirements that an individual take a cheap oral generic before using Apretude are “extremely rare,” Smith said, arguing that a step therapy setup doesn’t make sense here because failure of oral PrEP means infection.