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ViiV takes on Gilead’s PReP dominance with HIV injectable data

Phase 3 trial halted early after significant improvement seen over Truvada

ViiV Healthcare

ViiV Healthcare was hit hard when the FDA rejected its injectable HIV therapy cabotegravir late last year, but could bounce back thanks to new data for the drug as pre-exposure prophylaxis (PrEP).

A phase 3 trial of an injection of cabotegravir every two months has been halted early after the investigators saw a significant improvement over daily oral PrEP with Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate).

An interim analysis from the HPTN 083 study found the ViiV’s injectable was 69% more effective than the oral therapy at preventing the transmission of HIV.

There was a fairly broad standard deviation in the results, showing that cabotegravir was non-inferior to Truvada, with the difference “approaching superiority in favour of cabotegravir”, according to ViiV, which says it will use the data for future regulatory submissions.

Among the 50 people in the trial who acquired HIV, 12 were treated with cabotegravir and 38 received Truvada.

PrEP is a big market for HIV therapies that was effectively created when Truvada was approved by the FDA in 2012 to reduce HIV transmission within couples. Analysts have estimated that PrEP usage accounted for around $2bn out of Truvada’s $3bn sales last year.

For ViiV – a joint venture majority-owned by GlaxoSmithKline – the study is a big boost to its ambitions for cabotegravir, an HIV integrase inhibitor that it hopes could provide long-term HIV therapy with a single injection, avoiding treatment compliance issues with daily oral drugs such as skipped doses.

The FDA rejected a once-monthly combination of cabotegravir plus Johnson & Johnson’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine last year after taking issue with chemistry manufacturing and controls (CMC) data in the application.

“New options are needed for HIV prevention that offer an effective alternative to daily oral PrEP,” said ViiV’s head of R&D Kimberly Smith.

“If approved, this long-acting injectable has the potential to be a game-changer for HIV prevention by reducing the frequency of dosing from 365 days to six times per year,” she added.

HPTN 083 enrolledmen who have sex with men (MSM) and transgender women who have sex with men, and ViiV says it is now waiting for the results of a companion study in 3,200 women who are at increased risk of HIV acquisition.

The PrEP market is however due for a shake-up as Truvada’s patents are due to expire next year, allowing generics to be offered for sale, and that could lead to downward pressure on pricing.

Gilead is trying to position its recently-approved two-drug combination Descovy (emtricitabine/tenofovir alafenamide) as a successor to Truvada that is safer, with significant improvements on measures of bone and kidney toxicity.

A two-monthly injectable could be an attractive alternative to daily dosing, particularly for people who may be worried about adhering to a daily dosing regimen, although it could also increase the number of clinic visits required over a year.

Article by
Phil Taylor

18th May 2020

From: Research



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