Gilead has announced the results of Stage 3 clinical trials of “the Quad,” which would be the world’s first four-in-one daily HIV pill. The Quad contains two new (and not yet FDA approved) drugs: the integrase inhibitor, Elvitegravir, and Cobicistat, which is meant to mitigate the side-effects of Elvitegravir.
Via press release:
“These data show that the Quad is as effective [as Atripla] as a current standard of care in HIV therapy. The safety profile of Quad was also comparable to that of Atripla, and was better tolerated in terms of key neurological side effects,” said Paul Sax, MD, Clinical Director of the HIV Program and Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, and principal investigator of Study 102. “Based on these results, I believe the Quad could represent a potentially important new treatment regimen for a wide range of HIV patients initiating therapy.”
Gilead also produces Atripla. Both Atripla and the Quad contain Truvada, which is under consideration as a daily pre-exposure prophylactic (PReP) for the uninfected.
Reuters has more:
The safety data, presented here on Wednesday at the Conference on Retroviruses and Opportunistic Infections, showed that patients on Atripla had significantly higher rates of dizziness, abnormal dreams, insomnia and rash, compared with the Quad. The experimental pill did result in higher rates of nausea, 21 percent vs 14 percent. The study found that at 48 weeks of treatment, 88 percent of Quad patients, compared with 84 percent of Atripla patients, achieved target levels of HIV virus.
As millions of patients are well into their second decade of daily HIV therapy, we’ll see more of this focus on refining the treatments to reduce their immediate and long-term side-effects.