FDA approves single pill HIV combo

The product is the first ever once-daily single pill regimen to be approved for the treatment of HIV.

It combines Sustiva, manufactured by Bristol-Myers Squibb, and Truvada, manufactured by Gilead Sciences. Truvada itself is a fixed-dose product that contains two of Gilead’s anti-HIV medications, Viread and Emtriva, in a single once-daily tablet for use as part of combination therapy.

“The availability of Atripla marks the culmination of 10 years of efforts to simplify dosing while helping to achieve and maintain effective viral suppression for adults infected with HIV-1,” said Dr John Bartlett, of Johns Hopkins University.

Clinical data support the use of the three-drug regimen contained in Atripla in HIV treatment-naive patients. An ongoing non-inferiority study is comparing a once-daily regimen of Viread, Emtriva and Sustiva, the components of Atripla, with twice-daily Combivir and once-daily Sustiva in treatment-naive patients with HIV.

Through 48 weeks, 84% of patients in the Viread/Emtriva/Sustiva group compared to 73% of patients in the Combivir/Sustiva group have achieved and maintained HIV-1 RNA less than 400 copies/mL. This difference largely results from the higher number of discontinuations in the Combivir/Sustiva group due to adverse events and other reasons including lost to follow-up, patient withdrawal, non-compliance and protocol violation.