Study Results Announced for Sofosbuvir in HCV/HIV Co-Infected Patients

Gilead Sciences announced results from PHOTON-1, a Phase 3 study evaluating the investigational once daily nucleotide analogue sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.

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PHOTON-1 is an ongoing open-label study designed to evaluate the efficacy and safety of 12 or 24 weeks of sofosbuvir 400mg once daily plus weight-based RBV (1,000 or 1,200 mg/day) among HCV treatment-naïve patients with genotype 1, 2 or 3 HCV infection who are also HIV-positive. Ninety-five percent of PHOTON-1 patients were already receiving antiretroviral therapy for their HIV infection.

In the trial, 76% (n=87/114) of genotype 1 HCV treatment-naïve patients receiving 24 weeks of an all-oral, interferon-free regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks (SVR12) after completing therapy. Patients who achieve SVR12 are considered cured of HCV infection.

PHOTON-1 also assessed 12 weeks of sofosbuvir plus RBV among genotype 2 and 3 HCV treatment-naïve patients with HIV. Among genotype 2 patients receiving this regimen, 88%(n=23/26) achieved SVR12, while 67% (n=28/42) of genotype 3 patients achieved SVR12. All patients in PHOTON-1 who did not achieve SVR12 had viral relapse after cessation of therapy, with the exception of two participants who were non-adherent to study drugs.

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