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Gilead Sciences, Inc. (Nasdaq: GILD) has announced results from a Phase 3 study, PHOTON-1, evaluating the investigational once-daily nucleotide analogue inhibitor sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. In the trial, 76 percent (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 after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. These data will be presented this week during the 64th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2013) in Washington, D.C.
Up to one-third of people living with HIV in the United States are co-infected with HCV. In parts of Europe up to 50 per cent of HIV infected patients are infected with HCV. Current HCV medicines are associated with suboptimal cure rates among co-infected patients and can cause significant interactions with HIV drugs.
"There is a clear need for HCV treatment regimens that are more effective and safer for patients who are co-infected with HIV," said Douglas Dieterich, MD, Professor of Medicine in the Division of Liver Diseases and Director of Continuing Medical Education in the Department of Medicine at Mount Sinai School of Medicine. "In this study, sofosbuvir-based all-oral therapy achieved high SVR rates in a hard-to-treat patient population. This regimen may have the potential to help us overcome the clinical challenge of treating HCV/HIV co-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 percent (n=23/26) achieved SVR12, while 67 percent (n=28/42) of genotype 3 patients achieved SVR12. All patients in PHOTON-1 who did not achieve SVR12 had a viral relapse after cessation of therapy, with the exception of two participants who were non-adherent to study drugs.
Treatment discontinuations due to adverse events were reported in three percent of patients receiving 24 weeks of therapy and four percent of patients receiving 12 weeks of therapy. The most common side effects observed in the study were consistent with the safety profile of RBV and included fatigue, nausea, headache and insomnia.
PHOTON-1 is an ongoing, open-label Phase 3 study being conducted at sites in the United States and Puerto Rico to evaluate the efficacy and safety of 12 or 24 weeks of sofosbuvir 400 mg once daily plus weight-based ribavirin (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 receiving antiretroviral therapy for their HIV infection. The HIV treatment regimens permitted in the study were based on the results of a separate Phase 2 drug-drug interaction study conducted by Gilead demonstrating that sofosbuvir did not significantly affect the pharmacokinetic parameters of drugs from various classes of In parts of Europe up to 50 per cent of HIV infected patients are infected with HCVantiretrovirals. The most common HIV treatment regimens taken by patients in PHOTON-1 were Gilead's Truvada® (emtricitabine/tenofovir disoproxil fumarate) administered with efavirenz, atazanavir/ritonavir, darunavir/ritonavir or raltegravir.
Additional information about PHOTON-1 can be found at www.clinicaltrials.gov.
Sofosbuvir is an investigational product and its safety and efficacy have not been established.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Sciences, Gilead. "Phase 3 results announced for an all oral, sofosbuvir-based regimen for the treatment of hepatitis C in patients co-infected with HIV." Medical News Today. MediLexicon, Intl., 5 Nov. 2013. Web.
11 Dec. 2013. <http://www.medicalnewstoday.com/releases/268345>
Sciences, G. (2013, November 5). "Phase 3 results announced for an all oral, sofosbuvir-based regimen for the treatment of hepatitis C in patients co-infected with HIV." Medical News Today. Retrieved from
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