November 02, 2013
Gilead Announces Phase 3 Results for an All-Oral, Sofosbuvir-Based Regimen for the Treatment of Hepatitis C in Patients Co-Infected With HIV
Up to one-third of people living with HIV in
“There is a clear need for HCV treatment regimens that are more
effective and safer for patients who are co-infected with HIV,” said
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 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
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 antiretrovirals. 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.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable longer-term resulting from clinical trials
evaluating sofosbuvir, including in combination with other products and
among patients with HCV/HIV co-infection or HCV monoinfection. In
addition, regulatory authorities may not approve sofosbuvir for
HCV-related indications and any marketing approval may have substantial
limitations on its use. As a result, sofosbuvir may never be
successfully commercialized. Further, Gilead may make a strategic
decision to discontinue development of sofosbuvir if, for example,
Gilead believes commercialization will be difficult relative to other
opportunities in its pipeline. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended
Truvada is a registered trademark of
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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)