November 02, 2013
Gilead Announces Phase 2 Results for Sofosbuvir-Based Regimens in Hepatitis C Patients Before and After Liver Transplantation
-- Studies Support Efficacy and Safety of an All-Oral Sofosbuvir-Based Regimen for the Prevention and Treatment of Recurrent HCV Infection Following Liver Transplants --
HCV infection is the most common cause of liver transplantation in
In a study conducted among pre-transplant HCV patients (Study 2025), up to 48 weeks of sofosbuvir/RBV therapy was administered. Among patients with undetectable HCV (<25 IU/mL) at the time of transplantation, 64 percent (n=25/39) achieved undetectable HCV RNA 12 weeks post-transplant (pTVR12). Patients who achieve pTVR12 are considered cured of HCV infection. In a second study conducted among post-transplant HCV patients (Study 0126), patients with established recurrent HCV infection following liver transplantation received 24 weeks of sofosbuvir/RBV therapy. Seventy-seven percent (n=27/35) of patients in this study have achieved a sustained virologic response four weeks post-treatment (SVR4).
“Recurrence of HCV following liver transplantation almost always occurs
in clinical practice. These patients are at higher risk for disease
progression, the development of cirrhosis, liver graft failure,
re-transplantation and increased morbidity and mortality,” said
Three percent and five percent of patients discontinued treatment due to adverse events in the pre- and post-transplant studies, respectively. No serious adverse events reported were associated with sofosbuvir. The most common adverse events observed were consistent with the safety profile of RBV, and included fatigue, anemia, headache and nausea in the pre-transplant study, and fatigue, headache, arthralgia (joint pain) and diarrhea in the post-transplant study.
About the Pre-Transplant Study
Study 2025 is an on-going open-label Phase 2 study evaluating the efficacy and safety of sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) for up to 48 weeks or until liver transplantation. Sixty-one patients with HCV infection (Child-Pugh class A or B cirrhosis) and liver cancer, who were either treatment-naïve or treatment-experienced were enrolled.
About the Post-Transplant Study
Study 0126 is an ongoing open-label Phase 2 study evaluating the efficacy and safety of 24 weeks of treatment with sofosbuvir 400 mg once-daily plus RBV (starting at 400 mg/day) among 40 treatment-naïve and treatment-experienced patients with recurrent HCV infection. Patients in the study had received a transplant a median of four years prior to the study, and 40 percent were cirrhotic.
There were no deaths, graft losses or episodes of organ rejection among post-liver transplantation patients in the study.
Additional information about these studies 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 results from Studies 025 and 126
and other ongoing and subsequent clinical trials involving sofosbuvir,
alone or in combination with other products, for the treatment of HCV.
In addition, regulatory authorities will 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
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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)