Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options

Abstract

In patients with HCV genotype 2 or 3 infection for whom treatment with peginterferon and ribavirin was not an option, 12 or 16 weeks of treatment with sofosbuvir and ribavirin was effective. Efficacy was increased among patients with HCV genotype 2 infection and those without cirrhosis. In previously treated patients with genotype 3 infection, 16 weeks of therapy was significantly more effective than 12 weeks. (Funded by Gilead Sciences; POSITRON and FUSION ClinicalTrials.gov numbers, NCT01542788 and NCT01604850, respectively.).

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

“…19 In the POSITRON trial, SVR rate was 93% (101/109) among IFN-unwilling, ineligible, or intolerant GT-2 patients. 35 In the FUSION trial, among treatment-experienced GT-2 patients, SVR rates were better, with 16 weeks of therapy (94%) than after 12 weeks (86%). This was also the case in GT-2 patients with cirrhosis; SVR rates were better after 16 weeks of therapy (78%; 7/9) than after 12 weeks (60%; 6/10).…”

“…This observation indicated that cirrhotic patients might need therapy for more than 12 weeks. 35 In the VALENCE trial, among patients with GT-2 HCV treated for 12 weeks with SOF and RBV, SVR rate was 93% (68/73), being 94% (59/63) without and 82% (9/11) with cirrhosis. According to treatment experience, SVR rate was 97% (29/30) in treatment-naive noncirrhotic patients, 100% (2/2) in treatment-naive cirrhotic patients, 91% (30/33) in treatment-experienced noncirrhotic patients, and 88% (7/8) in treatment-experienced cirrhotic patients.…”

“…The main evidence of SOF and RBV therapy in GT-3 has come from the FISSION, 19 (treatment-naive HCV, interferon-eligible), POSITRON 35 (treatment-naive and treatment-experienced HCV, people who were ineligible for interferon or intolerant to it or unwilling to have it), FUSION 35 (treatment-experienced HCV), the VALENCE 28 (treatment-naive and treatment-experienced)], an arm in the ELECTRON trial, 31 and the BOSON trial. 37 Treatment-naive genotype 3: The FISSION trial compared results of 12 weeks of SOF and RBV therapy with that of 24 weeks Peg-IFNa and RBV in treatment-naive HCV patients.…”

A Budget Impact Analysis of Newly Available Hepatitis C Therapeutics and the Financial Burden on a State Correctional System

“…43 Total costs of HCV medication guidelines by the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) as of January 2015 with cure rates from clinical trials is summarized in Table 1. 28,29,44,31,32,45 For the purposes of calculating total medication costs, we assumed entirely interferon-free regimens with the highest SVRs from clinical trials across all genotypes, given the current community standard of care. For genotypes 1 and 4, we calculated total drug costs of a SOF/LDV regimen, with varying duration of 8 to 24 weeks based on fibrosis and treatment history for genotype 1 patients.…”

“…SVRs as high as 97 % were achieved in genotype 2 patients with SOF+RBV combination therapy. 28,29 In the fall of 2014, SOF and ledipasvir (LDV) together were approved as a fixed-dosed combination and SOF+SMV were approved as combination therapy. More recently, the FDA has approved the co-formulated ombitasvir, paritaprevir, and ritonavir with dasabuvir regimen (OBV/PTV/r+DSV) for genotype 1 patients and those with advanced cirrhosis, also eliminating RBV in some cases.…”