title: Sofosbuvir plus ribavirin in treatment-naïve patients with chronic hepatitis C virus genotype 1 or 3 infection in India.
abstract: Until 2014, pegylated interferon plus ribavirin was the recommended standard of care for the treatment of chronic hepatitis C virus (HCV) infection in India. This open-label phase 3b study, conducted across 14 sites in India between 31 March 2014 and 30 November 2015, evaluated the efficacy and safety of sofosbuvir plus ribavirin therapy among treatment-naïve patients with chronic genotype 1 or 3 HCV infection. A total of 117 patients with genotype 1 or 3 HCV infection were randomized 1:1 to receive sofosbuvir 400 mg and weight-based ribavirin (1000 or 1200 mg) daily for 16 or 24 weeks. Among those with genotype 1 infection, the primary efficacy endpoint of sustained virologic response at 12 weeks post-treatment (SVR12) was reported in 90% (95% confidence intervals [CI], 73-98) and 96% (95% CI, 82-100) of patients following 16 and 24 weeks of treatment, respectively. For patients with genotype 3 infection, SVR12 rates were 100% (95% CI, 88-100) and 93% (95% CI, 78-99) after 16 and 24 weeks of therapy, respectively. Adverse events, most of which were mild or moderate in severity, occurred in 69% and 57% of patients receiving 16 and 24 weeks of treatment, respectively. The most common treatment-emergent adverse events were asthenia, headache and cough. Only one patient in the 24-week group discontinued treatment with sofosbuvir during this study. Overall, sofosbuvir plus ribavirin therapy achieved SVR12 rates ≥90% and was well tolerated among treatment-naïve patients with chronic genotype 1 or 3 HCV infection in India.
authors.affiliation: Global Hospitals, Mumbai, Maharashtra, India.
authors.forename: S R
authors.initials: SR
authors.lastname: Shah
authors.affiliation: Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India.
authors.forename: A
authors.initials: A
authors.lastname: Chowdhury
authors.affiliation: Nirmal Hospital Pvt Ltd, Surat, Gujarat, India.
authors.forename: R
authors.initials: R
authors.lastname: Mehta
authors.affiliation: Global Hospitals, Hyderabad, Andhra Pradesh, India.
authors.forename: D
authors.initials: D
authors.lastname: Kapoor
authors.affiliation: Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
authors.forename: A
authors.initials: A
authors.lastname: Duseja
authors.affiliation: Lakeshore Hospital, Kochi, Kerala, India.
authors.forename: A
authors.initials: A
authors.lastname: Koshy
authors.affiliation: Seth G.S. Medical College and King Edward Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: A
authors.initials: A
authors.lastname: Shukla
authors.affiliation: Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
authors.forename: A
authors.initials: A
authors.lastname: Sood
authors.affiliation: Artemis Hospitals, Gurgaon, Haryana, India.
authors.forename: K
authors.initials: K
authors.lastname: Madan
authors.affiliation: Medanta - The Medicity, Gurgaon, Haryana, India.
authors.forename: R
authors.initials: R
authors.lastname: Sud
authors.affiliation: Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India.
authors.forename: S
authors.initials: S
authors.lastname: Nijhawan
authors.affiliation: Fortis Memorial Research Institute, Gurgaon, Haryana, India.
authors.forename: R
authors.initials: R
authors.lastname: Pawan
authors.affiliation: VGM Hospital, Coimbatore, Tamil Nadu, India.
authors.forename: M
authors.initials: M
authors.lastname: Prasad
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: K
authors.initials: K
authors.lastname: Kersey
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Jiang
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: E
authors.initials: E
authors.lastname: Svarovskaia
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: B
authors.initials: B
authors.lastname: Doehle
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: B
authors.initials: B
authors.lastname: Kanwar
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Subramanian
authors.affiliation: All India Institute of Medical Science, New Delhi, Delhi, India.
authors.forename: S K
authors.initials: SK
authors.lastname: Acharya
authors.affiliation: Institute of Liver and Biliary Sciences, New Delhi, Delhi, India.
authors.forename: S
authors.initials: S
authors.lastname: Sarin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D007194:India; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: India; genotype 1; genotype 3; hepatitis C virus phylogenetics; treatment-naïve