Sandeep Singh Sidhu1, Nirmaljeet Singh Malhi2, Omesh Goyal3, Rupinder Singh4, Usha Dutta5, Rajiv Grover6, J S Sidhu7, Vijay Nanda8, Harmeet Saluja9, Ajesh Bansal10, Gursewak Singh11, Alok Sehgal12, Harsh Kishore3, Simran Sidhu12. 1. Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India. sandeepsidhu1963@gmail.com. 2. Department of Gastroenterology, SatguruPartap Singh Hospital, Ludhiana, Punjab, India. 3. Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India. 4. Department of Gastroenterology, Malwa Hospital, Bathinda, Punjab, India. 5. Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh Union Territory, India. 6. Department of Gastroenterology, AIMC Bassi Hospital, Ludhiana, Punjab, India. 7. Department of Gastroenterology, Parvati Hospital, Amritsar, Punjab, India. 8. Department of Gastroenterology, Premier Gastroenterology Institute, Jalandhar, Punjab, India. 9. Department of Gastroenterology, Deep Hospital, Ludhiana, Punjab, India. 10. Department of Gastroenterology, Max SuperspecialityHospital, Bathinda, Punjab, India. 11. Department of Gastroenterology, Care Hospital, Bathinda, Punjab, India. 12. Himalayan Institute of Medical Sciences, Dehradun, UttarKhand, India.
Abstract
BACKGROUND AND AIMS: Recently, Sofosbuvir was launched in India at affordable cost. We conducted a real-life study to determine the efficacy and safety of Sofosbuvir plus Ribavirin, with and without peginterferon-alfa 2a, in patients with chronic hepatitis C (CHC) genotype 3, the commonest genotype in South Asia. METHODS: This study included data of CHC patients from 11 sites in northern India between March 2015 and December 2015 (n = 1203). Patients with CHC genotype 3 (n = 931), who were treated with either Sofosbuvir 400 mg plus weight-based Ribavirin, daily ×24 weeks (n = 432) (dual therapy), or Peginterferon-α2a 180 mcg weekly, Sofosbuvir 400 mg plus weight-based Ribavirin, daily ×12 weeks (n = 499) (triple therapy) were included for analysis. Primary outcome was the proportion of patients achieving sustained viral response at 12 weeks post-therapy. RESULTS: The overall SVR rates were 91 and 92% in the dual and triple therapy arms, respectively. The SVR rates in treatment experienced were 67 and 74% versus 93 and 96% in naïve patients, on the dual and triple therapy arms, respectively. The SVR rates of cirrhotics were 73 and 75% on the dual and triple treatment arms, respectively. The SVR rates were low in the experienced cirrhotic patients: 44% (dual therapy) and 58% (triple therapy). Common adverse events were fatigue, headache, and myalgia. CONCLUSION: Both dual and triple therapy regimes resulted in SVR rates of >95% in CHC genotype 3 who were naive non-cirrhotics. However, the SVR rates were low in treatment-experienced cirrhotics.
BACKGROUND AND AIMS: Recently, Sofosbuvir was launched in India at affordable cost. We conducted a real-life study to determine the efficacy and safety of Sofosbuvir plus Ribavirin, with and without peginterferon-alfa 2a, in patients with chronic hepatitis C (CHC) genotype 3, the commonest genotype in South Asia. METHODS: This study included data of CHCpatients from 11 sites in northern India between March 2015 and December 2015 (n = 1203). Patients with CHC genotype 3 (n = 931), who were treated with either Sofosbuvir 400 mg plus weight-based Ribavirin, daily ×24 weeks (n = 432) (dual therapy), or Peginterferon-α2a 180 mcg weekly, Sofosbuvir 400 mg plus weight-based Ribavirin, daily ×12 weeks (n = 499) (triple therapy) were included for analysis. Primary outcome was the proportion of patients achieving sustained viral response at 12 weeks post-therapy. RESULTS: The overall SVR rates were 91 and 92% in the dual and triple therapy arms, respectively. The SVR rates in treatment experienced were 67 and 74% versus 93 and 96% in naïve patients, on the dual and triple therapy arms, respectively. The SVR rates of cirrhotics were 73 and 75% on the dual and triple treatment arms, respectively. The SVR rates were low in the experienced cirrhotic patients: 44% (dual therapy) and 58% (triple therapy). Common adverse events were fatigue, headache, and myalgia. CONCLUSION: Both dual and triple therapy regimes resulted in SVR rates of >95% in CHC genotype 3 who were naive non-cirrhotics. However, the SVR rates were low in treatment-experienced cirrhotics.
Entities:
Keywords:
Chronic hepatitis C; Pegylated interferon; Sofosbuvir and Ribavirin
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