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Results of sofosbuvir‐based combination therapy for chronic hepatitis C cohort of Indian patients in real‐life clinical practice
Author(s) -
Sood Ajit,
Midha Vandana,
Mahajan Ramit,
Narang Vikram,
Mehta Varun,
Wander Praneet,
Sharma Suresh,
Kaur Kirandeep,
Singh Dharmatma
Publication year - 2017
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.13628
Subject(s) - sofosbuvir , medicine , ribavirin , tolerability , gastroenterology , cirrhosis , pegylated interferon , hepatitis c , viral load , hepatitis c virus , clinical trial , combination therapy , adverse effect , immunology , virus
Background and Aim The introduction of sofosbuvir has revolutionized the treatment of chronic hepatitis C. This study was planned to observe whether the efficacy and tolerability of sofosbuvir‐based regimens demonstrated in phase 3 clinical trial results translate into real‐life clinical practice. Methods This prospective, non‐randomized observational study conducted in Dayanand Medical College and Hospital, Punjab, included all consecutive treatment‐naïve patients with chronic hepatitis C (genotypes 1–5) who were treated with sofosbuvir‐based regimens. Response to therapy was assessed at week 4 (rapid virological response), week 12 or 24 (end of treatment response), and 12 weeks after cessation of therapy (sustained virological response [SVR]). Results Of 947 patients diagnosed with chronic hepatitis C virus and considered for treatment with direct‐acting antivirals, 736 patients (77.1%) opted for treatment (age 45.1 ± 10.1 years, 64% men, genotype 3 [80%], genotype 1 [14.7%], and genotype 4 [4.9%]). Viral load was high (>600 000 IU/mL) in 361/736 (49%); 330 patients (44.8%) had cirrhosis (80 [14.3%] were decompensated). Patients with genotypes 1, 4, and 5 ( n = 135) were treated with triple drug regime (pegylated interferon, ribavirin, and sofosbuvir) for 12 weeks. Patients with genotype 3 ( n = 589) were treated either with dual therapy (sofosbuvir and ribavirin) for 24 weeks ( n = 405) or triple therapy for 12 weeks ( n = 184). SVR was achieved in 453/473 (95.8%). SVR rates did not differ among different genotypes but were higher in non‐cirrhotics. Conclusion Sofosbuvir‐based treatment regimens achieve high SVR rates in real‐life cohort of Indian patients with chronic hepatitis C infection (including those with cirrhosis).