title: Results of sofosbuvir-based combination therapy for chronic hepatitis C cohort of Indian patients in real-life clinical practice.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Sofosbuvir-based treatment regimens achieve high SVR rates in real-life cohort of Indian patients with chronic hepatitis C infection (including those with cirrhosis).
authors: Department of Gastroenterology, Dayanand Medical College, Ludhiana, Punjab, India.
authors: Ajit
authors: A
authors: Sood
authors: Department of Internal Medicine, Dayanand Medical College, Ludhiana, Punjab, India.
authors: Vandana
authors: V
authors: Midha
authors: Department of Gastroenterology, Dayanand Medical College, Ludhiana, Punjab, India.
authors: Ramit
authors: R
authors: Mahajan
authors: Department of Pathology, Dayanand Medical College, Ludhiana, Punjab, India.
authors: Vikram
authors: V
authors: Narang
authors: Department of Gastroenterology, Dayanand Medical College, Ludhiana, Punjab, India.
authors: Varun
authors: V
authors: Mehta
authors: Dayanand Medical College, Ludhiana, Punjab, India.
authors: Praneet
authors: P
authors: Wander
authors: College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.
authors: Suresh
authors: S
authors: Sharma
authors: Dayanand Medical College, Ludhiana, Punjab, India.
authors: Kirandeep
authors: K
authors: Kaur
authors: Dayanand Medical College, Ludhiana, Punjab, India.
authors: Dharmatma
authors: D
authors: Singh
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage*; D044466:Asian People; D015331:Cohort Studies; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007194:India; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage; D000069474:Sofosbuvir / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a; D000069474:Sofosbuvir
keywords: SVR; chronic hepatitis C; real-life experience; sofosbuvir