Ajit Sood1, Vandana Midha2, Ramit Mahajan1, Vikram Narang3, Varun Mehta1, Praneet Wander4, Suresh Sharma5, Kirandeep Kaur4, Dharmatma Singh4. 1. Department of Gastroenterology, Dayanand Medical College, Ludhiana, Punjab, India. 2. Department of Internal Medicine, Dayanand Medical College, Ludhiana, Punjab, India. 3. Department of Pathology, Dayanand Medical College, Ludhiana, Punjab, India. 4. Dayanand Medical College, Ludhiana, Punjab, India. 5. College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India.
Abstract
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).
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).
Authors: S S Solomon; M S Sulkowski; P Amrose; A K Srikrishnan; A M McFall; B Ramasamy; M S Kumar; S Anand; D L Thomas; S H Mehta Journal: J Viral Hepat Date: 2017-08-14 Impact factor: 3.728
Authors: Yuely A Capileno; Rafael Van den Bergh; Dmytro Donchunk; Sven Gudmund Hinderaker; Saeed Hamid; Rosa Auat; Gul Ghuttai Khalid; Razia Fatima; Aashifa Yaqoob; Catherine Van Overloop Journal: PLoS One Date: 2017-04-27 Impact factor: 3.240
Authors: Ajit Sood; A Suryaprasad; A Trickey; S Kanchi; V Midha; M A Foster; E Bennett; S Kamili; F Alvarez-Bognar; S Shadaker; V Surlikar; R Garg; P Mittal; S Sharma; M T May; P Vickerman; F Averhoff Journal: PLoS One Date: 2018-07-26 Impact factor: 3.240