IRCT20170614034526N4 IRCT 2019-03-28 Hilton Pharma Pvt Ltd Efficacy & Safety of Velpatasvir-Sofosbuvir combination in treatment of Hepatitis-C patients of Pakistan, Phase-IV Interventional Trial CAVES-IT A prospective, interventional, multi-center trial to evaluate the Efficacy and Safety of Sofosbuvir-Velpatasvir for the treatment of Chronic Hepatitis C patients in Pakistan. 2018-04-02 anticipated 155 Complete https://irct.ir/trial/38095 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Chronic Hepatitis-C. Intervention group: Sofosbuvir 400 mg + Velpatasvir 100 mg once daily for 12 weeks. https://www.cureus.com/articles/25447-efficacy-and-safety-of-sofosbuvir-velpatasvir-combination-in-hepatitis-c-virus-infected-pakistani-patients-without-cirrhosis-or-with-compensated-cirrhosis-a-prospective-open-label-interventional-trial Background In Pakistan, there is a paucity of published clinical data regarding the efficacy of sofosbuvir-velpatasvir in the management of patients with hepatitis C without cirrhosis or with compensated cirrhosis. Methods A prospective, open-label, multicenter, interventional trial was conducted in patients with hepatitis C without cirrhosis or with compensated cirrhosis. Hepatitis C patients without cirrhosis or with compensated cirrhosis were screened, and 133 patients were enrolled in the study. They received sofosbuvir 400 mg plus velpatasvir 100 mg combination once daily for 12 weeks. Patients were followed up for six months after the start of therapy. Hepatitis C viral load was assessed at baseline, at week 12, and after 24 weeks following the start of the treatment. The trial was prospectively registered with the Iranian Registry of Clinical Trials (IRCT) with the identification number IRCT20170614034526N4. Results Among enrolled patients, 79 were male, and 54 were female. Ninety-five (71.4%) patients were without cirrhosis, and 38 had compensated cirrhosis. Patients without cirrhosis had a mean age of 45.90 ±10.99 years, and patients with compensated cirrhosis had a mean age of 52.60 ±12.29 years. As per the intention-to-treat analysis, all patients without cirrhosis and 35 (92.1%) patients with compensated cirrhosis achieved undetectable viral load hepatitis C virus (HCV) ribonucleic acid (RNA) of <15 IU/mL at 12 weeks from the start of treatment. Eighty-six (90.5%) patients without cirrhosis achieved sustained virologic response 12 weeks after the end of therapy. Patients with compensated cirrhosis experienced more adverse events (31.5%) than patients without cirrhosis (20.15%). Conclusion Direct-acting antiviral therapy using sofosbuvir and velpatasvir combination is effective and safe in HCV patients without cirrhosis and patients with compensated cirrhosis. No - There is not a plan to make this available Justification or reason for not sharing IPD is To maintain the participants' confidentiality, however data would be made available if Ethics committee and local regulatory bodies demands.