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.

To evaluate the safety & efficacy of Sofosbuvir-Velpatasvir combination in real world setting in Pakistan. Further, this study aims to assess sustained virologic response at 12 weeks after the end of therapy.

prospective, open label, single arm, intervention & multi center trial.

Study is to be conducted at Gastroenterology department in Jinnah Post-graduate Medical center Karachi, Jinnah Hospital Lahore, Gulab Devi Hospital Lahore, Hayatabad Medical Complex Peshawar, and Pakistan Institute of Medical Sciences, Islamabad, Pakistan. Hepatitis-C patients visiting gastroenterology department of the mentioned institutes would be enrolled after meeting selection criteria. Treatment naive or treatment experienced patients would be prescribed sofosbuvir-velpatasvir combination for 12 weeks as per physician's discretion. Patients would be followed at week 04, week 12 and week 24 of the baseline visit.

Inclusion Criteria: Subjects willing to undergo screening and sign informed consent. Male or female outpatients ≥18 years of age. Serologically and histologically proven CHC, detectable HCV RNA, elevated ALT, and compensated liver disease. Exclusion Criteria: Unable to give written informed consent. Pregnant and/or Nursing Women. Contraindicated to medicine or any of the component of prescribed therapy

sofosbuvir 400 mg + Velpatasvir 100 mg combination

Primary Outcome: Sustained Virologic Response (SVR) assessed at week 24 from baseline visit through HCV-RNA PCR. Secondary Outcome: End of treatment response (ETR) would be assessed at week 12 from baseline visit through HCV-RNA PCR.

To maintain the participants' confidentiality, however data would be made available if Ethics committee and local regulatory bodies demands.

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.