Decentralized Care with Generic Direct-Acting Antivirals in the Management of Chronic Hepatitis C in a Public Health Care Setting

Abstract Background and Aims The prevalence of anti-hepatitis C virus antibody in Punjab, India is 3.6% with an estimated 728,000 persons with viremic chronic hepatitis C (CHC). The Mukh-Mantri Punjab Hepatitis C Relief Fund, launched on 18th June 2016, provides no-cost generic direct-acting antivirals (DAAs) with sofosbuvir+ledipasvir±ribavirin or sofosbuvir+daclatasvir±ribavirin with the goal to eliminate CHC from Punjab. We assessed the safety and efficacy of decentralized treatment of CHC in a public health care setting. Methods Primary care providers from 3 University and 22 District Hospitals were trained to provide algorithm based DAAs treatment and supervised by telehealth clinics conducted fortnightly. The diagnosis of cirrhosis was based on clinical and radiological evidence, including AST-to-platelet ratio index (APRI ≥2.0) and FIB-4 score (>3.25) or on liver stiffness measurement ≥12.5 kPa on Fibroscan. Results We enrolled 48,088 persons with CHC (63.8% male; mean age 42.1 years; 80.5% rural; 14.8% compensated cirrhosis; 69.9% genotype[G]3) between 18thJune2016 to 31stJuly2018. While 36,250 (75.4%) persons completed treatment, 5497 (11.4%) had treatment interruptions and 6341 (13.2%) persons are currently ongoing treatment. SVR-12 was achieved in 91.6% of persons per protocol, 67.6% in intention to treat (ITT) analysis where all interruptions were treated as failures and 91.2% in a modified ITT analysis where all persons with successful SVR-12 in the interruptions arm were included as cured. SVR-12 rates in persons with and without cirrhosis and G3 versus non-G3 were comparable. SVR-12 was 84.4% of persons who had treatment interruptions. Conclusion Decentralized care of CHC with generic all oral DAA regimens is safe and effective regardless of genotype or presence of cirrhosis. Lay Summary • We assessed the safety and efficacy of public health care using no-cost all oral generic direct acting antiviral drugs against hepatitis C in the state of Punjab, India. • The goal is elimination of chronic hepatitis C (CHC) by 2030 and involves primary care providers at 25 sites in the state. • We enrolled 48,088 persons (63.8% male; mean age 42.1 years; 80.5% rural; 14.8% compensated cirrhotic; 69.9% genotype 3) between 18thJune2016 to 31stJuly2018. • Cure was achieved in 91.6% patients demonstrating that Decentralized care of CHC with generic all oral regimens is safe and effective.