Decentralized care with generic direct-acting antivirals in the management of chronic hepatitis C in a public health care setting

Authors

Radha K. Dhiman, Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India; Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF), Punjab Government, Punjab, India; Technical Resource Group - National Viral Hepatitis Control Program (NVHCP), Government of India, India; Injection Safety Project, Punjab Government, Punjab, India
Gagandeep S. Grover, Hepatitis C Virus Infection State Program, Punjab, India; Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF), Punjab Government, Punjab, India
Madhumita Premkumar, Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
Sunil Taneja, Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
Ajay Duseja, Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
Sanjeev Arora, ECHO Institute University of New Mexico, USA, New Mexico, United States
Sahaj Rathi, Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
Sandeep Satsangi, Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
Akash Roy, Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India
MMPHCF Investigators

Document Type

Article

Publication Date

12-1-2019

Abstract

BACKGROUND & AIMS: The prevalence of anti-hepatitis C virus antibody in Punjab, India is 3.6%, with 728,000 people estimated to have 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 of eliminating 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 DAA treatment and supervised by telehealth clinics conducted fortnightly. The diagnosis of cirrhosis was based on clinical and radiological evidence, including aspartate aminotransferase-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 individuals with CHC (63.8% male; mean age 42.1 years; 80.5% rural; 14.8% compensated cirrhosis; 69.9% genotype [GT] 3) between 18th June 2016 to 31st July 2018. While 36,250 (75.4%) patients completed treatment, 5,497 (11.4%) had treatment interruptions and 6,341 (13.2%) patients are currently ongoing treatment. Sustained virological response at 12 weeks after treatment completion (SVR12) was achieved in 91.6% of patients 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 patients with successful SVR12 in the interruptions arm were included as cured. SVR12 rates in patients with and without cirrhosis and GT3 versus non-GT3 were comparable. The SVR12 rate was 84.4% in patients who had treatment interruptions.

CONCLUSION: Decentralized care of patients with CHC using generic all-oral DAA regimens is safe and effective regardless of genotype or presence of cirrhosis. ClinicalTrials.gov number: NCT01110447.

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 individuals (63.8% male; mean age 42.1 years; 80.5% rural; 14.8% compensated cirrhotic; 69.9% genotype 3) between 18th June 2016 to 31st July 2018. Cure was achieved in 91.6% of patients, demonstrating that decentralized care of CHC with generic all-oral regimens is safe and effective.

Recommended Citation

Dhiman RK, Grover GS, Premkumar M, Taneja S, Duseja A, Arora S, Rathi S, Satsangi S, Roy A; MMPHCRF Investigators. Decentralized care with generic direct-acting antivirals in the management of chronic hepatitis C in a public health care setting. J Hepatol. 2019 Dec;71(6):1076-1085. doi: 10.1016/j.jhep.2019.07.006. Epub 2019 Jul 17. PMID: 31325468.