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

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.

• Authors: Radha K Dhiman, Gagandeep S Grover, Madhumita Premkumar, Sunil Taneja, Ajay Duseja, Sanjeev Arora, Sahaj Rathi, Sandeep Satsangi, Akash Roy, MMPHCRF Investigators
• Journal: Journal of hepatology (J Hepatol) Vol. 71 Issue 6 Pg. 1076-1085 (12 2019) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 31325468 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019. Published by Elsevier B.V.

Chemical References

• Antiviral Agents
• Benzimidazoles
• Fluorenes
• ledipasvir
• Ribavirin
• Sofosbuvir

Topics

• Adult
• Antiviral Agents (administration & dosage, adverse effects)
• Benzimidazoles (administration & dosage, adverse effects)
• Clinical Protocols (classification)
• Delivery of Health Care (methods, organization & administration, standards)
• Disease Eradication (methods, organization & administration)
• Drug Therapy, Combination
• Female
• Fluorenes (administration & dosage, adverse effects)
• Hepatitis C, Chronic (complications, diagnosis, drug therapy, epidemiology)
• Humans
• India (epidemiology)
• Liver Cirrhosis (diagnosis, epidemiology, prevention & control, virology)
• Male
• Public Health (methods)
• Ribavirin (administration & dosage, adverse effects)
• Sofosbuvir (administration & dosage, adverse effects)
• Sustained Virologic Response
• Telemedicine (methods, trends)