Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Background and Aims: The prevalence of hepatitis C virus infection (HCV) infection in Punjab,
 India is 3.29%, with an estimated burden of around 650,000 viremic chronic HCV (CHC)
 patients. The Mukh Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) was launched in June 2016
 to provide free treatment to all CHC aiming to eliminate HCV from Punjab. The study assessed
 the feasibility of decentralized care and efficacy and safety of 12 or 24 weeks of sofosbuvir
 (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV) in the treatment of CHC
 patients in a public health care setting.
An algorithm was developed using SOF-based regimens to treat all patients (RKD). Genotyping
 is not recommended for patients without cirrhosis of liver and they are being treated with
 SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis of liver
 (Figure 1). Patients with liver cirrhosis and genotype 3 are being treated with SOF+DCV+RBV
 for 24 weeks, while non-genotype 3 patients are being treated with SOF+LDV+RBV for 12-weeks
 or with SOF+LDV for 24-weeks (in RBV intolerant patients). SVR-12 is mandatory in all
 patients. Methods: Decentralized care: All patients are being evaluated and treated at 3
 Government Medical Colleges and 22 District Hospitals; they were followed up to 12 weeks
 post-treatment to look for sustained viral response (SVR-12). Health care worker capacity
 building: 90 medical specialists were trained in a 4-hr predefined course, followed by online
 continued medical education sessions by regular Extension for Community Healthcare Outcomes
 (ECHO) Clinic are being conducted fortnightly. 50 pharmacists, 2 from each of the 25 centres,
 dispense medicine as per specialist prescription. Data Management: 25 trained data entry
 operators and Clinton Health Access Initiative (CHAI) are managing epidemiological data on
 CHC hotspots, high-risk groups, local service providers, etc. Monitoring: Medical alerts are
 being used for compliance monitoring. Study design: A cost-effective algorithm has been
 developed using SOF-based regimens to treat all patients. The diagnosis of cirrhosis is based
 on clinical evidence including Aspartate Transaminase (AST)-to-platelet ratio index (APRI ≥
 2.0) and FIB-4 score (>3.25) or on liver stiffness measurement (LSM) ≥12.5 kilopascal (kPa)
 on fibroscan. The study aims to validate the efficacy and safety of generic all oral Direct
 Acting Antiviral (DAA) regimens in a decentralized algorithm based public health model in
 Punjab, India regardless of genotype/presence of cirrhosis.
Inclusion Criteria:

 -  Chronic Hepatitis C

 -  Age: >18 years

 Exclusion Criteria:

 -  Chronic liver disease of a non-HCV etiology

 -  Serum Creatinine >1.5 mg/dl

 -  Evidence of hepatocellular carcinoma or other malignancy

 -  Significant cardiovascular, pulmonary, or neurological disease

 -  History of solid organ or bone marrow transplantation.