Clinical trial NCT03488485: Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Official title: Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis c
Keywords: Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF
Direct antivirals, DAAs
Chronic hepatitis C
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: Directorate of Health and Family Welfare, Punjab
First posted: 2018-04-05
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Real Life Efficacy Study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sustained Virological Response
timeFrame: Up to study completion ( average 12 -24 weeks after therapy)
Secondary outcomes:
measure: Serious adverse effects
timeFrame: Up to study completion ( average 12 -24 weeks after therapy)
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References: