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Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model

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ClinicalTrials.gov Identifier: NCT03488485
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Directorate of Health and Family Welfare, Punjab
Information provided by (Responsible Party):
Radha K Dhiman, Postgraduate Institute of Medical Education and Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis c Drug: Direct Acting Antivirals Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Real Life Efficacy Study
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Actual Study Start Date : June 18, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
DAA arm

Direct Acting Antivirals therapy An algorithm was developed using DAA (Sofosbuvir-based regimens to treat all patients (RKD).

Non Cirrhotics: Sofosbuvir (SOF)+ Daclatasvir (DCV) for 12-weeks

Cirrhotics:

Genotype 3 were treated with SOF+DCV+ ribavirin (RBV) for 24 weeks, Non-Genotype 3 patients were treated with SOF+LDV+RBV for 12-weeks or with SOF+LDV for 24-weeks (in RBV intolerant patients).

 Drug: Direct Acting Antivirals
DAAs given in patients with viremic chronic hepatitis C
Other Names:
  • Sofosbuvir
  • Daclatasvir
  • Ledipasvir


Outcome Measures
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Primary Outcome Measures :
  1. Sustained Virological Response [ Time Frame: Up to study completion ( average 12 -24 weeks after therapy) ]
    HCV RNA Load undetectable


Secondary Outcome Measures :
  1. Serious adverse effects [ Time Frame: Up to study completion ( average 12 -24 weeks after therapy) ]
    Assessment of drug related adverse effects, clinical events, decompensation of liver disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488485


Contacts
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Contact: Radha K Dhiman, DM 911722756335 rkpsdhiman@hotmail.com

Locations
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India
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Radha K Dhiman, DM    911722756335    rkpsdhiman@hotmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Directorate of Health and Family Welfare, Punjab
More Information
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Responsible Party: Radha K Dhiman, Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03488485    
Other Study ID Numbers: IEC/2018/000324
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radha K Dhiman, Postgraduate Institute of Medical Education and Research:
Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF
Direct antivirals, DAAs
Chronic hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Ledipasvir
Antiviral Agents
Anti-Infective Agents