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| Name | Class |
|---|---|
| Directorate of Health and Family Welfare, Punjab | OTHER |
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The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed
Consecutive chronic hepatitis C (HCV) infected children [age: ≥12 to <18 years; both treatment-naïve (TN) and treatment-experienced, (TE)] are being enrolled.
Genotyping is not recommended for non-cirrhotic or TN patients and are treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis and TE patients.
Patients with liver cirrhosis or TE and genotype (GT)-3 are being treated with SOF+DCV for 24 weeks,
while non-GT-3 patients are being treated with SOF+LDV for 24-weeks. Patients < 35 kg are being given half doses of medications and patients ≥35 kg are being given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non cirrhotic | Active Comparator | Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg), LDV (90 mg) and DCV (60 mg) per day |
|
| Genotype 1,4,5 and 6 with cirrhosis | Active Comparator | Sofosbuvir (SOF)+ Ledipasvir (LDV) for 12-weeks + weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and LDV (90 mg) per day |
|
| Genotype 2 and 3 with Cirrhosis | Active Comparator | Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks+ weight based Ribavirin Patients < 35 kg will be given half doses of medications and patients ≥35 kg will be given adult dosages of SOF (400 mg) and DCV (60 mg) per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Acting Antivirals | Drug | Sofosbuvir and Daclatasvir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virological Response (SVR 12) | HCV RNA undetectable by quantitative Real time Polymerase Chain Reaction (PCR) | 12 weeks after completion of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radha K Dhiman, DM | Contact | 911722756335 | rkpsdhiman@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Medical Education and Research | Recruiting | Chandigarh | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30211847 | Derived | Dhiman RK, Grover GS, Premkumar M, Taneja S, Duseja A, Rathi S, Satsangi S. Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):74-80. doi: 10.1097/MPG.0000000000002139. |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| DAAs in Cirrhotics Genotype 2/3 | Drug | Sofosbuvir and Daclatasvir with weight based ribavirin |
|
| DAAs in Cirrhotics Genotye 1,4,5,6 | Drug | Sofosbuvir and Ledipasvir with weight based ribavirin |
|
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |