Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

Study Overview
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Brief Summary
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REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.

Detailed Description
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The high prices of Hepatitis C Virus (HCV) Direct Acting Antiviral (DAA) medications in many countries have led patients to seek out less expensive generic alternatives. The efficacy and safety of these generic medications has not been formally demonstrated in clinical practice. The primary goal of REDEMPTION is to collate the clinical results of these generic medications. The secondary goal is to answer efficacy questions for which there is currently insufficient trial data available - for example Sofosbuvir+Daclatasvir appears to be an inexpensive pan genotypic solution to treat HCV globally but this is supported by a total n of less than 1000, and in some common genotypes, such as HCV Genotype 2, by an n of only 52 making for a wide margin of error and a high degree of uncertainty.

Official Title
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Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Sofosbuvir+Ledipasvir
* Drug: Sofosbuvir+Daclatasvir
* Drug: Sofosbuvir+Velpatasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Quantitative HCV RNA > 100 Exclusion Criteria: Contraindications to DAA medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sofosbuvir+Ledipasvir<br>Following patients treating with Sofosbuvir+Ledipasvir | Drug: Sofosbuvir+Ledipasvir<br>* DAA medication treatment<br>* Other names: Harvoni (generic);|
| Sofosbuvir+Daclatasvir<br>Following patients treating with Sofosbuvir+Daclatasvir | Drug: Sofosbuvir+Daclatasvir<br>* DAA medication treatment<br>* Other names: Daklinza (generic);|
| Sofosbuvir+Velpatasvir<br>Following patients treating with Sofosbuvir+Velpatasvir | Drug: Sofosbuvir+Velpatasvir<br>* DAA medication treatment<br>* Other names: Epclusa (generic);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR) | Viral load 4 weeks after cessation of treatment as measured by HCV RNA PCR, where SVR is defined as HCV RNA < Lower Limit Of Quantification (LLOQ) | 4-7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects | Collating common side effects on treatment | 3-6 months | 
| Rapid Virological Response (RVR) by HCV RNA PCR | Viral load 4 weeks after starting treatment as measured by HCV RNA PCR | 4 weeks | 
| End Of Treatment (EOT) Response by HCV RNA PCR | Viral load at end of treatment as measured by HCV RNA PCR | 3-6 months | 
| Sustained Virological Response (SVR12) by HCV RNA PCR | Viral load 12 weeks after cessation of treatment as measured by HCV RNA PCR, where SVR is defined as HCV RNA < Lower Limit Of Quantification (LLOQ) | 6-12 months |