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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir+Ledipasvir | Following patients treating with Sofosbuvir+Ledipasvir |
| |
| Sofosbuvir+Daclatasvir | Following patients treating with Sofosbuvir+Daclatasvir |
| |
| Sofosbuvir+Velpatasvir | Following patients treating with Sofosbuvir+Velpatasvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir+Ledipasvir | Drug | DAA medication treatment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Quantitative HCV RNA > 100
Exclusion Criteria:
Contraindications to DAA medications
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Worldwide, Hepatitis C Genotypes 1-6
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| Name | Affiliation | Role |
|---|---|---|
| James Freeman, MB,BS,BSc | ACRRM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FixHepC | Hobart | Tasmania | 7004 | Australia |
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| Label | URL |
|---|---|
| REDEMPTION Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 13, 2019 | |
| Reset | May 13, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 13, 2019 | May 13, 2019 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
| D016568 | Drugs, Generic |
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
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| Sofosbuvir+Daclatasvir | Drug | DAA medication treatment |
|
|
| Sofosbuvir+Velpatasvir | Drug | DAA medication treatment |
|
|
| 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 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |