Hepatitis C
Conditions
Brief summary
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
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.
Interventions
DRUGSofosbuvir+Ledipasvir
DAA medication treatment
DRUGSofosbuvir+Daclatasvir
DAA medication treatment
DAA medication treatment
Sponsors
FixHepC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
Quantitative HCV RNA \> 100
Exclusion criteria
Contraindications to DAA medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response 4 (SVR4) by Hepatitis C Virus (HVC) RNA Polymerase Chain Reaction (PCR) | 4-7 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | 3-6 months | Collating common side effects on treatment |
| Rapid Virological Response (RVR) by HCV RNA PCR | 4 weeks | Viral load 4 weeks after starting treatment as measured by HCV RNA PCR |
| End Of Treatment (EOT) Response by HCV RNA PCR | 3-6 months | Viral load at end of treatment as measured by HCV RNA PCR |
| Sustained Virological Response (SVR12) by HCV RNA PCR | 6-12 months | 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) |
Countries
Australia
Outcome results
None listed