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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.
Full 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.
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Inclusion criteria
Quantitative HCV RNA > 100
Exclusion criteria
Contraindications to DAA medications
10,000 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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