Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION)

FixHepC

Status: Unknown

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir+Ledipasvir; Drug: Sofosbuvir+Velpatasvir; Drug: Sofosbuvir+Daclatasvir

Study type: Observational

Funder types: Other

Identifiers

NCT02657694

REDEMPTION

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Quantitative HCV RNA > 100

Exclusion criteria

Contraindications to DAA medications

Trial design

10,000 participants in 3 patient groups

Sofosbuvir+Ledipasvir

Description:

Following patients treating with Sofosbuvir+Ledipasvir

Treatment:

Drug: Sofosbuvir+Ledipasvir

Sofosbuvir+Daclatasvir

Description:

Following patients treating with Sofosbuvir+Daclatasvir

Treatment:

Drug: Sofosbuvir+Daclatasvir

Sofosbuvir+Velpatasvir

Description:

Following patients treating with Sofosbuvir+Velpatasvir

Treatment:

Drug: Sofosbuvir+Velpatasvir