Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

FixHepC10,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Hepatitis C

Interventions

Sofosbuvir+LedipasvirDRUG

DAA medication treatment

Sofosbuvir+DaclatasvirDRUG

DAA medication treatment

Sofosbuvir+VelpatasvirDRUG

DAA medication treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 82 Years

Medical Language ↔ Plain English

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

Locations (1)

FixHepC

Hobart, Tasmania, Australia

Outcomes

Primary Outcomes

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)

Time frame: 4-7 months

Secondary Outcomes

Side Effects

Collating common side effects on treatment

Time frame: 3-6 months

Rapid Virological Response (RVR) by HCV RNA PCR

Viral load 4 weeks after starting treatment as measured by HCV RNA PCR

Time frame: 4 weeks

End Of Treatment (EOT) Response by HCV RNA PCR

Viral load at end of treatment as measured by HCV RNA PCR

Time frame: 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)

Time frame: 6-12 months

Data from ClinicalTrials.gov

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