Re-treatment of HCV Following DAA Failure - Trial NCT03483987

Timeline & Enrollment

Primary Outcome

SVR12

Summary

HCV infection is treated with oral drugs, termed as 'direct-acting anti-viral agents' (DAAs).
 In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and
 velpatasvir [VEL]). Globally, DAA based regimens have obtained excellent rates of cure. Cure
 of HCV infection is defined as undetectable HCV RNA 12 weeks after stopping drugs, also
 referred to as sustained virological response at week 12 (SVR12).
 
 Using these DAA based treatment regimens, a small number (up to 5%) of people fail to achieve
 SVR12 and HCV RNA reappear after a few weeks of stopping the drugs (virological relapse).
 Data on management of virological relapse are extremely limited, especially in genotype 3,
 and no guidelines exist regarding re-treatment options for such group. Hence, we plan to
 re-treat such people using what appear to be the best combination treatment in each situation
 and to review our experience over time.
 
 Participants with chronic HCV infection who relapsed following standard DAA-based treatment
 regimen will be invited to participate. We propose to re-treat them with the anti-HCV drug
 combination which appears to be the most suited to his/her clinical profile, based on the
 current empiric knowledge - the choice of drugs will be based on HCV genotype, the previous
 treatment regimen and the presence/absence of liver cirrhosis, etc.
 
 During anti-HCV treatment, participants will be given expected standard of care and HCV RNA
 will be tested at 4-week intervals starting from week 4 and till RNA becomes undetectable,
 and then at the end of treatment and 12 weeks after the treatment was stopped - as is the
 usual practice during such treatment. Relevant clinical, laboratory and treatment details
 will be recorded in a pre-defined data collection form. Treatment outcome will be categorized
 as success (SVR12), treatment failure (any detectable HCV RNA at the end of 24 weeks
 treatment duration) or relapse (HCV RNA negative at the end of treatment, but positive at 12
 weeks after stopping treatment).
 
 If possible, a 5-ml blood specimen will be collected before starting re-treatment from all
 participants; in addition, another similar specimen will be collected following the treatment
 in those in whom the re-treatment is unsuccessful. These will be stored and may be used in
 future for virological studies to look for drug-resistance variations.

ICD-10 Classifications