A strategic post-licensing trial of oral direct acting antiviral Hepatitis C treatment in VIETNam incorporating a novel design with multiple ARMS
Which approaches can reduce the amount of drug needed to treat hepatitis C and does choice of drug matter?
What is this study about?
The VIETNARMS trial will test two different first-line therapies, sofosbuvir/daclatasvir (SOF/DCV) and sofosbuvir/velpatasvir (SOF/VEL). For each, it will evaluate the efficacy of four strategies in which the amount of drug used and/or the cost of drug used to cure an HCV-infected person could be reduced, as well as providing evidence on different approaches to treatment that may be tailored to individual needs, namely
i) By demonstrating non-inferiority of alternative DAA combination therapy, thereby increasing competition and lowering prices.
ii) By tailoring duration of DAA treatment based on early treatment response, as was previously done with interferon-based regimens using rapid virological response.
iii) By using adjunctive therapies (ribavirin (RBV), pegylated interferon (PEG-IFN)) in combination with DAAs to optimise cure rates with reduced drug exposure.
iv) By altering dosing schedule to an induction-maintenance approach, thereby reducing total pill burden and facilitating treatment adherence.
Who is funding the study?
Wellcome Trust (UK)
When is it taking place?
2019 - 2024
Where is it taking place?
Who is included?
1092 non-cirrhotic participants with chronic infection with HCV