VIETNARMS

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?

Vietnam

Who is included?

1092 non-cirrhotic participants with chronic infection with HCV