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). These drugs are type of direct-acting antiviral (DAA) combination therapy.

For each therapy, the trial will evaluate the effectiveness of four strategies in which the amount of drug used and/or the cost of drug used to cure someone with Hepatitis C could be reduced, as well as providing evidence on different approaches to treatment that may be tailored to individual needs:

  • Demonstrating that an alternative DAA combination therapy works just as well as current standard treatment, thereby increasing market competition and lowering prices.
  • Tailoring the length of DAA treatment based on early responses to treatment, as was previously done with interferon-based regimens using rapid virological response.
  • Using an additional (adjunctive) therapy, pegylated interferon (PEG-IFN), in combination with DAAs to optimise cure rates with reduced drug exposure.
  • Altering the dosing schedule to an induction-maintenance approach, thereby reducing the number of pills patients have to take and helping them stick to their treatment regimen.

Who is funding the study?

This study is funded by the Wellcome Trust.

When is it taking place?

Trial opened in 2019 and is expected to run until 2024.

Where is it taking place?


Who is included?

We aim to recruit 624 non-cirrhotic participants with chronic infection with Hepatitis C.