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VIETNARMS trial offers new treatment options for people with hepatitis C

08 May 2025

Results from the VIETNARMS trial provide new evidence of effective treatment options for people with hepatitis C infection that could improve access to curative therapy in a range of settings.

The findings published today in The Lancet address two questions: (i) which of the recommended WHO first-line treatments performs best in those with mild-to-moderate liver disease?  And (ii) what approaches to treatment can be effective for those who struggle to adhere to a 12-week course of treatment?

Hepatitis C is a viral infection that damages the liver, potentially leading to liver failure and/or liver cancer. Treatment takes the form of direct-acting antiviral (DAA) tablets. Currently, the standard-of-care in low- and middle-income countries is one of two drug combinations: sofosbuvir and daclatasvir (SOF/DCV) or sofosbuvir and velpatasvir (SOF/VEL).

Uptake of treatments differs between countries. Prior to the VIETNARMS study, there was concern that SOF/VEL may be less effective in populations with a high proportion of rare viral genotypes (such as genotype 6 in Vietnam). The two regimens had never been directly compared in clinical trials until now.

The VIETNARMS trial included 624 people with hepatitis C infection and mild liver disease in Vietnam. They were randomly assigned to receive either SOF/DCV or SOF/VEL DAA tablets.

The VIETNARMS trial confirmed previous findings that both drug combinations were very effective at treating hepatitis C. Despite its reputation as a less effective drug, SOF/DCV actually performed slightly better than SOF/VEL: 97.4% of participants taking SOF/DCV had a sustained viral response 12 weeks after treatment ended, compared to 95.1% of those taking SOF/VEL, with a 93% probability that SOF/DCV was more effective.

found that both drugs were effective across all genotypes, particularly genotype 6, which is common in Vietnam. The team found no evidence that either drug was more effective at treating any particular genotype.

These data are helpful for low-income countries looking to decide on the best treatments to include in their hepatitis elimination programmes. SOF/DCV was one of the first treatment combinations, but for commercial reasons, it is no longer available in most high-income healthcare systems. However, the combination is due to come off patent in and, in future, may provide an option in all healthcare settings.

Many countries’ current priority is to make treatment available to as many people as possible as simply as possible. However, as those able to take treatment are cured, more focus will be needed on those who struggle to access care, either because of the price or because of the challenge of taking treatment for 12 weeks. This can be especially difficult for those with dependency or mental health challenges.

To address this second challenge, the VIETNARMS trial studied four strategies for treatment tested across both drug combinations:

  • Standard-of-care: Participants take their assigned DAA tablets daily for 12 weeks, in line with current recommendations.
  • Induction maintenance: Participants take their assigned DAA tablets daily for two weeks, before reducing this to five days per week for the remaining 10 weeks (“weekends off”).
  • Injectable pegylated interferon (PEG-IFN): Participants take their assigned DAA tablets daily for just four weeks, alongside injections of a drug called PEG-IFN once a week.
  • Response guided treatment: After one week of daily DAA tablets, participants’ viral response to treatment is measured. Depending on this response, the length of treatment may be shortened to four or eight weeks or may remain at 12 weeks.

Compared to standard-of-care, the other treatment strategies substantially reduced drug exposure, and participants were less likely to miss doses. All strategies were non-inferior to standard-of-care, meaning they were not worse than standard-of-care by more than a pre-specified amount (here 10%).

Induction maintenance was the most effective strategy, with 99.3% of participants showing a sustained viral response 12 weeks after treatment compared to 98.7% of participants on standard-of-care.

Both other strategies achieved slightly lower, but still high, rates of cure: 94.1% of the PEG-IFN group and 92.9% of the response-guided treatment group had a sustained viral response 12 weeks after treatment.

Within the response-guided treatment group, participants with the lowest viral loads one week after starting treatment, who then had just four weeks of treatment, did worse than those with higher viral loads at one week who had eight or 12 weeks. Previous clinical trials had found that four weeks of DAA treatment alone is not enough for unselected patients; VIETNARMS showed that this was also the case for people with the best initial response. However, participants in the PEG-IFN group, who also had DAA treatment for just four weeks, did well, demonstrating the effectiveness of PEG-IFN.

It was very rare for participants to experience side effects from either drug combination. Participants assigned to the PEG-IFN strategy were more likely than those on other treatment strategies to report side effects, but these were short-lived, mild, and known effects of PEG-IFN injections.

The VIETNARMS trial results create a range of treatment options for people with hepatitis C who would struggle to access or stick to the current 12-week regimens with daily tablets. These findings could offer patients the choice of shorter regimens or taking weekends off treatment, while still curing hepatitis C infection effectively. Furthermore, demonstrating that both recommended DAA drug combinations are highly effective could increase market competition and lower the price of treatment in low- and middle-income countries.

VIETNARMS is the only trial of its kind to provide key information for both governments and prescribers as they seek to eliminate viral hepatitis as a public health threat.

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