Two interferon-free regimens have high hepatitis C cure rates for people with HIV

David Wyles and Susanna Naggie presenting at CROI 2015. Photo by Liz Highleyman, hivandhepatitis.com.

David Wyles and Susanna Naggie presenting at CROI 2015. Photo by Liz Highleyman, hivandhepatitis.com.

Story via NAM (@aidsmap)

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A pair of two-drug, 12-week regimens containing neither interferon nor ribavirin cured hepatitis C for more than 95% of people with HIV and hepatitis C co-infection, according to two studies presented to CROI this week.

The first regimen was sofosbuvir plus ledipasvir (Harvoni coformulation), produced by Gilead. The second was sofosbuvir (Sovaldi) plus daclatasvir (Daklinza), with the latter drug produced by Bristol-Myers Squibb. Ledipasvir and daclatasvir are both NS5A inhibitors.

In both studies, the response rates in people with HIV and hepatitis C co-infection were as high as those for people with hepatitis C mono-infection in other trials. This supports recent hepatitis C treatment guidelines recommending that HIV-positive and HIV-negative people should be treated in the same way for hepatitis C.

For sofosbuvir plus ledipasvir (Harvoni), 335 people with co-infection took part in the open-label, non-randomised study. The trial had broad inclusion criteria and included more difficult-to-treat groups such as prior non-responders and people with liver cirrhosis than many other studies. Almost all had genotype 1, more than half were treatment-experienced and three-quarters had unfavourable IL28B gene variants. All were taking HIV treatment and most had an undetectable viral load.

Participants took a once-daily tablet for twelve weeks, with an additional twelve weeks follow-up to assess sustained virological response (SVR12), or continued undetectable hepatitis C. The overall SVR12 rate was 96%, similar to that in people with mono-infection. Having taken treatment before, having liver cirrhosis or NS5A resistance variants made little difference to the cure rate.

However, SVR12 rates were slightly lower in participants who were black. This had not been observed in mono-infection studies. One possible explanation, which will be explored, is an influence of genetics on drug response when both ledipasvir and antiretrovirals are used.

For sofosbuvir (Sovaldi) plus daclatasvir (Daklinza), 151 previously untreated individuals with co-infection were randomised to either eight or twelve weeks of the regimen, while 52 treatment-experienced individuals all took it for twelve weeks. Almost all participants were taking HIV treatment and had an undetectable viral load.

While two-thirds had hepatitis C genotype 1a, people with genotypes 2 to 6 were included – an advantage of daclatasvir is that it is active against multiple genotypes whereas ledipasvir is primarily active against genotype 1.

Participants randomised to take the once-daily tablets for eight weeks had poorer results (SVR12 76%), but the twelve-week course worked well – an SVR12 of 96% in people who had never taken treatment before and 98% in treatment-experienced individuals. Rates were similar across genotypes.

Both regimens studied were generally safe and well-tolerated.

Related links
Read this news story in full on aidsmap.com
View a webcast of Susanna Naggie presenting
View a webcast of David Wyles presenting

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