6 week treatment cures almost all “hard to treat” participants
A six-week treatment of sofosbuvir (Sovaldi), ledipasvir and a third drug cured a majority of people with genotype 1 Hep C virus who had never been treated before, according to research presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI 2014) in Boston.
The study was run by the US National Institutes of Allergy and Infectious Disease (NIAID). NIAID is conducting trials of simplified, more tolerable Hep C treatments in people who experience barriers to accessing treatment and challenges with treatment adherence.
Of the 60 study participants, most were living on a low income. The majority of participants had factors associated with a poor response to treatment, including male gender, genotype 1a virus and carrying a gene that is associated with a poor response to interferon (IL28B CT or TT). One quarter of participants had severe liver damage.
There were three trial arms:
- Sofosbuvir (Sovaldi) and ledipasvir for 12 weeks
- Sofosbuvir (Sovaldi) and ledipasvir plus a third direct acting anti-viral, GS 9669, for six weeks
- Sofosbuvir (Sovaldi) and ledipasvir plus a third direct acting anti-viral, GS 9451, for six weeks
Participants with severe liver damage were enrolled in the 12-week trial arm only.
The cure rate for the first and third trial arms was 100% and for the second arm it was 95%.
The most common side effects were headache, fatigue and diarrhea, but none were considered serious.
According to the researchers, “Hepatitis C can be successfully and safely treated in 6 weeks using 3 direct acting agents with different mechanisms of action.” (HIVandhepatitis.com, March 2014, in English)
Sofosbuvir (Sovaldi) and ribavirin cures 75% HIV and Hep C co-infected participants with genotype 1
A 24-week treatment of sofosbuvir (Sovaldi) and ribavirin cured 75% of participants with genotype 1 Hep C virus who had never been treated before and were co-infected with Hep C and HIV, reported researchers at the 21st Conference on Retroviruses and Opportunistic Infections (CROI 2014), in Boston.
There were 3 trials arms:
- Participants with genotype 1 virus who had never been treated before: sofosbuvir (Sovaldi) and ribavirin for 24 weeks
- Participants with genotype 2 or 3 virus who had never been treated before: sofosbuvir (Sovaldi) and ribavirin for 12 weeks
- Participants with genotypes 2 or 3 virus who had been treated but did not respond to treatment: sofosbuvir (Sovaldi) and ribavirin for 24 weeks.
The cure rate for trial arm 1 was 75%. In the second and third trials arms participants with genotype 2 had high cure rates (88% and 92%). However, in the second trial arm, participants with genotype 3 had much lower cure rates with the 12-week treatment (67%). The cure rate for genotype 3 was substantially higher with the 24-week treatment (94%).
The most common side effects were fatigue, insomnia, headache and nausea.
“The interferon-free regimen of sofosbuvir + ribavirin resulted in high [sustained virological response] SVR12 and SVR24 rates in HIV-infected patients with HCV genotype 1, 2 and 3 coinfection,” concluded the researchers. (HIVandhepatitis.com, March 2014, in English)
Simeprevir (Galexos) triple therapy cures almost 75% of HIV and Hep C co-infected participants
Simeprevir (Galexos) in combination with peg-interferon and ribavirin cured almost three-quarters of participants with HIV and hepatitis C co-infection, reported researchers at the 21st Conference on Retroviruses and Opportunistic Infections (CROI 2014), in Boston.
This late-stage trial included participants with genotype 1a and 1b virus. The majority of participants were taking HIV treatment and had well controlled HIV.
Participants who had never been treated and people who had been treated but relapsed received 12 weeks of simeprevir (Galexos) and 24 or 48 weeks of peg-interferon and ribavirin. People who had some or no response to previous treatment and people with severe liver damage received 12 weeks of simeprevir (Galexos) and 48 weeks of peg-interferon and ribavirin.
Overall, 74% of participants had a sustained virological response (SVR) or cure. The majority of participants were eligible for a shorter treatment of 24 weeks. Participants with mild to moderate liver damage had higher cure rates than people with severe liver damage (80% vs. 64%). The most common side effects were headache, rash and nausea. (HIVandhepatitis.com, March 2014, in English)
Looking for more hepatitis C information from CROI 2014?
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