In clinical trials, about 80% of participants treated with simeprevir have been cured of HCV. These trials have largely recruited people with HCV infection alone (mono-infection). Due to shared routes of transmission, some HCV-positive people are also infected with HIV (co-infection) and they also require HCV treatment.
Researchers conducted a study called C212 where 106 HCV-HIV co-infected volunteers were recruited and underwent assessments of liver injury and other health issues. Each participant's HCV treatment history was reviewed and depending on their treatment history they were assigned to one of two regimens described below.
People who had never been previously treated for HCV or who were classed as relapsers because of their response to prior HCV treatment received the following regimen:
People who doctors classified as "prior relapsers, prior partial responders, prior null responders" or who had severe liver injury due to HCV (cirrhosis) were assigned the following regimen:
Participants were not allowed to use HIV protease inhibitors because of possible drug interactions. Instead, they were allowed to take a regimen using drugs from the following categories:
Furthermore, during the study, researchers did not allow the use of experimental therapies.
The average profile of participants at the start of the study was as follows:
At this time participants have not been monitored to the end of the study. However, data on the proportion of participants who have achieved undetectable HCV viral load for 12 consecutive weeks after the cessation of therapy (this period is called SVR12) is available.
Overall, 74% of participants had an SVR12 and would be extremely likely to recover from HCV infection (further monitoring is ongoing to confirm this).
Recovery rates in different sub-groups of participants were as follows:
This is a dramatic improvement compared to just using interferon and ribavirin alone in historical trials (recovery rates in co-infection would be about 30%).
Among participants with a severe degree of liver injury (graded as F3 or F4), there was an overall recovery rate of 64%.
Among participants with different genotypes of HCV, recovery rates were as follows:
Only two participants had their HIV viral load rise above the 50-copy/ml mark. However, in both cases this occurred 12 weeks after they left the study.
Most side effects were due to exposure to peginterferon + ribavirin and included the following:
These rates of side effects were generally similar to what is seen in people who have HCV infection alone and who have received treatment.
Dieterich D, Rockstroh JK, Orkin C, et al. Simeprevir plus peginterferon and ribavirin in HCV genotype 1/HIV-1 co-infection (study C212). In: Program and abstracts of the 21st Conference on Retroviruses and Opportunistic Infections, 3-6 March 2014. Abstract 24.
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