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Simepervir in HIV Co-Infection

March/April 2014

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:

  • simeprevir + PR (peginterferon + ribavirin) for 12 weeks. After this time simeprevir was stopped and therapy with PR continued for 12 more weeks and then stopped. Then participants continued to be monitored for 24 weeks.

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:

  • simeprevir + PR (peginterferon + ribavirin) for 12 weeks. After this time simeprevir was stopped and therapy with PR continued for 36 more weeks. Then participants were monitored for 24 weeks.
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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:

  • nukes: 3TC, FTC, tenofovir, abacavir
  • non-nukes: rilpivirine (Edurant and in Complera)
  • integrase inhibitors: raltegravir
  • fusion inhibitor: T20 (Fuzeon)
  • co-receptor blockers: maraviroc

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:

  • 85% men, 15% women
  • age: 48 years
  • 27% had genes associated with a favourable response to interferon
  • HCV viral load: 10 million copies/ml
  • 82% of participants had the strain of HCV called genotype 1a
  • 12% of participants had cirrhosis
  • HIV viral load: 89% of participants had less than 50 copies/ml
  • CD4+ count: 629 cells/ml


Results

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:

  • no previous treatment: 79% recovered
  • prior relapsers: 87% recovered
  • partial prior responders: 70%
  • prior null responders: 57%

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:

  • Genotype 1b: 89% recovered
  • Genotype 1a: 71% recovered


Results: HIV

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.


Results: Adverse Events

Most side effects were due to exposure to peginterferon + ribavirin and included the following:

  • fatigue: 41%
  • nausea: 26%
  • headache: 28%
  • less-than-normal levels of neutrophils: 28%
  • less-than-normal levels of red blood cells: 21% (in only two participants was this severe)
  • itchy skin: 20%
  • rash: 17%
  • sensitivity to sunlight: 2%

These rates of side effects were generally similar to what is seen in people who have HCV infection alone and who have received treatment.


Reference

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.




This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.
 

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