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Research Alert: Study Casts Doubt on "Shock and Kill" Cure Strategy

Boceprevir: Effective in Previous Non-Responders

December 23, 2010

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In the past, some HCV-positive people may have undergone treatment with standard therapy but did not recover from this infection. Researchers refer to such people as "non-responders." People with HCV genotype 1 are traditionally the least responsive to therapy.

In the Respond 2 study, researchers compared two strategies for trying to increase recovery from HCV infection. Participants were divided into the following three groups:

  • Group 1 (control): 4 weeks of therapy with peginterferon + ribavirin, followed by 44 weeks of peginterferon + ribavirin + placebo, for a total of 48 weeks of therapy. After this, participants were monitored for an additional 24 weeks. At the end of 24 weeks of monitoring, they were then assessed for HCV viral load.
  • Group 2 (boceprevir + standard therapy): 4 weeks of therapy with peginterferon + ribavirin, followed by 44 weeks of boceprevir + peginterferon + ribavirin, for a total of 48 weeks of therapy. After this, participants were monitored for an additional 24 weeks. At the end of this period, they were then assessed for HCV viral load.
  • Group 3 (boceprevir response-guided therapy): 4 weeks of peginterferon + ribavirin, followed by 32 weeks of boceprevir + peginterferon + ribavirin, for a total of 36 weeks of therapy. At the end of 36 weeks, if HCV viral load was undetectable, therapy was discontinued and participants were monitored for 36 more weeks. If at the end of the initial 36 weeks of therapy HCV viral load was still detectable, participants received 12 more weeks of peginterferon + ribavirin. At the end of this time, therapy was stopped and participants were monitored for 24 more weeks and then assessed for HCV viral load.

The average profile of participants who entered the Respond 2 study was as follows:

  • age -- 43 years
  • 35% females, 65% males
  • HCV genotypes 1a and 1b were common
  • 90% of participants had an HCV viral load greater than 800,000 IUs/ml
  • 35% of participants were described as non-responders to prior HCV therapy and the remaining 65% had relapsed under previous therapy

Boceprevir was taken at a dose of 800 mg three times daily.


Results -- Sustained Virologic Response (SVR)

Overall, SVRs were distributed among the three treatment groups as follows:

  • Group 1 (control; peginterferon + ribavirin): 21% achieved an SVR while 32% relapsed
  • Group 2 (boceprevir + standard therapy): 66% achieved an SVR while 12% relapsed
  • Group 3 (boceprevir response-guided therapy): 59% achieved an SVR while 15% relapsed


Results -- SVR According to the HCV Detectability at Week 8

  • Group 1 (control; peginterferon + ribavirin): 100% of participants whose viral load was undetectable achieved an SVR, while 12% of participants whose viral load was detectable achieved an SVR
  • Group 2 (boceprevir + standard therapy): 88% of participants whose viral load was undetectable achieved an SVR, while 40% of participants whose viral load was detectable achieved an SVR
  • Group 3 (boceprevir response-guided therapy): 88% of participants whose viral load was undetectable achieved an SVR, while 43% of participants whose viral load was detectable achieved an SVR

Overall, boceprevir increased the chances of participants achieving an SVR.


Results -- According to Response to Prior Therapy

Among non-responders to previous peginterferon + ribavirin, here is the proportion who achieved an SVR in the present study:

  • Group 1 (control): 7%
  • Group 2 (boceprevir + peginterferon + ribavirin): 52%
  • Group 3 (boceprevir response-guided therapy): 40%

Among people who relapsed when previously treated with peginterferon + ribavirin, here is the proportion who achieved an SVR in the present study:

  • Group 1 (control): 29%
  • Group 2 (boceprevir + peginterferon + ribavirin): 75%
  • Group 3 (boceprevir response-guided therapy): 69%
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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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