Advertisement
Advertisement

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

Boceprevir: The Sprint Study, Phase III Results

December 23, 2010

 1  |  2  |  Next > 

Boceprevir, previously called SCH503034, has demonstrated antiviral activity against HCV in smaller studies. The purpose of the Sprint study was to assess two different ways of using boceprevir when added to standard therapy (peginterferon + ribavirin) and also to compare boceprevir-containing regimens to standard therapy in a large number of people.


Study Details

None of the participants had been previously treated for HCV. Once enrolled, they were randomly assigned to one of the following 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 peginterferon + ribavirin, followed by 44 weeks of boceprevir + peginterferon + ribavirin, for a total of 48 weeks of therapy. After this, participants were monitored for 24 more 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 24 weeks of boceprevir + peginterferon + ribavirin, for a total of 28 weeks of therapy. At the end of 28 weeks, if HCV viral load was undetectable, therapy was discontinued and participants were monitored for 48 weeks. If at the end of 28 weeks HCV viral load was still detectable, participants received an additional 20 weeks of peginterferon + ribavirin. At the end of 20 weeks, therapy was stopped and participants were monitored for 24 more weeks and then assessed for HCV viral load.

The average profile of 1,098 study participants at the start of the study was as follows:

  • 40% females, 60% males
  • age -- 50 years
  • more than 90% of volunteers had HCV viral loads greater than 400,000 IU/ml at baseline
  • major ethno-racial groups: researchers classified 939 participants as "non-Black" and 159 others as "Black"

Common HCV sub types were as follows:

  • genotype 1a -- 60%
  • genotype 1b -- 36%


Results -- Recovery From HCV Infection

Due to genetic factors, people of African ancestry tend to have a poorer response to HCV therapy than people of other ethno-racial groups, so the study team analysed the results of this study based on race and ethnicity.

Sustained virologic response (SVR) among non-Black people:

  • Group 1 (peginterferon + ribavirin): 42% SVR
  • Group 2 (boceprevir + 48 weeks peginterferon + ribavirin): 71% SVR
  • Group 3 (boceprevir response-guided therapy): 70% SVR

SVR among Black people:

  • Group 1 (peginterferon + ribavirin): 23% SVR
  • Group 2 (boceprevir + 48 weeks peginterferon + ribavirin): 53% SVR
  • Group 3 (boceprevir response-guided therapy): 42% SVR

SVRs were even greater among non-Black people whose HCV viral load fell by at least one log at week 4 compared to baseline:

  • Group 1 (peginterferon + ribavirin): 52% SVR
  • Group 2 (boceprevir + 48 weeks peginterferon + ribavirin): 82% SVR
  • Group 3 (boceprevir response-guided therapy): 82% SVR


Results -- Week 8 Seems to Be a Critical Time

Here are the proportions of participants who subsequently achieved SVR among those whose HCV viral load at week 8 was undetectable or detectable:

  • Group 1 (peginterferon + ribavirin): 86% SVR when viral load was undetectable
  • Group 1 (peginterferon + ribavirin): 31% SVR when viral load was detectable
  • Group 2 (boceprevir + 48 weeks peginterferon + ribavirin): 91% SVR when viral load was undetectable
  • Group 2 (boceprevir + 48 weeks peginterferon + ribavirin): 43% SVR when viral load was detectable
  • Group 3 (boceprevir response-guided therapy): 89% SVR when viral load was undetectable
  • Group 3 (boceprevir response-guided therapy): 43% SVR when viral load was detectable
 1  |  2  |  Next > 



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.
 

No comments have been made.
 

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:

Advertisement