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Purpose / DescriptionThis phase 3, double-blind, placebo-controlled trial examined the effiacacy of telaprevir in combination with peginterferon and ribavirin in treatment-naïve patients with genotype 1 infection. Investigators randomized 1,088 patients to one of three treatment arms: (1) telaprevir for the first 8 weeks plus peginterferon and ribavirin (T8/PR group) followed by an additional 12 or 36 weeks of peginterferon and ribavirin; (2) telaprevir for the first 12 weeks in combination with peginterferon plus ribavirin (T12/PR group), followed by an additional 12 or 36 weeks of peginterferon and ribavirin, or (3) a placebo-controlled arm of peginterferon plus ribavirin for 48 weeks (PR group). In the two telaprevir groups, patients who had undetectable HCV RNA at week 4 and 12 (defined as an extended rapid virologic response [eRVR]) completed a 24-week course of therapy while those who did not meet this response-guided treatment criterion completed 48 weeks. Sustained virologic response at week 24 post treatment (SVR24) was observed in 72% in the T8/PR group, 79% in the T12/PR group, and 46% in the control arm (PR group). Among all patients treated with telaprevir, 58% had an eRVR and received a total of 24 weeks of therapy. Thus, in treatment-naive patients with genotype 1 chronic HCV infection, the addition of telaprevir to peginterferon and ribavirin significantly improved the treatment responses when compared with peginterferon and ribavirin alone. Further, use of telaprevir shortened the duration of therapy in most patients from 48 to 24 weeks.
Treatments
Telaprevir![Telaprevir Incivek](//cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
![Telaprevir Incivek](http://cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
Telaprevir
Tradename:IncivekClass:DiscontinuedReferences
- Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-16.
Purpose / DescriptionThis open-label phase 3 trial involved treatment-naïve patients with genotype 1 chronic HCV who received therapy with telaprevir plus peginterferon and ribavirin. All patients received telaprevir for 12 weeks, but treatment duration with peginterferon and ribavirin varied depending on whether patients had undetectable HCV RNA levels at weeks 4 and 12 (extended rapid virologic response [eRVR]). Patients with an eRVR were randomized at week 20 to receive peginterferon plus ribavirin for an additional 4 (T12/PR24 group) or 28 more weeks (T12/PR48 group). All of the patients who do not achieve eRVR received a total of 48 weeks of peginterferon and ribavirin (T12PR48). Among the 540 subjects enrolled, 352 (65%) achieved an eRVR. Among the 352 patients who achieved an eRVR, the SVR24 rates were comparable in the T12/PR24 group (92%) and the T12/PR48 group (88%). The patients who did not achieve eRVR had SVR24 rate of 64%. This study demonstrated that response guided therapy is an appropriate strategy in treatment-naive patients with genotype 1 HCV who are receiving treatment with telaprevir plus peginterferon and ribavirin. This strategy, however, may not be valid for patients with cirrhosis. For the subset of cirrhotic patients in this study, the response-guided therapy approach appeared to have suboptimal efficacy– among the 30 patients who achieved eRVR, the SVR rates were 61% for T12/PR24 versus 92% for T12/PR48.
Treatments
Telaprevir![Telaprevir Incivek](//cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
![Telaprevir Incivek](http://cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
Telaprevir
Tradename:IncivekClass:DiscontinuedReferences
- Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011;365:1014-24.
Purpose / DescriptionIn this phase 3, dosing trial, 740 treatment-naive patients with genotype 1 chronic hepatitis C were randomized to receive a 12-week course of telaprevir at a dose of 1125 mg bid or 750 mg every 8 hours, in combination with peginterferon and ribavirin. All patients received 12 weeks of telaprevir with peginterferon and ribavirin, followed by peginterferon and ribavirin for a duration that depended on the response to therapy. Specifically, patients with an undetectable HCV RNA level after 4 weeks of therapy received a total of 24 weeks whereas all others received 48 weeks. The SVR12 rates were nearly identical in the two treatment dosing arms of telaprevir: 74% in the twice daily group and 73% in the every 8 hour group. Among those subjects who achieved an undetectable HCV RNA level at week 4, the SVR response rates were particularly good (86% in the twice daily group and 85% in the every 8 hour group).
Treatments
Telaprevir![Telaprevir Incivek](//cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
![Telaprevir Incivek](http://cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
Telaprevir
Tradename:IncivekClass:DiscontinuedReferences
- Buti M, Agarwal K, Horsmans Y, et al. Telaprevir twice daily is noninferior to telaprevir every 8 hrs for patients with chronic hepatitis C. Gastroenterology. 2014;146:744-53.
Purpose / DescriptionThis phase 3 randomized, double-blind, trial enrolled 663 patients with chronic HCV genotype 1 infection who were previously treated with peginterferon plus ribavirin and did not achieve SVR, including prior relapsers and non-responders. The nonresponders included two subgroups: prior partial responders and prior null responders. Subjects were randomized in a 2:2:1 ratio to one of three regimens: (a) telaprevir combined with peginterferon plus ribavirin for 12 weeks, followed by 36 weeks of peginterferon plus ribavirin (T12/PR48), (b) peginterferon plus ribavirin given for a lead-in phase of 4 weeks, followed by 12 week of telaprevir plus peginterferon and ribavirin, followed by 32 weeks of peginterferon plus ribavirin (Lead In-T12/PR48), or (c) placebo-controlled arm of peginterferon plus ribavirin for 48 weeks (PR48). The SVR rates were markedly higher in the telaprevir-treated patients (64% without lead in and 66% with lead in) when compared with the peginterferon plus ribavirin alone (17%). There were notable differences in SVR according to prior treatment history: the best SVR rates were achieved in prior relapsers, intermediate SVR rates with prior partial responders, and poor SVR rates were seen with prior null responders. Overall, this study demonstrated that with hepatitis C treatment experienced patients, the addition of telaprevir to peginterferon and ribavirin markedly improves SVR rates, irrespective of whether a lead-in phase is used.
Treatments
Telaprevir![Telaprevir Incivek](//cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
![Telaprevir Incivek](http://cdn.hepatitisc.uw.edu/css/images/drugs/4.png)
Telaprevir
Tradename:IncivekClass:DiscontinuedReferences
- Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011;364:2417-28.