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Telaprevir and peginterferon with or without ribavirin for chronic HCV infection.
N Engl J Med. 2009 Apr 30; 360(18):1839-50.NEJM

Abstract

BACKGROUND

In patients with chronic infection with hepatitis C virus (HCV) genotype 1, treatment with peginterferon alfa and ribavirin for 48 weeks results in rates of sustained virologic response of 40 to 50%. Telaprevir is a specific inhibitor of the HCV serine protease and could be of value in HCV treatment.

METHODS

A total of 334 patients who had chronic infection with HCV genotype 1 and had not been treated previously were randomly assigned to receive one of four treatments involving various combinations of telaprevir (1250 mg on day 1, then 750 mg every 8 hours), peginterferon alfa-2a (180 microg weekly), and ribavirin (dose according to body weight). The T12PR24 group (81 patients) received telaprevir, peginterferon alfa-2a, and ribavirin for 12 weeks, followed by peginterferon alfa-2a and ribavirin for 12 more weeks. The T12PR12 group (82 patients) received telaprevir, peginterferon alfa-2a, and ribavirin for 12 weeks. The T12P12 group (78 patients) received telaprevir and peginterferon alfa-2a without ribavirin for 12 weeks. The PR48 (control) group (82 patients) received peginterferon alfa-2a and ribavirin for 48 weeks. The primary end point, a sustained virologic response (an undetectable HCV RNA level 24 weeks after the end of therapy), was compared between the control group and the combined T12P12 and T12PR12 groups.

RESULTS

The rate of sustained virologic response for the T12PR12 and T12P12 groups combined was 48% (77 of 160 patients), as compared with 46% (38 of 82) in the PR48 (control) group (P=0.89). The rate was 60% (49 of 82 patients) in the T12PR12 group (P=0.12 for the comparison with the PR48 group), as compared with 36% (28 of 78 patients) in the T12P12 group (P=0.003; P=0.20 for the comparison with the PR48 group). The rate was significantly higher in the T12PR24 group (69% [56 of 81 patients]) than in the PR48 group (P=0.004). The adverse events with increased frequency in the telaprevir-based groups were pruritus, rash, and anemia.

CONCLUSIONS

In this phase 2 study of patients infected with HCV genotype 1 who had not been treated previously, one of the three telaprevir groups had a significantly higher rate of sustained virologic response than that with standard therapy. Response rates were lowest with the regimen that did not include ribavirin. (ClinicalTrials.gov number, NCT00372385.)

Authors+Show Affiliations

Assistance Publique-Hôpitaux de Paris, Henri Mondor Hospital, University of Paris 12 and INSERM Unité 955, Créteil, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19403903

Citation

Hézode, Christophe, et al. "Telaprevir and Peginterferon With or Without Ribavirin for Chronic HCV Infection." The New England Journal of Medicine, vol. 360, no. 18, 2009, pp. 1839-50.
Hézode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009;360(18):1839-50.
Hézode, C., Forestier, N., Dusheiko, G., Ferenci, P., Pol, S., Goeser, T., Bronowicki, J. P., Bourlière, M., Gharakhanian, S., Bengtsson, L., McNair, L., George, S., Kieffer, T., Kwong, A., Kauffman, R. S., Alam, J., Pawlotsky, J. M., & Zeuzem, S. (2009). Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. The New England Journal of Medicine, 360(18), 1839-50. https://doi.org/10.1056/NEJMoa0807650
Hézode C, et al. Telaprevir and Peginterferon With or Without Ribavirin for Chronic HCV Infection. N Engl J Med. 2009 Apr 30;360(18):1839-50. PubMed PMID: 19403903.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. AU - Hézode,Christophe, AU - Forestier,Nicole, AU - Dusheiko,Geoffrey, AU - Ferenci,Peter, AU - Pol,Stanislas, AU - Goeser,Tobias, AU - Bronowicki,Jean-Pierre, AU - Bourlière,Marc, AU - Gharakhanian,Shahin, AU - Bengtsson,Leif, AU - McNair,Lindsay, AU - George,Shelley, AU - Kieffer,Tara, AU - Kwong,Ann, AU - Kauffman,Robert S, AU - Alam,John, AU - Pawlotsky,Jean-Michel, AU - Zeuzem,Stefan, AU - ,, PY - 2009/5/1/entrez PY - 2009/5/1/pubmed PY - 2009/5/8/medline SP - 1839 EP - 50 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 360 IS - 18 N2 - BACKGROUND: In patients with chronic infection with hepatitis C virus (HCV) genotype 1, treatment with peginterferon alfa and ribavirin for 48 weeks results in rates of sustained virologic response of 40 to 50%. Telaprevir is a specific inhibitor of the HCV serine protease and could be of value in HCV treatment. METHODS: A total of 334 patients who had chronic infection with HCV genotype 1 and had not been treated previously were randomly assigned to receive one of four treatments involving various combinations of telaprevir (1250 mg on day 1, then 750 mg every 8 hours), peginterferon alfa-2a (180 microg weekly), and ribavirin (dose according to body weight). The T12PR24 group (81 patients) received telaprevir, peginterferon alfa-2a, and ribavirin for 12 weeks, followed by peginterferon alfa-2a and ribavirin for 12 more weeks. The T12PR12 group (82 patients) received telaprevir, peginterferon alfa-2a, and ribavirin for 12 weeks. The T12P12 group (78 patients) received telaprevir and peginterferon alfa-2a without ribavirin for 12 weeks. The PR48 (control) group (82 patients) received peginterferon alfa-2a and ribavirin for 48 weeks. The primary end point, a sustained virologic response (an undetectable HCV RNA level 24 weeks after the end of therapy), was compared between the control group and the combined T12P12 and T12PR12 groups. RESULTS: The rate of sustained virologic response for the T12PR12 and T12P12 groups combined was 48% (77 of 160 patients), as compared with 46% (38 of 82) in the PR48 (control) group (P=0.89). The rate was 60% (49 of 82 patients) in the T12PR12 group (P=0.12 for the comparison with the PR48 group), as compared with 36% (28 of 78 patients) in the T12P12 group (P=0.003; P=0.20 for the comparison with the PR48 group). The rate was significantly higher in the T12PR24 group (69% [56 of 81 patients]) than in the PR48 group (P=0.004). The adverse events with increased frequency in the telaprevir-based groups were pruritus, rash, and anemia. CONCLUSIONS: In this phase 2 study of patients infected with HCV genotype 1 who had not been treated previously, one of the three telaprevir groups had a significantly higher rate of sustained virologic response than that with standard therapy. Response rates were lowest with the regimen that did not include ribavirin. (ClinicalTrials.gov number, NCT00372385.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/19403903/Telaprevir_and_peginterferon_with_or_without_ribavirin_for_chronic_HCV_infection_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa0807650?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -