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Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection.
N Engl J Med. 2002 Sep 26; 347(13):975-82.NEJM

Abstract

BACKGROUND

Treatment with peginterferon alfa-2a alone produces significantly higher sustained virologic responses than treatment with interferon alfa-2a alone in patients with chronic hepatitis C virus (HCV) infection. We compared the efficacy and safety of peginterferon alfa-2a plus ribavirin, interferon alfa-2b plus ribavirin, and peginterferon alfa-2a alone in the initial treatment of chronic hepatitis C.

METHODS

A total of 1121 patients were randomly assigned to treatment and received at least one dose of study medication, consisting of 180 microg of peginterferon alfa-2a once weekly plus daily ribavirin (1000 or 1200 mg, depending on body weight), weekly peginterferon alfa-2a plus daily placebo, or 3 million units of interferon alfa-2b thrice weekly plus daily ribavirin for 48 weeks.

RESULTS

A significantly higher proportion of patients who received peginterferon alfa-2a plus ribavirin had a sustained virologic response (defined as the absence of detectable HCV RNA 24 weeks after cessation of therapy) than of patients who received interferon alfa-2b plus ribavirin (56 percent vs. 44 percent, P<0.001) or peginterferon alfa-2a alone (56 percent vs. 29 percent, P<0.001). The proportions of patients with HCV genotype 1 who had sustained virologic responses were 46 percent, 36 percent, and 21 percent, respectively, for the three regimens. Among patients with HCV genotype 1 and high base-line levels of HCV RNA, the proportions of those with sustained virologic responses were 41 percent, 33 percent, and 13 percent, respectively. The overall safety profiles of the three treatment regimens were similar; the incidence of influenza-like symptoms and depression was lower in the groups receiving peginterferon alfa-2a than in the group receiving interferon alfa-2b plus ribavirin.

CONCLUSIONS

In patients with chronic hepatitis C, once-weekly peginterferon alfa-2a plus ribavirin was tolerated as well as interferon alfa-2b plus ribavirin and produced significant improvements in the rate of sustained virologic response, as compared with interferon alfa-2b plus ribavirin or peginterferon alfa-2a alone.

Authors+Show Affiliations

University of North Carolina, Chapel Hill 27599, USANo 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
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

12324553

Citation

Fried, Michael W., et al. "Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Infection." The New England Journal of Medicine, vol. 347, no. 13, 2002, pp. 975-82.
Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347(13):975-82.
Fried, M. W., Shiffman, M. L., Reddy, K. R., Smith, C., Marinos, G., Gonçales, F. L., Häussinger, D., Diago, M., Carosi, G., Dhumeaux, D., Craxi, A., Lin, A., Hoffman, J., & Yu, J. (2002). Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. The New England Journal of Medicine, 347(13), 975-82.
Fried MW, et al. Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Infection. N Engl J Med. 2002 Sep 26;347(13):975-82. PubMed PMID: 12324553.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. AU - Fried,Michael W, AU - Shiffman,Mitchell L, AU - Reddy,K Rajender, AU - Smith,Coleman, AU - Marinos,George, AU - Gonçales,Fernando L,Jr AU - Häussinger,Dieter, AU - Diago,Moises, AU - Carosi,Giampiero, AU - Dhumeaux,Daniel, AU - Craxi,Antonio, AU - Lin,Amy, AU - Hoffman,Joseph, AU - Yu,Jian, PY - 2002/9/27/pubmed PY - 2002/10/3/medline PY - 2002/9/27/entrez SP - 975 EP - 82 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 347 IS - 13 N2 - BACKGROUND: Treatment with peginterferon alfa-2a alone produces significantly higher sustained virologic responses than treatment with interferon alfa-2a alone in patients with chronic hepatitis C virus (HCV) infection. We compared the efficacy and safety of peginterferon alfa-2a plus ribavirin, interferon alfa-2b plus ribavirin, and peginterferon alfa-2a alone in the initial treatment of chronic hepatitis C. METHODS: A total of 1121 patients were randomly assigned to treatment and received at least one dose of study medication, consisting of 180 microg of peginterferon alfa-2a once weekly plus daily ribavirin (1000 or 1200 mg, depending on body weight), weekly peginterferon alfa-2a plus daily placebo, or 3 million units of interferon alfa-2b thrice weekly plus daily ribavirin for 48 weeks. RESULTS: A significantly higher proportion of patients who received peginterferon alfa-2a plus ribavirin had a sustained virologic response (defined as the absence of detectable HCV RNA 24 weeks after cessation of therapy) than of patients who received interferon alfa-2b plus ribavirin (56 percent vs. 44 percent, P<0.001) or peginterferon alfa-2a alone (56 percent vs. 29 percent, P<0.001). The proportions of patients with HCV genotype 1 who had sustained virologic responses were 46 percent, 36 percent, and 21 percent, respectively, for the three regimens. Among patients with HCV genotype 1 and high base-line levels of HCV RNA, the proportions of those with sustained virologic responses were 41 percent, 33 percent, and 13 percent, respectively. The overall safety profiles of the three treatment regimens were similar; the incidence of influenza-like symptoms and depression was lower in the groups receiving peginterferon alfa-2a than in the group receiving interferon alfa-2b plus ribavirin. CONCLUSIONS: In patients with chronic hepatitis C, once-weekly peginterferon alfa-2a plus ribavirin was tolerated as well as interferon alfa-2b plus ribavirin and produced significant improvements in the rate of sustained virologic response, as compared with interferon alfa-2b plus ribavirin or peginterferon alfa-2a alone. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/12324553/Peginterferon_alfa_2a_plus_ribavirin_for_chronic_hepatitis_C_virus_infection_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa020047?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -