FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 357:124-134 July 12, 2007 Number 2 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Liang, T. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Patients infected with hepatitis C virus (HCV) genotype 2 or 3 have sustained virologic response rates of approximately 80% after receiving treatment with peginterferon and ribavirin for 24 weeks. We conducted a large, randomized, multinational, noninferiority trial to determine whether similar efficacy could be achieved with only 16 weeks of treatment with peginterferon alfa-2a and ribavirin.

Methods We randomly assigned 1469 patients with HCV genotype 2 or 3 to receive 180 µg of peginterferon alfa-2a weekly, plus 800 mg of ribavirin daily, for either 16 or 24 weeks. A sustained virologic response was defined as an undetectable serum HCV RNA level (<50 IU per milliliter) 24 weeks after the end of treatment.

Results The study failed to demonstrate that the 16-week regimen was noninferior to the 24-week regimen. The sustained virologic response rate was significantly lower in patients treated for 16 weeks than in patients treated for 24 weeks (62% vs. 70%; odds ratio for 16 weeks vs. 24 weeks, 0.67; 95% confidence interval, 0.54 to 0.84; P<0.001). In addition, the rate of relapse (a detectable HCV RNA level during follow-up in patients who had undetectable HCV RNA at the end of treatment) was significantly greater in the 16-week group (31%, vs. 18% in the 24-week group; P<0.001). The sustained virologic response rates in patients with a pretreatment serum HCV RNA level of 400,000 IU per milliliter or less was 82% with the 16-week regimen and 81% with the 24-week regimen. Among patients with a rapid virologic response (an undetectable HCV RNA level by week 4), sustained virologic response rates were 79% in the 16-week group and 85% in the 24-week group (P=0.02).

Conclusions Treatment with peginterferon and ribavirin for 16 weeks in patients infected with HCV genotype 2 or 3 results in a lower overall sustained virologic response rate than treatment with the standard 24-week regimen. (ClinicalTrials.gov number, NCT00077636 [ClinicalTrials.gov] .)

Source Information

From the Virginia Commonwealth University Medical Center, Richmond (M.L.S.); Ospedali Riuniti, Bergamo, Italy (F.S.); Saint Louis University, St. Louis (B.R.B.); University of Florida, Gainesville (D.N.); Royal Adelaide Hospital, Adelaide, Australia (H.H.); Universitat Autònoma de Barcelona, Barcelona (R.S.); University of Alberta Hospital, Edmonton, Canada (S.D.S.); Hôpital Purpan, Toulouse, France (K.B.); Roche, Nutley, NJ (A.L.); Roche, Welwyn, United Kingdom (A.S.); and Saarland University Hospital, Homburg/Saar, Germany (S.Z.).

Address reprint requests to Dr. Shiffman at the Liver Transplant Program, Virginia Commonwealth University Medical Center, 1251 E. Marshall St., Box 663, Richmond, VA 23298, or at mshiffma{at}vcu.edu.

Full Text of this Article

Related Letters:

Peginterferon Alfa-2a and Ribavirin for 16 or 24 Weeks in HCV
Andriulli A., Mangia A., Liu C.-H., Chen D.-S., Kao J.-H., Shiffman M. L., the ACCELERATE Investigators
Extract | Full Text | PDF  
N Engl J Med 2007; 357:1660-1662, Oct 18, 2007. Correspondence

This article has been cited by other articles:

• Navaneethan, U., Kemmer, N., Neff, G. W. (2009). Review: Predicting the probable outcome of treatment in HCV patients. Therapeutic Advances in Gastroenterology 2: 287-302 [Abstract]  
• Nash, K. L, Bentley, I., Hirschfield, G. M (2009). Managing hepatitis C virus infection. BMJ 338: b2366-b2366 [Full Text]  
• Chevaliez, S., Bouvier-Alias, M., Pawlotsky, J.-M. (2009). Performance of the Abbott Real-Time PCR Assay Using m2000sp and m2000rt for Hepatitis C Virus RNA Quantification. J. Clin. Microbiol. 47: 1726-1732 [Abstract] [Full Text]  
• Martro, E., Garcia-Sierra, N., Gonzalez, V., Saludes, V., Matas, L., Ausina, V. (2009). Evaluation of an Automated Nucleic Acid Extractor for Hepatitis C Virus Load Quantification. J. Clin. Microbiol. 47: 811-813 [Abstract] [Full Text]  
• Jensen, D. M. (2009). Individualizing HCV treatment with peginterferon and ribavirin: what needs to be done?. Therapeutic Advances in Gastroenterology 2: 5-10  
• Cross, T J S, Antoniades, C G, Harrison, P M (2008). Current and future management of chronic hepatitis C infection. Postgrad. Med. J. 84: 172-176 [Abstract] [Full Text]  
• Kuller, L. (2007). Is Phenomenology the Best Approach to Health Research?. Am J Epidemiol 166: 1109-1115 [Abstract] [Full Text]  
• Andriulli, A., Mangia, A., Liu, C.-H., Chen, D.-S., Kao, J.-H., Shiffman, M. L., the ACCELERATE Investigators, (2007). Peginterferon Alfa-2a and Ribavirin for 16 or 24 Weeks in HCV. NEJM 357: 1660-1662 [Full Text]  
• Liang, T. J. (2007). Shortened Therapy for Hepatitis C Virus Genotype 2 or 3 -- Is Less More?. NEJM 357: 176-178 [Full Text]  
• (2007). HCV Treatment -- How Short Can We Go?. JWatch Infect. Diseases 2007: 2-2 [Full Text]  
• (2007). Peginterferon plus Ribavirin for 16 or 24 Weeks for Genotype 2 or 3 HCV Infections. JWatch Gastroenterology 2007: 1-1 [Full Text]