Peginterferon Alfa-2a Plus Ribavirin for the Treatment of Dual Chronic Infection With Hepatitis B and C Viruses

Interim results of this trial were presented at the 49th International Association for the Study of the Liver meeting, September 7–11, 2006, Cairo, Egypt; at the 42nd European Association for the Study of the Liver meeting, April 11–15, 2007, Barcelona, Spain; at the 58th American Association for the Study of the Liver Meeting, November 1–5, 2007, Boston, MA; at the 17th Asian Pacific Association for the Study of the Liver meeting, March 25–28, 2007, Kyoto, Japan; at the 18th Asian Pacific Association for the Study of the Liver meeting, March 23–26, 2008, Seoul, South Korea; and at the 43rd European Association for the Study of the Liver meeting, April 23–27, 2008, Milan, Italy.

Received 16 July 2008; accepted 23 October 2008. published online 30 October 2008.

Refers to article:

Treatment of HBV/HCV Coinfection: Releasing the Enemy Within , 22 December 2008
Stuart C. Gordon, Kenneth E. Sherman
Gastroenterology
February 2009 (Vol. 136, Issue 2, Pages 393-396)
Full Text | Full-Text PDF (227 KB)

Background & Aims

Dual chronic infection with hepatitis C virus (HCV) and hepatitis B virus (HBV) is common in areas endemic for either virus. Combination therapy with ribavirin and pegylated interferon (peginterferon) is the standard of care for patients with HCV monoinfection. We investigated the effects of combination therapy in patients infected with both HBV and HCV (genotypes 1, 2, or 3).

Methods

The study included 321 Taiwanese patients with active HCV infection; 161 also tested positive for hepatitis B surface antigen (HBsAg) and 160 were HBsAg-negative (controls). Patients with HCV genotype 1 infection received peginterferon alfa-2a (180 μg) weekly for 48 weeks and ribavirin (1000–1200 mg) daily. Patients with HCV genotypes 2 or 3 received peginterferon alfa-2a weekly for 24 weeks and ribavirin (800 mg) daily. At 24 weeks posttreatment, patient samples were examined for a sustained virologic response (SVR) against HCV (serum HCV levels decreased to <25 IU/mL).

Results

In patients with HCV genotype 1 infection, the SVR was 72.2% in dually infected patients vs 77.3% in monoinfected patients after treatment. For patients with HCV genotype 2/3 infections, the SVR values were 82.8% and 84.0%, respectively, after treatment. Serum HBV DNA eventually appeared in 36.3% of 77 dual-infected patients with undetectable pretreatment levels of HBV DNA; this was not accompanied by significant hepatitis. Posttreatment HBsAg clearance was observed in 11.2% of 161 dual-infected patients.

Conclusions

Combination therapy with peginterferon alfa-2a and ribavirin is equally effective in patients with HCV monoinfection and in those with dual chronic HCV/HBV infection.

Abbreviations used in this paper: PCR, polymerase chain reaction, peginterferon, pegylated interferon, SVR, sustained virologic response

⁎ National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan

‡ Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

§ Chang Gung Memorial Hospital-Kaohsiung, Kaohsiung, Taiwan

∥ Changhua Christian Hospital, Changhua, Taiwan

¶ Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan

# Chi Mei Medical Center, Tainan, Taiwan

⁎⁎ Tri-Service General Hospital, Taipei, Taiwan

‡‡ Chia-Yi Chang Gung Memorial Hospital, Chiayi Hsien, Taiwan

§§ Cathay General Hospital, Taipei, Taiwan

Address requests for reprints to: Ding–Shinn Chen, MD, Distinguished Chair Professor, Department of Internal Medicine, National Taiwan University College of Medicine, 1 Chang-Te Street, Taipei 10002, Taiwan. fax: (886) 2-23317624

The statistical analysis of the entire data sets pertaining to efficacy and safety was performed independently by a biostatistician (C.–L. Chen, National Taiwan University College of Medicine) who is not employed by the corporate entity.

The corresponding authors (D.–S. Chen and P.–J. Chen) had full access to all of the data and take full responsibility for the veracity of the data and analysis. The study sponsors did not play any role in the study design; in the collection, analysis, and interpretation of data; and in the decision to submit the report for publication.

US National Institutes of Health registration number for clinical trial: NCT00361179. An Open Label, Comparative, Multi-Center Study, To Evaluate the Efficacy and Safety of Peginterferon Alfa-2a Plus Ribavirin in the Treatment of Patients With Chronic Hepatitis C/Hepatitis B Co-Infection and Chronic Hepatitis C.

The authors disclose the following: This study was supported in part by grants from the Department of Health, the National Science Council, Executive Yuan, Taiwan; National Taiwan University; and National Health Research Institutes, Taiwan.

PII: S0016-5085(08)01887-8

doi:10.1053/j.gastro.2008.10.049

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