Pegylated Interferon Alfa-2a (Pegasys) plus Ribavirin for Patients with HCV and HBV Coinfection 

By Liz Highleyman

Due to similar routes of transmission, dual infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) is not uncommon, especially in areas with a high endemic level of both diseases. It is estimated that around 7%-11% of people with chronic HBV infection also have HCV, while 2%-10% of chronic hepatitis C patients also have HBV.
 
Individuals with dual HBV-HCV coinfection typically have more severe liver disease and an increased risk of hepatocellular carcinoma (HCC). But to date, there has been limited study of treatment for HBV-HCV coinfection.

Clinical trials assessing the use of conventional interferon monotherapy in the HBV-HCV coinfected population have produced disappointing results. Recent pilot studies using conventional interferon plus ribavirin for 24 weeks have produced sustained HCV clearance rates comparable to that for HCV monoinfected patients.

In a study presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases in Boston (November 2-6, 2007), researchers assessed the use of pegylated interferon plus ribavirin in patients with dual HBV-HCV infection.

All 321 study participants had active hepatitis C with serum ALT level > 1.5 times the upper limit of normal and HCV RNA > 1,000 copies/mL. Half also had detectable hepatitis B surface (HBsAg). Among the HBV-HCV coinfected patients, about half had detectable HBV DNA at study entry. Baseline patient characteristics were generally similar, but there the HCV genotype non-1 monoinfected group had a higher proportion of women compared with the other groups.

Patients with HCV genotype 1 (n=207) received 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus 1000-1200 mg/day ribavirin for 48 weeks, while those with other genotypes (n=114) were treated with the same dose of Pegasys plus 800 mg/day fixed-dose ribavirin for 24 weeks.

Results

• The most difficult-to-treat patients -- those with HBV-HCV genotype 1 coinfection -- achieved a sustained HCV clearance rate of 73%, compared with 77% for genotype 1 HCV monoinfected patients.

• For HCV-HBV coinfected patients with HCV genotypes other than 1, the sustained HCV clearance rate was 86%, compared with 88% for non-1 HCV monoinfected patients.

• There was little difference in sustained HCV clearance rates between HCV genotype 1 and non-1 patients at the end of treatment and 24 weeks after completion of treatment (in contrast with most past HCV monotherapy studies).

• Overall, HCV monoinfected patients had a slightly higher sustained ALT normalization rate compared with HBV-HCV coinfected patients (70% vs 62% for genotype 1; 78% vs 67% for non-1).

• 69% of HBV-HCV coinfected subjects experienced HBV virological response at the end of treatment and 56% experienced sustained HBV clearance.

• Conversely, 36% of coinfected patients with undetectable pre-treatment HBV DNA experienced HBV viral load rebound.

• None of the patients with HBV rebound experienced ALT elevation >200 IU/L and almost all experienced sustained HCV clearance.

• 10% of HBV-HCV coinfected patients experienced HBsAg clearance.

Conclusion

“Combination therapy with [Pegasys plus ribavirin] appears to be safe and effective for treatment of patients dually infected with HCV and HBV,” the researchers concluded. “Importantly, a substantial proportion of the dually infected patients achieved HBsAg clearance -- an important indicator of long-term treatment success.”

National Taiwan University College of Medicine and National Taiwan University Hospital, Taiwan; Kaohsiung Medical University Hospital, Taiwan; Chang Gung Memorial Hospital, Kaohsiung, Taiwan; Changhua Christian Hospital, Taiwan; Ren-Ai Branch, Taipei City Hospital, Taiwan; Chi-Mei Medical Center, Taiwan; Tri-Service General Hospital, Taiwan.

11/30/07

Reference
C Liu, W Chuang, CM Lee, and others. An Open Label, Comparative, Multicenter Study Of Peginterferon Alfa-2a Plus Ribavirin in The Treatment Of Patients With Chronic Hepatitis C/Hepatitis B Co-Infection Versus Those With Chronic Hepatitis C Monoinfection. 58th Annual Meeting of the American Association for the Study of Liver Diseases. Boston, MA, November 2-6, 2007. Abstract 233.