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HIV and Hepatitis.com Coverage of the
61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010)
October 29 - November 2, 2010, Boston, MA
Antiviral Therapy for Chronic Hepatitis B Patients with Decompensated Liver Cirrhosis

 
SUMMARY: Chronic hepatitis B patients with decompensated liver cirrhosis can be treated safely and effectively with antiviral agents, according to a systematic review presented at the recent American Association for the Study of Liver Diseases "Liver Meeting" (AASLD 2010) in Boston. Entecavir (Baraclude) has demonstrated good potency, matching that of lamivudine, but without resistance; newer agents such as tenofovir (Viread) require further study in this population.
 

By Liz Highleyman

Over years or decades, chronic hepatitis B virus (HBV) infection can progress to advanced liver disease including cirrhosis and hepatocellular carcinoma. Compensated cirrhosis means the liver is heavily damaged but can still carry out its normal functions; decompensated cirrhosis occurs when the liver is no longer able to perform it critical functions.

Antiviral agents that suppress HBV can prevent or slow liver disease progression, and people with decompensated cirrhosis therefore stand to benefit greatly from effective treatment. But these drugs can cause side effects that patients with severe illness may be unable to tolerate.

A.K. Singal from the University of Texas Medical Branch and R.J. Fontana from the University of Michigan at Ann Arbor performed a systematic review of English language medical literature published between 1995 and 2010, looking for studies that evaluated the effectiveness and safety of oral antiviral agents for people with decompensated HBV cirrhosis (defined as a CTP score > 7). Studies were graded for quality on a scale of 0-10.

The researchers identified 21 relevant studies with a quality score > 5, including 13 looking at lamivudine (Epivir-HBV), 3 looking at adefovir (Hepsera) in lamivudine-resistant patients, and 5 looking at entecavir. They extracted 1-year efficacy and safety data for patients treated for more than 6 months, and calculated odds ratios (OR) for controlled studies and pooled proportions for open studies.

Results

Pooled data on 6 controlled studies showed that patients taking lamivudine (n = 920) did better than control subjects (n = 1237) with regard to:
 
Undetectable HBV DNA: OR 148;
ALT normalization: OR 76;
CTP score decrease of at least 2 points: OR 9.2;
Development of hepatocellular carcinoma: OR 0.36;
Liver transplantation: OR 0.33.
Patient survival was similar, however, and 22% of lamivudine recipients developed lamivudine resistance.
Patients taking adefovir and those taking lamivudine had similar survival, but adefovir recipients were much less likely to develop resistance (1.5%).
Adefovir potency was lower than that of lamivudine, however, with only 57% of patients achieving undetectable HBV DNA and 67% achieving normal ALT.
Entecavir showed higher efficacy, similar to that of lamivudine, but with 0% resistance.
All 3 drugs were safe, without serious adverse events except for kidney insufficiency in < 1% of patients (2 of 226) taking adefovir in 1 study.
1 small randomized clinical trial found that entecavir had better efficacy than lamivudine with regard to undetectable HBV DNA (100% vs 72%) at 1 year.

Based on these findings, the researchers concluded, "Oral agents are effective and safe for treating decompensated HBV cirrhosis."

"Lamivudine is limited by resistance at 1 year and adefovir is limited by potency," they continued. "Entecavir has advantages of potency without resistance in treatment-naive patients."

The investigators acknowledged that comparative studies of newer potent agents with low resistance -- for example entecavir vs tenofovir -- are needed to determine optimal treatment for hepatitis B patients with decompensated cirrhosis.

A study published earlier this year showed that entecavir improved liver function in people with decompensated cirrhosis, and in October the drug was approved for this indication.

Like adefovir, tenofovir carries a small risk of kidney toxicity, a concern because many people with decompensated cirrhosis already have some degree of kidney impairment. A study presented at last year's AASLD meeting, however, showed that tenofovir -- especially when combined with emtricitabine (Emtriva) -- was effective and well-tolerated in this population. Telbivudine (Tyzeka) has also demonstrated good results in hepatitis B patients with decompensated liver disease.

Investigator affiliations: Gastroenterology, University of Texas Medical Branch, Galveston, TX; Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI.

11/16/10

Reference
AK Singal and RJ Fontana. A systematic review of oral antiviral agents in decompensated HBV cirrhosis. 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010). Boston, October 29-November 2, 2010. Abstract 375.


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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