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HIV and Hepatitis.com Coverage of the
45th Annual Meeting of the European
Association for the Study of the Liver (EASL 2010)

April 14 - 18, 2010, Vienna, Austria
Child-Pugh Score Changes Do Not Predict Liver Failure among HIV/HCV Coinfected Patients during Hepatitis C Treatment

SUMMARY: Changes in Child-Pugh score, a clinical measure used to indicate the level of liver damage and risk of hepatic decompensation, may not reliably predict liver failure in HIV positive people with chronic hepatitis C virus (HCV) coinfection, since changes in the component parameters may be due to other causes, according to a poster presented at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010) this month in Vienna.

By Liz Highleyman

Mark Sulkowski from Johns Hopkins University School of Medicine and fellow investigators analyzed data from HIV/HCV coinfected patients enrolled in the PARADIGM study to determine whether shifts in Child-Pugh score predict liver decompensation.

Hepatic decompensation occurs when the liver can no longer carry out its normal functions, leading to symptoms such as ascites (abdominal fluid accumulation), bleeding varices (varicose veins) in the esophagus, and hepatic encephalopathy, or brain impairment due to build-up of toxic substances.

The Child-Pugh score is calculated based on 2 clinical parameters (ascites and encephalopathy) and 3 laboratory parameters, albumin (a blood protein), total bilirubin (a pigment released when old red blood cells are broken down), and international normalized ratio (a measure of blood clotting ability based on prothrombin time).

PARADIGM included previously untreated HIV/HCV coinfected adults with HCV genotype 1. Participants had a CD4 cell count of at least 100 cells/mm3 and were either on stable antiretroviral therapy (ART) or did not yet require HIV treatment. Individuals with compensated liver cirrhosis (Child-Pugh score < 6) were eligible for the study.

Participants were randomly assigned (1:2) to receive 180 mcg/week pegylated interferon alfa-2a (Pegasys) for 48 weeks plus either 800 mg/day fixed-dose ribavirin or 1000-1200 mg/day weight-adjusted ribavirin. Child-Pugh scores were assessed at 1 to 6 week intervals during treatment and follow-up.

Results

At study entry, 46 participants had cirrhosis, all but 1 of whom had baseline Child-Pugh scores available.
Nearly half of cirrhotic patients (22 out of 45) experienced shifts in Child-Pugh score during treatment and follow-up.
All such shifts were secondary to decreases in serum albumin and/or increases in total bilirubin:
 
> 1 point shift in albumin only: 40% in 800 mg/day ribavirin arm and 13% in 1000-1200 mg/day arm;
> 1 point shift in total bilirubin only: 7% and 17%, respectively;
> 1 point shift in albumin or total bilirubin: 60% and 43%, respectively.
There was 1 episode of hepatic decompensation characterized by bleeding esophageal varices in a patient with a baseline Child-Pugh score of 5; this occurred 3 months after the patient discontinued treatment due to insufficient response.

These findings led the investigators to conclude, "During this study, shifts in Child-Pugh score occurred in approximately 50% of coinfected patients with compensated cirrhosis but hepatic decompensation was a rare event."

Explaining these results, they noted that shifts in Child-Pugh score may be due to changes in albumin and bilirubin levels that are not directly related to liver function. Decreased albumin levels, for example, may result from treatment-related anorexia (loss of appetite) and weight loss. Increased total bilirubin may be caused by the protease inhibitor atazanavir (Reyataz) or by hemolytic anemia due to ribavirin.

These results, they advised, "suggest that a shift in Child-Pugh score is not a reliable predictor of hepatic decompensation among coinfected cirrhotic patients treated with pegylated interferon alfa-2a plus ribavirin."

Johns Hopkins University School of Medicine, Baltimore, MD; Massachusetts General Hospital, Harvard Medical School, Boston, MA; St. Michael's Medical Center, Newark, NJ; AIDS Healthcare Foundation, Los Angeles, CA; Virginia Commonwealth University, Richmond, VA; University of California San Diego, San Diego, CA; Hospital São João, Porto, Portugal; Hospital del Mar, Barcelona, Spain; Roche, Nutley, NJ; Fundacion de Investigacion de Diego, Santurce, Puerto Rico; Ponce School of Medicine, Santurce, PR.


4/27/10

Reference
M Sulkowski, RT Chung, J Slim, and others (PARADIGM Study Investigators). Shifts in Child-Pugh score in patients coinfected with HIV-HCV undergoing treatment with peginterferon alfa-2a (40kd) and ribavirin are not predictive of hepatic decompensation. 45th Annual Meeting of the European Association for the Study of the Liver (EASL 2010). Vienna, Austria. April 14-18, 2010. (Abstract).


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



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