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News Review

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HEPATITIS JOURNAL REVIEW:
A Bi-Monthly Publication of the Hepatitis Support Project

June 20, 2004 Volume 1, Issue 11


Liz Highleyman

To download pdf version click here


In This Issue:

Hepatitis C

24-Week Treatment for Genotypes 2 and 3

Amantadine Efficacy and Safety

Natural History of Cirrhosis

Hepatocellular Carcinoma Risk Factors and Survival


24-Week Treatment for Genotypes 2 and 3

Given the side effects and cost of hepatitis C therapy, HCV patients and their doctors have an interest in limiting the length of treatment if this does not compromise effectiveness. Data reported by Stefan Zeuzum and colleagues in the June issue of the Journal of Hepatology confirm that – as recommended in the June 2002 National Institutes of Health HCV management guidelines – a 24-week course of pegylated interferon plus ribavirin is adequate for patients with HCV genotypes 2 or 3. Both genotypes respond better to interferon-based therapy than genotype 1, and the two have been grouped together in most studies. This trial, however, revealed that after receiving Peg-Intron plus ribavirin (800-1400 mg/day depending on weight) for 24 weeks, the sustained virological response (SVR) rate was higher in the 42 patients with genotype 2 compared with the 182 subjects with genotype 3 (93% vs 79% in an intent-to-treat analysis). The researchers suggested that the difference between the two genotypes may be due to the presence of high baseline HCV viral load and steatosis (fatty liver), both of which are associated with a lower likelihood of achieving SVR, and both of which occurred more frequently among the individuals with genotype 3 in this study. The authors concluded that treatment for 24 weeks is sufficient for patients with genotypes 2 or 3.

In an editorial in the same issue, Alfredo Alberti noted that Zeuzem’s study “is important in suggesting that HCV-2 and HCV-3 infected patients should not be considered identical in relation to response to antiviral therapy, as it has been customary to believe up to now.” Future research may show that a longer course of therapy is beneficial for genotype 3 patients with high viral loads and/or steatosis. Another issue for future trials is whether 800 mg of ribavirin is sufficient for patients with genotypes 2 or 3 when used with Peg-Intron, as was seen in past studies using Pegasys. And, suggested Alberti, it would be interesting to explore whether an even shorter course of therapy or even lower medication doses might still be effective for “easy to treat” patients with genotypes 2 or 3, low HCV viral load, and minimal liver damage.

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Amantadine Efficacy and Safety

Given the limitations of current HCV treatment, the need for new therapies is clear. In the June issue of the American Journal of Gastroenterology, Jill Smith and colleagues reported results of an open-label dose-escalation study of amantadine (Symmetrel), a drug used to treat influenza and Parkinson’s disease. Past research has demonstrated that amantadine reduces ALT levels and may improve response rates when combined with interferon plus ribavirin. One hundred study participants received 200 mg daily doses of amantadine, escalating to 500 mg. Elevated ALT levels normalized in 35% of patients taking 200 mg, 49% of those taking 300 mg, 53% of those taking 400 mg, and 56% of those taking 500 mg. Muscle pain and fatigue improved as doses increased. However, toxic blood levels of the drug (more than 1,600 ng/ml) also increased with each 100 mg escalation, from 0% to 6% to 27% to 49%, respectively. Side effects included erectile dysfunction, mental confusion, hair loss, and hoarseness. Biochemical response did not improve significantly at doses higher than 300 mg, but toxicity did increase. The researchers therefore concluded that the 300 mg dose offers the best combination of efficacy and safety.

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Natural History of Cirrhosis

Two recent studies examined the natural history of liver cirrhosis in individuals with viral hepatitis. In the May issue of Gut, L. Benvegnu and colleagues investigated the progression and outcome of initially compensated cirrhosis in a cohort of 312 Italian patients with hepatitis B (43 patients), C (254 patients), or both (15 patients), followed for an average of about eight years. Tests were performed every six months to assess liver disease progression and identify major complications. During the follow-up period, 102 patients (about 33%) developed at least one complication. The most common were hepatocellular carcinoma (HCC, a type of liver cancer; about 21%), ascites (about 20%), gastrointestinal bleeding (about 5%), and encephalopathy (about 2%). About 20% experienced liver disease progression as evidenced by an increased Child-Pugh cirrhosis score. About 19% died from liver disease during follow-up, most (70%) due to HCC. The authors concluded that HCC was “the most frequent and life-threatening complication, particularly in HCV positive cases.”

The same month in the Journal of Hepatology, Ramon Planas and colleagues from Spain reported on the natural history of decompensated cirrhosis in patients with hepatitis C. Two hundred patients were followed from their first hospitalization for hepatic decompensation; average follow-up was about three years. The most common initial complications related to decompensation were ascites (48%), gastrointestinal bleeding (about 33%), severe bacterial infection (about 15%), and encephalopathy (5%). During follow-up, about 17% developed HCC and about 43% died. “Once decompensated HCV-related cirrhosis was established,” the researchers concluded, “patients showed not only a very high frequency of readmissions, but also developed decompensations different from the initial one.”

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Hepatocellular Carcinoma Risk Factors and Survival

As Steedman Sarbah and colleagues reported in the May issue of Digestive Diseases and Sciences, the incidence of HCC appears to be increasing in the United States, likely as a long-term consequence of hepatitis C that was contracted years or decades ago, before current treatments were available. Using medical records and patient databases, Sarbah’s team examined the factors associated with the development of liver cancer in 214 individuals with HCC and 516 controls with cirrhosis but no HCC. Older age, male sex, and African American or other non-Caucasian race/ethnicity were all independently and significantly associated with an increased risk of developing HCC.

Fortunately, according to a report by Angelo Sangiovanni and colleagues in the April issue of Gastroenterology, cirrhotic patients with HCC appear to be surviving longer now than they did in the past. Following a cohort of more than 400 outpatients with compensated cirrhosis for an average of about 12 years, the researchers found that HCC developed in 112 individuals, for a rate of 3.4% per year. They also found that those who developed HCC during the most recent five-year period of follow-up had a lower mortality rate than those who developed liver cancer during the middle or the earliest five-year period (10%, 37%, and 45%, respectively). “Cirrhotic patients developing a HCC during the last five years of surveillance survived longer than previously, as a consequence of improved management of the tumor and complications of cirrhosis,” the authors concluded.

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