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News Review

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

May 31 , 2005 Volume 2, Issue 7


Liz Highleyman

To download pdf version click here


In This Issue: Hepatitis C

Peg-Intron Plus Ribavirin in Children

Short-Term Therapy for Genotype 2a

HCV and Cognitive Impairment

Noni Fruit May Cause Liver Toxicity



Peg-Intron Plus Ribavirin in Children

The combination of pegylated interferon plus ribavirin has been shown to effectively treat chronic hepatitis C in adults, but few data are available on the efficacy of this regimen in children. In the May issue of Hepatology, Stefan Wirth and colleagues from Wuppertal, Germany, reported on an uncontrolled, open-label study of pegylated interferon-alpha-2b (Peg-Intron) (1.5 mcg/kg body weight once weekly) plus ribavirin (15 mg/kg once daily) for 48 weeks in 62 children and adolescents (age 2-17); 23 subjects who did not show an early virological response discontinued therapy after six months, and one dropped out early due to injection site reactions.

After a 24-week post-treatment follow-up period, 22 out of 46 children (48%) with genotype 1 HCV achieved sustained virological response (SVR), as did all 13 subjects (100%) with genotypes 2 or 3, and 1 of the 2 patients (50%) with genotype 4. Looking at transmission route, 19 of the 27 children (70%) with parenteral (blood-to-blood) infection, 12 out of 25 (48%) with vertical (mother-to-child) infection, and 5 of 9 (56%) with unknown route of infection achieved SVR. Response rates were higher among subjects with normal liver enzyme levels before starting therapy (a group that has traditionally been excluded from treatment). In terms of side effects, most subjects experienced flu-like symptoms, 83% developed decreased white blood cell counts (although only three had leukopenia severe enough to require interferon dose reduction), 10% developed thyroid dysfunction, and one developed diabetes; rates of depression were not reported.

The authors concluded that treatment with Peg-Intron plus ribavirin "showed encouraging results and was well tolerated" in children and adolescents with chronic hepatitis C. This regimen is not currently approved for children, but some doctors prescribe it off-label because it is the most effective therapy for adults. Notably, the overall response rate in this study (59%) was not significantly higher than those seen in past pediatric studies using standard (non-pegylated) interferon plus ribavirin. It is not clear why the subjects with parenteral infection had a higher response rate than those infected before or during birth. Further studies are underway to determine whether combination HCV therapy is necessary for children and teens, since they seem to respond better than adults to pegylated interferon alone.

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Short-Term Therapy for Genotype 2a

Six weeks of interferon therapy may be sufficient for some individuals with genotype 2a HCV, which is easier to treat than the more common genotype 1. In a study by A. Tabaru and colleagues from Japan reported in the April American Journal of Gastroenterology, 13 treatment-naive chronic hepatitis C patients with genotype 2a were given standard interferon monotherapy for 24 weeks (the usual course of treatment for genotypes 2 and 3), while 12 were treated with the same regimen for six weeks. All subjects cleared HCV by the end of treatment, but four patients in the 24-week arm and five in the six-week arm relapsed within the six-month follow-up period. The resulting SVR rates - 53.8% and 58.3%, respectively - did not differ significantly based on whether patients received the longer or shorter course of therapy. Among patients with low HCV viral loads, the SVR rates were 83.3% in the 24-week arm and 100% in the six-week arm. The authors suggested that for genotype 2a patients with "good predictive factors," such as low viral load, the duration of interferon therapy may be shortened to less than 24 weeks; they recommended further research to determine the optimal course of treatment. It is possible that even more promising results might be achieved using pegylated interferon.

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HCV and Cognitive Impairment

Neurocognitive problems are common in individuals with chronic hepatitis C, though their severity varies widely from mild "brain fog" to more serious cognitive dysfunction. M.P. McAndrews and colleagues from Ontario looked at the prevalence and significance of neurocognitive dysfunction in hepatitis C patients lacking other risk factors (e.g., substance use, depression, interferon therapy); the results were reported in the May Hepatology. The researchers studied 37 patients at a liver disease clinic and 46 healthy control subjects. Cognitive function was determined using 10 measures, including neuropsychological testing and magnetic resonance spectroscopy (MRS) to assess brain activity. Compared with the control subjects, the hepatitis C patients had slightly poorer learning efficiency; however, only 13% of the HCV patients demonstrated clinically significant impairment. Fatigue and depression (which were worse in the HCV group) did not correlate with degree of learning inefficiency. On the MRS test, the patients with HCV showed increased levels of choline and decreased levels of N-acetyl aspartate (two chemicals associated with brain activity) in their white matter (a type of brain tissue rich in nerve fibers that transmit information). Interestingly, the researchers found that liver disease severity was not correlated with either memory impairment or MRS abnormalities. "While our findings support an association between hepatitis C and indicators of central nervous system involvement," the authors concluded, "the clinical significance of these effects is limited."

In related research, a team from the University of California at San Diego found that HCV coinfection was linked to a higher risk of cognitive impairment among HIV positive individuals who used methamphetamine; these results were reported in the April 26 issue of Neurology. The study included 40 HIV/HCV coinfected methamphetamine users, 110 subjects with two risk factors (HIV, HCV, or methamphetamine use), 190 with one risk factor, and 90 uninfected control subjects who did not use methamphetamine; because the study initially set out to examine the effects of methamphetamine use in HIV positive individuals, it did not include an HCV monoinfected group that did not use methamphetamine. More than one-third (37%) of HIV positive methamphetamine users had HCV, compared with just 2% of HIV negative non-users. The researchers used various tests to assess learning, recall, attention and working memory, information processing speed, verbal fluency, abstraction and problem solving, and motor ability. After adjusting for demographic factors, they found that HCV serostatus was a "significant predictor" of neuropsychological performance, both globally and in the areas of learning, abstraction, and motor skills. However, HCV serostatus did not predict attention and working memory or verbal fluency. Not only were HCV, HIV, and methamphetamine use all independently associated with neurocognitive impairment, but the three risk factors had an additive effect. As in the study described above, liver disease severity (determined on the basis of liver enzyme levels) was not correlated with degree of cognitive impairment. "Hepatitis C virus infection contributes to the neuropsychological deficits observed among HIV-infected and stimulant-dependent populations," the authors concluded. "[I]ts identification and treatment are likely to result in improved neurobehavioral outcomes among individuals with HIV infection and substance use disorders." In an editorial in the same issue entitled "Triple Trouble," Wilfred van Gorp and Charles Hinkin suggested that attention to hepatitis C could potentially improve neuropsychological performance among HIV positive stimulant users, which in turn could have a beneficial effect on factors such as daily functioning, medication adherence, and employment status.

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Noni Fruit May Cause Liver Toxicity
Many therapeutic herbs and herbal preparations have been linked to potential liver toxicity. A case report published in the April European Journal of Gastroenterology suggests that another plant should be added to this list. G. Millonig and colleagues reported on a 45-year-old man who presented with highly elevated blood levels of transaminases (ALT and AST, two liver enzymes) and lactate dehydrogenase (an enzyme suggestive of tissue damage). The man did not have viral hepatitis or several other liver conditions and did not take any regular medications. He reported drinking a preparation made from noni (Morinda citrifolia), a tropical fruit. Liver biopsy confirmed signs of hepatotoxity. The man's transaminase levels normalized after he stopped consuming noni. The fruit, which has been promoted as a remedy for a variety of ailments, is also known as Indian Mulberry, mengkudu, and hai ba ji.

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