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News Review

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

July 10, 2004 Volume 1, Issue 12


Liz Highleyman

To download pdf version click here


In This Issue:

Hepatitis C

Genotype 3 HCV May Resolve Spontaneously

HCV Treatment for Patients on Methadone

Length of Interferon Therapy

Thyroid Disorders Common in People with HCV

Genotype 3 HCV May Resolve Spontaneously

HCV genotype 3 infection is more likely to resolve spontaneously than other genotypes, according to a study published in the July issue of the Journal of Medical Virology. Heiner Wedemeyer and colleagues studied 92 men with evidence of HCV infection in a German prison. Among those who had HCV antibodies (indicating that they had been infected), men with genotype 3 were less likely to have detectable HCV in their blood compared with genotype 1 patients, suggesting that the immune system had cleared the virus on its own. The majority of men infected with genotype 3 HCV (63%) still developed chronic hepatitis C, but this was significantly lower than the rate of chronic disease in men with genotype 1 (93%). Because sustained virological response (SVR) rates using pegylated interferon plus ribavirin are very good in patients with genotype 2 or 3 HCV—in the range of 75-80%—some experts recommend that such patients should usually be treated. However, the authors suggest that given the higher rate of spontaneous viral clearance, it may be reasonable to wait before treating those with genotype 3. “Wait and see for genotype 3, treat immediately for genotype 1,” Wedemeyer advised.

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HCV Treatment for Patients on Methadone

Although the latest National Institutes of Health (NIH) consensus guidelines for the management of hepatitis C recommend that injection drug users should not automatically be excluded from HCV therapy, many physicians consider active drug users and those on opioid substitution therapy to be difficult to treat. A new German study reported in the July 2004 issue of Hepatology found that HCV treatment is “reasonably safe and sufficiently effective” in patients on methadone maintenance. Stefan Mauss and colleagues studied 100 subjects, 50 on stable methadone maintenance for at least six months and 50 who had not used illicit drugs or opioid substitution for at least five years; about 60% in both groups had genotype 1 HCV. All were treated with pegylated interferon (Peg-Intron) plus ribavirin. During the first eight weeks of treatment, methadone patients were five times more likely than non-methadone control subjects to either request to stop HCV therapy or to discontinue due to nonadherence (22% vs 4%). After eight weeks, however, rates of discontinuation for these reasons were similar (10% vs 8%, respectively). Rates of discontinuation due to side effects or virological failure were somewhat higher in the methadone group (20% vs 12%), but the difference was not statistically significant. No serious psychiatric events occurred in either group, although 15 patients in the methadone arm and 10 in the non-methadone group took antidepressants during therapy. End of treatment response rates were 50% in the methadone group and 76% in the non-methadone arm. After 24 additional weeks of follow-up, the corresponding SVR rates were 42% and 56%, indicating that the relapse rate was higher in the non-methadone group. However, since relatively few patients completed a full course of treatment, the difference did not reach statistical significance. In a pivotal study of pegylated interferon/ribavirin, the all-genotype SVR rate was 56%, similar to that seen in the non-methadone group in this study. “[T]he control group has a better chance of treatment response than the group on methadone maintenance,” wrote the authors, “and this response is driven by increased compliance and reliability.” Because a substantial proportion of methadone patients achieved SVR and because most discontinuations occurred early, thus limiting the cost of unsuccessful therapy—the results of this study support the NIH recommendation that hepatitis C patients on methadone maintenance should be offered therapy.

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Length of Interferon Therapy

Given the side effects and cost associated with interferon therapy, HCV patients and researchers are interested in whether lower doses might be effective. A study in the July 2004 issue of the American Journal of Gastroenterology suggests that lower doses of interferon are not as beneficial as higher doses. Paul Pockros and colleagues treated 639 HCV patients with thrice-weekly conventional interferon or one of two doses of once-weekly Pegasys brand pegylated interferon: 135 mcg or the usual 180 mcg. As expected, patients receiving Pegasys did better than those receiving conventional interferon. Interestingly, though, the SVR rates were the same in the 135 mcg and 180 mcg groups (28% for the two Pegasys arms vs 11% for the conventional interferon arm). But the researchers found that patients in the 180 mcg Pegasys arm experienced more histological (liver tissue health) improvement compared with the 135 mcg Pegasys group (58% vs 48%, compared with 45% for conventional interferon). This study did not use ribavirin, and the researchers did not break down their results by genotype in their abstract. Despite these limitations, the data suggest caution in using lower doses of pegylated interferon, and indicate that SVR is not the only important factor to consider when evaluating the benefits of HCV therapy.

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Thyroid Disorders Common in People
with HCV


Thyroid disorders are common in people with chronic hepatitis C, according to a study published in the July 1 issue of the American Journal of Medicine. Previous research has shown that 2-20% of people with hepatitis C develop thyroid dysfunction. Such problems are associated with both HCV infection itself and with interferon therapy. In this study, Alessandro Antonelli and colleagues examined the prevalence of thyroid disorders in 630 subjects. Compared with HCV negative controls, patients with HCV had higher rates of hypothyroidism (low production of thyroid hormones) and autoimmune thyroiditis (a condition in which the body’s own immune system attacks the thyroid gland). Although the HCV patients had higher levels of thyroid stimulating hormone (a pituitary gland hormone that stimulates the thyroid gland), they had significantly lower levels of free T3 and T4 (two hormones produced by the thyroid gland). Hypothyroidism was observed in 13% of subjects with HCV, compared with 3-5% of uninfected control subjects. In addition, the HCV patients had higher levels of anti-thyroid antibodies, markers of an autoimmune response. “The significant association of chronic hepatitis C with hypothyroidism and thyroid autoimmune phenomena implies that these patients should be screened for thyroid function on a periodic basis,” Antonelli recommended. If thyroid hormone levels are found to be too low, patients can be treated with synthetic supplements.

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