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HCV Treatment and Obesity

The Editors at Hepatitis Central
August 4, 2005

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This article contains quite a few tidbits of good information (in addition to the primary focus). The description of “signs” that a small number of patients have does a good job of covering possible symptoms and effects of the disease. It also seems that the main difference in success between Pegasys and Peg-Intron in these patients may have more to do with the difference in dosing between standard levels of medication and weight based dosing.

PEG-Intron Shows Higher Sustained Responses in Obese Patients

by John C. Martin
Article Date: 08-03-05

A small observational study from the Cleveland Clinic is suggesting that the hepatitis C treatment PEG-Intron (peginterferon alfa-2b) helps obese patients with the viral infection achieve sustained therapy responses better than its competitor product, Pegasys (peginterferon alfa-2a).1

The results of the preliminary trial were released at Digestive Disease Week, an annual gastroenterology conference, held this year in Chicago.

Interferon/Ribavirin: The ‘Gold Standard’

According to estimates, nearly 4 million Americans are infected with hepatitis C. Three-quarters of this population go on to become chronically infected, and most have accompanying chronic liver disease. HCV accounts for about 15% of acute viral hepatitis, up to 70% of chronic hepatitis cases, and half of all cases of cirrhosis, end-stage liver disease, and liver cancer. The disease is transmitted primarily through contact with blood or blood products, and the “gold standard” treatment at this point includes the combination of a pegylated, or longer-lasting, interferon combined with ribavirin.2

Symptoms of HCV may be absent, but in some cases may include the following:

  • Fatigue
  • Mild discomfort or tenderness on your upper right side
  • Nausea
  • Poor appetite
  • Muscle and joint pains

A small number of people with the infection develop certain signs, such as skin rashes, kidney disease, neuropathy, cyroglobulins (abnormal blood proteins), rheumatoid factor (an abnormally produced autoantibody that reacts against immunoglobulins in the blood), and low levels of complement (proteins) in the blood.2

PEG-Intron (peginterferon alfa-2b), manufactured by Schering-Plough Pharmaceuticals, is a form of pegylated, or longer-lasting, interferon for hepatitis C. It is prescribed alone or in combination with an oral antiviral medication called ribavirin for adults with the disease. Another pegylated interferon, Pegasys (peginterferon alfa-2a), manufactured by Hoffman-LaRoche Pharmaceuticals, is also combined with ribavirin as a treatment for hepatitis C. Both PEG-Intron and Pegasys, manufactured by Hoffman-LaRoche Pharmaceuticals, are injectable medications used as therapy for hepatitis C.

Sustained Treatment Responses Compared

Doctors in the study compared sustained virologic responses (SVR) in people classified as obese with those considered non-obese using both medications. SVR is defined as continual non-detectable levels of the hepatitis virus for a minimum of six months after therapy ends.3 “Obese patients with hepatitis C virus (HCV) may have more rapid progression of liver disease and lower rates of response to antiviral therapy than nonobese patients,” wrote the study’s lead investigator, Nizar Zein, MD, in the department of Gastroenterology and Hepatology at the Cleveland Clinic, and his associates.

Thus, the investigators wanted to determine if either Pegasys or PEG-Intron, both combined with the oral antiviral drug, ribavirin, could help their obese patients achieve an SVR.

Study Participant Characteristics

Through a record search, Zein and his group identified nearly 100 patients who had arrived at the Cleveland Clinic between 2001 and 2004 for treatment of their hepatitis C. None of the patients had received treatment prior to their arrival. Each of the patients was infected with genotype 1 HCV, the most common and most difficult to treat strain of the virus.
Thirty-five patients were classified as obese, and the remaining 61 patients were designated non-obese. Each had undergone a biopsy before therapy to determine the health of their livers.

The researchers reported no significant differences in disease characteristics like liver enzyme levels or levels of HCV RNA, the virus’ genetic material that doctors look for as an indicator of its presence. Forty percent of the obese patients had steatosis, or fatty liver, compared with just 16 percent of those classified as non-obese. “But frequency of advanced fibrosis or marked inflammation were not significantly different” between the two groups, Zein and his team wrote.

Which Medication Had Better Outcomes?

When analyzing which patients taking Pegasys in combination with ribavirin had achieved an SVR, the researchers found that two of eleven obese patients in this group (18 percent) did so, compared to eight of 29 non-obese patients (28 percent). By contrast, of those in the group taking PEG-Intron combined with ribavirin, nine of 17 obese patients (52 percent) and 14 of 29 non-obese patients (48 percent) similarly achieved a sustained response, the investigators found.

“Mild fibrosis, lower pretreatment HCV RNA, and weight-based dosing were independently associated with attainment of SVR,” wrote the study team. In this research, weight-based doses of PEG-Intron were given to the patients compared with standard dosing using Pegasys. That means people taking PEG-Intron are assigned a specific dose based on their individual weight, as opposed to a standard dose that everyone taking Pegasys receives.

“Obese and non-obese patients have equal SVR when treated with weight-based doses of [peginterferon alfa-2b] in combination with ribavirin,” wrote Zein and his group in conclusion. “However, when treated with standard-dosed [peginterferon alfa-2a] and ribavirin, obese patients are less likely to attain SVR.”

So far, no formal clinical trials have been published comparing the efficacy of PEG-Intron versus Pegasys. However, Schering is sponsoring such a trial whose results will reportedly be released in 2007.

  1. Cesario K, Khandwala F, Edwards K, Carey W, Barnes D, Zein N. Impact of obesity on degree of liver disease and response to therapy in patients with chronic hepatitis C genotype 1 infection. Digestive Disease Week 2005. 2005 May 14-19. Chicago, IL.
  2. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). National Institutes of Health. Chronic Hepatitis C: Current Disease Management. Available at: http://digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm. Accessed July 28, 2005.
  3. Fried MW, Shiffman ML, Reddy KR et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002 Sep 26;347(13):975-82.
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