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Hepatitis C Triple Therapy Response Predicted in Four Weeks

Nicole Cutler L.Ac. October 21, 2011

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Results from a newly published study reveal a way to predict who can be cured of Hepatitis C, providing motivation for affected individuals to complete treatment.

Receiving treatment for chronic Hepatitis C is not guaranteed to result in a cure. This can be devastating because of the treatment’s great expense and capability for causing misery. Thus, the medical community has gone to great strides to figure out ways of predicting the chances that a certain individual can be cured of this viral disease. Claiming to fairly accurately predict who will successfully triumph over Hepatitis C after just a month of treatment, a new study delivers good news to those who are about to begin Hepatitis C treatment.

With the approval of two new medications in 2011, treatment for chronic Hepatitis C has made great progress. Prior to the recent FDA approval of the protease inhibitors Incivek and Victrelis, the standard treatment of pegylated interferon and ribavirin only achieved a 50 percent success rate. With the addition of one of these two new drugs to the therapeutic regimen, the chances of successful treatment have risen to 75 percent or higher.

Although a dramatic improvement over the year-long regimen for pegylated interferon and ribavirin, the new triple drug treatment still lasts six months for most people. The 25 percent of individuals who are not cured of Hepatitis C within six months must still pay for the pricey medications for half a year (if their health insurance doesn’t cover it) and contend with a long list of potentially severe side effects – all for nothing. However, the results of a phase 3 study demonstrates that after just four weeks of triple drug therapy (pegylated interferon, ribavirin and Incivek), patients and their physicians should have a pretty good idea if the treatment will cure their Hepatitis C.

Incivek was approved by the FDA in May 2011 to treat chronic Hepatitis C genotype 1 in conjunction with pegylated interferon and ribavirin. This drug has been met by much excitement by the hepatitis community because it both shortens treatment duration and increases the likelihood of virus elimination. However, since this triple drug regimen relies on pegylated interferon and ribavirin, the side effects associated with these medications still apply. The most common side effects for pegylated interferon and ribavirin include:

  • fatigue
  • flu-like symptoms such as fever, headache and muscle aches
  • anxiety
  • skin rash
  • depression
  • gastrointestinal symptoms such as nausea and diarrhea
  • anemia
  • chest pain
  • hair loss

When adding Incivek to the Hepatitis C drug regimen, the following side effects are added to the list:

  • itching
  • vomiting
  • anal or rectal problems
  • taste changes

Enduring any combination of the side effects listed above can be a major challenge, and many people quit treatment prematurely. As such, encouragement to persevere through these ailments is crucial for completing the treatment and having a chance at viral eradication. According to a study published in the September 15, 2011 issue of the New England Journal of Medicine, such motivation may exist.

Conducted on individuals new to Hepatitis C treatment, this phase 3 Incivek study identified a close similarity between patients who responded to the triple drug treatment after just four weeks and those who achieved successful viral eradication. According to Kenneth Sherman, MD, PhD, Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Division of Digestive Diseases for UC Health and principal investigator of the study, “With Incivek, we know by week four how patients are initially responding and, for people who have not been treated before, we know by week 12 what their chances are of completing all therapy in 24 weeks. I believe these are important motivators for patients to start and stay on treatment.”

Since Incivek has already been approved by the FDA, this recently published study may appear to provide little new information. However, closer evaluation reveals its clinical relevance. Patients who respond to treatment with Incivek, pegylated interferon and ribavirin within the first four weeks of treatment have a significant likelihood of being cured of Hepatitis C. Thus, a positive response after one month of Hepatitis C treatment provides substantial motivation to endure the drugs’ side effects and complete another five months of triple drug therapy.

References:

http://scienceblog.com/41501/hepatitis-c-in-2011-a-predictive-marker-for-response-to-therapy/, Hepatitis C: In 2011, a predictive marker for response to therapy, Retrieved September 25, 2011, ScienceBlog.com, 2011.

http://www.drugs.com/clinical_trials/new-england-journal-medicine-publishes-data-phase-3-illuminate-study-incivek-telaprevir-hepatitis-c-12346.html, New England Journal of Medicine Publishes Data from Phase 3 ILLUMINATE Study of INCIVEK(telaprevir) in Hepatitis C, Retrieved September 25, 2011, drugs.com, 2011.

http://www.hepatitis.va.gov/provider/reviews/treatment-side-effects.asp, Interferon and Ribavirin Treatment Side Effects, Retrieved September 25, 2011, United States Department of Veteran Affairs, 2011.

http://www.hepatitis-central.com/mt/archives/2006/07/understanding_h.html, Understanding Hepatitis C Interferon Therapy, Nicole Cutler, L.Ac., Retrieved September 25, 2011, Hepatitis Central, 2011.

http://www.thirdage.com/news/incivek-phase-3-study-results-published-in-new-england-journal-of-medicine_09-15-2011, INCIVEK Phase 3 Study Results Published in New England Journal of Medicine, Roberta Seldon, Retrieved September 24, 2011, ThirdAge Media LLC, 2011.

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