New Practice Guidelines for HCV Genotype 1

Horizons in Hemophilia, December 2011 

Submitted by the National Hemophilia Foundation

In October, the American Association for the Study of Liver Diseases (AASLD) approved a new practice guideline for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. Approximately 70% of people with HCV have genotype 1. The lead author of the guideline was Marc Ghany, MD, from the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

The new guidelines are for use by physicians. They include the addition of one of the two new protease inhibitors--boceprevir and telaprevir--to standard HCV treatment regimens. On May 13, 2011, the FDA approved Merck’s boceprevir under the brand name Victrelis™; May 23rd it approved Vertex Pharmaceutical’s telaprevir under the brand name Incivek™. The first new HCV therapies in 10 years, both products represent a new class of drugs called direct-acting antivirals that prevent viral enzymes from replicating.  
 
The current standard of treatment combines weekly injections of pegylated interferon and a daily ribavirin oral pill. However, that regimen is not ideal--nearly 50% of patients do not respond to it. Those who do often experience debilitating side effects that can last the duration of the treatment—either 24 or 48 weeks.
 
The new drugs help boost the success of HCV treatment, protecting patients from the potentially severe and life-threatening impact of HCV symptoms, which include liver cancer, cirrhosis, end-stage liver disease and liver failure. Success is measured by patients’ ability to “clear” the virus by achieving a sustained virological response (SVR) for at least six months after completing therapy. Though not technically a cure--HCV is often not completely eradicated from the liver--SVR is still the goal for clinicians. Lowering the viral load to undetectable levels in the bloodstream diminishes the disease’s harmful effects.

The inclusion of a protease inhibitor increases the likelihood that a patient with HCV genotype 1 will reach SVR in up to half the time–24 weeks vs. 48 weeks. The guidelines also note that a blood-based genotype test can be used to predict responses to HCV treatment with pegylated interferon, ribavirin and either of the protease inhibitors.

“Recommendations suggest preferred approaches to the diagnostic, therapeutic and preventive aspects of care,” said Ghany and coauthors. “They are intended to be flexible, in contrast to standards of care, which are inflexible policies to be followed in every case.” That flexibility will be necessary as treatment schedules will vary between patients and side effects will need to be managed carefully. The new drug regimen is not recommended for people with post-transplant HCV or those co-infected with HCV and HIV.

“Hepatologists, gastroenterologists, and others who treat patients with chronic hepatitis C now have the option of two newly approved drugs that directly interfere with the ability of the hepatitis C virus to persist in the patient,” said Gary Davis, MD, chair of AASLD’s special interest group on hepatitis C. “Administration of these drugs is not straight-forward and increases the complexities of patient management. The new AASLD guidelines review how and when to use these agents in the clinic. This timely document should be a great asset in the management of our patients with hepatitis C.”

The new guidelines were published in the October 2011 issue of the journal Hepatology.

Source: Poz.com, October 7, 2011; PR Newswire press release dated September 28, 2011.