Sunday, May 20, 2012

DDW-New and future Hepatitis C therapies examined in clinical session

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New and future HCV therapies examined in clinical session

A DDW Combined Clinical Session on New Therapies for HCV: Practitioners Delivering Specialty Care Saturday morning included a discussion of new and future hepatitis C therapies as well as a talk on Project ECHO (Extension for Community Healthcare Outcomes), a new model for hepatitis C care designed to expand access to treatment.

The latest therapies for HCV include the protease inhibitors boceprevir and telaprevir, which the FDA approved last year for the treatment of HCV infections. These agents work by inhibiting HCV replication in the body. Both drugs are meant to supplement the current standard for hepatitis C treatment: a combination of the drugs ribavirin and pegylated interferon alfa-2a or ribavirin and pegylated interferon alfa-2b.

According to Norah A. Terrault, MD, MPH, professor of medicine/gastroenterology and director of the Viral Hepatitis Center at the University of California, San Francisco, the new protease inhibitors have improved sustained viral response (SVR) rates, but some problems remain.

“What we’ve learned so far with approval and then implementation of a protease inhibitor triple-therapy is that this is a significant advance,” Dr. Terrault said. “When we think that for more than a decade we were dealing with just peg-interferon and ribavirin, the approval of protease inhibitors was really a step forward. The SVR rates are significantly improved, particularly in treatment-na├»ve patients and those who have been treated and relapsed.”

But there are still groups of patients where the response rates are suboptimal, she added. Among prior-partial and null responders, the anticipated virological response rates are less than 50 percent even with triple therapy, Dr. Terrault said.

Another problem is that the duration of treatment is still 48 weeks for all cirrhotics and for patients who do not achieve extended rapid virological response rates. Side effects have also increased with triple therapy, as have drug-drug interactions.

As a result, new therapies are being developed to address some of these problems, including peg-interferon and ribavirin combined with one or two direct antiviral agents, as well as therapies free of peg-interferon, Dr. Terrault said.

Boceprevir and telaprevir target HCV NS3. Secondgeneration NS3 protease inhibitors under study include danoprevir and BI-20133. A phase IIb trial of BI-20133 demonstrated that this agent increased the SVR rate compared with boceprevir and telaprevir and was better tolerated.

Other drugs being studied include HCV NS5A inhibitors such as daclatasvir, and NS5B nucleoside and non-nucleoside inhibitors, including GS-7977. Early studies have shown promising results with significant benefits for HCV patients, Dr. Terrault said.

Sanjeev Arora, MD, professor of internal medicine (gastroenterology and hepatology) and director of Project ECHO at the University of New Mexico School of Medicine, Albuquerque, described ECHO as a telemedicine and distance-learning program designed to improve access to quality health care for New Mexicans with hepatitis C, especially those in rural areas and prisons.

There are approximately 28,000 HCV patients in New Mexico, and 2,300 of them are in the prison system. Project ECHO links health-care providers from rural clinics, the Indian Health Service and prisons with specialists at the University of New Mexico. At weekly clinics, the linked providers present and discuss HCV patients with the specialists.

The ECHO model uses videoconferencing techniques to train primary care providers to treat hepatitis C and other complex diseases. More than 50 percent of the providers in community health centers in rural areas of New Mexico are physician assistants and nurse practitioners, Dr. Arora said.

A prospective cohort study published in The New England Journal of Medicine in 2011 compared treatment for HCV infection at the University of New Mexico’s HCV clinic with treatment by primary care providers at 21 ECHO sites in rural areas and prisons in the state. Dr. Arora and his colleagues found that the ECHO model is an effective way to treat HCV in underserved communities.

A total of 57.5 percent of patients treated at the UNM HCV clinic and 58.2 percent of those treated at ECHO sites had a sustained viral response to therapy.

“The potential benefits to the health system of such a model can be improved quality and safety, reduced variations in care, improved access to care to rural patients and improvement in disparities in care,” Dr. Arora said.

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