Hepatitis C

Host of Investigational Treatments Available for Increasingly Prevalent Disease

Hepatitis C is an increasingly prevalent disease in the U.S., says University of Virginia Health System hepatologist Abdullah Al-Osaimi, M.D., with an estimated 3 million to 5 million Americans having the disease. Left untreated, it can lead to cirrhosis of the liver and death.

The standard treatment now in use for Hepatitis C is a year-long combination of pegylated interferon and ribavirin, says UVA hepatologist Patrick Northup, M.D., MHES. Among the 70 percent of Americans with the most difficult-to-treat version of the disease, Hepatitis C Genotype 1, 35 percent to 45 percent are cured by the standard treatment, Northup says. However, the standard treatment can be difficult to tolerate, with side effects including severe fatigue, drops in blood-cell counts and psychiatric side effects.

UVA is a national leader in researching potential improvements to Hepatitis C treatment, participating in a host of multicenter clinical trials investigating new treatment regimens.

The goal over the next five to seven years, Northup says, is “to develop a new treatment regimen that will change the way we manage patients with Hepatitis C infection.” Researchers nationwide hope to get new drugs approved for Hepatitis C treatment that could improve the cure rate to 60 percent to 65 percent as well as shorten the treatment course to fewer months and diminish side effects from treatment.

UVA has several open Hepatitis C trials available and plans to open additional trials in the coming months. “There will be a constant stream of studies over the next 12 months,” Northup says.

Along with potential new treatments, UVA also has clinical trials examining treatments to help more patients tolerate standard Hepatitis C treatment. Referring physicians should consult with Al-Osaimi or Northup for specific inclusion or exclusion criteria for each trial, though Al-Osaimi says that the trials are generally looking for Hepatitis C patients without known heart disease or drug or alcohol abuse within 12 months of the trial. Here’s a look at some of the trials now open at UVA.

 

Investigational Therapy

This Phase III study is examining the safety and effectiveness of Boceprevir®, an investigational drug, in combination with the standard treatment of pegylated interferon and ribavirin. This trial is seeking patients with Genotype 1 Hepatitis C who have previously not responded to treatment with just pegylated interferon and ribavirin.

 

Investigational Therapies to Help Patients Tolerate Standard Treatment

Two randomized, double-blind studies now open at UVA (ENABLE 1 and ENABLE 2) are examining the safety and effectiveness of Eltrombopag® in helping to build up platelet counts in thrombocytopenic patients with Hepatitis C to enable them to undergo treatment with pegylated interferon and ribavirin.

 

Treating Hepatitis C Patients with Insulin Resistance

This study is examining the safety and effectiveness of two treatments for Hepatitis C Genotype 1 patients with insulin resistance who have not previously been treated for Hepatitis C. Patients will be randomized to receive the diabetes drug pioglitazone together with pegylated interferon and ribavirin or only receive pegylated interferon and ribavirin.

To refer a patient for treatment or for inclusion in a clinical trial, call UVA Physician Direct at 800.552.3723.

Hepatology Care at UVA

The Hepatology Clinic at the University of Virginia Health System’s Digestive Health Center of Excellence provides leading-edge surgical and medical care for patients with liver disease. Services available at UVA include:

  • Living donor transplantation: UVA is one of a few medical centers in the country performing liver transplants using living liver donors. UVA is among a handful of centers selected by the National Institute of Diabetes and Digestive and Kidney Diseases to participate in a study evaluating outcomes from living donor transplants for both donors and recipients.
  • Fatty liver disease: UVA physicians are experts at identifying causes of nonalcoholic steatohepatitis, and UVA researchers are working to develop investigational non-invasive diagnostics and novel therapies to address the metabolic causes of this disease.
  • Immunosuppressants for chronic end-stage liver disease: UVA physicians have helped develop advanced treatment protocols to improve outcomes for hepatitis patients.
  • Liver cancer: UVA has a comprehensive liver cancer center designed to provide multidisciplinary care at the cutting edge of medicine for patients with primary liver malignancies.

To refer a patient for hepatology care, call UVA Physician Direct at 800.552.3723.