Victor Garcia is one of the California success stories. The 59-year-old Sacramento resident recently completed a clinical trial at the medical center using Victrelis (boceprevir), the drug approved in early May by the Food and Drug Administration for general use against the disease. The other drug physicians are hailing as a cure, Incivek (telaprevir), was approved by the FDA on May 23.
“It’s extended my life,” said Garcia, a father of five. “My doctor originally told me I didn’t have that long to live, so I was really fortunate to get into the study. Now it’s amazing to think that I don’t have hepatitis C at all anymore.”
Garcia, who says he doesn’t know how he contracted the disease, took part in two clinical trials at UC Davis, one of the top five enrolling sites for testing the safety and effectiveness of the two drugs against the chronic virus. Victrelis was evaluated as part of a phase 3 clinical trial involving 1,500 adult patients around the nation. A protease inhibitor that prevents viral replication, Victrelis was tested on Garcia and other hepatitis C patients who had previously been treated with other drugs, but were unable to be cured.
Victrelis, like Incivek, is part of a “triple therapy.” The drug is added to the current standard of care for hepatitis C – a combination of the drugs peginterferon alfa and ribavirin, which among Latino and African-American patients had a low success and cure rate. In Garcia’s case, the addition of Victrelis made all the difference.
“This is an exciting time,” said Lorenzo Rossaro, professor of internal medicine and chief of the Division of Gastroenterology and Hepatology at UC Davis, who directed the clinical trials at the medical center. “To realize that a majority of my patients can be cured of devastating disease is one of the most wonderful experiences imaginable for a physician.”
Rossaro co-authored recent studies published in the New England Journal of Medicine and Lancet about the impressive and sustained virologic responses hepatitis C patients had with boceprevir. He estimates that the success rates for triple therapy will be between 70 to 80 percent. The treatment, which lasts from 24 to 48 weeks, is determined by each patient’s response to the rigorous drug regimen, which consists of once-a-week injections and multiple daily pills. How well patients tolerate the drugs, and how quickly the virus is eliminated from their bloodstream, determines the length of treatment.
While the new drugs have a significantly higher cure rate, they are not 100 percent effective in all cases. Both Vitrelis and Incivek can have significant side effects — including rashes, low red-blood cell counts (anemia), nausea, fatigue, headache and diarrhea, which force one out of seven patients to halt treatment.
“Because the new hepatitis drug cocktail is so powerful, this triple therapy requires providers to closely monitor their patients,” said Rossaro. “With all the cases that now can be treated and probably cured, specialists and primary-care providers will be playing very important roles in this effort.”
Rossaro noted that using telemedicine (medical consultations using videoconferencing equipment) will be an important way to reach patients in smaller, more rural communities, as well as train more providers to help manage the disease. With an estimated 650,000 hepatitis C cases in California, he and other specialists are working with the UC Davis Center for Health and Technology to provide telemedicine consultation services, education and training for primary-care providers who can help dispense and monitor the triple-therapy drugs.
“At $1,100 a week, the new drug therapy might appear to be a very expensive,” said Rossaro. “But compared to years of clinic visits, hospitalizations, liver transplantation and the costs arising from the complications of the infection, this is extremely cost effective because it offers a complete cure. It’s going to be worth every penny.”
Hepatitis C is a viral disease that causes inflammation of the liver and can lead to diminished liver function, liver failure and liver cancer. According to the Centers for Disease Control and Prevention, it is the leading cause of chronic liver disease and the basis for a majority of liver transplants taking place in the U.S. Most victims have no symptoms of the disease until the liver damage occurs, which can take several years.
Hepatitis C can be contracted in a number of ways, with sharing needles for intravenous drug use being the leading risk factor. Before 1992, when widespread screening of the blood supply began in the United States, hepatitis C was also spread through blood transfusions and organ transplants. Infection is most prevalent among people born during 1945-1965, the majority of whom were likely infected during the 1970s and 1980s when infection rates were highest. Other causes include exposure to infected blood; having sex with an infected person; sharing personal items such as a razor or toothbrush with someone who is infected with the virus; unsterilized tattoo or piercing tools; or being born to a mother who is infected with the virus.
UC Davis Medical Center is a comprehensive academic medical center where clinical practice, teaching and research converge to advance human health. Centers of excellence include the National Cancer Institute-designated UC Davis Cancer Center; the region’s only level 1 pediatric and adult trauma centers; the UC Davis MIND Institute, devoted to finding treatments and cures for neurodevelopmental disorders; and the UC Davis Children’s Hospital. The medical center serves a 33-county, 65,000-square-mile area that stretches north to the Oregon border and east to Nevada. It further extends its reach through the award-winning telemedicine program, which gives remote, medically underserved communities throughout California unprecedented access to specialty and subspecialty care. For more information, visit medicalcenter.ucdavis.edu.