UC Davis clinical trials -- helping revolutionize hepatitis C treatment
Jesse De La Cruz didn’t have any hepatitis C symptoms for nearly 15 years. Physicians say that’s fairly typical of an illness also known as “the silent killer.” Fortunately, the 62-year-old Stockton resident appears to have completely beaten the virus that can be devastating and deadly in its later stages. Cruz rid himself of the illness through a 12-week clinical trial at UC Davis Medical Center that tested two new but costly drugs that are now undergoing U.S. Food and Drug Administration review to evaluate safety and effectiveness.
“We are currently experiencing a revolution in hepatitis C treatment,” said Lorenzo Rossaro, professor of medicine and chief of the Division of Gastroenterology and Hepatology at UC Davis. “We have rapidly gone from giving patients a grim prognosis of lifelong liver disease to being able to offer a complete cure in most cases. It’s a cure that while very expensive — about a $1,000 a pill — is simple and swift.”
According to Rossaro, who directs clinical trials for new hepatitis C therapies at the medical center in Sacramento, including the one that De La Cruz participated in, different regimens are still being tested and fine-tuned. Rossaro predicts that an even better therapy using only pills [oral direct antiviral agents] will be available by the end of this year, offering nearly a 100-percent cure rate in 12 weeks or less. Previous generations of hepatitis C therapies, which offered a cure in only half of the patients, included a daunting 6-12 months of drug injections combined with pills that produced significant side effects and caused many patients to abandon their treatment before it was completed.
Hepatitis C affects some 3 to 5 million people in the United States, and 170 million worldwide. Without treatment, many infected with the virus eventually develop chronic liver disease, with some progressing to permanent liver damage, liver cancer and death. Late last year, the U.S. Food and Drug Administration approved two direct antiviral agents – sofosbuvir and simeprevir – that are bioengineered to shut down hepatitis C virus replication. Combined with more traditional hepatitis treatment drugs, the new regimens move toward getting rid of injections altogether, eliminating the debilitating side effects in some patients and at least reducing the total duration of treatment for others.
Interview with Dr. Rossaro on new hep C treatment clinical trial.
“I took the pill once a day at the same time, either with a meal or right after, and had no side effects,” said De La Cruz, who completed a three-month clinical trial last fall. “In the beginning, my viral load [the hepatitis C viral particles floating in the blood] was very high, in the millions. But after the first week of treatment, when they tested for it again the levels had dropped. And by the end [of treatment], the viral load was non-detectable and my liver had regained its health.”
With the current drug regimens priced at $60,000 to $80,000 (about $1,000 per pill), the high cost of the therapy has prompted questions and some controversy. But Rossaro says the cost pales in comparison to a lifetime of treatments – sometimes involving liver transplants – that are often needed for patients who have not cleared the infection.
“If we think about costs, we should consider the cost per cure and not the cost per pill,” said Rossaro. “Once the virus is gone for good, the risk of dying with liver disease is minimal, if not zero. This type of virus cure is a revolution that we also hope to achieve for other blood diseases such as HIV and hepatitis B.”
Rossaro says he’s confident that health insurance companies will accept the burden of such costs, noting that conventional hepatitis C treatments were also expensive, involved a complex regimen of injections and pills over a lengthy period, had multiple harsh side effects, and often did not work.
“Ultimately, these new drugs are cheaper than the cost of treating a chronic disease over many years and with all the medical complications it involves,” Rossaro said.
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In many ways, De La Cruz is typical of most of Rossaro’s patients with hepatitis C. Because he had no symptoms, the specter of a chronic and possibly life-threatening illness never really crossed De La Cruz’s mind. He is also typical because of his age and how he acquired the infection, which is transmitted through blood exposure: He probably contracted the virus when he shared needles while using heroin in his earlier years.
Rossaro explained that many baby boomers – those born between 1945 and 1965 – were involved in risky behavior before the danger of HIV transmission was widely understood.
“The baby boomers are the most important target for current screening programs and treatment,” he said. “Largely because of them, we can expect a tsunami of hepatitis C patients that will be screened, diagnosed, and then need to be cured in the next few years.”
Rossaro credits the strength of UC Davis’ clinical-trials program for its important contributions to the revolution in the treatment for hepatitis C. Last year, the medical center was the number one clinical-trials site in nation for enrollment efficiency and the number of hepatitis C participants enrolled in the “single pill,” 12-week clinical trial. The results of that trial were recently filed with the FDA, and this month, in a collaboration among its departments of Pharmacy, Infectious Disease and Gastroenterology, UC Davis opened an additional hepatitis C clinic in Sacramento to better handle the influx of new patients needing treatments.
Another important factor for success is an extensive telemedicine program, which enables UC Davis specialists to easily reach beyond Sacramento through a secure broadband connection that provides patients with convenient access to specialty care and the latest research insights without making them travel to the capital city. Many telemedicine sites around the state are being used for the hepatitis C management, including the one in Stockton that recruited De La Cruz to the clinical trial and is still being used to monitor his health.
"I was a very lucky guy to participate in the treatment,” said De La Cruz, a former gang member and Folsom Prison inmate turned book author and doctoral-degree student at CSU Stanislaus. “I am raising my grandson and want to live to raise him and teach him how to be a man. I am very grateful. I was treated with respect by the whole UC Davis team."