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January 31, 2014 // By Lee-Ann Donegan // Comments

New Hope on Horizon for Hepatitis C Patients

Gastrointestinal // Infectious Disease Share this article

The 3.2 million Americans with hepatitis C may get some much-needed relief through a new regimen of all oral medications that are proving to cure most disease, with fewer side-effects than the current treatment options.

The new medications are being testing in clinical trials here at Penn Medicine.

Hepatitis C is the most common chronic bloodborne infection in the U.S., with its complications, cirrhosis of the liver and liver cancer the leading reasons for liver transplantion. The disease currently kills more Americans than HIV. 

The virus was primarily transmitted through contact with contaminated blood from blood transfusions prior to 1992; intravenous drug use and dirty tattoo needle use. Infection rates peaked in the U.S. in the 1970s and 80s, prior to the availability of blood tests for hepatitis C infection, better testing of blood donors and the use of more advanced methods of manufacturing clotting factors for those patients with hemophilia or bleeding disorders.

In the past, hepatitis C screening was targeted for those at high risk or those with abnormalities in liver tests, which proved less than effective at identifying infected individuals. Thus the effort has shifted to target baby boomers born between 1945 and 1965, independent of risk factors for hepatitis C, as the CDC has observed high prevalence rates in this population.

Hepatitis C is controlled best when treated early. The challenge is that the virus has few overt symptoms and is therefore difficult to diagnose, causing the disease to progress untreated, as it has with many baby boomers.

The virus has many forms or genotypes.  Some can result in mild illness lasting a few weeks, but for most patients, it is progresses to a serious, lifelong illness that requires ongoing medical attention, and often, courses of medication that can be difficult for patients to tolerate.

Current treatments are less than optimal, as they require weekly injections and come with a variety of side-effects, including insomnia, flu-like symptoms, and depression.

But, a new combination of oral drugs offers great news for aging boomers and others with the most common form of the disease.  In studies, the drugs are curing the disease in over 90 percent of patients who have failed standard treatments or who have never been treated for the disease, according to research published earlier this month in the New England Journal of Medicine.

The new drug regimen, an antiviral cocktail, “blocks two different proteins important in virus replication,” says K. Rajender Reddy, MD, a professor of Medicine and medical director of Hepatology/Transplantation Hepatology, who was involved in one of two key studies showing overwhelming success in controlling the disease.

The first study, which Penn Medicine patients participated in, studied subjects who had never before been treated for their disease or had failed conventional treatment. During the study, patients received two new oral antiviral pills, daclastavir and sofosbuvir, for either 12 or 24 weeks, with or without a third drug called ribavirin.

Ninety-eight percent of the previously untreated patients and 98 percent of patients who had failed conventional therapy were considered cured, with no detectable virus in their blood three months after stopping treatment. 

A second study saw more than 93 percent of patients report the virus cleared from their system after eight, 12 or 24 weeks of treatment with three different antiviral oral medications. 

“These new regimens will be game changers in the treatment of chronic hepatitis C,” said Vincent Lo Re, MD, MSCE, Penn Medicine Infectious Diseases physician. “Given the high prevalence of this chronic infection, particularly in baby boomers who didn’t know they were infected, having new, highly-effective options to tackle the virus will be a tremendous benefit to patients that will ultimately help us to reduce liver-related complications and re-infection rates.”

Both studies proved to be safe and offer new, effective and life-altering treatments for Hepatitis C patients, with the cost—the drugs can be thousands of dollars per treatment course—and FDA approval the only foreseen obstacles.

Dr. Reddy agrees saying, “These drugs offer an exciting new option for patients who had struggled for years to stay healthy with the current treatment options. This, along with better and more widespread screening will help curtail the spread of the disease.”

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