A researcher from University of Texas Health Science Center in San Antonio is part of a nationwide research team led by Johns Hopkins that has managed to make significant advancements in the research of treatments and a potential cure for hepatitis C, a liver-damaging infectious disease that has led to more deaths in America in recent years Americans than HIV/AIDS. Dr. Eric Lawitz of UTHSCSA has been in the news before when BioNews Texas profiled his work on a New Antiviral Drug Treatment Study That Has Offered Hope For a Hepatitis C Cure. His new contributions to this study will certainly bolster those efforts.
The new study, which is to be reported in today’s issue of the New England Journal of Medicine, the research team indicate that combined treatments that include a pair of experimental, oral antiviral drugs, daclatasvir and sofosbuvir, have proven to be safe and highly effective in treating hepatitis C. (Sofosbuvir is one of the drugs that UTHSCSA’s Dr. Lawitz has previously tested as well.) This new combination of hepatitis C therapies worked effectively even when used on patients who have not previously responded to conventional “triple therapy,” which includes hepatitis C protease inhibitors, telaprevir or boceprevir, plus peginterferon and ribavirin.
Leader of the study Mark Sulkowski, M.D., medical director of the Johns Hopkins Center for Viral Hepatitis, explained that, “This research paves the way for safe, tolerable and effective treatment options for the vast majority of those infected with hepatitis C. Standard treatments for the disease are going to improve dramatically within the next year, leading to unprecedented advances for the treatment of patients infected with the hepatitis C virus.”
The structure of the research study involved 211 men and women had either hepatitis A, B, or C, all of whom were treated with the experimental drug combination therapy at eighteen medical centers across the United States and Puerto Rico. A recent press release explains that, “Among patients with genotype 1 — the most common strain of the infection in the United States — 98 percent of the 126 previously untreated patients and 98 percent of 41 patients whose infections remained even after the triple therapy were considered cured, with no detectable virus in their blood three months after the treatment had stopped. Results were similar in study participants infected with genotypes 2 or 3, strains which are less common in the United States. The study participants took a daily combination of 60 milligrams of daclatasvir and 400 milligrams of sofosbuvir, with or without ribavirin.”
The hepatitis C therapies included in the study are quickly gaining acceptance in mainstream U.S. medicine. On December 6th, 2013, the FDA approved sofosbuvir in combination with peginterferon and ribavirin for the treatment of genotype 1 infection and in combination with only ribavirin for genotype 2 and 3 infection — a major step for getting the treatment into the pipeline for use in treating the disease. Daclatasvir, however, has yet to be approved by the FDA.
Dr. Sulkowski explained that FDA approval for declatasavir and other new hepatitis C drugs would do away with the need for patients to endure weekly injections of peg interferon. He also believes that the so-called “pill burden” of what had been standard therapy for genotype 1 could be dramatically reduced from a staggering 18 pills per day and one injection per week — the current regimen — to as few as one or two pills per day and no injections. Being able to improve the treatment regimen for patients would improve drug adherence and overall outcomes for the disease. Side effects from the new pill combination were reported to be generally mild, but did include fatigue, headache and nausea. However, considering that the peginterferon-based therapy is known for severe side effects, which may include fatigue and depression, the new regimen would be a much-needed improvement.
The new study is one of the first to show that hepatitis C can be cured without the use of ribavirin, which is known to cause anemia.
The advent of simpler pill-only regimens, Sulkowski adds, should make it easier for those infected with hepatitis C to be cured, preventing the development of liver cancer and liver failure and obviating the need for liver transplant. Currently, he says, fewer than 5 percent of the estimated 3.2 million Americans with hepatitis C have been cured, according to the U.S. Centers for Disease Control and Prevention (CDC). Further, the CDC estimates that between 50 and 75 percent of people who live with chronic hepatitis C are unaware that they are infected. Sulkowski goes to explain that, “the arrival of simpler treatment regimens could not come soon enough. Many of the people diagnosed with the infection, mainly those born between 1945 and 1965, were infected during the 1970s and 1980s through injection drug use and tainted blood transfusions and are now suffering from cirrhosis and liver cancer tied to chronic infection. This is why, he says, the CDC recommended hepatitis C screenings in 2012 for all baby boomers.”
Notes: Besides Sulkowski, other study investigators involved in this study were Maribel Rodriguez-Torres, M.D., at the Fundacion de Investigacion in San Juan, Puerto Rico; K. Rajender Reddy, M.D., at the University of Pennsylvania; Tarek Hassanein, M.D., at Southern California Liver Center in Coronado, Calif.; Ira Jacobson, M.D., at Weill Cornell Medical College in New York; Eric Lawitz, M.D., at the University of Texas Southwestern Medical Center in San Antonio; Anna Lok, M.D., at the University of Michigan, Ann Arbor; Federico Hinestrosa, M.D., at Orlando Immunology Center in Florida; Paul Tuluvath, M.D., at Mercy Medical Center in Baltimore, Md.; Howard Schwartz, M.D., at Miami Research Associates in Florida; David Nelson, M.D., at the University of Florida; and Gregory Everson, M.D., at the University of Colorado Denver.
Additional research support was provided by David Gardner, M.D.; Timothy Eley, Ph.D.; Megan Wind-Rotolo, Ph.D.; Shu-Pang Huang, Ph.D.; Min Gao, Ph.D.; Dennis Hernandez, Ph.D.; Fiona McPhee, Ph.D.; Diane Sherman, M.S.; Robert Hindes, M.D.; Claudio Pasquinelli, M.D., Ph.D.; and Dennis Grasela, Ph.D., all from Bristol-Myers Squibb; and by William Symonds, Pharm.D., from Gilead Sciences.
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