(RxWiki News) Hepatitis C patients may soon have a much more effective and simple treatment. One recent study showed that combining two new medications was safe and reduced the amount of active virus in patients.
This study showed a very high rate of success treating both new patients and those who had been treated with other medications previously.
The researchers used both sofosbuvir (Sovaldi), which was recently approved by the FDA, and daclatasvir, which is still awaiting approval, to treat both men and women diagnosed with hepatitis C.
After three months of treatment with this medication combination, a majority of the patients in this study showed no signs of hepatitis C in their blood.
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This study was led by Mark Sulkowski, MD, medical director of the Johns Hopkins Center for Viral Hepatitis.
The researchers looked at 211 participants who had been diagnosed with hepatitis C and were treated at one of 18 medical centers in the United States or Puerto Rico.
These participants took a daily combination of 60 milligrams of daclatasvir and 400 milligrams of sofosbuvir (Sovaldi). This combination was used with or without ribavirin (Copegus, Rebetol, Ribasphere and Virazole), an anti-viral medication often used to treat hepatitis C and known to cause anemia, according to the researchers.
These researchers found that 98 percent of 126 previously untreated patients showed no detectable hepatitis C virus in their blood after three months of the treatment.
This study also showed that 98 percent of the 41 patients who had previously been treated unsuccessfully were free of any detectable hepatitis C virus in their blood after three months.
The researchers wrote that the current treatment consists of taking as many as 18 pills a day along with a weekly injection. If the FDA approves daclatasvir and other new medications for treating hepatitis C, it could reduce treatment to taking two pills a day for most patients, according to these researchers.
The most common side effects included headache, nausea, and fatigue. Single instances of stroke, gastroenteritis, and acute renal failure from dehydration also occured.
"The hope of a safe, effective, injection-free treatment for hepatitis C could be on the horizon. The combination of these oral medications appeared highly effective (98 percent) against hepatitis C in this smaller study," said E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsburg, Kentucky.
"Certainly, further research with larger patient populations is warranted, but this combination (daclatasvir and sofosbuvir) was a significant improvement over existing triple-drug treatment regimens. Hepatitis C currently kills more adults than HIV/AIDS, so the potential impact of the results of this study cannot be underestimated," Carter told dailyRx News.
"Effective and early treatment of hepatitis C can reduce the development of liver cancer and failure. If patients have questions about this study, I would encourage them to discuss the results with their primary care provider or pharmacist," he said.
In a press release, Dr. Sulkowski said "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.”
A larger study is needed to validate the results of this study.
This study was published January 15 in the New England Journal of Medicine.
The study was funded by Gilead Sciences and Bristol-Myers Squibb, the makers of sofosbuvir (Sovaldi) and daclatasvir.
Dr. Sulkowski is a paid consultant to both Gilead Sciences and Bristol-Myers Squibb.
