Clinical trials showed that a new combination pill can cure patients of their hepatitis C infection, with few side effects. The combo therapy involving two experimental drugs, daclatasvir and sofosbuvir, was highly effective in eliminating the hepatitis C virus (HCV) in nearly all patients, even those who can’t take or don’t respond to the conventional treatments.
Sofosbuvir (brand name Sovaldi), manufactured by Gilead Sciences in California, got the green light from the US Food and Drug Administration (FDA) in December.
“This research paves the way for safe, tolerable and effective treatment options for the vast majority of those infected with hepatitis C,” says study leader Mark Sulkowski, M.D., medical director of the Johns HopkinsCenter for Viral Hepatitis. “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.”
Clinical trial involving 211 hepatitis C patients
In order to assess the safety and efficacy of the combination drug treatment, researchers carried out a clinical trial on 211 hepatitis C patients at 18 medical centers across the United States and Puerto Rico.
The study subjects were assigned to a daily combination of 60 milligrams of daclatasvir (still in the approval process), and 400 milligrams of sofosbuvir. Some patients also received ribavirin, presently the conventional treatment, in addition to the combination pill.
Revelations of the study
By 12 weeks, nearly 98 percent of the patients had achieved what doctors call a functional cure, in which the virus is eliminated and prevented from replicating. The combination pill therapy was well-tolerated with very high rates of cure even in patients with virus genotype 1 (common in the United States) and those with genotypes 2 and 3 which are more common elsewhere. Moreover, the study established that hepatitis C could be cured without the use of ribavirin that can cause anaemia.
Common side effects perceived were nausea, anemia, upper respiratory tract infection and headache. Most of them were classified as mild by the treating physician and no patient had to discontinue treatment because of adverse events.
According to Mark Sulkowski, if declatasavir and other new drugs for hepatitis C get clearance from the FDA, treatment for hepatitis patients, could move from an era of injectable medications with significant toxicity to that of all-oral combination pill therapy.
“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,” said Sulkowski.
Given that the new treatment for the deadly liver virus is expected to cost at least $US80,000 ($A89,490) per year, the question at hand is how many will get access to the new drug for hepatitis C?
The study is reported in the Jan. 16 issue of the New England Journal of Medicine.