Less than a week ago, the U.S. Food and Drug Administration’s (FDA) advisory panel approved Gilead Science’s hepatitis C (HCV) drug, sofosbuvir, after finding that it cured more patients with the disease in less time than current treatments. Adding to the promise of new-age HCV treatments, a new study found that a combination pill containing sofosbuvir, and another Gilead drug, ledipasvir, was able to cure virtually all patients who took it.

Researchers found that the combination pill, taken once a day, eliminated the virus from 95 percent of patients who had never received treatment. Even better, 95 percent of patients who had responded poorly to currently available treatments also responded well to the sofosbuvir/ledipasvir combination. Both Sofosbuvir, a polymerase inhibitor, and ledipasvir, which blocks the non-structural NS5A protein, play key roles in preventing the replication of the viral RNA, and therefore, the spread of the virus.

Figuring Out How To Treat All Cases Of HCV

The development of a newer generation of HCV medications includes getting rid of interferon injections, a protein that is released by host cells in response to pathogens, as well as a host of antiviral medications, both of which a patient must take for up to a year. This form of treatment can often come with serious side effects, including depression and flu-like symptoms, and it can only cure between 65 and 75 percent of patients. For patients who are unable to follow through with treatment, there are no other options.

“We’ve had nothing to offer them,” Dr. David Bernstein, chief of the division of hepatology at North Shore University Hospital in Manhasset, N.Y., told HealthDay. “It’s painted a rather bleak picture for these patients.”

95% Of Patients Were Cured Of HCV

For the study, researchers recruited 100 HCV patients, 60 of whom had never been treated for the disease before and 40 who had responded poorly to previous treatment. Of these patients, some also took the antiviral drug ribavirin, which is commonly used with interferon in current treatment. Each patient took the pill once a day, with nearly all patients who had undergone therapy before showing no signs of the virus within 12 weeks and those who hadn’t undergone therapy showing no signs within 24 weeks.

“These types of advances are game-changers,” Bernstein told HealthDay. “We’re going to be curing [very high percentages of people] with simple oral agents, one pill once a day with mild to no side effects.”

Almost 50 percent of patients showed some signs of side effects, but the highest rates were seen among patients who had also taken the ribavirin, with one even developing anemia. Other side effects included nausea, upper respiratory tract infection, and headache.

Although sofosbuvir is currently awaiting approval by the FDA. Should the agency agree with its panel’s advice, the drug will be the first new HCV drug to be approved since 2011, according to MedPage Today. On the other hand, ledipasvir is still going through clinical trials.

“We are moving from an era of injectable medications with significant toxicity to an era of all-oral combination pill therapy that provides the promise of being well-tolerated with very high rates of cure,” Dr. Eric Lawitz, lead author of the study and clinical professor of medicine at the University of Texas Health Science Center, told HealthDay.

Hepatitis C is a contagious, long-term liver disease that causes inflammation and scarring of the liver (cirrhosis) — sometimes it also results in liver cancer. About 3.2 million Americans are living with the disease, and many of them don’t even know it — 70 to 80 percent of people with acute HCV never show symptoms — according to the Centers for Disease Control and Prevention. The virus can remain in the body for decades before a person who is infected realizes it, usually by finding out that they have or are developing liver problems.

Source: Lawitz E, Poordad F, Pang P, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. The Lancet. 2013.