The U.S Food and Drug Administration approved on Friday a new drug that can help treat chronic Hepatitis C virus (HCV) infection. It has also received a breakthrough therapy designation from the federal agency.

FDA approved Sovaldi (sofosbuvir), manufactured by Gilead Sciences Inc., based in Foster City, Calif. The 400 mg once-a-day tablet has been proven safe and effective in treating HCV types 1, 2, 3, and 4 including those that are already waiting for liver transplant and/or with HCV/HIV-1 infection.

“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

According to the Centers for Disease Control and Prevention (CDC), Hepatitis C is an infection targeting the liver. It can start as a mild infection lasting for weeks until it becomes a lifetime condition. The virus transmission usually happens during blood transfusion and organ transplants or by sharing needles and injections with someone infected. Common symptoms of HCV infection are fatigue, joint pain, belly pain, itchy skin, sore muscles, dark urine, and jaundice.

Sovaldi is a nucleotide analog inhibitor that prevents a specific protein responsible for the spread of HCV infection in the body. It has to be combined with another treatment called “ribavirin” for 12 to 24 weeks depending on the genotype of the infection. However, for those who are already waiting for liver transplant, it has to be taken for 48 weeks or until the transplant is done.

Sovaldi was tested on 1,947 participants who had never received any treatment for HCV infection or had not shown improvement on other treatment. They were all assessed after 12 weeks to check if their blood has been cleared of the disease. The researchers found that the treatment had really helped cure the patients in different genotypes of the HCV infection.

“I believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of hepatitis C,” said Ira Jacobson, MD, Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York City and a principal investigator in the Sovaldi clinical trials.