Hepatitis C (HCV) researchers have long sought to unlock the mystery behind finding a cure for this devastating disease and now believe the newest drug approved by the FDA for the treatment of HCV shows the promise of a cure. The drug is a cocktail of sorts, marketed by Gilead Sciences, under the name Harvoni, and is a fixed-dose combination of the drugs sofobuvir and ledipasvir. The U.S. Food and Drug Administration (FDA) approved the drug for use in HCV patients on Oct.10, 2014.
The FDA approved the fixed-dose combination drug that links one already approved HCV treatment drug – sofobuvir – with a newly approved drug – ledipasvir. This is the third drug approved by the FDA for treatment of Hepatitis C in less than a year. Ledipasvir, marketed by Gilead Sciences, under the name Sovaldi, received FDA approval in Dec 2013, along with the drug simeprevir (Olysio) marketed by Janssen Therapeutics.
According to a press release from the FDA dated Oct 10, this newly approved, fixed-dose combination drug will help with the treatment of HCV sufferers without the use of the drugs interferon and ribarvin, two components currently needed for the administration of any HCV treatment protocol. The new drug will be used to treat chronic HCV, with the genotype 1 infection.
These most recent approvals of new treatment options for HCV are, “changing the treatment paradigm” for chronic Hepatitis C sufferers, said Dr. Edward Cox from the Center for Drug Evaluation and Research at the FDA. Previously, interferon and ribarvin therapy was the only option for those with a HCV infection. The new drug gives healthcare professionals, “multiple treatment options” adding that this new therapy will, “help simplify treatment regimens.” Dr. Cox is the Director of the Office of Antimicrobial Products at the FDA.
According to a press release from Gilead Sciences, Harvoni is a once a day, single tablet therapy for treating adults with the HCV infection. Ledipasvir’s mechanism of action hinders the NS5A protein, while sofobuvir disrupts the replication of the RNA polymerase nucleotide. In clinical trials for Harvoni, high cure rates were achieved, as reported by Dr. Nezam Afdhal, Professor of Medicine at the Harvard Medical School and lead researcher of the clinical trails for Harvoni.
A majority of HCV patients, “can be cured…in only eight or 12 weeks,” Afdhal said, adding that the new drug, “significantly advances treatment,” for chronic Hepatitis C sufferers. Gilead Sciences is working to establish broad access to all HCV sufferers, having unlocked the mystery to curing the Hepatitis C virus. The clinical trial indicated a cure rate of 94 to 99 percent in participants who achieved a sustained viral response 12 weeks (SVR-12) after beginning treatment.
The LGBT community has yet to weigh in on this discovery. A majority of HIV sufferers with HCV have not tolerated previous treatment options that include interferon and ribarvin well in the past. According to the Centers for Disease Control and Prevention (CDC), fully 25 percent of those infected with the HIV virus also have the Hepatitis C virus. HCV is said to cause chronic cirrhosis of the liver, and the HCV infection develops quickly in HIV infected individuals. HCV in HIV infected patients may determine alternative treatment options for the deadly disease.
This reported “cure” for Hepatitis C has been well received in the scientific community. The clinical trials appear to have unlocked the mystery of a curative therapy for Hepatitis C, and Gilead’s establishment of “broad access” to the drug is great news for all sufferers, and those infected with the HIV virus as well.
By Jim Donahue