An all-oral combination therapy of sofosbuvir, ledipasvir and ribavirin boasts a 100 percent cure rate among people with hepatitis C virus (HCV), HIVandHeptatis.com reports. Edward Gane from Auckland Clinical Studies presented these most recent results from the Gilead Sciences–sponsored ELECTRON study at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.
The researchers gave the nucleotide analog polymerase inhibitor sofosbuvir (GS-7997) along with the NS5A replication complex inhibitor ledipasvir (GS-5885) to 25 people with hep C who had never taken therapy and to nine who had failed a previous therapy, all of them with genotype 1 of the virus, the most difficult to treat. Four weeks into the 12-week treatment, every treatment naive participant and all but one of the null responder group experienced a rapid virologic response (RVR). By the end of therapy, all participants had a fully suppressed viral load, and at the four- and 12-week points after therapy, 100 percent of the group maintained a sustained virologic response (SVR, considered a cure).
The therapy was generally safe and well tolerated. Serious side effects included bloody urine (36 percent, mostly in women), severe anemia (20 percent) and increased coagulation (8 percent). Common and less serious side effects included mild-to-moderate anemia (20 percent), depression (8 percent) and headache (4 percent).
A current Gilead-sponsored Phase III trial is investigating a single combination therapy pill of sofosbuvir and ledipasvir. In addition, researchers plan to test the two drugs without ribavirin.
To read the HIVandHepatitis.com story, click here.
To read the CROI abstract, click here.