Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) and ribavirin cures hepatitis C virus (HCV) at mostly high rates among those with decompensated cirrhosis or who have had recurrent hep C after a liver transplant, MedPage Today reports. Researchers in the SOLAR-2 trial gave 12 or 24 weeks of the regimen to 328 people with genotype 1 or genotype 4 of the virus, more than 75 percent of whom were treatment experienced. They presented their findings at the 50th International Liver Congress in Vienna, Austria.
The study authors used the Child-Pugh scoring system to stratify the severity of liver disease among the participants. A Child-Pugh class A means a 100 percent one-year survival chance and an 85 percent two-year survival rate. Class B means an 81 percent one-year and a 57 percent two-year survival rate. And class C means a 45 percent one-year and a 35 percent two-year survival rate.
The participants who had not had a transplant were in Child-Pugh classes of B or C. The post-transplant group included all three Child-Pugh class, as well as those with fibrosis scores F0 through F3, meaning a range of no fibrosis to advanced fibrosis.
The participants were randomly assigned to take either 12 or 24 weeks of treatment.
Ninety-five percent of post-transplant participants with fibrosis scores F0 through F3 or Child-Pugh A status who were treated for 12 weeks achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), as did 98 percent of such participants treated for 24 weeks.
Those with Child-Pugh B or C status had cure rates of 85 percent after 12 weeks of treatment and 88 percent after 24 weeks, regardless of whether they had received a transplant.
The respective cure rates after 12 and 24 weeks of treatment among those with genotype 1 were 96 percent and 98 percent if they had less liver damage and 88 percent and 89 percent if they were in the group that had Child-Pugh B or C status.
The respective cure rates after 12 and 24 weeks of treatment among those with genotype 4 were 91 percent and 100 percent if they had less liver damage, and just 57 percent and 86 percent in the group that had Child-Pugh B or C status.
Between 92 and 95 percent of participants reported at least one adverse side effect, although 14 to 28 percent reported a serious side effect, which were more common in those with advanced liver disease.
To read the MedPage Today article, click here.
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