Studies of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) and AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir) have boasted excellent cure rates among people with genotype 1 of hep C and cirrhosis.
Researchers examined pooled results of seven Phase II and III trials in which Harvoni was given for 12 or 24 weeks, with or without ribavirin, to people with genotype 1 and cirrhosis. Cure rates ranged from the low 90 percent range to 100 percent.
An average of 95 percent of those who took just Harvoni for 12 weeks were cured, as were 98 percent of those who took the tablet for twice that long. Those who took Harvoni and ribavirin for a respective 12 and 24 weeks had a 96 percent and 100 percent cure rate. Among study participants who had failed a previous treatment attempt, 90 percent were cured if they took 12 weeks of just Harvoni, as were 96 percent of those who doubled the treatment time and took ribavirin.
Meanwhile, a Phase IIIb trial tested 12 weeks of Viekira Pak among 60 people who had compensated cirrhosis, the milder stage of the condition, and genotype 1b of hep C. (Genotype 1 has two subtypes, 1a and 1b.) All of them were cured.
“For patients with cirrhosis and none of the complications of cirrhosis like bleeding varices [dilated blood vessels] or fluid in the abdomen, they should be treated as soon as possible with no need to wait for future treatments,” says Andrew Muir, MD, chief of gastroenterology at Duke University. “The questions remain in the patients with more advanced cirrhosis, and especially for those who are eligible for a liver transplant.”
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