Researchers recruited 233 participants, all of whom had HCV genotype 1 or 4 and who had received a liver transplant. The participants were randomly assigned to one of the following regimens:
For participants with severe liver injury and whose doctors considered their prospects of survival poor, the dose of ribavirin was initiated at 600 mg/day and gradually increased. All other participants received ribavirin at standard doses and schedules.
Prior to the study, researchers divided participants into the following subgroups based on the severity of their liver injury and life expectancy:
For an explanation of these terms, please see Grading severe liver disease and predicting survival.
The average profile of participants upon entering the study was as follows:
Rates of recovery from HCV infection were similar whether participants received 12- or 24-week regimens.
Among participants with a minimal or moderate degree of liver injury, the recovery rates were as follows:
Among participants with more serious liver injury (cirrhosis) the rates of recovery listed according to Child-Turcotte-Pugh (CTP) scores were as follows:
Virtually all participants reported adverse effects, a term that includes side effects caused by treatment and complications that can arise for other reasons, such as the disease process.
Participants with no liver injury or a mild-to-moderate degree of liver injury were distributed as follows:
Severe and very serious adverse effects were distributed as follows:
Four deaths occurred during the study. All deaths occurred in participants classed as CTP-A or CTP-B. Causes of death were as follows:
Overall, in people who had HCV infection after a liver transplant, 12 or 24 weeks of a regimen based on ledipasvir + sofosbuvir resulted in relatively high rates of cure.
Reddy RK, Everson GT, Flamm SL, et al al. Ledipasvir/sofosbuvir with ribavirin for the treatment of HCV in patients with post-transplant recurrence: Preliminary results of prospective, multicenter study. In: Program and abstracts of The Liver Meeting, 7-11 November 2014. Abstract 8.
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