Spotlight Series on Hepatitis C


Ledipasvir and Sofosbuvir With or Without Ribavirin in People With Liver Transplants

April 2015

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:

  • a 12-week regimen of ledipasvir + sofosbuvir + ribavirin -- 112 participants
  • a 24-week regimen of ledipasvir + sofosbuvir -- 111 participants

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:

  • CTP-A
  • CTP-B
  • CTP-C

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:

  • 80% men and 20% women
  • age -- 60 years
  • HCV strain -- most common genotype was 1a, found in 70% of participants
  • HCV viral load -- 6.6 log
  • most participants had received a liver transplant several years earlier


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:

  • 12-week regimen -- 97% achieved an SVR12
  • 24-week regimen -- 98% achieved an SVR12

Among participants with more serious liver injury (cirrhosis) the rates of recovery listed according to Child-Turcotte-Pugh (CTP) scores were as follows:


  • 12-week regimen -- 96% (53 of 55 participants) had an SVR12
  • 24-week regimen -- 98% (55 of 56 participants) had an SVR12


  • 12-week regimen -- 85% (22 of 26 participants) had an SVR12
  • 24-week regimen -- 83% (15 of 18 participants) had an SVR12


  • 12-week regimen -- 60% (three of five participants) had an SVR12
  • 24-week regimen -- 83% (two of three participants) had an SVR12

Safety and Tolerability

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:

  • 12-week regimen -- 27%
  • 24-week regimen -- 25%

Severe and very serious adverse effects were distributed as follows:


  • 12-week regimen -- 15%
  • 24-week regimen -- 28%


  • 12-week regimen -- 23%
  • 24-week regimen -- 35%


  • 12-week regimen -- one person
  • 24-week regimen -- one person

Four deaths occurred during the study. All deaths occurred in participants classed as CTP-A or CTP-B. Causes of death were as follows:

  • development of PML (progressive multifocal leukoencephalopathy), a rare complication caused by the JC virus. PML can occur in people with weakened immune systems, such as those with AIDS or who are taking transplant drugs or other medicines that suppress the immune system.
  • complications arising from bulging blood vessels in the chest
  • internal bleeding
  • complications of cirrhosis

Key Points

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.

This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.

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