Transplant Trial Watch

Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial.

Colombo M, Aghemo A, et al.

Annals of Internal Medicine 2017; 166(2): 109-117.


Aims
To compare the efficacy and safety of 12 and 24 weeks of ledipasvir–sofosbuvir without ribavirin in kidney transplant patients with chronic hepatitis C virus (HCV) genotype 1 or 4 infection.

Interventions
Participants were randomised to receive either 12 versus 24 weeks of treatment with a fixed-dose combination of ledipasvir (90 mg) and sofosbuvir (400 mg).

Participants
114 recipients of a kidney transplant ≥6 months before the baseline study visit, aged ≥18 years who had chronic HCV genotype 1 or 4 infection, with plasma HCV RNA levels ≥15 IU/mL.

Outcomes
The primary outcomes measured were the percentage of patients with HCV RNA less than the lower limit of quantification (LLOQ) 12 weeks after stopping the study drug, and any adverse event leading to permanent discontinuation of the study drug.

Follow-up
24 weeks

CET Conclusions
This industry-sponsored study investigates the use of the combination of ledipasvir and sofosbuvir in stable renal transplant recipients with chronic hepatitis C. Patients were randomised to either 12 or 24 weeks of treatment, and both groups achieved sustained virological response at 12 weeks after the end of therapy of 100%. Treatment was well tolerated with only 3 serious adverse events reported to be due to the study medication. The SVR12 seen is impressive, and treatment appears much better tolerated in this population than standard treatment with interferon and ribavirin. The lack of a control arm on this standard therapy makes direct comparison impossible, however. The results do offer the possibility of opening up the HCV-positive donor pool to selected recipients, but this would warrant careful further investigation and consideration.

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
No

Trial registration
ClinicalTrials.gov - NCT02251717

Funding source
Industry funded