Treatment of Patients With Hepatitis C Virus Infection With Ledipasvir-Sofosbuvir in the Liver Transplant Setting.

Abstract

BACKGROUND:

Hepatitis C virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma and the leading indication for liver transplantation. In the Middle East, genotype 4 HCV infection is the most common genotype. However, limited data exists on the treatment of genotype-4 in the liver transplant setting. We evaluated the safety and efficacy of ledipasvir (LDV)-sofosbuvir (SOF) in treating HCV genotype-4 infected patients with cirrhosis or postliver transplantation.

METHODS:

This prospective, single-arm, observational study includes cohort of patients with cirrhosis before liver transplantation (cohort A) and a cohort of postliver transplantation patients (cohort B). Patients received LDV/SOF (90-400 mg) once daily for 12 to 24 weeks with or without ribavirin (RBV). Patients with creatinine clearance below 30 were excluded.

RESULTS:

A total of 111 patients (61 cirrhotic; 50 postliver transplants) with HCV genotype 4 were treated in King Faisal Specialist Hospital and Research Center; 55% cohort A and 44% cohort B received RBV. Sustained virological response sustain virological response (SVR)12 was 91.8% and 86% of cohorts A and B, respectively. There were no treatment-related mortality or serious adverse effects. RBV dose reduction occurred in 25% without any treatment discontinuation. SVR12 rates in cohort A were significantly higher in patients with a viral load below 800 000 (100% vs 83.9%, P value = 0.022). Viral load did not impact SVR rates in cohort B. The use of RBV did not increase SVR12 and was associated with anemia.

CONCLUSIONS:

LDV/SOF without RBV is an effective and safe treatment option for patients with HCV genotype 4 infection in preliver and postliver transplant settings.

• Authors: Faisal Abaalkhail, Hussein Elsiesy, Hany Elbeshbeshy, Mohamed Shawkat, Sarra Yousif, Waheed Ullah, Saleh Alabbad, Ahmed Al-Jedai, Aziza Ajlan, Dieter Broering, Sammy Saab, Mohammed Al Sebayel, Waleed Al-Hamoudi
• Journal: Transplantation (Transplantation) Vol. 101 Issue 11 Pg. 2739-2745 (11 2017) ISSN: 1534-6080 [Electronic] United States
• PMID: 28795982 (Publication Type: Journal Article, Observational Study)

Chemical References

• Antiviral Agents
• Benzimidazoles
• Fluorenes
• Tablets
• ledipasvir, sofosbuvir drug combination
• Ribavirin
• Uridine Monophosphate
• Sofosbuvir

Topics

• Administration, Oral
• Antiviral Agents (administration & dosage, adverse effects)
• Benzimidazoles (administration & dosage, adverse effects)
• Drug Administration Schedule
• Female
• Fluorenes (administration & dosage, adverse effects)
• Genotype
• Hepacivirus (drug effects, genetics)
• Hepatitis C (complications, diagnosis, drug therapy)
• Humans
• Liver Cirrhosis (diagnosis, surgery, virology)
• Liver Transplantation (adverse effects)
• Male
• Middle Aged
• Prospective Studies
• Ribavirin (administration & dosage)
• Saudi Arabia
• Sofosbuvir
• Sustained Virologic Response
• Tablets
• Time Factors
• Treatment Outcome
• Uridine Monophosphate (administration & dosage, adverse effects, analogs & derivatives)
• Viral Load