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Ledipasvir and Sofosbuvir for untreated HCV genotype 1 infection in end stage renal disease patients: A prospective
Mandarapu Surendra1, Sree Bhushan Raju1, Nimmagadda Sridhar1
1Department of Nephrology, Nizam's Institute of Medical Sciences (NIMS), Hyderabad, Telangana, India.
Insights
Ledipasvir and Sofosbuvir effectively treated Hepatitis C virus (HCV) in hemodialysis patients, achieving high sustained virological response (SVR12) rates. This combination therapy proved safe for end-stage renal disease (ESRD) patients on dialysis.
Area of Science:
- Hepatology
- Nephrology
- Virology
Background:
- Hepatitis C virus (HCV) infection significantly increases mortality in end-stage renal disease (ESRD) patients.
- Direct-acting antiviral (DAA) agents offer new treatment options for HCV, but data in dialysis patients are limited.
- Ledipasvir/Sofosbuvir is approved for HCV genotype 1 but its use in patients on dialysis requires further investigation.
Purpose of the Study:
- To assess the safety and efficacy of Ledipasvir and Sofosbuvir in hemodialysis (HD) patients with HCV genotype 1 infection.
- To evaluate sustained virological response (SVR12) as the primary efficacy endpoint.
- To determine the incidence of adverse drug effects leading to treatment discontinuation.
Main Methods:
- A single-center, prospective, open-label observational study.
- Treatment-naive HD patients with normal liver histology received Ledipasvir/Sofosbuvir on alternate days for 12 weeks.
- Primary endpoint: SVR12; Secondary endpoint: treatment discontinuation due to adverse events.
Main Results:
- Twenty-one patients were treated; two deaths were unrelated to therapy.
- Sustained virological response (SVR12) was achieved in all 19 evaluable patients.
- No patients discontinued therapy due to severe adverse drug effects; mild adverse events (headache, giddiness) were managed symptomatically.
Conclusions:
- Ledipasvir and Sofosbuvir combination therapy administered on alternate days is effective in ESRD patients on hemodialysis.
- The treatment demonstrated excellent SVR12 rates, comparable to other populations.
- The regimen is safe for dialysis patients, with no major adverse reactions observed.
Introduction:
Hepatitis C virus (HCV) infection in end stage renal disease (ESRD) is associated with increased mortality. Recently, numerous directly acting antiviral agents have been approved for the management of HCV. Ledipasvir along with Sofosbuvir has been approved for management of genotype 1 infection in patients with eGFR ≥30 mL/min. However, there is paucity of data regarding its role in the management of patients on dialysis.
Material And Methods:
This is a single center prospective open label observational study to assess the safety and efficacy of Ledipasvir and Sofosbuvir in hemodialysis (HD) patients who were diagnosed with HCV genotype 1 infection. Eligibility criteria were treatment naive HD patients with normal liver histology. We administered Ledipasvir and Sofosbuvir combination tablet on alternate days for a period of 12 weeks. Primary efficacy end point was the assessment of sustained virological response (SVR12), and the safety end point was the discontinuation of therapy secondary to adverse drug effects.
Results:
A total of 21 patients were treated with this regimen. Two patients expired during the study period and are not related to the therapy. SVR12 was achieved in all the 19 patients. None of the patients in our study discontinued the therapy or had severe adverse drug effects. One patient had head ache and another patient had giddiness which were managed symptomatically.
Conclusion:
Ledipasvir and Sofosbuvir combination therapy on alternate days, is effective even in ESRD patients, with excellent SVR12 rates, and it is as safe as in other population groups, without any major adverse reactions.
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