Effectiveness, treatment completion and safety of sofosbuvir/ledipasvir and paritaprevir/ritonavir/ombitasvir + dasabuvir in patients with chronic kidney disease: an ERCHIVES study

Autor: Abdul-Badi Abou-Samra, Y. Ren, Jean Marie Arduino, Ritesh N. Kumar, Adeel A. Butt, Amy Puenpatom
Rok vydání: 2018
Předmět:
Cyclopropanes
Male
Sofosbuvir
Sustained Virologic Response
chemistry.chemical_compound
0302 clinical medicine
2-Naphthylamine
Electronic Health Records
Pharmacology (medical)
Anilides
030212 general & internal medicine
education.field_of_study
Sulfonamides
Dasabuvir
Gastroenterology
virus diseases
Valine
Hepatitis C
Middle Aged
Treatment Outcome
030211 gastroenterology & hepatology
Drug Therapy
Combination
Female
Uridine Monophosphate
medicine.drug
Glomerular Filtration Rate
Ledipasvir
medicine.medical_specialty
Macrocyclic Compounds
Proline
Lactams
Macrocyclic
Population
Antiviral Agents
Medication Adherence
03 medical and health sciences
Internal medicine
medicine
Humans
Renal Insufficiency
Chronic
education
Uracil
Aged
Retrospective Studies
Fluorenes
Ritonavir
Hepatology
business.industry
Hepatitis C
Chronic
medicine.disease
digestive system diseases
Ombitasvir
chemistry
Paritaprevir
Case-Control Studies
Benzimidazoles
Carbamates
business
Zdroj: Alimentary pharmacologytherapeutics. 48(1)
ISSN: 1365-2036
Popis: Background Chronic kidney disease (CKD) was a relative contraindication to hepatitis C virus (HCV) treatment in the interferon/ribavirin era. Aim To determine the efficacy, tolerability and safety of sofosbuvir/ledipasvir (SOF/LDV) and paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens in persons with CKD. Methods We identified persons initiated on a SOF/LDV or PrOD regimen from October 30, 2014 to April 30, 2016. We excluded those with missing HCV genotype or eGFR values. We determined treatment completion and sustained virologic response (SVR) rates, and proportion developing worsening renal function or grade 3/4 haematologic toxicity. Results Among 13 663 persons on SOF/LDV±ribavirin, 14% and 1% persons had CKD Stage 3 and 4-5 respectively, 67.8% completed treatment, 98.2% achieved SVR. Treatment completion or SVR rates did not decline with advanced CKD or ribavirin administration. Among 3961 persons on PrOD±ribavirin, 9% and 3% persons had CKD Stage 3 and 4-5, respectively, 74.0% completed treatment and 98.2% achieved SVR. A decrease in treatment completion rates was seen in CKD stage 4-5 and those on ribavirin, but this did not impact SVR rates. A >10 mL/min/1.73 m2 drop in eGFR from baseline was observed in 30%-38% of persons with baseline eGFR ≥60 mL/min/1.73 m2 , but in only 0%-6% with CKD4-5. Grade 3/4 anaemia was more frequent in persons with CKD4-5, but ribavirin co-administration did not appear to affect this. Conclusions SOF/LDV and PrOD achieved high SVR rates in CKD population. Treatment completion rates were lower than expected. A decline in eGFR and development of anaemia were observed in a substantial proportion of persons, but the clinical implications remain unclear.
Databáze: OpenAIRE
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