This article is written live from ID Week 2017 Annual Meeting in San Diego, CA. MPR will be reporting news on the latest findings from leading experts in infectious diseases. Check back for more news from IDWeek 2017.
SAN DIEGO—At IDWeek 2017, researchers presented that sustained virologic response (SVR) rates among patients treated with sofosbuvir/ledipasvir (SOF/LDV) or paritaprevir/ritonavir/ombitasvir + dasabuvir (PrOD) were high in the chronic kidney disease (CKD) population even though nearly a quarter did not complete the full treatment course.
Patients with CKD were “particularly difficult to treat” because of reduced treatment efficacy and common adverse events. Literature was also lacking regarding the safety and efficacy of SOF/LDV and PrOD in this patient population. Some newer direct-acting antiviral (DAA) regimens have been associated with a higher risk of anemia and a faster progression of kidney disease, independent of ribavirin use.
In order to examine the efficacy, treatment completion, and safety profile of SOF/LDV and PrOD, 2 commonly used DAA regimens, study authors used the electronically retrieved cohort of HCV infected veterans (ERCHIVES) to identify adults who were initiated on those regimens. Patients with information on HCV genotype and estimated GFR (eGFR) estimations at baseline and ≥12 weeks after start of therapy were included for the analysis; patients with HIV infection were not included.
A total of 9,837 patients on SOF/LDV, 3,826 on SOF/LDV+RBV, 1,017 on PrOD, and 2,944 on PrOD+RBV were included. Primary outcome measures were SVR rates and progression of renal disease on and up to 12 weeks post-treatment completion stratified by CKD stage. Secondary outcomes included treatment completion rates and hematologic toxicity stratified by regimen and CKD stage.
Genotype 1a was the most common genotype among the SOF/LDV+RBV (70.0%) and PrOD+RBV (79.5%) groups compared to only 4.3% of patients in the PrOD group. CKD stage 4/5 was seen in 0.8% in the SOF/LDV+RBV group, 1.1% in the SOF/LDV group, 2.2% in the PrOD+RBV group, and 5.4% in the PrOD group.
Among CKD stage 3 patients, the data showed a 68.9% treatment completion rate in the SOF/LDV group vs. 78.9% in the PrOD group. Overall SVR rates were 97.0% in the SOF/LDV group and 96.0% in the PrOD group.
A slight decrease in treatment completion rates was seen in CKD stages 4/5 and those taking PrOD+RBV but the effect of RBV on SVR was not established, authors reported. Moreover, about 33% of patients with CKD stages 1/2 in the SOF+LDV experienced a >10mL/min/1.73m2 decline in eGFR vs. 16.5% of patients with stage 3 and 6.5% of patients with stage 4/5. Similar declines in eGFR were seen for the other treatment arms “but its clinical significant remains unclear.”
Regarding safety, the occurrence of grade 3/4 anemia significantly increased across the treatment groups with each CKD stage (range 9.7% [SOF/LVD] to 21.8% [PrOD]) among patients with CKD stage 4/5.
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Butt, A. Effectiveness and Safety of Sofosbuvir/Ledipasvir and Paritaprevir/ritonavir / Ombitasvir + Dasabuvir in Patients with Chronic Kidney Diseases: Results from ERCHIVES. Poster presented at IDWeek; October 4–8, 2017; San Diego, CA. http://www.idweek.org