ntroduction: Glecaprevir/Pibrentasvir (G/P) demonstrated high efficacy and safety in the treatment of HCV infected patients with chronic kidney disease (CKD) in registered trials, but data in a real-life scenario are still scant. Aim: To evaluate the efficacy and safety of G/P in a cohort of HCV infected patients with CKD. Methods: Patients with a reduced renal function (eGFR <60ml/min/1,73m2) were included. A complete clinical and lab- oratory assessment was performed at Baseline, End of Therapy (EoT) and sustained virologic response (SVR). SVR was defined as an undetectable serum HCV-RNA after (at least) 12 weeks from EoT. An adverse event (AE) was defined as any untoward medical occur- rence or any unfavorable sign (including an abnormal laboratory finding) or symptom, during the drug administration and which does not necessarily have a causal relationship with treatment. If an AE caused death, hospitalization or therapy discontinuation, was defined as serious adverse event (SAE). Results: One-hundred-twenty-two patients were enrolled: 30.3% had an end stage renal disease (ESRD), 46,7% were male, median age 69 ± 13 yrs, 16,4% were cirrhotics. Genotype 2 was the most frequent (53.3%), genotype 1b (33.6%), 3 (7.4%), 1a (4.1%), 4 (1.6%). Treatment duration was 8 weeks for 93 pts and 12 weeks for the remaining. At the time of statistical analysis 117/119 pts showed an EoT virologic response and 107/109 reached a SVR (98.2%). There was no difference between ESRD patients and all the others (96.4% vs 98.8% p = 0.427). There were no virologic failures, 2 discontinuations for no drug-related SAEs. Thirteen pts reported pruritus as the most frequent AE and 3 SAE (death for car accident, jaundice and cryoglobulinemic syndrome) were reported. Full data will be shown at the AISF meeting. Conclusions: Real-life G/P therapy confirms an excellent effi- cacy and safe profile in HCV-infected patients with CKD also in those with ESRD.
Real-life effectiveness and safety of Glecaprevir/Pibrentasvir in HCV infected patients with chronic kidney disease
Aglitti, A.;Tripodi, M. F.;Masarone, M.;Persico, M.
2019-01-01
Abstract
ntroduction: Glecaprevir/Pibrentasvir (G/P) demonstrated high efficacy and safety in the treatment of HCV infected patients with chronic kidney disease (CKD) in registered trials, but data in a real-life scenario are still scant. Aim: To evaluate the efficacy and safety of G/P in a cohort of HCV infected patients with CKD. Methods: Patients with a reduced renal function (eGFR <60ml/min/1,73m2) were included. A complete clinical and lab- oratory assessment was performed at Baseline, End of Therapy (EoT) and sustained virologic response (SVR). SVR was defined as an undetectable serum HCV-RNA after (at least) 12 weeks from EoT. An adverse event (AE) was defined as any untoward medical occur- rence or any unfavorable sign (including an abnormal laboratory finding) or symptom, during the drug administration and which does not necessarily have a causal relationship with treatment. If an AE caused death, hospitalization or therapy discontinuation, was defined as serious adverse event (SAE). Results: One-hundred-twenty-two patients were enrolled: 30.3% had an end stage renal disease (ESRD), 46,7% were male, median age 69 ± 13 yrs, 16,4% were cirrhotics. Genotype 2 was the most frequent (53.3%), genotype 1b (33.6%), 3 (7.4%), 1a (4.1%), 4 (1.6%). Treatment duration was 8 weeks for 93 pts and 12 weeks for the remaining. At the time of statistical analysis 117/119 pts showed an EoT virologic response and 107/109 reached a SVR (98.2%). There was no difference between ESRD patients and all the others (96.4% vs 98.8% p = 0.427). There were no virologic failures, 2 discontinuations for no drug-related SAEs. Thirteen pts reported pruritus as the most frequent AE and 3 SAE (death for car accident, jaundice and cryoglobulinemic syndrome) were reported. Full data will be shown at the AISF meeting. Conclusions: Real-life G/P therapy confirms an excellent effi- cacy and safe profile in HCV-infected patients with CKD also in those with ESRD.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
