Use of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus infection and severe renal impairment
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Background/Aims: Data on treatment efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) for chronic hepatitis C virus (HCV) infection in Asian patients with severe renal impairment are limited. This study aimed to study the treatment and side effects of GLE/PIB in these patients infected with non-1 genotype (GT) HCV. Methods: We prospectively recruited patients with Child’s A cirrhosis and eGFR <30 mL/min/1.73 m2 in Hong Kong and Taiwan during 2017–2018 to receive GLE/PIB treatment. Results: Twenty-one patients (GT2, n=7; GT3, n=6; and GT6, n=8) received GLE/PIB for 11.2±1.8 weeks. All except one were treatment-naïve. GLE/PIB was initiated in 16 patients while on dialysis (seven on peritoneal dialysis [PD] and nine on hemodialysis) and in five patients before dialysis. One patient died of PD-related peritonitis during treatment and two were lost to follow up. The SVR12 rate in the remaining 18 patients was 100%. All patients achieved undetectable levels at 4-, 12-, 24- and 48-week after treatment. Patients with deranged alanine aminotransferase showed normalization after 4 weeks and the response was sustained for 48 weeks. No significant adverse event was observed. Conclusions: GLE/PIB treatment was associated with high efficacy and tolerability in HCV-infected patients with severe renal impairment.
Abstract
Background/Aims: Data on treatment efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) for chronic hepatitis C virus (HCV) infection in Asian patients with severe renal impairment are limited. This study aimed to study the treatment and side effects of GLE/PIB in these patients infected with non-1 genotype (GT) HCV. Methods: We prospectively recruited patients with Child’s A cirrhosis and eGFR <30 mL/min/1.73 m2 in Hong Kong and Taiwan during 2017–2018 to receive GLE/PIB treatment. Results: Twenty-one patients (GT2, n=7; GT3, n=6; and GT6, n=8) received GLE/PIB for 11.2±1.8 weeks. All except one were treatment-naïve. GLE/PIB was initiated in 16 patients while on dialysis (seven on peritoneal dialysis [PD] and nine on hemodialysis) and in five patients before dialysis. One patient died of PD-related peritonitis during treatment and two were lost to follow up. The SVR12 rate in the remaining 18 patients was 100%. All patients achieved undetectable levels at 4-, 12-, 24- and 48-week after treatment. Patients with deranged alanine aminotransferase showed normalization after 4 weeks and the response was sustained for 48 weeks. No significant adverse event was observed. Conclusions: GLE/PIB treatment was associated with high efficacy and tolerability in HCV-infected patients with severe renal impairment.
참고문헌 (29)
- Fabrizi F, "New treatment for hepatitis C in chronic kidney disease, dialysis, and transplant", Kidney Int, 89, pp.988~994 (2016)
- Fabrizi F, "Impact of hepatitis C on survival in dialysis patients : a link with cardiovascular mortality?", J Viral Hepat, 19, pp.601~607 (2012)
- Fabrizi F, "Meta-analysis of observational studies : hepatitis C and survival after renal transplant", J Viral Hepat, 21, pp.314~324 (2014)
- Fabrizi F, "Antiviral therapy(pegylated interferon and ribavirin)of hepatitis C in dialysis patients : metaanalysis of clinical studies", J Viral Hepat, 21, pp.681~689 (2014)
- Feld JJ, "Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6infection", N Engl J Med, 373, pp.2599~2607 (2015)
- Foster GR, "Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection", N Engl J Med, 373, pp.2608~2617 (2015)
- Curry MP, "Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis", N Engl J Med, 373, pp.2618~2628 (2015)
- Dumortier J, "Anti-viral triple therapy with telaprevir in haemodialysed HCV patients : is it feasible?", J Clin Virol, 56, pp.146~149 (2013)
- Wiegand J, "Letter : telaprevir triple therapy in chronic hepatitis C genotype 1 patients receiving haemodialysis", Aliment Pharmacol Ther, 39, pp.1342~1344 (2014)
- Kaya S, "Evaluation of telaprevircontaining triple therapy in the treatment of chronic hepatitis C in hemodialysed patients", Infect Dis(Lond), 47, pp.658~661 (2015)
- Mehawej M, "Boceprevir-based triple antiviral therapy for chronic hepatitis C virus infection in kidney-transplant candidates", J Transplant, 2015, pp.159795~ (2015)
- Ng TI, "In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS5A inhibitor pibrentasvir", Antimicrob Agents Chemother, 61, pp.e02558~16 (2017)
- Poordad F, "Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment", Hepatology, 66, pp.389~397 (2017)
- D’Ambrosio R, "Real-world effectiveness and safety of glecaprevir", pibrentasvir in 723 patients with chronic hepatitis C, 2019, pp.70, 379~387
- Zeuzem S, "Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3infection", N Engl J Med, 378, pp.354~369 (2018)
- Kidney Disease: Improving Global Outcomes (KDIGO) Hepatitis C Work Group, "KDIGO 2018 clinical practice guideline for the prevention, diagnosis, evaluation, and treatment of hepatitis C in chronic kidney disease", Kidney Int Suppl, 8, pp.91~165 (2018)
- Flamm S, "Glecaprevir", pibrentasvir in patients with chronic HCV genotype 3 infection : an integrated phase 2, J Viral Hepat, pp.2019, 26[DOI]
- Puoti M, "High SVR12 with 8-week and 12-week glecaprevir", pibrentasvir therapy : an integrated analysis of HCV genotype 1-6 patients without cirrhosis, 2018, pp.69, 293~300
- Gane E, "Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment", N Engl J Med, 377, pp.1448~1455 (2017)
- Prescott LE, "Detection and clinical features of hepatitis C virus type 6 infections in blood donors from Hong Kong", J Med Virol, 50, pp.168~175 (1996)
- Thong VD, "Hepatitis C virus genotype 6 : virology, epidemiology, genetic variation and clinical implication", World J Gastroenterol, 20, pp.2927~2940 (2014)
- Asselah T, "Efficacy and safety of glecaprevir", pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection(ENDURANCE-5, 6) : an open-label, multicentre, phase 3b trial, 2019, pp.4, 45~51
- Kwo PY, "Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis", J Hepatol, 67, pp.263~271 (2017)
- "A study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in treatment-naive and treatment-experienced, non-cirrhotic asian adults with chronic hepatitis C virus genotype (GT) 1 to GT6 infection with or without human immunodeficiency virus co-infection (VOYAGE-1)"[URL]
- "Efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in treatment-naive and treatmentexperienced asian adults with chronic hepatitis C virus genotype (GT)1 to GT6 infection with compensated cirrhosis and with or without human immunodeficiency virus co-infection (VOYAGE-2)"[URL]
- Kato S, "Aspects of immune dysfunction in end-stage renal disease", Clin J Am Soc Nephrol, 3, pp.1526~1533 (2008)
- Smyth B, "Prescribing for patients on dialysis", Aust Prescr, 39, pp.21~24 (2016)
- Kwong VW, "Peritoneal dialysis in Asia", Kidney Dis(Basel), 1, pp.147~156 (2015)
- Lim SG, "Management of hepatitis C virus infection in the Asia-Pacific region : an update", Lancet Gastroenterol Hepatol, 2, pp.52~62 (2017)