Safety and efficacy of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection genotype 1–6 and chronic kidney disease: an integrated analysis

Pol, Stanislas; Pockros, Paul J.; Pugatch, David; Bräu, Norbert; Landis, Charles; Elkhashab, Magdy; Sasadeusz, Joe; Tran, Anthony; Hu, Yilan-L.; Kosloski, Matthew P.; Mensa, Federico

doi:10.1016/s0168-8278(17)31967-0

Cited by 15 publications

(9 citation statements)

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“…The frequency of pruritus was higher in CKD stage 4-5 patients, however, these patients do have a higher background rate compared to those with lower CKD stages [65][66][67]. The safety profile was similar in patients with or without compensated cirrhosis with low rates of drug-related serious adverse events (<1%) and adverse events leading to discontinuation (≤4%) [67]. Based on the above considerations, patients with mild to moderate renal impairment (down to eGFR ≥30 ml/min/1.73 m 2 ) can be treated with all combinations (that is, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, ritonavir-boosted paritaprevir/ombitasvir plus dasabuvir, elbasvir/grazoprevir, glecaprevir/pibrentasvir, sofosbuvir and daclatasvir or sofosbuvir and simeprevir) without dose adjustments.…”

Section: No Dose Adjustment Of Glecaprevir/pibrentasvir Ismentioning

confidence: 84%

“…Neither did the level of renal impairment impact on the safety profile of glecaprevir/pibrentasvir, with similar frequencies and types of adverse events across CKD stages. The frequency of pruritus was higher in CKD stage 4-5 patients, however, these patients do have a higher background rate compared to those with lower CKD stages [65][66][67]. The safety profile was similar in patients with or without compensated cirrhosis with low rates of drug-related serious adverse events (<1%) and adverse events leading to discontinuation (≤4%) [67].…”

Section: Figure 1 Routes Of Elimination For Current Daasmentioning

confidence: 87%

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Expert Opinion on the Management of Renal Manifestations of Chronic HCV Infection

et al. 2018

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Chronic HCV infection is a non-traditional (but modifiable) risk factor for chronic kidney disease and has been implicated in glomerular injury and nephrosclerotic disease. Three HCV direct-acting antiviral regimens are available for patients with severe kidney impairment: ombitasvir, paritaprevir with the pharmacokinetic enhancer ritonavir, and dasabuvir; glecaprevir plus pibrentasvir; and elbasvir plus grazoprevir. In patients with severe kidney impairment, sofosbuvir-free regimens are preferred because sofosbuvir accumulation has been associated with a progressive worsening of renal function. In this Review, we provide our expert opinion on the current HCV treatment paradigm and highlight the remaining issues that need to be overcome to improve the treatment of HCV in this population. Incidence of CKD in patients with HCV infection The stages of CKD as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines range from normal (CKD stage 1) to kidney failure (CKD stage 5) and are described in Table 1 [7]. Until recently, data regarding the prevalence of CKD in patients with hepatitis C were limited. In HCV-positive patients, the prevalence of low glomerular filtration rate (GFR <60 ml/min/1.73 m 2) is reported to range from 5.1 to 17.2% [8-10], and the prevalence of renal insufficiency (serum creatinine ≤1.5 mg/dl) is 4.8% in US veterans [11]. In patients coinfected with HIV and HCV, the unadjusted frequency of low GFR (30-59) ranged from 3.7 to 4% [12]. Based on the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) modified guidelines [13], the prevalence of CKD was significantly greater among patients with detectable HCV RNA compared with age-, race-and gender-matched anti-HCV-negative controls (9.1% versus 5.1%; P<0.04) [14]. According to data from the Chronic Hepatitis Cohort Study, the prevalence of estimated (e)GFR <80 ml/min/1.73 m 2 was 33% and eGFR <30 ml/min/1.73 m 2 was 2% in patients with HCV infection, including those with hepatic fibrosis [15].

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Section: No Dose Adjustment Of Glecaprevir/pibrentasvir Ismentioning

confidence: 84%

Section: Figure 1 Routes Of Elimination For Current Daasmentioning

confidence: 87%

Expert Opinion on the Management of Renal Manifestations of Chronic HCV Infection

et al. 2018

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“…The two of them had a virological failure. 18 Pol et al's 19 studies in which GLE/PIB was used for 12 weeks in 2,238 patients found a total SVR rate of 98%; it was found efficient in both chronic kidney disease stage 1-3 (98%; 2,087/2,135) and stage 4-5 (98%; 101/103). No dose adjustment was needed in mild, moderate and severe renal failure for GLE/PIB or OBV/r/DSV.…”

Section: Discussionmentioning

confidence: 99%

The efficacy of the direct-acting antiviral combination in hemodialysis patients with chronic hepatitis C virus Genotype 1 infection

Öztürk

GÜREL

Oruç

2023

Turkish Journal of Internal Medicine

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Background Interferon and ribavirin treatments previously used in treating chronic hepatitis C virus (HCV) infection cannot be used effectively in hemodialysis patients due to dose adjustment and drug-related side effects. Direct-acting antivirals (DAAs) therapies have been reported to be effective in hemodialysis patients. This study aimed to evaluate the effectiveness of DAAs in hemodialysis patients with chronic hepatitis C. Material and Methods Twenty hemodialysis patients with chronic hepatitis C followed in the gastroenterology outpatient clinic between 2016 and 2018 were evaluated retrospectively. Results Twelve of the 20 patients were male, and eight were female. The mean age of the patients was 50.7±8.6 years. Six patients had no treatment experience. Fourteen patients had been previously treated with interferon and/or ribavirin but did not achieve sustained virological response (SVR). Genotype 1b was detected in 14 patients, genotype 1a in 4 patients, and genotype 1 in 2 patients. Patients were treated with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) and dasabuvir (DSV) or ribavirin (RBV) for 12 or 24 weeks. Two patients were cirrhotic and had a Child-Pugh score of A. Treatment was discontinued in 2 patients due to thrombus formation in the arteriovenous fistula in the first month of DAAs treatment. SVR12 was evaluated in 14 of 18 patients and found to be 100%. One of the ten patients accepted as SVR24 had a relapse. This rate of SVR24 was similar to that in the general population. Conclusions Our results supported that the OBV/PTV/r and DSV or RBV regimen was a safe and effective therapy for hemodialysis patients with chronic hepatitis C virus genotype 1.

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“…25 Interestingly, renal function improved in patients with CKD stage 3 confirming results reported with the zepatier combination. 26 Because ofthe contraindication of sofosbuvir in patients with renal insufficiency, this pangenotypic combination of a once daily dose of 3 tablets appears to be the best therapeutic option. in an observational Spanish cohort study, 30 626/1599 HIV/HCV coinfected patients (39%) achieved an SVR.…”

Section: Pangenotypic Combinationsmentioning

confidence: 99%

Treatment of hepatitis C: the use of the new pangenotypic direct‐acting antivirals in “special populations”

Pol

Parlati

2018

Liver International

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Safety and efficacy of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection genotype 1–6 and chronic kidney disease: an integrated analysis

Cited by 15 publications

References 0 publications

Expert Opinion on the Management of Renal Manifestations of Chronic HCV Infection

Expert Opinion on the Management of Renal Manifestations of Chronic HCV Infection

The efficacy of the direct-acting antiviral combination in hemodialysis patients with chronic hepatitis C virus Genotype 1 infection

Treatment of hepatitis C: the use of the new pangenotypic direct‐acting antivirals in “special populations”

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