Efficacy and safety of glecaprevir/pibrentasvir in renally-impaired patients with chronic hepatitis C virus genotype 1–6 infection

Persico, Marcello; Flisiak, Robert; Abunimeh, Manal; Sise, Meghan E.; Park, J.Y.; Kaskas, Marwan; Bruchfeld, Annette; Wörns, Marcus‐Alexander; Aglitti, Andrea; Xue, Zhen; Rullman, Janean; Pocalla, A.; Läwitz, E.

doi:10.1016/s0168-8278(18)30803-1

Cited by 7 publications

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“…Only 13 subjects reported an adverse event among which the most frequent was pruritus which is also a common symptom in ESRD patients. Notably, the prevalence of adverse events in our study was lower than that reported in other clinical trials . This finding might reflect differences between real‐life studies and clinical trials.…”

Section: Discussioncontrasting

confidence: 84%

“…There were no virological failures, thus all patients achieved a SVR at PP analysis. These findings are superimposable to the efficacy results obtained in the Expedition‐4 and Expedition‐5 clinical trials …”

Section: Discussionmentioning

confidence: 99%

“…Notably, the prevalence of adverse events in our study was lower than that reported in other clinical trials. 13,15,21 This finding might reflect differences between real-life studies and clinical trials. In fact, adverse events might be underestimated in real life because the clinician may miss or not report an adverse effect, whereas in clinical trials, the clinician/investigator may be more aware of the need to report such events.…”

Section: Discussionmentioning

confidence: 99%

“…There were no viro- findings are superimposable to the efficacy results obtained in the Expedition-4 and Expedition-5 clinical trials. 13,15 Given the high efficacy of an 8-week G/P regimen in non-cir- Panel supports this therapeutic approach in non-cirrhotic patients with CKD and/or ESRD. 19 Notably, despite the different prevalence of liver cirrhosis between patients with and without ESRD, the prevalence of SVR did not differ between the two groups.…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9][10][11][12] No dosage adjustment is required in patients with mild, moderate or severe renal impairment, including those on dialysis. In clinical trials, G/P was found to be highly effective and safe in HCV-infected patients with CKD, [13][14][15] but data in a real-life scenario are scarce. Therefore, the aim of this study was to assess the efficacy and safety profile of G/P in the treatment of HCV-infected patients with CKD or ESRD in daily clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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Real‐life efficacy and safety of glecaprevir/pibrentasvir in HCV‐infected patients with chronic kidney disease

et al. 2019

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Summary Background Clinical trials have shown that glecaprevir/pibrentasvir (G/P) therapy is effective and safe for HCV‐infected patients with chronic kidney disease (CKD), but data in a real‐life setting are scarce. Aim To evaluate the efficacy and safety of G/P in HCV‐infected patients with reduced renal function. Patients and Methods All consecutive HCV‐infected patients with CKD (eGFR <60 mL/min/1.73 m2) treated with G/P were enrolled. An adverse event (AE) was defined as any untoward medical occurrence or any unfavourable sign or symptom, during drug administration that was not necessarily causally treatment‐related. An AE causing death, hospitalisation or therapy discontinuation was considered a serious AE (SAE). Results A total of 121 patients were enrolled. Thirty‐six patients had end‐stage renal disease (ESRD), 57 were male, overall median age was 69 ± 13 years and 20 had cirrhosis. Genotype 2 was the most frequent (53.7%). Treatment lasted 8 weeks in 93 patients, 21 of whom had ESRD, and 12 weeks in 28 patients. At modified intention‐to‐treat analysis, 119/120 patients achieved a sustained virologic response (SVR) without differences between cirrhotics and non‐cirrhotics, whereas at per protocol analysis all patients achieved a SVR. Notably, SVR did not differ between patients with and without ESRD (35/35 vs 84/85 P = 0.427). There were no virologic failures. Thirteen patients reported an AE (mostly pruritus), three had a SAE (death in a car accident and two jaundice) and one spontaneously stopped treatment. Conclusion This real‐life study confirms the high efficacy and safety of G/P, also administered for 8 weeks, in HCV‐infected patients with CKD or with ESRD.

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Section: Discussioncontrasting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Real‐life efficacy and safety of glecaprevir/pibrentasvir in HCV‐infected patients with chronic kidney disease

et al. 2019

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Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection

et al. 2019

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Background Chronic hepatitis C virus (HCV) infection with genotypes (GT) 1 and 2 accounts for over 50% of HCV infections globally, including over 97% of all HCV infections in Japan. Here, we report an integrated analysis of efficacy and safety of 8-week treatment with the all-oral, fixed-dose combination of the direct acting antivirals (DAA), glecaprevir and pibrentasvir (G/P), in DAA-naïve Japanese and overseas patients without cirrhosis and with HCV GT1 or GT2 infection. Methods Data from 899 DAA-naïve patients without cirrhosis and with HCV GT1 or GT2 infection treated with G/P (300/120 mg) for 8 weeks in the six Phase 2 or 3 overseas or Japan-only clinical trials were included. All patients who received ≥ 1 dose of G/P were included in an intent-to-treat (ITT) analysis. The objectives were to evaluate rate of sustained virologic response 12 weeks post-treatment (SVR12) and safety of the 8-week regimen in the ITT population. Results Overall, SVR12 was achieved by 98.9% (889/899) of DAA-naïve patients without cirrhosis, including 99.2% (597/602) of GT1-infected and 98.3% (292/297) of GT2-infected patients. Less than 1% (2/899) of patients overall and no Japanese patients experienced virologic failure. SVR12 rate was > 97% for patients regardless of baseline characteristics, and common comorbidities or co-medications. Overall, < 1% (2/899) discontinued G/P due to an adverse event (AE) and 1.6% (14/899) of patients experienced a serious AE. Conclusions 8-week G/P treatment is safe and efficacious in DAA-naive patients without cirrhosis and with HCV GT1 or GT2 infection, demonstrating high SVR12 rates regardless of baseline patient and disease characteristics. ClinicalTrials.gov identifiers The trials discussed in this paper were registered with ClinicalTrials.gov as follows: NCT02707952 (CERTAIN-1), NCT02723084 (CERTAIN-2), NCT02243280 (SURVEYOR-I), NCT02243293 (SURVEYOR-II), NCT02604017 (ENDURANCE-1), NCT02738138 (EXPEDITION-2). Electronic supplementary material The online version of this article (10.1007/s00535-019-01569-7) contains supplementary material, which is available to authorized users.

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Eight Weeks of Treatment With Glecaprevir/Pibrentasvir Is Safe and Efficacious in an Integrated Analysis of Treatment-Naïve Patients With Hepatitis C Virus Infection

Zuckerman

Gutiérrez

Dylla

et al. 2020

Clinical Gastroenterology and Hepatology

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BACKGROUND & AIMS: The direct-acting antiviral combination glecaprevir/pibrentasvir has been approved by the Food and Drug Administration for 8 weeks of treatment in treatment-naïve patients with hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. We performed an integrated analysis of data from trials to evaluate the overall efficacy and safety of 8 weeks of glecaprevir/pibrentasvir in treatment-naïve patients without cirrhosis or with compensated cirrhosis. METHODS: We pooled data from 8 phase 2 or phase 3 trials of treatment-naïve patients with HCV genotype 1 to 6 infections, without cirrhosis or with compensated cirrhosis, who received 8 weeks of glecaprevir/pibrentasvir. RESULTS: Of 1248 patients, 343 (27%) had cirrhosis. Most patients were white (80%) and had HCV genotype 1 infection (47%) or genotype 3 infection (22%); the median age was 54 years. Overall rates of sustained virologic response at post-treatment week 12 were 97.6% (1218 of 1248) in the intention to treat (ITT) and 99.3% (1218 of 1226) in the modified ITT populations. When we excluded patients with genotype 3 infections with compensated cirrhosis (consistent with the European label), rates of sustained virologic response at post-treatment week 12 were 97.6% in the ITT and 99.4% in the modified ITT populations. Eight virologic failures (7 in patients without cirrhosis and 1 in a patient with cirrhosis) occurred in the ITT population. Virologic failure was not associated with markers of advanced liver disease or populations of interest (current alcohol use, opioid substitution therapy, history of injection-drug use, and severe renal impairment). Treatment-emergent adverse events (AEs) occurred in 58% of patients. The most frequent AEs (>10%) were headache (12%) and fatigue (12%). Serious AEs and AEs that led to glecaprevir/pibrentasvir discontinuation were reported in 2% and less than 1% of patients, respectively.

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Efficacy and safety of glecaprevir/pibrentasvir in renally-impaired patients with chronic hepatitis C virus genotype 1–6 infection

Cited by 7 publications

References 0 publications

Real‐life efficacy and safety of glecaprevir/pibrentasvir in HCV‐infected patients with chronic kidney disease

Real‐life efficacy and safety of glecaprevir/pibrentasvir in HCV‐infected patients with chronic kidney disease

Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection

Eight Weeks of Treatment With Glecaprevir/Pibrentasvir Is Safe and Efficacious in an Integrated Analysis of Treatment-Naïve Patients With Hepatitis C Virus Infection

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