Effectiveness, treatment completion and safety of sofosbuvir/ledipasvir and paritaprevir/ritonavir/ombitasvir + dasabuvir in patients with chronic kidney disease: an ERCHIVES study

Butt, Adeel A.; Ren, Yue; Puenpatom, Amy; Jm, Arduino; Kumar, Ritesh; Ab, Abou-Samra

doi:10.1111/apt.14799

Cited by 37 publications

(37 citation statements)

References 26 publications

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“…On the other hand, Saxena et al in the famous TARGET study, reported treatment discontinuation in 79/1789 (4%), half of them discontinued treatment because of adverse events; serious adverse events occurred in (6%) . Treatment completion rate of SOF‐based therapy in our study is paradoxically better than that observed with the use of renal disease specific regimens, whether it was paritaprevir/ritonavir/ombitasvir+dasabuvir±ribavirin in ERCHIVES study where only 69% (38/55) of patients with stage 4 − 5 CKD completed therapy, or grazoprevir/elbasvir in the C‐SURFER study where 6/122 patients (4.9%) were excluded from the primary efficacy analysis for non‐virological reasons . The latter were death, loss to follow‐up, non‐compliance, patient withdrawal and withdrawal by physician for violent behaviour.…”

Section: Discussioncontrasting

confidence: 63%

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Eletreby

El‐Serafy

Anees

et al. 2019

Liver International

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Background and Aims This study aimed to assess the safety and efficacy of sofosbuvir (SOF)‐based regimens in patients with moderate to severe renal impairment; a subject which has been questioned by many investigators with conflicting results. Methods This is a real‐life multicentre retrospective cohort study on 4944 chronic Hepatitis C virus (HCV) patients with chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m2) who received SOF‐based therapy in specialized treatment centres affiliated to the National Committee for the Control of Viral Hepatitis in Egypt. The efficacy and safety of SOF‐based regimens was assessed. Results Week 12 virological response rates were 97.5%, 96.7%, 85.7% and 80% in the total cohort, patients with eGFR <30 mL/min/1.73 m2, patients with associated hepatic decompensation and patients on dialysis respectively. Various treatment regimens did not statistically affect the response rates. Treatment experience, cirrhosis and diabetes were predictors of treatment failure on multivariate analysis. Serious adverse events occurred in 0.1% of cases. Forty patients (0.8%) discontinued treatment. Conclusion Sofosbuvir‐based regimens are effective and safe for treating patients with chronic HCV and moderate to severe CKD, and in those with associated hepatic decompensation.

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Section: Discussioncontrasting

confidence: 63%

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Eletreby

El‐Serafy

Anees

et al. 2019

Liver International

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“…In this study, all 24 patients receiving hemodialysis, including 17 with genotype 2, achieved SVR12 without treatment discontinuation. For dialysis‐dependent patients, GLE/PIB would be a promising treatment option, although recent studies of SOF‐based regimens for patients with advanced CKD/dialysis dependence have shown a high virologic effect and a low rate of adverse events related to renal impairment …”

Section: Discussionmentioning

confidence: 99%

“…Among patients infected with HCV genotype 2, the prevalence of subtype 2a was higher than that of subtype 2b, although for approximately 15% the HCV subtype was unknown. Of those with HCV genotype 2, 79.2% (n = 152) were treatment-naïve, 26.0% (n = 50) had diabetes mellitus, 22.9% (n = 44) had cirrhosis, 7.8% (n = 15) had a history of HCC treatment prior to GLE/PIB, and 7.4% (n = 17) were receiving hemodialysis. Of the treatmentexperienced patients, 21 had previously received SOF and ribavirin (RBV).…”

Section: Patient Characteristicsmentioning

confidence: 99%

Glecaprevir and pibrentasvir for Japanese patients with chronic hepatitis C genotype 1 or 2 infection: Results from a multicenter, real‐world cohort study

Ogawa

Furusyo

Nakamuta

et al. 2019

Hepatology Research

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Aim Glecaprevir (GLE) and pibrentasvir (PIB) are new direct‐acting antiviral agents (DAAs) with pangenotypic inhibitors that respectively target the hepatitis C virus (HCV) NS3/4 protease and NS5A. The aim of this study was to evaluate the effectiveness and safety of combining GLE and PIB for patients with HCV genotype (GT) 1 or 2 infection in the clinical setting, including patients DAA‐experienced or on hemodialysis. Methods This multicenter, real‐world, retrospective, cohort study consisted of 314 Japanese patients who were treated with GLE (300 mg) and PIB (120 mg) for a fixed 8‐ or 12‐week duration. We evaluated the sustained virologic response rate 12 weeks after the end of treatment (SVR12) and adverse events. Results Among the treated patients, 122 had GT1 and 192 GT2 infection. The overall SVR12 rates in the per‐protocol populations were 99.2% (119/120) for GT1 and 98.9% (183/185) for GT2. High SVR12 rates were observed in almost all subgroups, including cirrhosis, receiving hemodialysis, or previous all‐oral DAA groups treated with asunaprevir and daclatasvir (GT1b), ledipasvir/sofosbuvir (GT1), or sofosbuvir and ribavirin (GT2). Virological relapse occurred in only 1.0% (3/305) of the patients who completed treatment. The most common adverse events were pruritus and fatigue (>5% of patients). Serious adverse events were rare and discontinuation due to an adverse event was required for 1.6% of the patients. Conclusions In this real‐world cohort study, treatment with GLE/PIB achieved high SVR12 rates with a low rate of serious adverse events among patients with HCV GT1 or 2 infection.

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“…We included the data of two patients who previously experienced treatment with SOF + RBV, both of whom achieved SVR12 in retreatment with LDV/SOF. Regarding the use of SOF for patients with renal impairment, recent studies have shown a high virological effect and a low rate of adverse effects, irrespective of the extent of chronic kidney disease (CKD) and whether or not the patient was receiving hemodialysis . Because of the small sample size in the present study, especially for the special populations, such as cirrhosis, CKD, or treatment experience, we were unable to conclusively show the effectiveness of LDV/SOF for HCV GT2 patients.…”

Section: Discussionmentioning

confidence: 59%

Ledipasvir and sofosbuvir for 12 weeks for hepatitis C virus genotype 2 infection: A propensity score matched analysis

Ogawa

Nomura

Nakamuta

et al. 2019

Hepatology Research

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Aim Hepatitis C virus genotype 2 is common in East Asia, sub‐Saharan Africa, and Latin America. However, many countries in these areas lag behind other areas of the world in government approval for new direct‐acting antivirals. The aim of this study was to evaluate the treatment outcome of ledipasvir/sofosbuvir (LDV/SOF) for patients with chronic hepatitis C virus genotype 2 infection. Methods This is a two‐part multicenter, real‐world cohort study. Study 1 consisted of 58 consecutive patients who were treated with LDV/SOF for 12 weeks. Study 2 used propensity score matching for LDV/SOF (n = 58) and glecaprevir/pibrentasvir (n = 207) treatment groups (1:1) with a set of clinically important variables. Sustained viral response 12 weeks after the end of treatment (SVR12) and adverse events were evaluated in both studies. Results In study 1, the overall SVR12 rates of the intention‐to‐treat and modified intention‐to‐treat populations were 94.8% (55/58) and 96.5% (55/57), respectively. High SVR12 rates were observed in almost all subgroups, including older age, compensated cirrhosis, and treatment experience. In study 2, propensity score matching of the entire study population yielded 52 matched pairs with similar baseline characteristics. There were no statistically significant differences between the LDV/SOF (96.1%) and glecaprevir/pibrentasvir (98.0%) groups in the overall SVR12 rates of the modified intention‐to‐treat populations, and their rates of treatment discontinuation and adverse events were similar. Conclusions Treatment with LDV/SOF for hepatitis C virus genotype 2 resulted in a high rate of SVR12 and excellent tolerability. The outcomes of LDV/SOF were very similar to those of glecaprevir/pibrentasvir.

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Effectiveness, treatment completion and safety of sofosbuvir/ledipasvir and paritaprevir/ritonavir/ombitasvir + dasabuvir in patients with chronic kidney disease: an ERCHIVES study

Abstract: SOF/LDV and PrOD achieved high SVR rates in CKD population. Treatment completion rates were lower than expected. A decline in eGFR and development of anaemia were observed in a substantial proportion of persons, but the clinical implications remain unclear.

Cited by 37 publications

References 26 publications

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Glecaprevir and pibrentasvir for Japanese patients with chronic hepatitis C genotype 1 or 2 infection: Results from a multicenter, real‐world cohort study

Ledipasvir and sofosbuvir for 12 weeks for hepatitis C virus genotype 2 infection: A propensity score matched analysis

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