Evolution of eGFR in chronic HCV patients receiving sofosbuvir-based or sofosbuvir-free direct-acting antivirals

Liu, Chen–Hua; Lee, Hsuan-Shu; Lin, Jia‐Hua; Liu, Chun‐Jen; Su, Tung‐Hung; Tseng, Tai Chung; Chen, Pei‐Jer; Chen, Ding‐Shinn

doi:10.1016/j.jhep.2019.11.014

Cited by 52 publications

(46 citation statements)

References 38 publications

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“…SOF is a pyrimidine nucleoside analogue that acts as an HCV RNA chain terminator by inhibiting HCV NS5B RNA polymerase, and can be used in combination with NS3/4A protease inhibitors, NS5A inhibitors, and/or ribavirin to achieve HCV elimination. SOF-based treatment has been shown to be highly effective and tolerable in both clinical trials and real-world data, irrespective of age, fibrosis status, or HCV genotype [20][21][22], although patients at an advanced CKD stage could be at risk of estimated glomerular filtration rate (eGFR) decline [23]. Our recent short-term analysis, within two years, consisted of patients treated with an SOF-based regimen and was done to determine predictive markers for HCC incidence [24].…”

Section: Discussionmentioning

confidence: 99%

Incidence of Hepatocellular Carcinoma after Treatment with Sofosbuvir-Based or Sofosbuvir-Free Regimens in Patients with Chronic Hepatitis C

Ogawa

Nomura

Nakamuta

et al. 2020

Cancers

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Advanced fibrosis/cirrhosis and related biomarkers have been recognized as useful predictors of the development of hepatocellular carcinoma (HCC) by patients with chronic hepatitis C (CHC) following hepatitis C virus (HCV) cure by direct-acting antivirals (DAAs). However, it remains unclear if DAAs themselves have an influence on or facilitate the development of HCC. This multicenter cohort study included CHC patients without a history of HCC who achieved HCV elimination by DAAs. Cohorts of 835 patients treated with a sofosbuvir (SOF)-based regimen and 835 treated with a SOF-free regimen were matched 1:1 by propensity scoring with nine variables to evaluate differences in HCC incidence. The median observation period was 3.5 years. Sixty-nine cases of HCC were found during 5483.9 person-years (PY) over the entire follow-up period. The annual incidence was similar for both groups (SOF-based 1.25 and SOF-free 1.27 per 100 PY, respectively: adjusted hazard ratio (HR) 1.26, 95% confidence interval (CI) 0.75–2.12, p = 0.39). However, the annual incidence within the first two years was higher for patients treated with SOF than for those without, but did not reach significance (1.50 and 0.97 per 100 PY incidence rates, respectively: adjusted HR 2.05, 95% CI 0.98–4.25, p = 0.06). In summary, DAA treatment with SOF was not associated with an increase in the development of de novo HCC.

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Section: Discussionmentioning

confidence: 99%

Incidence of Hepatocellular Carcinoma after Treatment with Sofosbuvir-Based or Sofosbuvir-Free Regimens in Patients with Chronic Hepatitis C

Ogawa

Nomura

Nakamuta

et al. 2020

Cancers

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“…Patient demographics, hemogram, international normalized ratio (INR), serum albumin, total bilirubin (upper limit of normal [ULN]: 1.0 mg/dL), direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) (ULN: 30 U/L for males and 19 U/L for females), estimated glomerular ltration rate (eGFR), anti-HCV, hepatitis B surface antigen (HBsAg) (Abbott Architect HBsAg qualitative assay, Abbott Laboratories, Abbott Park, Illinois, USA), anti-HIV (Abbott Architect HIV Ag/Ab Combo, Abbott Laboratories, Abbott Park, Illinois, USA), HCV RNA, HCV genotype (Roche Cobas HCV GT, Roche Diagnostics GmbH, Mannheim, Germany, or Abbott RealTime HCV Genotype II, Abbott Laboratories, Abbott Park, Illinois, USA) were assessed for all patients [19,20]. The stage of hepatic brosis was graded by brosis index based on 4 parameters (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI).…”

Section: Methodsmentioning

confidence: 99%

Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan

Liu

Chen

et al. 2021

Hepatol Int

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Background Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan. Methods Between July 2019 and March 2020, 1,880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR 12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported. Results The SVR 12 rates by EP and PP analyses were 95.6% (1,798 of 1,880 patients; 95% con dence interval (CI): 94.6%-96.5%) and 99.3% (1,798 of 1,811 patients; 95% CI: 98.8%-99.6%), respectively. Among 82 patients who failed to achieve SVR 12 , 13 (15.9%) were attributed to virologic failures. The SVR 12 rates were comparable regardless of baseline characteristics. A total of 1,859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations. Conclusions SOF/VEL for 12 weeks is e cacious and well-tolerated chronic HCV-infected patients with compensated liver disease in Taiwan.

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“…We found that the decline in eGFR was greater with TDF-than with TAFcontaining regimens during LDV/SOF treatment (8.33 ml/min/1.73 m 2 vs. 6.35 ml/min/ 1.73 m 2 ). However, the eGFR declines were reversible in both the TDF and TAF groups at SVR12 assessment, suggesting the removal of the adverse impact of LDV/SOF on renal function and probably the beneficial impact of HCV eradication on renal function [37]. Compared to baseline, patients receiving TAF had an eGFR decline by 3.0 ml/min/1.73 m 2 at SVR12 assessment.…”

Section: Discussionmentioning

confidence: 92%

“…Controversies exist regarding the potential nephrotoxicity of SOF [34][35][36]. A prospective study revealed that patients receiving SOF-based DAAs demonstrated trends of on-treatment worsening of eGFR, which were independently related to increasing age, SOF-based DAAs, and more advanced CKD stages [37]. LDV, an inhibitor of P-glycoprotein and BCRP efflux transporters, may increase tenofovir concentration when given with TDF, which may increase the risk of TDF-related nephrotoxicity.…”

Section: Discussionmentioning

confidence: 99%

Real-World Experience with Coformulated Ledipasvir and Sofosbuvir for HIV-Positive Patients with HCV Genotype 2 Infection: A Multicenter, Retrospective Study

Liou¹,

Sun²,

Yang³

et al. 2021

Infect Dis Ther

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Introduction: While coformulated ledipasvir (90 mg)/sofosbuvir (400 mg) (LDV/SOF) is approved for the treatment of hepatitis C virus (HCV) genotype 2 (GT2) infection in Taiwan, Japan, and New Zealand, data regarding its use for HIV (Human Immunodeficiency Virus)positive patients infected with HCV GT2 are sparse. We aimed to assess the effectiveness and tolerability of LDV/SOF for HIV-positive patients with HCV GT2 coinfection. Methods: From January 2019 to July 2020, consecutive HIV-positive Taiwanese patients infected with HCV GT2 who received LDV/SOF were retrospectively included for analysis. The effectiveness was determined by sustained virologic response 12 weeks off-therapy (SVR12).

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Evolution of eGFR in chronic HCV patients receiving sofosbuvir-based or sofosbuvir-free direct-acting antivirals

Cited by 52 publications

References 38 publications

Incidence of Hepatocellular Carcinoma after Treatment with Sofosbuvir-Based or Sofosbuvir-Free Regimens in Patients with Chronic Hepatitis C

Incidence of Hepatocellular Carcinoma after Treatment with Sofosbuvir-Based or Sofosbuvir-Free Regimens in Patients with Chronic Hepatitis C

Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan

Real-World Experience with Coformulated Ledipasvir and Sofosbuvir for HIV-Positive Patients with HCV Genotype 2 Infection: A Multicenter, Retrospective Study

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