Sofosbuvir and risk of estimated glomerular filtration rate decline or end-stage renal disease in patients with renal impairment
© 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd..
BACKGROUND: Sofosbuvir, a prodrug nucleoside inhibitor of hepatitis C virus, has a predominant circulating metabolite that is renally eliminated. Whether sofosbuvir is associated with chronic kidney disease (CKD) progression is not well understood.
METHODS: We performed a retrospective analysis of patients with estimated glomerular filtration rate (eGFR) 30-89 mL/min/1.73 m2 treated with sofosbuvir in 76 Phase 2/3 registrational trials. We evaluated eGFR at each study visit. Separately, we performed a retrospective analysis of an administrative claims database (IQVIA PharMetrics Plus™) to compare the risk of incident end-stage renal disease (ESRD) associated with the use of sofosbuvir or non-sofosbuvir regimens among patients with CKD using propensity score methods. Exposure, CKD status and outcomes were determined using diagnosis and medication claim codes. Cox proportional hazards methods were used to estimate ESRD risk.
RESULTS: Among 4642 trial participants with baseline stage 2 CKD (eGFR 60-89 ml/min/1.73 m2 ) and 682 trial participants with stage 3 CKD (eGFR 30-59 ml/min/1.73 m2 ) mean (SD) eGFR improved from baseline to 4 weeks post-treatment (+0.7 [9.3] and +2.6 [8.8] ml/min/1.73 m2 , respectively; p < 0.001 each). In the second analysis, among 2042 patients with CKD receiving sofosbuvir-based regimens compared to 431 receiving non-sofosbuvir-based regimens, after adjusting for baseline covariates and weighting based on treatment propensity scores, there was no significant difference in risk of ESRD (adjusted HR = 0.85, 95% CI: 0.51-1.42).
CONCLUSIONS: Clinical trial participants with CKD did not experience worsening eGFR during sofosbuvir-based treatment, and sofosbuvir was not associated with an increased risk of ESRD in patients with CKD in a nationally-representative administrative claims database.
| Errataetall: |
CommentIn: Aliment Pharmacol Ther. 2022 Apr;55(8):1052-1053. - PMID 35362131 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:55 |
|---|---|
| Enthalten in: |
Alimentary pharmacology & therapeutics - 55(2022), 9 vom: 04. Mai, Seite 1169-1178 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Sulkowski, Mark [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antiviral Agents |
|---|
| Anmerkungen: |
Date Completed 19.04.2022 Date Revised 11.11.2023 published: Print-Electronic CommentIn: Aliment Pharmacol Ther. 2022 Apr;55(8):1052-1053. - PMID 35362131 Citation Status MEDLINE |
|---|
| doi: |
10.1111/apt.16830 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM33766501X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM33766501X | ||
| 003 | DE-627 | ||
| 005 | 20231225234931.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1111/apt.16830 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1125.xml |
| 035 | |a (DE-627)NLM33766501X | ||
| 035 | |a (NLM)35235245 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Sulkowski, Mark |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Sofosbuvir and risk of estimated glomerular filtration rate decline or end-stage renal disease in patients with renal impairment |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 19.04.2022 | ||
| 500 | |a Date Revised 11.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Aliment Pharmacol Ther. 2022 Apr;55(8):1052-1053. - PMID 35362131 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Sofosbuvir, a prodrug nucleoside inhibitor of hepatitis C virus, has a predominant circulating metabolite that is renally eliminated. Whether sofosbuvir is associated with chronic kidney disease (CKD) progression is not well understood | ||
| 520 | |a METHODS: We performed a retrospective analysis of patients with estimated glomerular filtration rate (eGFR) 30-89 mL/min/1.73 m2 treated with sofosbuvir in 76 Phase 2/3 registrational trials. We evaluated eGFR at each study visit. Separately, we performed a retrospective analysis of an administrative claims database (IQVIA PharMetrics Plus™) to compare the risk of incident end-stage renal disease (ESRD) associated with the use of sofosbuvir or non-sofosbuvir regimens among patients with CKD using propensity score methods. Exposure, CKD status and outcomes were determined using diagnosis and medication claim codes. Cox proportional hazards methods were used to estimate ESRD risk | ||
| 520 | |a RESULTS: Among 4642 trial participants with baseline stage 2 CKD (eGFR 60-89 ml/min/1.73 m2 ) and 682 trial participants with stage 3 CKD (eGFR 30-59 ml/min/1.73 m2 ) mean (SD) eGFR improved from baseline to 4 weeks post-treatment (+0.7 [9.3] and +2.6 [8.8] ml/min/1.73 m2 , respectively; p < 0.001 each). In the second analysis, among 2042 patients with CKD receiving sofosbuvir-based regimens compared to 431 receiving non-sofosbuvir-based regimens, after adjusting for baseline covariates and weighting based on treatment propensity scores, there was no significant difference in risk of ESRD (adjusted HR = 0.85, 95% CI: 0.51-1.42) | ||
| 520 | |a CONCLUSIONS: Clinical trial participants with CKD did not experience worsening eGFR during sofosbuvir-based treatment, and sofosbuvir was not associated with an increased risk of ESRD in patients with CKD in a nationally-representative administrative claims database | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a GS-331007 | |
| 650 | 4 | |a chronic kidney disease | |
| 650 | 4 | |a dialysis | |
| 650 | 4 | |a direct-acting antiviral | |
| 650 | 4 | |a end-stage renal disease | |
| 650 | 4 | |a sofosbuvir | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 650 | 7 | |a Sofosbuvir |2 NLM | |
| 650 | 7 | |a WJ6CA3ZU8B |2 NLM | |
| 700 | 1 | |a Telep, Laura E |e verfasserin |4 aut | |
| 700 | 1 | |a Colombo, Massimo |e verfasserin |4 aut | |
| 700 | 1 | |a Durand, Francois |e verfasserin |4 aut | |
| 700 | 1 | |a Reddy, K Rajender |e verfasserin |4 aut | |
| 700 | 1 | |a Lawitz, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Bourlière, Marc |e verfasserin |4 aut | |
| 700 | 1 | |a Cheinquer, Nelson |e verfasserin |4 aut | |
| 700 | 1 | |a Scherbakovsky, Stacey |e verfasserin |4 aut | |
| 700 | 1 | |a Ni, Liyun |e verfasserin |4 aut | |
| 700 | 1 | |a Force, Lindsey |e verfasserin |4 aut | |
| 700 | 1 | |a Ramroth, Heribert |e verfasserin |4 aut | |
| 700 | 1 | |a Gaggar, Anuj |e verfasserin |4 aut | |
| 700 | 1 | |a Chokkalingam, Anand P |e verfasserin |4 aut | |
| 700 | 1 | |a Sise, Meghan E |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Alimentary pharmacology & therapeutics |d 1992 |g 55(2022), 9 vom: 04. Mai, Seite 1169-1178 |w (DE-627)NLM012692506 |x 1365-2036 |7 nnns |
| 773 | 1 | 8 | |g volume:55 |g year:2022 |g number:9 |g day:04 |g month:05 |g pages:1169-1178 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1111/apt.16830 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 55 |j 2022 |e 9 |b 04 |c 05 |h 1169-1178 | ||