Treatment and Renal Outcomes Up to 96 Weeks After Tenofovir ... : Hepatology (original) (raw)

Original Articles: Viral Hepatitis

Treatment and Renal Outcomes Up to 96 Weeks After Tenofovir Alafenamide Switch From Tenofovir Disoproxil Fumarate in Routine Practice

Toyoda, Hidenori1; Leong, Jennifer2; Landis, Charles3; Atsukawa, Masanori4; Watanabe, Tsunamasa5; Huang, Daniel Q.6,7; Liu, Joanne3,8; Quek, Sabrina Xin Zi9; Ishikawa, Toru10; Arai, Taeang4; Yokohama, Keisuke11; Chuma, Makoto12; Takaguchi, Koichi13; Uojima, Haruki14; Senoo, Tomonori13; Dang, Hansen15; Maeda, Mayumi15; Hoang, Joseph15; Le, Richard H.15; Yasuda, Satoshi1; Thin, Khin N.15; Tran, Sally15; Chien, Nicholas15; Henry, Linda15; Asai, Akira11; Fukunishi, Shinya16; Cheung, Ramsey15,17; Lim, Seng Gee6,7; Trinh, Huy N.18; Nguyen, Mindie H.*,15

1Department of Gastroenterology and HepatologyOgaki Municipal HospitalOgakiJapan

2Henry D. Janowitz Division of GastroenterologyMt. Sinai Health SystemNew YorkNY

3Division of GastroenterologyUniversity of WashingtonSeattleWA

4Division of Gastroenterology and HepatologyNippon Medical SchoolTokyoJapan

5Division of Gastroenterology and HepatologySt. Marianna University School of MedicineKawasakiJapan

6Division of Gastroenterology and HepatologyDepartment of MedicineNational University HospitalSingapore

7Department of MedicineYong Loo Lin School of MedicineNational University of SingaporeSingapore

8University of WashingtonSeattleWA

9Department of MedicineNational University HospitalSingapore

10Department of GastroenterologySaiseikai Niigata HospitalNiigataJapan

112nd Department of Internal MedicineOsaka Medical CollegeOsakaJapan

12Gastroenterological CenterYokohama City University Medical CenterYokohamaJapan

13Department of HepatologyKagawa Prefectural Central HospitalKagawaJapan

14Department of Gastroenterology, Internal MedicineKitasato University School of MedicineSagamiharaJapan

15Division of Gastroenterology and HepatologyStanford University Medical CenterPalo AltoCA

16Premier Development Research of MedicineOsaka Medical CollegeOsakaJapan

17Division of Gastroenterology and HepatologyThe Palo Alto Veterans Affairs Health Care SystemPalo AltoCA

18San Jose GastroenterologySan JoseCA

* ADDRESS CORRESPONDENCE AND REPRINT REQUESTS TO:
Mindie H. Nguyen, M.D., M.A.S.
Professor of Medicine (Gastroenterology, Hepatology, and Liver Transplant) and, by courtesy, of Epidemiology and Population Health, Stanford University Medical Center
780 Welch Road, CJ250K
Palo Alto, CA 94304
E‐mail: [email protected]
Tel.: +1‐650‐498‐5691

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Abstract

Background and Aims

Real‐world data for treatment effectiveness and renal outcomes in chronic hepatitis B (CHB) patients who were switched to the new and safer prodrug tenofovir alafenamide (TAF) from tenofovir disoproxil fumarate (TDF) are limited. Therefore, we aimed to evaluate treatment and renal outcomes of this population.

Approach and Results

We analyzed 834 patients with CHB previously treated with TDF for ≥12 months who were switched to TAF in routine practice at 13 US and Asian centers for changes in viral (HBV DNA < 20 IU/mL), biochemical (alanine aminotransferase [ALT] < 35/25 U/L for male/female), and complete (viral+biochemical) responses, as well as estimated glomerular filtration rate (eGFR; milliliters per minute per 1.73 square meters) up to 96 weeks after switch. Viral suppression (_P_ < 0.001) and ALT normalization (_P_ = 0.003) rates increased significantly after switch, with a trend for increasing complete response (_P_trend = 0.004), while the eGFR trend (_P_trend > 0.44) or mean eGFR (P > 0.83, adjusted for age, sex, baseline eGFR, and diabetes, hypertension, or cirrhosis by generalized linear modeling) remained stable. However, among those with baseline eGFR < 90 (chronic kidney disease [CKD] stage ≥2), mean eGFR decreased significantly while on TDF (P = 0.029) but not after TAF switch (P = 0.90). By week 96, 21% (55/267) of patients with CKD stage 2 at switch improved to stage 1 and 35% (30/85) of CKD stage 3‐5 patients improved to stage 2 and 1.2% (1/85) to stage 1.

Conclusions

Overall, we observed continued improvement in virologic response, ALT normalization, and no significant changes in eGFR following switch to TAF from TDF.