RETRACTION: Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients with Chronic HBV Infection
| Autor: | Henry Lik-Yuen Chan, Wai-Kay Seto, François Habersetzer, John F. Flaherty, Fusao Ikeda, Teresa Santantonio, Hongyuan Wang, Scott Fung, Carol Stanciu, Shrikant Mukewar, Yasuhiro Asahina, Wan-Long Chuang, Anuj Gaggar, Cheng Yuan Peng, Maurizia Rossana Brunetto, D.T. Abdurakhmanov, Fehmi Tabak, Audrey H. Lau, Tetsuro Inokuma, Tuan T. Nguyen, G. Mani Subramanian, Todd T. Brown, Alnoor Ramji, Vithika Suri |
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| Rok vydání: | 2018 |
| Předmět: |
Bone mineral
medicine.medical_specialty FRAX Hepatology medicine.diagnostic_test business.industry Osteoporosis Gastroenterology medicine.disease Tenofovir alafenamide Bone remodeling law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial HBeAg law 030220 oncology & carcinogenesis Internal medicine medicine 030211 gastroenterology & hepatology business Dual-energy X-ray absorptiometry |
| Zdroj: | Clinical Gastroenterology and Hepatology. |
| ISSN: | 1542-3565 |
| DOI: | 10.1016/j.cgh.2018.06.023 |
| Popis: | Long-term use of tenofovir disoproxil fumarate (TDF) reduces bone mineral density (BMD). Tenofovir alafenamide (TAF), a new prodrug of tenofovir, has shown non-inferior efficacy to TDF in patients with chronic hepatitis B virus (HBV) infection, with improved bone effects at 48 weeks. We performed a randomized trial to evaluate the bone safety of TAF compared with TDF over 2 years, assessing baseline risk factors for bone loss, were evaluated after 2 years of treatment.In a double-blind study, hepatitis B e antigen (HBeAg)-positive patients (n = 873) and HBeAg-negative patients (n = 425) were randomly assigned (2:1) to groups given TAF (25 mg; n = 866) or TDF (300 mg; n = 432) once daily. We assessed bone safety, including hip and spine BMD, using dual-energy X-ray absorptiometry and measured changes in serum markers of bone turnover over 96 weeks.At baseline, treatment groups were well matched. At week 96, patients receiving TAF had significantly smaller decreases in hip BMD (mean reduction of 0.33%) than patients receiving TDF (mean reduction of 2.51%) (P.001) and spine BMD (reduction of 0.75% in patients receiving patients receiving TAF vs reduction of 2.57% in patients receiving TDF) (P.001). For hip BMD, the magnitude of difference in bone loss between the TAF and TDF groups increased at week 96 compared to week 48 (P.001). The TAF group had minimal changes in markers of bone turnover by 12 weeks of treatment, but the TDF group had significant changes, compared to baseline. Risk factors for bone loss had fewer effects in patients receiving TAF than TDF at week 96.In double-blind randomized trials, we found that after 2 years of treatment, patients receiving TAF had continued improvements in bone safety compared with patients receiving TDF. Clinicaltrial.gov ID NCT01940471 and NCT01940341. |
| Databáze: | OpenAIRE |
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