A phase 3 study comparing tenofovir alafenamide to tenofovir disoproxil fumarate in patients with HBeAg-negative, chronic hepatitis B: efficacy and safety results at week 96

Brunetto, M.R.; Lim, Young‐Suk; Gane, Ed; Seto, Wai‐Kay; Осипенко, М. Ф.; Ahn, S.H.; Janssen, Harry L.A.; Shukla, Akash; Chuang, Wan‐Long; Trinh, Huy N.; Çelen, Mustafa Kemal; Flaherty, John F.; Lau, Audrey H.; Gaggar, Anuj; Suri, Vithika; Bhardwaj, Neeru; Kim, K.; Subramanian, G. Mani; Pan, Calvin; Izumi, N.; Marcellin, Patrick; Chan, H.L.Y.; Buti, Marı́a

doi:10.1016/s0168-8278(17)30313-6

Cited by 10 publications

(6 citation statements)

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“…Tenofovir DF is effective at suppressing HBV DNA in mono‐ and co‐infected patients whether they are HBeAg positive or negative, and independent of the presence of lamivudine‐resistant virus . More recently, tenofovir alafenamide has also been shown to have non‐inferior efficacy and improved renal and bone toxicity compared to tenofovir DF in the management of HBV mono‐infection , but as stated previously there are no safety data in pregnant women therefore it should be avoided unless tenofovir DF is contraindicated. Phenotypic HBV resistance has not been ascribed to tenofovir DF in people with both HBV and HIV with up to 5 years of follow‐up and has only been demonstrated in vitro in treated individuals with suboptimal control as represented by detectable HBV DNA levels.…”

Section: Hiv and Hepatitis Virus Co‐infectionsmentioning

confidence: 95%

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

et al. 2019

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Section: Hiv and Hepatitis Virus Co‐infectionsmentioning

confidence: 95%

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

et al. 2019

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“…No HBV pol/RT amino acid substitutions associated with resistance to tenofovir were detected in either treatment group throughout the 48 weeks of the study . The study is ongoing, and the virological response results have been maintained at week 96 …”

Section: Efficacy: Complete Eradication Rarementioning

confidence: 99%

“…35 The study is ongoing, and the virological response results have been maintained at week 96. 36,37 In summary, complete eradication of the virus has proven difficult in patients with CHB, and long-term treatment is often required. ETV, TDF and TAF are the most potent currently available NUCs for CHB treatment and are the recommended first-line monotherapy.…”

Section: Efficacy: Complete Eradication Rarementioning

confidence: 99%

Long‐term safety and efficacy of nucleo(t)side analogue therapy in hepatitis B

Buti

Riveiro‐Barciela

Esteban

2018

Liver International

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Long-term treatment of chronic hepatitis B (CHB) with nucleos(t)ide analogues is often necessary to achieve durable viral suppression. Therefore, current guidelines recommend the most potent drugs with optimal resistance profiles. Entecavir (ETV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are the first-line monotherapies for CHB. All of these drugs are highly effective in suppressing viral replication but with slightly different safety profiles. This review provides an overview of the long-term efficacy and safety data that have become available over the 10 years since ETV and TDF were first approved for the treatment of chronic hepatitis, and recent data on TAF in patients with CHB. | SAFETYETV and TDF have been used for more than 10 years for the treatment of CHB, whereas TAF was approved for this indication in 2016.ETV and TDF have been shown to have excellent safety profiles and to be well tolerated by most patients, including those with advanced and decompensated cirrhosis. ETV is a nucleoside analogue, and TDF and TAF are nucleotide analogues. All these agents are given once daily at a fixed oral dose. 9-11 Because ETV and TDF are excreted mainly or completely by the kidneys, dose adjustments are required in patients with an estimated glomerular filtration rate (eGFR) <50 mL/ min/1.73 m 2 . However, no dose adjustment is required for TAF in patients older than 65, patients with liver impairment, renal impairment

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“…TAF is a targeted prodrug of tenofovir that provides improved delivery to hepatocytes. A higher proportion of patients achieved alanine aminotransferase (ALT) normalization with TAF compared with TDF (50% and 40%, respectively, in HBeAg‐negative patients [ P = 0.035]; 52% and 42%, respectively, in HBeAg‐positive patients [ P = 0.003]) . Notably, the optimized delivery of tenofovir through TAF has resulted in improved safety outcomes.…”

Section: Hepatitis B Virus Workhopmentioning

confidence: 99%

“…A higher proportion of patients achieved alanine aminotransferase (ALT) normalization with TAF compared with TDF (50% and 40%, respectively, in HBeAg-negative patients [P = 0.035]; 52% and 42%, respectively, in HBeAg-positive patients [P = 0.003]). 39,40 Notably, the optimized delivery of tenofovir through TAF has resulted in improved safety outcomes. In patients who switched from TDF to TAF, markers of renal safety (creatinine clearance; Fig.…”

Section: Hepatitis C Virus Workhopmentioning

confidence: 99%

Clinical Cases in Hepatitis: Towards improving liver disease management in Australia

Strasser

Thompson

Roberts

et al. 2019

J of Gastro and Hepatol

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Clinical Cases in Hepatitis 2018 was an interactive educational program for Australian physicians (gastroenterologists, hepatologists, and infectious disease specialists) actively involved in the treatment of liver diseases including hepatitis C virus, hepatitis B virus, and non‐alcoholic steatohepatitis. This educational program sponsored by Gilead Sciences took place on October 12–13, 2018, and provided timely, informative case‐based, and practical education to Australian physicians. This report summarizes keynote lectures from international leaders in the field of hepatitis C virus, hepatitis B virus, and non‐alcoholic steatohepatitis and practical clinical case studies designed to inform and educate Australian physicians on managing challenging patients.

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A phase 3 study comparing tenofovir alafenamide to tenofovir disoproxil fumarate in patients with HBeAg-negative, chronic hepatitis B: efficacy and safety results at week 96

Cited by 10 publications

References 0 publications

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

Long‐term safety and efficacy of nucleo(t)side analogue therapy in hepatitis B

Clinical Cases in Hepatitis: Towards improving liver disease management in Australia

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