1016 Low Rates of Nucleos(t)ide-Associated Adverse Events in the Long-Term Experience With Entecavir

Manns, M.P.; Akarca, US; Chang, Ting‐Tsung; Sievert, William; Yoon, Seok Keun; Tsai, Nicole; Ai, Min; Pangerl, Andreas; Beebe, S. R.; Yu, Miao; Wongcharatrawee, Suchat

doi:10.1016/s0168-8278(10)61017-3

Cited by 5 publications

(4 citation statements)

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“…Continued treatment of those who remained HBeAg(+) at week 96 resulted in HBeAg seroconversion and HBsAg loss in 33/141 (23%) and 2/145 (1.4%) additional patients, respectively [ 12 ]. Results also demonstrated that ETV was well tolerated [ 13 ] and that the emergence of viral resistance remained minimal (1.2%) following up to 6 years of treatment [ 14 , 15 ]. Importantly, histologic analyses of liver biopsies from 57 patients receiving ETV for a median of 6 years (range 3–7 years) revealed that 96% of patients demonstrated histologic improvement (a decrease by at least 2 points in the Knodell necroinflammatory score, without worsening of fibrosis) and 88% had reduced fibrosis (a decrease of at least 1 point in the Ishak fibrosis score) [ 7 ].…”

Section: The Importance Of Clinical Trial and Clinical Practice Datamentioning

confidence: 99%

“…In a prospective follow-up study in 37 patients with decompensated cirrhosis receiving LVD, ADV, ETV or TDF, four cases of lactic acidosis were reported, two in patients receiving TDF and two in untreated patients [ 32 ]. Furthermore, no cases of lactic acidosis were reported in the long-term rollover study ETV-901 [ 13 ]. Data from patients with hepatic decompensation also report few cases of lactic acidosis, with no cases recorded during 1 year of ETV therapy [ 33 ], none in the ETV/TDF/emtricitabine study [ 34 ] and one case in study ETV-048 (comparing ETV with ADV), which required no treatment and resolved despite continued ETV therapy [ 35 ].…”

Section: Safety and Tolerability Of Entecavir In Real-life Settingsmentioning

confidence: 99%

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First‐line treatment of chronic hepatitis B with entecavir or tenofovir in ‘real‐life’ settings: from clinical trials to clinical practice

Pol

Lampertico

2012

Journal of Viral Hepatitis

117

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Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are potent nucleos(t)ide analogues (NUCs) recommended as first-line monotherapies for chronic hepatitis B. In Phase III trials, ETV and TDF demonstrated superior efficacy, and comparable safety compared with other NUCs. In long-term clinical studies, both drugs achieved virologic response rates of around 95%, with very low rates of resistance development and good safety profiles. Clinical trials are conducted under standardized conditions with strict enrolment criteria that limit the heterogeneity of study populations. ‘Real-life’ populations tend to be composed of a wider range of patients, often older and with different morbidities, comorbidities that may impact treatment efficacy and co-factors, such as smoking and alcohol intake, which can have a direct impact on disease progression. Real-life studies provide better representations of everyday clinical practice and are important to confirm the results reported in clinical studies and to identify rare or late-emerging adverse events. In five ‘real-life’ studies of ETV in more than 1000 patients, up to 4 years of treatment resulted in virologic responses in 76–96% of patients. Two real-life studies of TDF reported response rates of 71–92% after up to 21 months of treatment. Low incidences of drug resistance and favourable tolerabilities were reported for both drugs, thus confirming the results from registration trials.

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Section: The Importance Of Clinical Trial and Clinical Practice Datamentioning

confidence: 99%

Section: Safety and Tolerability Of Entecavir In Real-life Settingsmentioning

confidence: 99%

First‐line treatment of chronic hepatitis B with entecavir or tenofovir in ‘real‐life’ settings: from clinical trials to clinical practice

Pol

Lampertico

2012

Journal of Viral Hepatitis

117

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show abstract

“…In registration trials, both antivirals demonstrated a long-lasting efficacy (viral suppression in more than 95% of patients over 5 years) associated with prevention of developing cirrhosis and to a greater extent, with fibrosis regression [36][37][38][39][40]. Moreover, these studies reported a minimal risk of drug resistance (1.2% with ETV after six years and 0% with TDF after 5 years) and a favourable safety profile [39][40][41][42][43]. However, as registration trials are conducted under standardized conditions in well-selected and compliant patients, long-term efficacy and safety of ETV and TDF remain to be confirmed in real-life patients who generally have a more complex clinical profile as they are usually older with a higher prevalence of cirrhosis and comorbidities treated with several concomitant medications.…”

Section: Na-based Therapy: Updatementioning

confidence: 99%

Current Concepts on Management of Chronic Hepatitis B

Santantonio¹,

Fasano²

2013

Practical Management of Chronic Viral Hepatitis

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“…In the current issue of the Expert Opinion journal, Manns et al, reported safety and adherence results in a large group of CHB patients from the ETV-901 rollover study who were treated with ETV for at least a 5-year period [8]. Most of the reported AEs were mild to moderate, 19% were grade 3 --4 events, with only 4% of them possibly related to ETV.…”

Section: Entecavirmentioning

confidence: 99%