755 5-Year Entecavir Treatment in Nuc-Naïve, Field-Practice Patients With Chronic Hepatitis B Showed Excellent Viral Suppression and Safety Profile but No Prevention of HCC in Cirrhotics

Lampertico, Pietro; Soffredini, R.; Viganò, Mauro; Minola, E.; Cologni, Giuliana; Rízzí, María; Zaltron, S.; Vavassori, Andrea; Castelli, Francesco; Angeli, Elena; Gubertini, G.; Magni, C.; Rizzardini, Giuliano; Testa, Anna; D’Offizi, Giampiero; Vinci, M.; Pinzello, G.; Fatta, E.; Colombo, Silvia; Fracassetti, O.; Poggio, P. Del; Coco, B.; Brunetto, M.R.; Andreoletti, M.; Colli, Agostino; Fasano, M.; Santantonio, T.; Colloredo, Guido; Pasulo, L.; Fagiuoli, S.; Colombo, Alberto; Bellati, G.; Milanese, M.; Strazzabosco, Mario; Pozzi, Massimo; Terreni, N.; Spinzi, Giancarlo; Quagliuolo, M.; Borzio, Mauro; Lunghi, G.; Facchetti, F.; Invernizzi, Federica; Colombo, M.

doi:10.1016/s0168-8278(13)60757-6

Cited by 28 publications

(36 citation statements)

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“…In general, these studies confirm the efficacy of ETV as demonstrated in RCTs in routine practice, with ETV monotherapy resulting in a rapid and significant reduction in viral load and a progressive increase in overall rates of undetectable HBV DNA over time. In the longest of these studies to date, rates of undetectable HBV were 99% by year 4, with alanine aminotransferase (ALT) normalization in 74% of patients, HBeAg seroconversion in 15% of patients, and HBsAg loss reported in 12 patients . Similar findings were reported in other long‐term European studies, although somewhat lower efficacy was reported recently in a long‐term study of Chinese patients where treatment of NA‐naïve patients for up to 4 years resulted in 45% of patients achieving undetectable HBV DNA, with normalization of ALT in 58% and HBeAg seroconversion in 24% .…”

Section: “Real‐world” Studiessupporting

confidence: 74%

“…A number of medium‐to‐large‐scale real‐life trials have reported data for up to 52 months of treatment with ETV predominantly in NA‐naïve patients (Table ) . In general, these studies confirm the efficacy of ETV as demonstrated in RCTs in routine practice, with ETV monotherapy resulting in a rapid and significant reduction in viral load and a progressive increase in overall rates of undetectable HBV DNA over time.…”

Section: “Real‐world” Studiesmentioning

confidence: 64%

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Long‐term therapy for chronic hepatitis B: Hepatitis B virus DNA suppression leading to cirrhosis reversal

Marcellin

Asselah

2013

J of Gastro and Hepatol

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Since the licensing of the first treatment for chronic hepatitis B in the nucleoside/tide analog class almost 15 years ago, considerable progress has been made in improving drug efficacy and safety with highly potent nucleoside/tide analogs exhibiting a high barrier to resistance. Physicians are now able to treat patients safely for many years and to be able to see convincing improvements in histology, including regression of fibrosis and even reversal of cirrhosis. The robust data that have been generated help us build confidence that we can now offer patients with chronic hepatitis B long-term, disease-modifying therapy that can alter the natural course of disease and help prevent the morbidity and mortality associated with it.

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Section: “Real‐world” Studiessupporting

confidence: 74%

Section: “Real‐world” Studiesmentioning

confidence: 64%

Long‐term therapy for chronic hepatitis B: Hepatitis B virus DNA suppression leading to cirrhosis reversal

Marcellin

Asselah

2013

J of Gastro and Hepatol

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“…The annual HCC rates under entecavir or tenofovir reported in these studies, and in singlearm studies assessing HCC outcomes during treatment with these NAs [44][45][46], are shown separately for non-cirrhotic and cirrhotic patients in Figures 1A and 1B. In non-cirrhotic patients treated with entecavir or tenofovir, annual HCC incidences ranged from 0.0-1.4% in Asian patients, and from 0.1-1.0% in predominantly Caucasian populations.…”

Section: Summary Of Annual Hcc Rates Under Entecavir or Tenofovirmentioning

confidence: 96%

“…Annual HCC incidences were calculated from studies with different follow-up duration by assuming constant incidence rates over time. In panel B, the following studies reported rates for compensated cirrhotics only (decompensated excluded): Wong [25,53]; Yang, naive/experienced cohort [33], Lampertico, ETV cohort [44]; Papatheodoridis, ETV/TDF cohort [54].…”

Section: Implications For Clinical Practice and Future Researchmentioning

confidence: 99%

Risk of hepatocellular carcinoma in chronic hepatitis B: Assessment and modification with current antiviral therapy

Papatheodoridis

Chan

Hansen

et al. 2015

Journal of Hepatology

413

334

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In the treatment of chronic hepatitis B (CHB), the ultimate goal is preventing hepatitis B virus (HBV)-associated liver disease, including hepatocellular carcinoma (HCC). Recently published studies show that in CHB patients treated with the currently recommended first-line nucleos(t)ide analogs (NAs) entecavir or tenofovir, annual HCC incidences range from 0.01% to 1.4% in non-cirrhotic patients, and from 0.9% to 5.4% in those with cirrhosis. In Asian studies including matched untreated controls, current NA therapy consistently resulted in a significantly lower HCC incidence in patients with cirrhosis, amounting to an overall HCC risk reduction of ∼30%; in non-cirrhotic patients, HCC risk reduction was overall ∼80%, but this was only observed in some studies. For patients of Caucasian origin, no appropriate comparative studies are available to date to evaluate the impact of NA treatment on HCC. Achievement of a virologic response under current NA therapy was associated with a lower HCC risk in Asian, but not Caucasian studies. Studies comparing entecavir or tenofovir with older NAs generally found no difference in HCC risk reduction between agents, except for one study which used no rescue therapy in patients developing lamivudine resistance. Overall, these data indicate that with the current, potent NAs, HCC risk can be reduced but not eliminated, probably due to risk factors that are not amenable to change by antiviral therapy, or events that may have taken place before treatment initiation. Validated pre- and on-therapy HCC risk calculators that inform the best practice for HCC surveillance and facilitate patient counseling would be of great practical value.

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“…Negli studi a 48 settimane in pazienti con epatite cronica B, TAF ha confermato una minore tossicità renale e ossea rispetto a TDF [49,50]. Tuttavia, a fronte dei dati di efficacia e sicurezza più che decennali otte-nuti nella pratica clinica con ETV [51][52][53][54][55][56][57][58][59][60], ci si chiede quale possa essere l'ambito d'impiego del TAF. Nei pazienti naïve, ETV ha confermato i risultati degli studi clinici in termini di efficacia e sicurezza e, soprattutto, grazie ai risultati di questo studio ETV ha dimostrato di essere una valida alternativa terapeutica anche per i pazienti esposti a LMV o con pregressa LMV-R che abbiano sviluppato un problema renale.…”

Section: Figura 12unclassified

Efficacia e sicurezza di entecavir dopo switch da tenofovir per comparsa di effetti collaterali renali: uno studio multicentrico italiano, di pratica clinica, su 103 pazienti con epatite cronica B

Viganò

2016

ABTPN

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Entecavir (ETV) e tenofovir disoproxil fumarato (TDF) rappresentano gli analoghi nucleos(t)idici di III generazione raccomandati in prima linea nei pazienti con epatite cronica B. Entrambi si caratterizzano per un'elevata efficacia e per il rischio pressoché nullo di sviluppo di farmaco-resistenza, tuttavia con l'impiego di TDF sono stati segnalati eventi avversi renali, come la riduzione del filtrato glomerulare (eGFR), l'ipofosfatemia, l'iperfosfaturia e la sindrome di Fanconi, e scheletrici quali osteomalacia e osteoporosi. In questo studio italiano di coorte, multicentrico, sono stati arruolati 103 pazienti con epatite cronica B [età media 63 anni, 83% maschi, 49% cirrotici, 97% HBeAg-negativi, 75% trattati con lamivudina (LMV), 46% con pregressa LMV-resistenza (R), 71% trattati con adefovir dipivoxil (ADV), 94% con ALT normali e 98% con HBV DNA <13 UI/mL] che sono passati a ETV per l'evidenza di una compromissione della funzione renale glomerulare e/o tubulare durante i 35 mesi (range: 3-112) di terapia con TDF (iniziato o ridotto durante il trattamento a 245 mg ogni 48/72 ore nel 40% dei casi). Al basale (inizio della terapia con ETV), una riduzione di eGFR <90 mL/minuto era presente in 94 Efficacia e sicurezza di entecavir dopo switch da tenofovir per comparsa di effetti collaterali renali: uno studio multicentrico italiano, di pratica clinica, su 103 pazienti con epatite cronica B

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755 5-Year Entecavir Treatment in Nuc-Naïve, Field-Practice Patients With Chronic Hepatitis B Showed Excellent Viral Suppression and Safety Profile but No Prevention of HCC in Cirrhotics

Cited by 28 publications

References 0 publications

Long‐term therapy for chronic hepatitis B: Hepatitis B virus DNA suppression leading to cirrhosis reversal

Long‐term therapy for chronic hepatitis B: Hepatitis B virus DNA suppression leading to cirrhosis reversal

Risk of hepatocellular carcinoma in chronic hepatitis B: Assessment and modification with current antiviral therapy

Efficacia e sicurezza di entecavir dopo switch da tenofovir per comparsa di effetti collaterali renali: uno studio multicentrico italiano, di pratica clinica, su 103 pazienti con epatite cronica B

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