P1058 Long-Term Efficacy of Tenofovir in Previously Treated and Naive Patients. Results From the Spanish Chronic Hepatitis B Registry (Ciberhep)

Tabernero, David; Sánchez-Tapias, J.M.; Calleja, J.L.; Moreira, V.; Manzano, María Luisa; Crespo, Javier; Pascasio, J.M.; Fernández, Castellanos; Aguirre, A.; Erdozain, J. C.; Piqueras, B.; Suarez, Edward C.; Moreno, Diego; Gea, Francisco; Fernandez-Bermejo, Miguel; Sánchez-Pobre, Pilar Cubiles; Cuenca, B. de; Rivero, M.; Moreno, J.J.; Buti, Marı́a

doi:10.1016/s0168-8278(14)61218-6

Cited by 5 publications

(4 citation statements)

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“…69 During 3-4 years of TDF treatment in HBeAg-negative CHB patients in real practice, the virological response rates ranged from 92% to 100% without the emergence of TDF resistance, while 75% of patients had normalised ALT. [70][71][72][73] No HBeAg-negative CHB patient cleared HBsAg wihin the first year of ETV or TDF therapy and very few ($1%) achieved this endpoint during long-term (8 years) therapy.…”

Section: Hbsagmentioning

confidence: 99%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,046

3,081

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Section: Hbsagmentioning

confidence: 99%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,046

3,081

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“…The long‐term follow‐up of the TDF‐registration trial reported that 99% of the 375 HBeAg negative patients achieved undetectable HBV DNA after 7 years, with no evidence of TDF‐resistance but only one patient achieved HBsAg seroclearance at year 5 . Four European field practice studies including 1597 CHB patients (mean age 47 years old, 75% HBeAg negative, 26% with cirrhosis) reported that a 3‐ to 4‐year course of TDF achieved virological response rates ranging from 92 to 100% with no TDF‐resistance (Fig. ).…”

Section: Nucleos(t)ides Analoguesmentioning

confidence: 99%

Optimal therapy of chronic hepatitis B: how do I treat my HBeAg‐negative patients?

Viganò

Invernizzi

Lampertico

2014

Liver International

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HBeAg negative chronic hepatitis B (CHB) is a frequent, progressive and difficult‐to‐cure phase of CHB. The end‐point of therapy is to persistently suppress viral replication to halt progression of liver disease. Two different treatment strategies are currently available: a short‐term course of pegylated interferon alpha (PEG‐IFN) or long‐term therapy with nucleot(s)ide analogues (NA), i.e. entecavir or tenofovir. Young patients with mild‐to‐moderate stages of liver disease can benefit from a 48‐week course of PEG‐IFN, while NA may be preferred in patients with more severe liver disease, in older patients, and in those who do not respond, are unwilling or have contraindications to PEG‐IFN. Nucleot(s)ide analogues provide persistent viral suppression and biochemical normalization in almost all patients, together with the regression of fibrosis and the prevention of decompensation, but the effect on hepatocellular carcinoma rates is limited. Thus, NAs have become the most popular treatment strategy worldwide but lifelong administration is associated with high cost, unknown safety and adherence issues and an unknown risk of drug‐resistance over time as well as limited rates of HBsAg seroclearance. On the other hand, PEG‐IFN treatment may achieve a SVR in nearly a quarter of patients ultimately leading to HBsAg loss in almost 30–50%. Interestingly, response rates to PEG‐IFN may further increase with more careful patient selection based on age, ALT and HBV DNA levels at baseline and by applying early on‐treatment stopping rules based on HBV DNA and HBsAg kinetics. The combination of NA and PEG‐IFN is not currently recommended but numerous studies are ongoing.

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“…Four European field practice studies including 1597 CHB patients (mean age 47 years, 75% HBeAg negative, 26% with cirrhosis) reported that a 3‐4 year course of TDF treatment achieved virological response rates ranging from 92% to 100% without emergence of TDF‐R (Figure ).…”

Section: Virological Biochemical and Serological Responsesmentioning

confidence: 99%

“…Moreover, this endpoint is rarely achieved (~1%) in HBeAg‐negative patients or in HBeAg‐positive patients infected at birth. On the other hand, in NUC‐treated HBeAg‐positive patients with good predictors of response, such as short duration of infection, genotype A, elevated ALT levels and moderate levels of HBV DNA, this endpoint can be achieved in up to 20% of the patients after 5 years of treatment . This is important because the best stopping rule for NUC‐treated patients is HBsAg loss and anti‐HBs seroconversion, and the latter is the only safe stopping rule in patients with cirrhosis.…”

Section: Virological Biochemical and Serological Responsesmentioning

confidence: 99%

Hepatitis B virus long‐term impact of antiviral therapy nucleot(s)ide analogues (NUCs)

Grossi

Viganò

Loglio

et al. 2017

Liver International

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The goal of antiviral therapy is to improve the quality of life and survival of patients with chronic hepatitis B (CHB) by halting the progression to cirrhosis, end‐stage liver disease or hepatocellular carcinoma (HCC), thus preventing anticipated liver‐related death. Oral administration of potent and less resistance‐prone nucleot(s)ide analogues (NUCs), such as entecavir (ETV) and tenofovir disoproxil fumarate (TDF) has become the most popular treatment strategy worldwide because of their excellent efficacy and safety profile as well as easy management confirmed in both registration trials and in clinical practice studies. Long‐term administration of ETV or TDF suppresses HBV replication in >95% of patients, resulting in biochemical remission, histological improvement including the regression of cirrhosis and prevention or reversal of clinical decompensation but not the development of HCC, particularly in patients with cirrhosis. Moreover, NUCs can be administered to all patients including those with severe liver disease, the elderly and in those who do not respond, are unwilling to take or have contraindications to interferon. The need for long‐term, perhaps indefinite, treatment is the main limitation of NUCs therapy with the associated costs, unknown long‐term safety and the low rates of hepatitis B surface antigen (HBsAg) seroclearance, which is still the best stopping rule for NUCs‐treated patients with cirrhosis.

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P1058 Long-Term Efficacy of Tenofovir in Previously Treated and Naive Patients. Results From the Spanish Chronic Hepatitis B Registry (Ciberhep)

Cited by 5 publications

References 0 publications

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Optimal therapy of chronic hepatitis B: how do I treat my HBeAg‐negative patients?

Hepatitis B virus long‐term impact of antiviral therapy nucleot(s)ide analogues (NUCs)

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