525 Tenofovir Monotherapy for Naïve Patients With Chronic Hepatitis B: A Multicenter European Study in Clinical Practice in 302 Patients Followed for 30 Months

Lampertico, Pietro; Soffredini, R.; Viganò, Mauro; Yurdaydın, Cihan; İdilman, Ramazan; Papatheodoridis, George V.; Ekaterini, M.; Buti, Marı́a; Esteban, Rafael; Zaltron, S.; Vavassori, Andrea; Carosi, G.; Minola, E.; Vinci, M.; Pinzello, G.; Giorgini, Alessia; Zuin, M.; Salmi, Andrea; Poggio, P. Del; Filippi, Francesca; Bruno, S.; Pasulo, L.; Fagiuoli, S.; Andreoletti, M.; Colli, Agostino; Maldini, F. Fumagalli; Milanese, M.; Colombo, Alberto; Bellati, G.; Angeli, Elena; Magni, C.; Gubertini, G.; Rizzardini, Giuliano; Fasano, M.; Santantonio, T.; Terreni, N.; Spinzi, Giancarlo; Facchetti, F.; Invernizzi, Federica; Colombo, M.

doi:10.1016/s0168-8278(12)60538-8

Cited by 8 publications

(8 citation statements)

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“…A study prolonging treatment with TDF for more than 3 years did not report discontinuation treatment or relapse rates . Experiences with long‐term ETV and TDF treatment in clinical practice showed that patients achieved treatment end‐points in a low rate; so few patients discontinued treatment, and their outcomes were not reported . In a randomized clinical trial, short‐term treatment with ETV showed 76% virological and 22% serological relapse rates .…”

Section: Introductionmentioning

confidence: 99%

Relapse rates in chronic hepatitis B naïve patients after discontinuation of antiviral therapy with entecavir

Ridruejo

Marciano

Galdame

et al. 2013

Journal of Viral Hepatitis

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Registration studies show entecavir (ETV) to be effective and safe in NUC-naïve patients with chronic hepatitis B, but relapse rates after treatment discontinuation have not been well established. Relapse rates and predictors of relapse were evaluated in naïve HBeAg-positive and HBeAg-negative patients treated with ETV. Treatment duration was defined according to international guidelines. Virological relapse was defined as reappearance in serum of hepatitis B virus (HBV) DNA to >2000 IU/mL after discontinuation of treatment. A hundred and sixty-nine consecutive patients were treated for a median 181 weeks. 61% were HBeAg positive, 23% had cirrhosis, and mean HBV DNA level was 6.88 ± 1.74 log10 IU/mL. Ninety-two per cent became HBV DNA negative; 71% of HBeAg+ve patients became HBeAg negative and 68% anti-HBe positive; 14% became HBsAg negative and 13% anti-HBs positive. At the end of the study, 36 patients discontinued treatment: one due to breakthrough associated with resistant variants and 35 (20%) due to sustained virological response; 33 of these patients developed HBeAg seroconversion and 18 HBsAg seroconversion. Median off-treatment time was 69 weeks. Nine patients (26%), all HBeAg positive at baseline, developed virological relapse after a median 48 weeks off-treatment, 3 of them showed HBeAg reversion and 4 lost anti-HBe. No patient with HBsAg seroconversion relapsed. HBeAg clearance after week 48 of treatment was associated with an increase risk of relapse. After ETV discontinuation, HBsAg seroconversion was maintained in 100% of the patients, HBeAg seroconversion maintained in 90%, and virological relapse rate was 24%.

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Section: Introductionmentioning

confidence: 99%

Relapse rates in chronic hepatitis B naïve patients after discontinuation of antiviral therapy with entecavir

Ridruejo

Marciano

Galdame

et al. 2013

Journal of Viral Hepatitis

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“…Adverse events were not included in this analysis. General safety data collected in real-life studies confirmed in the long run the safety outcomes observed in clinical trials, with <6% of patients stopping treatment due to adverse events [17][18][19].…”

Section: Adverse Eventsmentioning

confidence: 68%

“…Virological response rates were 90.2% with ETV [12] and 93.2% with TDF [13] after 1 year of treatment. Data beyond 1 year could be obtained from two observational studies on NA-naive Italian patients treated with ETV (n=418) and TDF (n= 302), followed-up for a total of 54 [18] and 36 [19] months, respectively. The observed response rates reached 100% after 4 years with ETV and 98% after 3 years with TDF.…”

Section: Health Outcomesmentioning

confidence: 99%

Individualized Treatment of Hbeag-Negative Chronic Hepatitis B Using Pegylated Interferon-α2A as First-Line and Week-12 HBV Dna/Hbsag Stopping Rule: A Cost-Effectiveness Analysis

Iannazzo

Coco²,

Brunetto³

et al. 2013

Antiviral Therapy

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“…In clinical trials of TDF, creatinine clearance remained stable over 3 years in more than 99% of patients with patients with CHB [ 13 ]. In a European multicenter cohort study of TDF for patients with CHB, the proportion of patients with eGFR < 50 ml/min/1.73m 2 remained stable throughout the study, and major changes in renal function were minimal [ 14 ]. In another TDF study, the median annual change in eGFR was much lower in HBV-infected patients than in HIV-infected patients [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

Tenofovir-associated nephrotoxicity in patients with chronic hepatitis B: two cases

Cho

et al. 2016

Clin Mol Hepatol

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Tenofovir disoproxil fumarate (TDF) is effective against chronic hepatitis B (CHB) infection and its use is increasing rapidly worldwide. However, it has been established that TDF is associated with renal toxicity in human immunodeficiency virus-infected patients, while severe or symptomatic TDF-associated nephrotoxicity has rarely been reported in patients with CHB. Here we present two patients with TDF-associated nephrotoxicity who were being treated for CHB infection. The first patient was found to have clinical manifestations of proximal renal tubular dysfunction and histopathologic evidence of acute tubular necrosis at 5 months after starting TDF treatment. The second patient developed acute kidney injury at 17 days after commencing TDF, and he was found to have membranoproliferative glomerulonephritis with acute tubular injury. The renal function improved in both patients after discontinuing TDF. We discuss the risk factors for TDF-associated renal toxicity and present recommendations for monitoring renal function during TDF therapy.

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525 Tenofovir Monotherapy for Naïve Patients With Chronic Hepatitis B: A Multicenter European Study in Clinical Practice in 302 Patients Followed for 30 Months

Cited by 8 publications

References 0 publications

Relapse rates in chronic hepatitis B naïve patients after discontinuation of antiviral therapy with entecavir

Relapse rates in chronic hepatitis B naïve patients after discontinuation of antiviral therapy with entecavir

Individualized Treatment of Hbeag-Negative Chronic Hepatitis B Using Pegylated Interferon-α2A as First-Line and Week-12 HBV Dna/Hbsag Stopping Rule: A Cost-Effectiveness Analysis

Tenofovir-associated nephrotoxicity in patients with chronic hepatitis B: two cases

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