A prospective study of nucleot(s)ide analog discontinuation in non-cirrhotic patients with HBeAg-negative chronic hepatitis B: Interim analysis identifies different viral kinetics after stopping tenofovir versus entecavir.

Blackwell Publishing Netherlands 2021-03-01

Background and Aim: Current guidelines recommend indefinite nucleot(-s)ide analog (NA) therapy for patients with HBeAg-negative chronic hepatitis B (CHB) infection. However, sustained virological response (SVR) has been described in patients after discontinuation of long-term NA therapy, as well as HBsAg loss. The HBV-STOP study is a prospective multicenter study of NA discontinuation in patients who have achieved long-term virological suppression of hepatitis B virus (HBV) on treatment. The study describes clinical outcomes after treatment discontinuation, with the aim of identifying determinants of SVR. Method(s): We performed an interim narrative analysis of outcomes at Week 48 after NA discontinuation. Outcomes at Week 96 are the primary endpoint for the study. Inclusion criteria for the study were HBeAg-negative, non-cirrhotic, and virological suppression for > 18 months on NA therapy uninterrupted for > 2 years. Criteria for recommencing NA therapy were HBV DNA > 2000 IU/mL with either alanine aminotransferase (ALT) > 5x ULN for > 16 weeks or ALT > 10x ULN for > 8 weeks, international normalized ratio > 1.5, bilirubin level > 2x ULN, ascites, hepatic encephalopathy, and investigator discretion. Result(s): The cohort is fully enrolled, and data are currently available for 111 patients. At baseline, median patient age was 56 years, 64% were male, and 85% were Asian. The median HBsAg level was 705 IU/mL (214-2325). All patients were non-cirrhotic. Virological reactivation occurred in all, with a median time to detection of 8 weeks (4-12). Patients stopping tenofovir (TDF) experienced virological and biochemical relapse earlier than patients stopping entecavir (ETV) (Fig. 1; P < 0.001). Twenty-three patients (21%) have experienced an ALT flare > 10x ULN; there was no significant difference in the rate of ALT flare > 10x ULN after stopping TDF versus ETV. Two patterns of ALT flare were observed: beneficial flares that were associated with reductions in HBV DNA and

entecavir; hepatitis B surface antigen; hepatitis B(e) antigen; tenofovir; virus DNA; drug withdrawal; adult; alanine aminotransferase blood level; ascites; bilirubin blood level; biochemical recurrence; cancer patient; cancer recurrence; chronic hepatitis B; clinical outcome; cohort analysis; conference abstract; controlled study; decompensated liver cirrhosis; drug therapy; female; hepatic encephalopathy; Hepatitis B virus; human; international normalized ratio; major clinical study; male; middle aged; multicenter study; narrative; nonhuman; outcome assessment; prospective study; sustained virologic response; viremia; alanine aminotransferase; endogenous compound; Conference Abstract

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AUSHL oai:repository.monashhealth.org:1/27133
Journal of Gastroenterology and Hepatology (Australia). Conference: Gastroenterological Society of Australia, GESA and Australian Gastroenterology Week, AGW 2020. Virtual. 35 (SUPPL 1) (pp 76-77), 2020. Date of Publication: November 2020.
1440-1746
https://repository.monashhealth.org/monashhealthjspui/handle/1/27133
Monash Health
634279820
(Hall, Burns, Anagnostou, Vogrin, Desmond, Visvanathan, Thompson) St Vincent's Hospital Melbourne, Sydney, NSW, Australia (Levy) Liverpool Hospital, Sydney, NSW, Australia (Sievert) Monash Health, Sydney, NSW, Australia (Lubel, Nicoll) Eastern Health, Sydney, NSW, Australia (Strasser) Royal Prince Alfred Hospital, Sydney, NSW, Australia (Ngu) Concord Repatriation General Hospital, Sydney, NSW, Australia (Angus) Austin Health, Sydney, NSW, Australia (Meredith) Bankstown Lidcombe Hospital, Sydney, NSW, Australia (Revill, Jackson, Bowden, Locarnini) Victorian Infectious Diseases Reference Laboratory, Melbourne, VIC, Australia
(Hall, Burns, Anagnostou, Vogrin, Desmond, Visvanathan, Thompson) St Vincent's Hospital Melbourne, VIC, Australia
(Levy) Liverpool Hospital, Sydney, NSW, Australia
(Lubel, Nicoll) Eastern Health, Sydney, NSW, Australia
(Strasser) Royal Prince Alfred Hospital, Sydney, NSW, Australia
(Ngu) Concord Repatriation General Hospital, Sydney, NSW, Australia
(Angus) Austin Health, Sydney, NSW, Australia
(Meredith) Bankstown Lidcombe Hospital, Sydney, NSW, Australia
(Revill, Jackson, Bowden, Locarnini) Victorian Infectious Diseases Reference Laboratory, Melbourne, VIC, Australia
(Sievert) Monash Health, Melbourne, VIC, Australia
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