Hepatology communications · 2025
Serum levels of hepatitis B core antibodies and hepatitis B core-related antigen at the time of nucleos(t)ide analog cessation and risk of severe flares in patients with chronic hepatitis B.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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van Bömmel Florian, Verbinnen Thierry, Agarwal Kosh, Vanwolleghem Thomas, Lampertico Pietro, Buti Maria, Janczewska Ewa, Bourliere Marc, Jezorwski John, Donohue Kathleen, Kim Gloria, Kakuda Thomas N, De Meyer Sandra, Bakala Adam, Biermer Michael, Lenz Oliver
Аннотация
BACKGROUND: In the nucleos(t)ide analog (NA)-control arm of the REEF-2 study (NCT04129554), virologic relapse (confirmed increase in HBV DNA >2000 IU/mL) and biochemical flare (ALT increases ≥3× upper limit of normal) were frequently observed after stopping NA treatment. We characterized the posttreatment virologic relapses and biochemical flares and assessed their association with end-of-treatment (EOT) HBV serum markers.
METHODS: In REEF-2, a randomized-controlled study, virologically suppressed HBeAg-negative patients stopped treatment at week 48, followed by 48 weeks of follow-up. EOT HBV RNA, hepatitis B core-related antigen, and quantitative anti-hepatitis B core (HBc) IgG levels were assessed in 41/45 NA-control arm patients; their association with off-treatment response was evaluated.
RESULTS: A similar proportion of patients with EOT HBV RNA or hepatitis B core-related antigen detectable and target not detectable had virologic relapse or ALT flares (p>0.05). A higher frequency of severe virologic relapse (peak HBV DNA >100,000 IU/mL) and/or severe biochemical flares (peak ALT ≥10× upper limit of normal) was observed in patients with EOT detectable hepatitis B core-related antigen levels, HBsAg <1000 IU/mL, and/or anti-HBc IgG titers <300 IU/mL, respectively (p<0.05). None of the 11 patients with EOT anti-HBc titers ≥300 IU/mL had severe virologic or biochemical flare off treatment (100% positive predictive value and 48% negative predictive value).
CONCLUSIONS: In this prospective study of patients who stopped NA, anti-HBc levels ≥300 IU/mL were associated with a low risk of developing virologic relapse and severe biochemical flares. Future research should confirm a potential protective effect of high anti-HBc IgG levels.
METHODS: In REEF-2, a randomized-controlled study, virologically suppressed HBeAg-negative patients stopped treatment at week 48, followed by 48 weeks of follow-up. EOT HBV RNA, hepatitis B core-related antigen, and quantitative anti-hepatitis B core (HBc) IgG levels were assessed in 41/45 NA-control arm patients; their association with off-treatment response was evaluated.
RESULTS: A similar proportion of patients with EOT HBV RNA or hepatitis B core-related antigen detectable and target not detectable had virologic relapse or ALT flares (p>0.05). A higher frequency of severe virologic relapse (peak HBV DNA >100,000 IU/mL) and/or severe biochemical flares (peak ALT ≥10× upper limit of normal) was observed in patients with EOT detectable hepatitis B core-related antigen levels, HBsAg <1000 IU/mL, and/or anti-HBc IgG titers <300 IU/mL, respectively (p<0.05). None of the 11 patients with EOT anti-HBc titers ≥300 IU/mL had severe virologic or biochemical flare off treatment (100% positive predictive value and 48% negative predictive value).
CONCLUSIONS: In this prospective study of patients who stopped NA, anti-HBc levels ≥300 IU/mL were associated with a low risk of developing virologic relapse and severe biochemical flares. Future research should confirm a potential protective effect of high anti-HBc IgG levels.