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Tenofovir-alafenamide Resistance manifested as virological breakthrough, and alanine transferase flares: 3 case reports

In a retrospective, multicentre, single-arm national cohort study of 71 pregnant women conducted between 4 December 2018 and 18 May 2020, three women [ages not stated] were described, who developed drug resistance manifested as virological breakthrough or alanine transferase (ALT) flares during treatment with tenofovir alafenamide for preventing mother-to-child transmission of hepatitis B virus during pregnancy [dosage, duration of treatment to reaction onsets and outcome not stated]. All the pregnant women, who had a history of chronic hepatitis B, were above 20 years of age and had hepatitis B e-antigen (HBeAg) positivity with HBV DNA levels above 200000 IU/mL during pregnancy were included in the study. They received oral tenofovir alafenamide 25 mg/day (every 24 hours at any time of each day) [Vemlidy; tenofovir alafenamide fumarate] therapy during pregnancy and postpartum. However, out of the three women, one woman developed drug resistance manifested as virological breakthrough during tenofovir alafenamide therapy. The remaining two women continued receiving tenofovir alafenamide therapy postpartum and developed ALT flares with peak ALT levels at 149 U/mL (1 women) and 159 U/mL (1 women). There were no congenital defects nor malformations reported in the infants after the delivery. Ding Y, et al. Efficacy and safety of tenofovir alafenamide fumarate for preventing mother-to-child transmission of hepatitis B virus: a national cohort study. Alimentary 803519812 Pharmacology and Therapeutics 52: 1377-1386, No. 8, Oct 2020. Available from: URL: http://doi.org/10.1111/apt.16043

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Reactions 12 Dec 2020 No. 1834