Summary

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• Vemlidy (tenofovir alafenamide) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 12 years of age and older with compensated liver disease.
• This summary is based on the review of four systematic review(s)/meta-analysis(es). ^[1-4]
• In treatment-naïve adolescents living with HIV, 92% (46/50) achieved viral suppression at 48 weeks, while 214 of 224 treatment-experienced participants were virally suppressed within the same period.
• In chronic hepatitis B (CHB) patients, tenofovir disoproxil fumarate (TDF) demonstrated superior virological response compared to entecavir (ETV) at multiple time points, with no significant difference observed between tenofovir alafenamide (TAF) and TDF after 48 weeks.
• In treatment-naïve CHB adults, TAF was superior in achieving ALT normalization, HBeAg loss, and seroconversion in the HBeAg-positive population and was among the most effective for virological response in both HBeAg-positive and HBeAg-negative populations.
• In the HIV-infected pediatric population, adverse events included one case of drug-related intermediate uveitis (Grade 3/4), with three discontinuations due to adverse events (including Grade 2 anxiety and insomnia, Grade 1 iridocyclitis, and Grade 1 pulmonary tuberculosis). Small median changes were observed in bone mineral density z-scores for the spine and total body less head, and weight-for-age z-scores increased by 0.25 from baseline to 48 weeks.
• Among patients treated with nucleos(t)ide analogues (NAs), TAF exhibited the highest density of adverse events per treated patient (1.14 AE/treated patient), with common adverse events including abdominal pain, nasopharyngitis/upper respiratory tract infections, fatigue, and headache. However, the general incidence of severe adverse events was low across all NAs, with the safety profile of TAF being less consolidated due to a smaller number of treated patients.
• The reviewed studies highlight specific population types, including infants, children, and adolescents living with HIV, as well as treatment-naïve CHB adult populations, with subgroups such as HBeAg-positive and HBeAg-negative patients. The findings indicate high rates of viral suppression in both treatment-naïve and treatment-experienced pediatric HIV patients, and TAF's effectiveness in achieving virologic response and other clinical outcomes (ALT normalization, HBeAg loss, seroconversion) across both HBeAg-positive and HBeAg-negative CHB populations.