~75% of patients enrolled in pivotal trials 108/110 were treatment-naïve.2
>30% of patients were
osteopenic or osteoporotic.2
>60% of patients were male.2
VEMLIDY: A demonstrated bone safety profile through 8 years1,2
Across multiple trials, VEMLIDY demonstrated both reduced impact and improvements in bone mineral density1,2
VEMLIDY showed reduced impact on BMD at Week 1441,3
Impacts on spine and hip BMD with VEMLIDY and TDF were compared in Trials 108 and 110.
The long-term clinical significance of these BMD changes is not known.1
The mean percentage change in BMD from baseline to Week 96 was -0.7% with VEMLIDY (n=746) compared to -2.6% with TDF (n=371) at the lumbar spine, and -0.3% (n=740) compared to -2.5% (n=369) at the total hip.1,3
BMD=bone mineral density; DXA=dual-energy X-ray absorptiometry; HBeAg=hepatitis B envelope antigen; TDF=tenofovir disoproxil fumarate.
aThe Week 144 analysis did not include the 180 patients (HBeAg−: 66 patients; HBeAg+: 114 patients) who had rolled over from double-blind TDF to open-label VEMLIDY at Week 96 prior to the trial amendment.
bOnly patients with nonmissing baseline data for spine or hip BMD were included in the spine or hip DXA analysis set.3
Key baseline characteristics:
Long-term BMD remained stable through 8 years in patients taking VEMLIDY
Pooled safety analysis (Week 384): Pooled safety analysis (observed data) from Trials 108 and 110 was assessed at Week 384. This analysis included 866 patients who initiated VEMLIDY at baseline, 207 patients who switched from TDF to VEMLIDY at Week 96, and 225 patients who switched from TDF to VEMLIDY at Week 144.2,c Only patients with nonmissing baseline data for spine or hip BMD were included in the spine or hip DXA analysis set.2
Mean percentage change in lumbar spine BMD from Week 96 to Week 120: +0.6% in patients who remained on VEMLIDY; +1.7% in those who switched from TDF to VEMLIDY.1
SD=standard deviation; TAF=tenofovir alafenamide.
The long-term clinical significance of these BMD changes is not known.1
Spine BMD remained stable in VEMLIDY patients, and there was an improvement seen in patients who switched to VEMLIDY from TDF.2
Mean percentage change in total hip BMD from Week 96 to Week 120: 0% in patients who remained on VEMLIDY; +0.6% in those who switched from TDF to VEMLIDY.1
cVEMLIDY group includes VEMLIDY patients who rolled over to open-label VEMLIDY at Week 96 or Week 144.2
The long-term clinical significance of these BMD changes is not known.1
Hip BMD remained stable in VEMLIDY patients, and there was an improvement seen in patients who switched to VEMLIDY from TDF.2
The 8-year analysis is not presented in the VEMLIDY full Prescribing Information.
Adverse Reactions
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were headache, upper respiratory tract infection, abdominal pain, cough, back pain, arthralgia, fatigue, nausea, diarrhea, dyspepsia, and pyrexia.
References: 1. VEMLIDY Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; March 2024. 2. Buti M, Lim YS, Chan HLY, et al. Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: final results from two randomised phase 3 trials. Aliment Pharmacol Ther. 2024;60(11-12):1573-1586. doi:10.1111/apt.18278 3. Data on file. Gilead Sciences, Inc. 4. TDF (tenofovir disoproxil fumarate) Prescribing Information. Gilead Sciences, Inc.; April 2019. 5. Chan HLY, Fung S, Seto WK, et al; GS-US-320-0110 investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1(3):185-195. doi:10.1016/S2468-1253(16)30024-3 6. Lee WA, He GX, Eisenberg E, et al. Selective intracellular activation of a novel prodrug of the human immunodeficiency virus reverse transcriptase inhibitor tenofovir leads to preferential distribution and accumulation in lymphatic tissue. Antimicrob Agents Chemother. 2005;49(5):1898-1906. doi:10.1128/AAC.49.5.1898-1906.2005 7. Murakami E, Wang T, Park Y, et al. Implications of efficient hepatic delivery by tenofovir alafenamide (GS-7340) for hepatitis B virus therapy. Antimicrob Agents Chemother. 2015;59(6):3563-3569. doi:10.1128/AAC.00128-15 8. Agarwal K, Fung SK, Nguyen TT, et al. Twenty-eight day safety, antiviral activity, and pharmacokinetics of tenofovir alafenamide for treatment of chronic hepatitis B infection. J Hepatol. 2015;62(3):533-540. doi:10.1016/j.jhep.2014.10.035