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
Pivotal Trials/Long-term Data
Switch Trial Data

Change in spine and hip BMD from baseline to Week 96 (including open-label treatment after Week 48)3,4,a

See primary endpoint data See trial design
Change in spine and hip

aAssessed by dual-energy X-ray absorptiometry (DXA).

bP<0.0001; fallback procedure confirmed statistical significance using the adjusted alpha.4

cP=Not significant.3

dP<0.0002.3

•The mean percentage change in BMD from baseline to Week 48 was +1.7% with VEMLIDY (n=243) compared to -0.1% with TDF (n=245) at the lumbar spine, and +0.7% (n=243) compared to -0.5% (n=245) at the total hip4

BMD decline at lumbar spine:
(patients with >5% decline)3

2% (VEMLIDY) vs 5% (TDF) at Week 48

BMD decline at the hip:
(patients with >7% decline)3

0% (VEMLIDY) vs 0% (TDF) at Week 48

•The long-term clinical significance of these BMD changes is not known.1

BMD=bone mineral density; SD=standard deviation; TDF=tenofovir disoproxil fumarate.

See BMD data from the pivotal trials
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.

Effect of VEMLIDY on renal safety parameters across multiple trials3

See renal safety data from the switch trial

More efficient delivery of tenofovir1,5-9

View mechanism of action

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. Lampertico P, Buti M, Fung S, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020;5(5):441-453. doi:10.1016/j.jhep.2017.11.039 5. TDF (tenofovir disoproxil fumarate) Prescribing Information. Gilead Sciences, Inc.; April 2019. 6. 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 7. 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 8. 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 9. 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