VEMLIDY was proven in robust, global clinical trials

The efficacy and safety profile of VEMLIDY in the treatment of adults with chronic hepatitis B infection with compensated liver disease was based on data from 3 randomized, double-blind, active-controlled trials with 1786 patients (HBeAg– and HBeAg+)1-3,a

a Study 4018 included 488 virologically suppressed patients; Study 108 included 425 HBeAg− patients; Study 110 included 873 HBeAg+ patients.

Pivotal Trials/
Long-term Data
Switch Trial Data

Pivotal trials and open-label extension (OLE): 108 and 110

~75% of patients enrolled in pivotal trials 108/110 were treatment-naïve2

The efficacy and safety of VEMLIDY in the treatment of adults with chronic HBV infection with compensated liver disease are based on data from 2 randomized, double-blind, active-controlled, noninferiority trials.1,4-7,b

b Key inclusion criteria: HBV DNA ≥20,000 IU/mL; ALT >60 U/L (males) or >38 U/L (females) and ≤10x ULN by central laboratory range.6,7

c The numbers of patients listed after Week 96 refer to those who entered the open-label phase or remained in the double-blind phase and exclude patients who prematurely discontinued double-blind study treatment by Week 96.4,5

Trial 108 (N=425)1
  • HBeAg- patients (79% treatment-naïve patients, 21% treatment-experienced patients)1,4
Trial 110 (N=873)1
  • HBeAg+ patients (74% treatment-naïve patients, 26% treatment-experienced patients)1,4

The primary endpoint for both studies was HBV DNA <29 IU/mL and noninferiority to TDF (10% margin; 95% confidence interval [CI] approach) at Week 48.6,7

Additional efficacy endpoints evaluated at Week 48, Week 96, and Week 144 for both trials included the proportion of patients with1,4,6:

  • HBV DNA <29 IU/mL
  • ALT normalization
  • HBsAg loss and seroconversion

HBeAg loss and seroconversion were also assessed in Trial 110.1

The original protocol was amended to extend the double-blind phase from 96 weeks to 144 weeks. However, before implementation of the protocol amendment, 540 patients entered the open-label phase at Week 96 (360 patients remained on VEMLIDY and 180 patients switched from TDF to VEMLIDY).4

By Week 144, a total of 1157 patients had entered the open-label phase.2

At Week 384, the full analysis set included 1298 patients who were enrolled in the study.2

The 8-year analysis is not presented in the VEMLIDY full Prescribing Information.

Treatment-naïve patients had <12 weeks of previous treatment with any nucleoside/nucleotide analog. Treatment-experienced patients met all entry criteria (including HBV DNA ≥20,000 IU/mL and serum ALT criteria) and had ≥12 weeks of previous treatment with any nucleoside/
nucleotide analog.1,4

ALT=alanine aminotransferase; BMD=bone mineral density; HBeAg=hepatitis B envelope antigen; HBsAg=hepatitis B surface antigen; SD=standard deviation; TDF=tenofovir disoproxil fumarate; ULN=upper limit of normal.

d“Other” includes genotypes E, F, H, and unknown.2

eExcludes patients with missing values.2

f Excluding interferon and TDF. Patients may have been on more than one prior therapy.4

g “Other” category included clevudine, tenofovir alafenamide, and other oral nucleoside/nucleotide agents.4

See switch trial 4018 design

Warnings and Precautions
  • New Onset or Worsening Renal Impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with TAF-containing products. Patients with impaired renal function and/
    or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients –
    See Dosage and Administration.

See data from the pivotal trials1,2

See pivotal and 8-year follow-up data

Proven antiviral efficacy1,3,4

View viral suppression data from the switch trial

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. 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. 4. Data on file. Gilead Sciences, Inc. 5. Chan HLY, Buti M, Agarwal K, et al. Maintenance of high levels of viral suppression and improved safety profile of tenofovir alafenamide relative to tenofovir disoproxil fumarate in chronic hepatitis B patients treated for 5 years in 2 ongoing phase 3 studies. Poster presented virtually at: AASLD 2020; November 13-16, 2020. Poster 803. 6. Agarwal K, Brunetto M, Seto WK, et al. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018;68(4):672-681. doi:10.1016/j.jhep.2017.11.039 7. 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