VEMLIDY—proven long-term ALT normalization in chronic hepatitis B patients with compensated liver disease1,2

Powerful efficacy maintained over the long term with 0% resistance2
Pivotal Trials/Long-term Data 
Switch Trial Data

ALT measurements at baseline and Week 481,3,a,b

See primary endpoint data See trial design

ALT measurements at Week 964,b

At Week 48, all patients who were in the TDF group in the controlled phase of the trial were switched to VEMLIDY which they used through Week 96 as part of the open-label extension phase. Patients who were originally assigned to VEMLIDY continued using it through Week 96.4

Adverse reactions observed with VEMLIDY in Trial 4018 were similar to those in Trials 108 and 110. Most common adverse reactions (incidence ≥5%, all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia.1

ALT=alanine aminotransferase; TDF=tenofovir disoproxil fumarate; ULN=upper limit of normal.

a At baseline, median duration of prior TDF treatment was 220 weeks and 224 weeks in VEMLIDY and TDF groups, respectively. Week 48 window was between Day 295 and Day 378 (inclusive).1

b Normal ALT was defined as per the 2018 AASLD criteria: >35 and >25 U/L in men and women, respectively.1

See ALT normalization data from the pivotal trials.

 

0% RESISTANCE

No HBV resistance with VEMLIDY in Trial 4018 through Week 961,4

See the details Proven in Trials 108/110 through Week 384

Genotypic resistance analysis was performed on patients experiencing HBV DNA ≥69 IU/mL at any study visit through Week 96.4

Warnings and Precautions
  • Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.

Effect of VEMLIDY on renal safety parameters1,2

See pivotal and 8-year follow-up data

Effect of VEMLIDY on renal function in patients from the switch trial4

See renal safety 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.