VEMLIDY delivers efficacy you can trust

Across multiple studies, VEMLIDY demonstrated powerful antiviral efficacy with no known resistance.1-5

Switch trial 4018 design

The efficacy and safety of switching from TDF 300 mg once daily to VEMLIDY 25 mg once daily in virologically suppressed adults with CHB infection were evaluated in a randomized, double-blind, active-controlled trial: Trial 4018 (N=488). Patients must have been taking TDF 300 mg once daily for ≥12 months, with HBV DNA less than the Lower Limit of Quantitation by local laboratory assessment ≥12 weeks prior to screening and HBV DNA >20 IU/mL at screening. Patients were randomized in a 1:1 ratio to either switch to VEMLIDY (n=243) or stay on TDF (n=245). At baseline, the median duration of exposure to TDF prior to the trial was similar in both treatment groups (TAF=220.0 weeks, TDF=224.3 weeks).

The primary efficacy endpoint was the proportion of patients with plasma HBV DNA ≥20 IU/mL at Week 48. Additional efficacy endpoints included the proportion of patients with HBV DNA >20 IU/mL, ALT normal and normalization, HBsAg loss and seroconversion, and HBeAg loss and seroconversion.1

See baseline characteristics

Viral suppression at Week 481,6,a,b

Switched to VEMLIDY
Continued on TDF
Chart showing virologic response at Week 48 for patients who switched to VEMLIDY® (tenofovir alafenamide) from TDF (tenofovir disoproxil fumarate) Chart showing virologic response at Week 48 for patients who switched to VEMLIDY® (tenofovir alafenamide) from TDF (tenofovir disoproxil fumarate)
ALT= alanine aminotransferase; CHB=chronic hepatitis B; HBV DNA=hepatitis B virus deoxyribonucleic acid; TDF=tenofovir disoproxil fumarate. aAt baseline, median duration of prior TDF treatment was 220 weeks (VEMLIDY) and 224 weeks (TDF).1 bNo subject discontinued treatment due to lack of efficacy. Treatment difference was adjusted by baseline age groups (>50, ≥50 years) and baseline HBeAg status strata. At Week 48, Trial 4018 had only 1 subject in each treatment group who had HBV DNA ≥20 IU/mL. The Trial met the primary endpoint of noninferiority.1,6

In trial 4018, no patients qualified for resistance analysis
through 48 weeks of VEMLIDY treatment1

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.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

  • Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

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.
  • New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). 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.
  • Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir DF. Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia.

Drug Interactions

  • Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
  • Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.

Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

  • Testing Prior to Initiation: HIV infection.
  • Prior to or when initiating, and during treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
  • Dosage in Adults: 1 tablet taken once daily with food.
  • Renal Impairment: Not recommended in patients with end stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.
  • Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

INDICATION

VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

Please click here to see full Prescribing Information for VEMLIDY, including BOXED WARNING.