VEMLIDY delivers efficacy you can trust, supported by pivotal trial data maintained through 5 years

Across multiple studies, VEMLIDY demonstrated powerful antiviral efficacy with 0% resistance.1-7

VEMLIDY demonstrated powerful antiviral suppression at Weeks 48, 96, and 144 (HBV DNA <29 IU/mL)1-4,a,b

Chart showing virology response in HBeAg- and HBeAg+ patients with VEMLIDY® (tenofovir alafenamide) vs TDF (tenofovir disoproxil fumarate) Chart showing virology response in HBeAg- and HBeAg+ patients with VEMLIDY® (tenofovir alafenamide) vs TDF (tenofovir disoproxil fumarate)

Primary efficacy endpoint: The proportion of patients with HBV DNA <29 IU/mL and noninferiority to TDF (10% margin; 95% CI approach) at Week 48 for both trials.1,2,4

Mean baseline plasma HBV DNA was 5.8 log10 IU/mL in Trial 108 and 7.6 log10 IU/mL in Trial 110.1,8

  • Trial 108 viral suppression at Week 96: VEMLIDY 90% (257/285), TDF 91% (127/140)8
  • Trial 110 viral suppression at Week 96: VEMLIDY 73% (423/581), TDF 75% (218/292)8

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.1,2,4,6

HBeAg=hepatitis B envelope antigen; TDF=tenofovir disoproxil fumarate. aSubject populations analyzed included all treatment-naïve and treatment-experienced subjects who were randomized into the trial and received at least 1 dose of study drug; a missing=failure approach was used.1,2,4 bThe Week 144 analysis did not include the 66 patients from the TDF group in Trial 108 and the 114 patients from the TDF group in Trial 110 who had rolled over from double-blind TDF to open-label VEMLIDY at Week 96 prior to the study amendment.6

Long-term viral suppression with VEMLIDY through 5 years

Pooled Open-Label Analysis: Pooled efficacy analysis from Trials 108 and 110 was assessed at Week 240 for the subset of patients who entered the OLE phase at Week 96 and Week 144. This analysis includes 741 subjects who continued on VEMLIDY (pooled), 150 subjects who switched from TDF to TAF at Week 96, and 202 subjects who switched from TDF to TAF at Week 144. Efficacy in the OLE was calculated using a missing=failure (M=F) subject analysis.6,c

Chart showing HBV DNA <29 IU/mL at Week 240 for VEMLIDY® (tenofovir alafenamide) vs TDF (tenofovir disoproxil fumarate)
OLE=open-label extension; TAF=tenofovir alafenamide. cThe open-label phase analysis excludes patients (n=69) whose site did not participate in open-label phase treatment at Week 144.6 dMean baseline plasma HBV DNA: 5.8 log10 IU/mL in Trial 108 and 7.6 log10 IU/mL in Trial 110.1

Most common adverse reactions (incidence ≥2%; all grades) at Week 240 OLE were headache, abdominal pain, cough, back pain, arthralgia, diarrhea, and dyspepsia.6

~75% of patients enrolled in pivotal trials 108/110 were treatment-naïve.6

The 5-year data is not presented in the VEMLIDY label.

0 %
RESISTANCE

with long-term treatment on VEMLIDY through 5 years1,5,6,8

See the details

Proven in Trials 108/110 through Week 240

Genotypic resistance analysis was performed on patients experiencing either1:

  • Virologic breakthrough (2 consecutive visits with HBV DNA ≥69 IU/mL [400 copies/mL] after having been <69 IU/mL, or ≥1.0-log10 increase in HBV DNA from nadir)
  • Early discontinuation at or after Week 24 with HBV DNA ≥69 IU/mL

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: POSTTREATMENT 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: 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.
  • Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). 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) in clinical studies through week 144 were headache, upper respiratory tract infection, abdominal pain, cough, back pain, arthralgia, fatigue, nausea, diarrhea, dyspepsia, and pyrexia.

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 see full Prescribing Information for VEMLIDY, including BOXED WARNING.