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

Powerful efficacy maintained over the long term with 0% resistance

Pivotal Trials/Long-term Data
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ALT normalization rates at Weeks 48, 96, and 144 (2016 AASLD criteria)1,2,a,b

See primary endpoint data

~75% of patients enrolled in pivotal Trials 108/110 were treatment-naïve.2

ALT normalization rates at Weeks 48, 96, and 144 (2016 AASLD criteria)a,b

Chart showing ALT normalization for VEMLIDY® (tenofovir alafenamide) vs TDF (tenofovir disoproxil fumarate) in HBeAg- and HBeAg+ patients Chart showing ALT normalization for VEMLIDY® (tenofovir alafenamide) vs TDF (tenofovir disoproxil fumarate) in HBeAg- and HBeAg+ patients

Week 48: ALT normalization was 50% (137/276) for VEMLIDY vs 32% (44/138) for TDF in Trial 108 and 45% (257/572) for VEMLIDY vs 36% (105/290) for TDF in Trial 110.1,3-5

Week 96: ALT normalization was 50% (139/276) for VEMLIDY vs 40% (55/138) for TDF in Trial 108 and 52% (299/572) for VEMLIDY vs 42% (121/290) for TDF in Trial 110.1,3-5

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.

AASLD=American Association for the Study of Liver Diseases; ALT=alanine aminotransferase; HBeAg=hepatitis B envelope antigen; TDF=tenofovir disoproxil fumarate; ULN=upper limit of normal. aThe population used for analysis of ALT normalization included only patients with ALT above ULN based on the AASLD 2016 criteria (>30 U/L and >19 U/L for males and females, respectively) at baseline.1 bPatient populations analyzed included all patients who were randomized into the study and received at least 1 dose of study drug; a missing=failure approach was used. The 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.2

Long-term ALT normalization with VEMLIDY through 8 years

Pooled open-label analysis: Pooled efficacy analysis from Trials 108 and 110 was assessed at Week 384 for the subset of patients who entered the open-label phase at Week 96 and Week 144. This analysis includes 832 patients who continued on VEMLIDY (pooled), 177 patients who switched from TDF to VEMLIDY at Week 96, and 225 patients who switched from TDF to VEMLIDY at Week 144. Efficacy in the OLE was calculated using a missing=failure (M=F) subject analysis.2

Chart showing ALT normalization at Week 384 for VEMLIDY® (tenofovir alafenamide) vs TDF (tenofovir disoproxil fumarate)
OLE=open-label extension. cThe population used for analysis of ALT normalization included only subjects with ALT>ULN per the 2018 AASLD criteria (35 U/L for males and 25 U/L for females) at baseline.6 dThe open-label phase analysis excludes patients (n=69) whose site did not participate in open-label phase treatment at Week 144.2

Most common adverse reactions (incidence ≥5%; all grades) at Week 384 OLE were headache, upper respiratory tract infection, nasopharyngitis, arthralgia, hypertension, cough, and back pain.2

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

0 % RESISTANCE

on long-term treatment with VEMLIDY through 8 years (Week 384)1,2

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

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.

Explore long-term cirrhosis data

See pivotal and 8-year follow-up data

Discover long-term fibrosis data

See pivotal and 8-year follow-up data

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.

Pregnancy and Lactation

  • Pregnancy: A pregnancy registry has been established for VEMLIDY. Available clinical trial data show no significant difference in the overall risk of birth defects for VEMLIDY compared with the background rate of major birth defects in the U.S. reference population.
  • Lactation: TAF and tenofovir can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VEMLIDY and any potential adverse effects on the breastfed infant from VEMLIDY or from the underlying maternal condition.

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.