ADVERSE EVENT PROFILE1,2

  • The proportion of patients who discontinued treatment due to adverse reactions of any severity is shown in the graph on the rightbelow
Graph depicting discontinuations due to adverse events for VEMLIDY® (tenofovir alafenamide) vs TDF (tenofovir disoproxil fumarate)
  • Based on the Week 96 and 144 analyses, the most common adverse reactions (all grades) reported in at least 5% of patients in the VEMLIDY group were:

Week 96

Headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia

Week 144

Headache, upper respiratory tract infection, cough, back pain, arthralgia, fatigue, nausea, diarrhea, dyspepsia, abdominal pain, and pyrexia

  • The safety profile of VEMLIDY in patients who remained on VEMLIDY in the open-label phase through Week 144 was similar to that in patients who switched from TDF to VEMLIDY at Week 96
  • Differences were observed between VEMLIDY and TDF in certain lipid parameters
    • Mean changes in fasting LDL-C and triglycerides from baseline to Week 96 were +7 mg/dL and +13 mg/dL, respectively, for VEMLIDY vs −10 mg/dL and −7 mg/dL for TDF
      • At Week 144: +8 mg/dL and +18 mg/dL for VEMLIDY and −8 mg/dL and −2 mg/dL for TDF
    • Fasting LDL-C >190 mg/dL was observed at Week 96 in 6% of patients receiving VEMLIDY vs 1% with TDF
      • At Week 144: 7% of patients receiving VEMLIDY vs 1% with TDF
    • The mean change in total cholesterol to HDL-C ratio at Weeks 96 and 144 from baseline was 0 for both VEMLIDY and TDF
  • In the open-label phase, lipid parameters at Week 144 in patients who remained on VEMLIDY were similar to those at Week 96
  • In patients who switched from TDF to VEMLIDY, the mean change from Week 96 to Week 144 in total cholesterol was 23 mg/dL, HDL-C was 3 mg/dL, LDL-C was 16 mg/dL, triglycerides was 28 mg/dL, and total cholesterol to HDL-C ratio was 0 mg/dL
HDL-C=high-density lipoprotein cholesterol; LDL-C=low-density lipoprotein cholesterol.

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.