Latest VEMLIDY switch trial data: efficacy and safety in virologically suppressed CHB patients. Review the data.

Don’t accept less than VEMLIDY


Antiviral efficacy proven in noninferiority trials with TDF, with safety demonstrated in renal and bone effects.2

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VEMLIDY: More efficient delivery of tenofovir

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VEMLIDY 25 mg demonstrates more efficient delivery of tenofovir to the hepatocytes vs TDF 300 mg, at approximately 1/10 the dose.2-6

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TDF=tenofovir disoproxil fumarate.
AASLD=American Association for the Study of Liver Diseases; AATA=Asian American Treatment Algorithm (also referred to as an Expert Consensus for the Management of Chronic Hepatitis B in Asian Americans); EASL=European Association for the Study of the Liver.

KIMBERLY BROWN, MD, FAASLD, FAST, AGAF

Chief of the Division of Gastroenterology and Hepatology
Henry Ford Hospital, Detroit, Michigan

Explore additional results from the VEMLIDY pivotal clinical trials in this presentation by Dr. Brown.

Kimberly Brown, MD, FAASLD, FAST, AGAF

Chief of the Division of Gastroenterology and Hepatology

Henry Ford Hospital, Detroit, Michigan

Explore efficacy and safety data from the VEMLIDY pivotal clinical trials in this presentation by Dr. Brown.

  1. Agarwal K, Brunetto M, Seto WK, et al. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018;68:672-681.
  2. American Association for the Study of Liver Diseases. Posters (Abstracts 301-2389). Hepatology. 2018;68:S184-S1353.
  3. Buti M, Gane E, Seto WK, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1:196-206.
  4. Chan HLY, Fung S, Seto WK, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1:185-195.
  5. Chan HLY, Lim YS, Seto WK, et al. 3-year efficacy and safety of tenofovir alafenamide compared with tenofovir disoproxil fumarate in HBeAg-negative and -positive patients with chronic hepatitis B. Poster presented at: AASLD 2018; November 9-13, 2018; San Francisco, CA. Poster 381.
  6. Chan HLY, Marcellin P, Pan CQ, et al. No resistance to tenofovir alafenamide detected through 144 weeks of treatment in patients with chronic hepatitis B. Poster presented at: AASLD 2018; November 9-13, 2018; San Francisco, CA. Poster 386.
  7. Data on file. Gilead Sciences, Inc.
  8. Seto WK, Buti M, Izumi N, et al. Bone and renal safety are improved in chronic HBV patients 1 year after switching to tenofovir alafenamide from tenofovir disoproxil fumarate. Poster presented at: AASLD 2018; November 9-13, 2018; San Francisco, CA. Poster 404.
  9. VEMLIDY Prescribing Information, Foster City, CA: Gilead Sciences, Inc.; February 2019.

Proven in robust, global clinical trials

See data comparisons:
VEMLIDY vs TDF


Study design

Education for your patients

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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.