Long-term considerations

For some patients, chronic HBV is a lifelong disease that requires long-term or potentially indefinite therapy.3,8,9

  • People with chronic HBV are at risk for developing comorbidities, including diabetes, metabolic syndrome, and renal and bone conditions10-15
    • Risk for some comorbidities increases with age

Screening for HBV

Screening can help identify chronic HBV early, so that necessary care, including antiviral therapy and/or surveillance for disease progression, may be considered.16

The USPSTF, CDC, and AASLD recommend screening the following patients16-20:

  • People born in regions with prevalence of HBV infection ≥2%
  • U.S.-born people not vaccinated as infants whose parents were born in regions with prevalence of HBV infection ≥8%
  • Household and sexual contacts of people with HBV infection
  • All pregnant women
  • Men who have sex with men
  • Injection drug users
  • People with certain medical conditions
    • Needing immunosuppressive therapy
    • Undergoing hemodialysis
    • Infected with HIV

AASLD: American Association for the Study of Liver Diseases; CDC: Centers for Disease Control and Prevention; USPSTF: U.S. Preventive Services Task Force.

Treatment goals

When a patient has been diagnosed with chronic HBV, treatment goals include3,6,17,21:

  • Achieving sustained suppression of HBV replication
  • ALT normalization
  • Reducing the risk of liver damage
  • HBeAg loss and HBsAg loss

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 is not recommended 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.
    Renal monitoring: Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein prior to initiating and during therapy in all patients as clinically appropriate.
  • 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) through Week 48 were headache, abdominal pain, fatigue, cough, nausea and back pain.

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-gp and 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

  • Dosage: Adults; 1 tablet taken once daily with food.
  • Renal Impairment: Not recommended in patients with CrCl <15 mL/min.
  • Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
  • Testing prior to initiation: HIV infection.

Indication

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

VEMLIDY Co-pay Coupon Program Terms and Conditions

The VEMLIDY Co-pay Coupon Program will cover the out-of-pocket costs of your VEMLIDY prescriptions up to a maximum of $3,600 per year. This maximum applies to all eligible Gilead medications for the program.

The VEMLIDY Co-pay Coupon Card (“Card”) can be used only by eligible residents of the U.S., Puerto Rico, or U.S. territories at participating eligible retail, specialty, or mail-order pharmacies in the U.S., Puerto Rico, or U.S. territories. Product must originate in the U.S. or Puerto Rico, or U.S. territories. You must be 18 years or older to use the Card for yourself or a minor.

The Card is limited to one per person and is not transferable. No substitutions are permitted. This Card is available for each valid prescription. No other purchase necessary. The offer cannot be combined with any other coupon, free trial, discount, prescription savings card, or other offer. Patient may not be currently receiving free drug assistance through Gilead Sciences, Inc. (“Gilead”)’s patient assistance programs.

The Card is not insurance and is not intended to substitute for insurance.

THE CARD IS VALID ONLY FOR PATIENTS WITH COMMERCIAL INSURANCE AND IS NOT VALID FOR PRESCRIPTIONS THAT ARE ELIGIBLE TO BE REIMBURSED:

  • IN WHOLE OR PART, BY MEDICARE, MEDICAID OR A MEDICARE PART D PLAN, TRICARE, VA, DoD, PUERTO RICO GOVERNMENT HEALTH INSURANCE PLAN, OR ANY OTHER FEDERAL OR STATE-FUNDED HEALTHCARE BENEFIT PROGRAM (COLLECTIVELY, “GOVERNMENT PROGRAMS”); OR
  • BY COMMERCIAL PLANS OR OTHER HEALTH OR PHARMACY BENEFIT PROGRAMS THAT REIMBURSE FOR THE ENTIRE COST OF PRESCRIPTION DRUGS.

Medicare Part D enrollees who are in the prescription drug coverage gap (the “donut hole”) are not eligible for the co-pay coupon. Patients who begin receiving prescription benefits from such Government Programs at any time will no longer be eligible to use the Card. Void where prohibited by law, taxed, or restricted.

Patient, pharmacist, and prescriber agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer. Both patient and pharmacist are each individually responsible for reporting receipt of coupon benefit to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Card, as required.

It is illegal to sell, purchase, trade, or counterfeit, or offer to sell, purchase, trade, or counterfeit the Card.

Certain information pertaining to your use of the Card will be shared with Gilead, the sponsor of the Card, and its affiliates. The information disclosed will include the date the prescription is filled, the number of pills or product dispensed by the pharmacists, and the amount of your co-pay that will be paid for by using this Card. For more information, please see the Gilead Privacy Policy at www.gilead.com.

Gilead reserves the right to terminate, rescind, revoke, or modify this Card at any time without notice.

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