VIREAD educational resources for you and your chronic hepatitis B patients

Gilead has been at the forefront of helping people with chronic hepatitis B (CHB) for more than 15 years. In addition, a variety of resources are available for healthcare providers and patients.

VIREAD Co-pay Coupon Program

Help your patients pay for VIREAD

This program may cover the out-of-pocket costs for your eligible patients’ VIREAD prescriptions – up to $300 per month for the next 12 months (max. $3600/year)

Copay Coupon Program

9 out of 10 eligible patients enrolled in the VIREAD Co-pay Coupon Program pay a $0 co-pay if they1:

  • Have commercial insurance
  • Have no insurance/pay cash
  • Are not enrolled in a government healthcare program, such as a Medicare Part D or Medicaid

Two ways to enroll your patients

Online It's easy to help your eligible patients save on their co-pay by registering them online now. Register Your Patients Now

By phone Call 877-627-0415 for enrollment support in English, Chinese, Korean, or Vietnamese.

VIREAD Co-pay Coupon Program handout

Available in 4 different languages (English, Korean, Chinese, and Vietnamese), share the Co-pay Coupon Program handout with your patients. Download Handout

If patients are enrolled in a government healthcare program such as Medicare Part D or Medicaid, they are not eligible. This includes patients who are Medicare Part D enrollees and in the prescription drug coverage gap, called the "donut hole."

Patient resources

PATIENT HANDOUT

This patient handout may help your patients understand CHB, how VIREAD may help to treat it, and more.
Download Patient Brochure

Healthcare provider resources

Informational materials

For more information about VIREAD for healthcare providers, materials on a variety of topics are available to download, print, or share with colleagues.

8-Year Study Data

Download VIREAD long-term data.

Download PDF
Resistance

Get information about VIREAD resistance profile.

Download PDF
Histology

Access details about VIREAD histology outcomes.

Download PDF
Lamivudine Resistance

Download data about VIREAD in LAM-resistant CHB patients.

Download PDF
China Trial

Get VIREAD data from a Chinese study population.

Download PDF

Indication and Usage

VIREAD® is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:

  • The indication in adults is based on data from treatment of subjects who were nucleoside–treatment-naïve and treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease
  • VIREAD was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease
  • The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy

Important Safety Information

Dosage and Administration

  • Recommended dose, in adults and pediatric patients ≥12 years of age (≥35 kg), for the treatment of chronic hepatitis B: one 300 mg tablet, once daily, taken orally, without regard to food
  • In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown
  • Safety and efficacy in pediatric patients <12 years of age or weighing <35 kg with chronic hepatitis B have not been established
  • The dosing interval of VIREAD should be adjusted (using recommendations in the table below) and renal function closely monitored in patients with baseline creatinine clearance <50 mL/min

Indication and Usage

VIREAD® (tenofovir disoproxil fumarate) is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:

  • The indication in adults is based on data from treatment of subjects who were nucleoside–treatment-naÏve and treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease
  • VIREAD was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease
  • The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy

Important Safety Information

TAP for Important Safety Information, including Boxed Warning on lactic acidosis, severe hepatomegaly with steatosis and post treatment exacerbation of hepatitis.

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, in combination with other antiretrovirals
  • Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. 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 VIREAD. If appropriate, resumption of anti-hepatitis B therapy may be warranted

Warnings and Precautions

  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of VIREAD. In all patients, assess estimated creatinine clearance (CrCl) prior to initiating and during therapy. In patients at risk for renal dysfunction, including those who previously experienced renal events while receiving adefovir dipivoxil, additionally monitor serum phosphorus, urine glucose, and urine protein. In patients with CrCl <50 mL/min, adjust dosing interval and closely monitor renal function. Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure, some requiring hospitalization and renal replacement therapy, have been reported after initiation of high dose or multiple NSAIDs in HIV-infected patients with risk factors for renal dysfunction; consider alternatives to NSAIDs in these patients. Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function
  • Coadministration with other products:
    • Do not use in combination with other products containing tenofovir disoproxil fumarate
    • Do not administer in combination with adefovir dipivoxil
  • Patients coinfected with HIV‑1 and HBV: Due to the risk of development of HIV‑1 resistance, VIREAD should only be used in HIV‑1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen. HIV‑1 antibody testing should be offered to all HBV-infected patients before initiating therapy with VIREAD
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia, have been seen in patients treated with VIREAD. Consider assessment of BMD in adult and pediatric patients who have a history of pathologic bone fracture or other risk factors for bone loss. In a clinical trial conducted in pediatric subjects 12 to <18 years of age with chronic hepatitis B, total body BMD gain was less in VIREAD-treated subjects as compared to the control group. In patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms, hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered

Adverse Reactions

  • In HBV-infected subjects with compensated liver disease: Most common adverse reaction (all grades) was nausea (9%). Other treatment-emergent adverse reactions reported in >5% of patients treated with VIREAD included: abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash
  • In HBV-infected subjects with decompensated liver disease: Most common adverse reactions (all grades) reported in ≥10% of patients treated with VIREAD were abdominal pain (22%), nausea (20%), insomnia (18%), pruritus (16%), vomiting (13%), dizziness (13%), and pyrexia (11%)

Drug Interactions

  • Didanosine: Coadministration increases didanosine concentrations. Use with caution and monitor for evidence of didanosine toxicity (e.g., pancreatitis, neuropathy). Didanosine should be discontinued in patients who develop didanosine-associated adverse reactions. In patients weighing >60 kg, the didanosine dose should be reduced to 250 mg once daily when it is coadministered with VIREAD and in patients weighing <60 kg, the didanosine dose should be reduced to 200 mg once daily when coadministered with VIREAD
  • HIV‑1 protease inhibitors: Coadministration decreases atazanavir concentrations and increases tenofovir concentrations; use atazanavir given with ritonavir. Coadministration of VIREAD with atazanavir and ritonavir, darunavir and ritonavir, or lopinavir/ritonavir increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity
  • Hepatitis C antivirals: Coadministration of VIREAD with HARVONI increases VIREAD exposure; monitor for adverse reactions associated with VIREAD. Consider an alternative HCV or HIV‑1 therapy in patients receiving VIREAD concomitantly with HARVONI and an HIV‑1 protease inhibitor with ritonavir or cobicistat
  • Drugs affecting renal function: Coadministration of VIREAD with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir

Dosage and Administration

  • Recommended dose, in adults and pediatric patients ≥12 years of age (≥35 kg), for the treatment of chronic hepatitis B: one 300 mg tablet, once daily, taken orally, without regard to food
  • In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown
  • Safety and efficacy in pediatric patients <12 years of age or weighing <35 kg with chronic hepatitis B have not been established
  • The dosing interval of VIREAD should be adjusted (using recommendations in the table below) and renal function closely monitored in patients with baseline creatinine clearance <50 mL/min

Dosage Adjustment for Patients with Altered Creatinine Clearance

Dosage Table

aCalculated using ideal (lean) body weight.

bGenerally once weekly assuming three hemodialysis sessions a week of approximately 4 hours duration. VIREAD should be administered following completion of dialysis.

  • The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance <10 mL/min; therefore, no dosing recommendation is available for these patients
  • No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50-80 mL/min). Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in these patients
  • No data are available to make dose recommendations in pediatric patients with renal impairment

Indication and Usage

VIREAD® (tenofovir disoproxil fumarate) is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:

  • The indication in adults is based on data from treatment of subjects who were nucleoside–treatment-naÏve and treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease
  • VIREAD was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease
  • The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy
Please click here to see full Prescribing Information, including BOXED WARNING.

VIREAD Co-pay Coupon Program Terms and Conditions

The VIREAD® (tenofovir disoproxil fumarate) tablets Co-pay Coupon Program will cover the out-of-pocket costs of your VIREAD prescription up to $300 every month for the next 12 months (up to $3,600 per year).

The VIREAD 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 only available with a valid prescription. 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”) 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 OR CASH-PAY PATIENTS 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 (“HEALTHCARE REFORM”), 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.

Patients without insurance coverage or who have commercial insurance that does not cover the Gilead product are considered “cash pay” patients. Medicare Part D enrollees who are in the prescription drug coverage gap (the “donut hole”) are not considered cash pay, and 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, including BOXED WARNING.

Reference: 1. Data on file. Gilead Sciences, Inc. Co-pay assistance report. December 2015.

This information is intended for US healthcare professionals

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