ADVERSE EVENT PROFILE1
- At Week 96, the proportion of patients who discontinued treatment due to adverse reactions of any severity was 1.5% for VEMLIDY and 0.9% for TDF (tenofovir disoproxil fumarate)
- Based on the Week 96 analysis, the most common adverse reactions (all grades) reported in at least 5% of patients in the VEMLIDY group were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia
- The safety profile of VEMLIDY in patients who continued to receive blinded treatment through Week 120 was similar to that at Week 96
- The safety profile of VEMLIDY in patients who remained on VEMLIDY in the open-label phase through Week 120 was similar to that in patients who switched from TDF to VEMLIDY at Week 96
- Differences were observed in certain lipid parameters
- Mean changes in fasting LDL-cholesterol 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
- Fasting LDL-cholesterol >190 mg/dL was observed at Week 96 in 6% of patients receiving VEMLIDY vs 1% with TDF
- The mean change in total cholesterol to HDL-cholesterol ratio at Week 96 from baseline was 0 for both VEMLIDY and TDF
- In the open-label phase, lipid parameters at Week 120 in patients who remained on VEMLIDY were similar to those at Week 96
- In patients who switched from TDF to VEMLIDY, mean change from Week 96 to Week 120 in total cholesterol was 23 mg/dL, HDL-cholesterol was 5 mg/dL, LDL-cholesterol was 16 mg/dL, triglycerides was 30 mg/dL, and total cholesterol to HDL ratio was 0 mg/dL
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.
Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, and dyspepsia.
- 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
- Dosage: Adults; 1 tablet taken once daily with food.
- Renal Impairment, Screening, and Monitoring: VEMLIDY is not recommended in patients with CrCl <15 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein prior to initiating and during treatment, on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus.
- Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
- Testing Prior to Initiation: HIV infection.
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.
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.