Generic Name: tenofovir alafenamide
Company: Gilead Sciences
Approval Status: Approved
Generic Version Available: No
Experimental Code: GS-7340
FDA-approved for the treatment of chronic hepatitis B infection in adults with compensated liver disease.
- Vemlidy was approved by the U.S. Food and Drug Administration for use by adults with chronic hepatitis B on November 10, 2016.
- In clinical studies, up to 94 percent of participants had reduction in hepatitis B viral load to less than 29 IU/ml after 48 weeks of therapy.
Adult Dose: One 25 mg tablet daily, with food. No dosage adjustment needed for people with kidney disease.
Pediatric Dose: N/A
Dosing Info: Treatment length is indefinite and depends on clinical outcomes. Do not change your dose or stop taking Vemlidy without talking to your medical provider.
- In clinical trials, the most common reported side effects were headache, abdominal pain, fatigue, cough, nausea, and back pain.
- Vemlidy may cause a serious condition called lactic acidosis (buildup of acid in the blood) and severe hepatomegaly (enlarged liver) with steatosis (fat in the liver). Fatal cases have been reported with the use of nucleoside analogs.
- New or worsening of kidney disease many occur. Assessment of kidney function is recommended before starting Vemlidy and during therapy as clinically appropriate.
- Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit.
- Vemlidy may interact with various drugs and herbs, particualrly certain anticonvulsants (phenobarbital, phenytoin), antimycobacterials (Rifampin), and St. John’s wort.
- Additional drug-drug interactions may occur; these are listed in Vemlidy’s full prescribing information. Potential interactions are listed at hep-druginteractions.org.
- HIV testing is recommended prior to taking Vemlidy.
- There are no adequate, well-controlled studies in pregnant women who have taken Vemlidy. Viread should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Vemlidy during pregnancy at 1-800-258-4263.
- The safety of breast feeding while taking Vemlidy has not been established.
For More Info: https://www.vemlidy.com
Co-Pay Program Info: https://www.hepmag.com/basics/hepatitis-b-basics/paying-hepatitis-b-treatment
Patient Assistance Program Info: https://www.hepmag.com/basics/hepatitis-b-basics/paying-hepatitis-b-treatment
Last Reviewed: March 4, 2019