Indications for Vemlidy (Tenofovir Alafenamide)
Vemlidy (tenofovir alafenamide) is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease. 1
Primary Indication Details
Tenofovir alafenamide (TAF) is specifically approved for:
- Adult patients with chronic HBV infection with compensated liver disease 1, 2
- Pediatric patients 6 years of age and older weighing at least 25 kg with compensated liver disease 1
TAF is classified as a nucleos(t)ide analogue (NA) with a high genetic barrier to resistance, making it one of the preferred first-line agents for chronic hepatitis B treatment 3.
Patient Populations
Recommended for:
- HBeAg-positive chronic hepatitis B patients 3, 4
- HBeAg-negative chronic hepatitis B patients 3, 4
- Patients with compensated cirrhosis 3
- All cirrhotic patients with detectable HBV DNA, regardless of ALT levels, should receive treatment 4
Not recommended for:
- Patients with decompensated (Child-Pugh B or C) hepatic impairment 1
- Patients with end-stage renal disease (ESRD) who are not receiving chronic hemodialysis 1
- HIV-1 coinfected patients when used as monotherapy (VEMLIDY alone should not be used in patients with HIV-1 infection) 1
Special Populations and Considerations
Renal Impairment
- No dosage adjustment required for patients with estimated creatinine clearance ≥15 mL/min 1
- Can be used in patients with ESRD receiving chronic hemodialysis (administered after hemodialysis completion) 1
- TAF has a more favorable renal safety profile compared to tenofovir disoproxil fumarate (TDF) 5, 6
Hepatic Impairment
- No dosage adjustment required for patients with mild hepatic impairment (Child-Pugh A) 1
- Not recommended for patients with decompensated (Child-Pugh B or C) hepatic impairment 1
Pregnancy
- Tenofovir alafenamide can be used for prevention of mother-to-child transmission in pregnant women with high viremia 4
- Prophylactic use is recommended starting at 24-32 weeks of pregnancy if HBV DNA is high (>200,000 IU/mL) 4
HIV Coinfection
- HIV antibody testing should be performed before initiating TAF 1
- TAF alone is not recommended for HIV-1 coinfected patients due to risk of developing HIV-1 resistance 1
- Patients with HIV coinfection should receive appropriate antiretroviral combination regimens 3, 4
Clinical Benefits and Advantages
- High antiviral potency with sustained viral suppression 5, 6
- High genetic barrier to resistance with no documented resistance development through 8 years of treatment 3, 5
- Improved bone and renal safety profile compared to tenofovir disoproxil fumarate 5, 6
- Long-term efficacy with high rates of viral suppression maintained through 8 years 5
Important Warnings and Precautions
Risk of severe acute exacerbation of hepatitis B after discontinuation of treatment 1
- Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months after stopping treatment
- Resumption of anti-hepatitis B therapy may be warranted if exacerbation occurs
Testing requirements before initiation 1:
- HIV-1 testing
- Assessment of serum creatinine, estimated creatinine clearance, urine glucose, and urine protein
- In patients with chronic kidney disease, serum phosphorus should also be assessed
Emerging Evidence
Recent research suggests potential expanded indications for TAF in the future:
- The ATTENTION trial showed that early treatment with TAF may reduce the risk of liver-related serious adverse events in adults with non-cirrhotic chronic hepatitis B and moderate or high viremia but normal or mildly elevated ALT concentrations 7
- This suggests that existing guidelines could potentially be expanded to allow early antiviral therapy in patients with moderate or high HBV viral load, irrespective of ALT concentrations 7
TAF represents an important advancement in the treatment of chronic hepatitis B, offering high efficacy with an improved safety profile compared to earlier nucleos(t)ide analogues.