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# Tabvolhep (Tenofovir Alafenamide/Emtricitabine) ## Overview Tabvolhep is a combination medication containing tenofovir alafenamide (TAF) and emtricitabine (FTC). It is a nucleoside reverse transcriptase inhibitor (NRTI) and is used for the treatment of HIV-1 infection. ## Primary Indications Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients at least 12 years of age and weighing at least 35 kg. ## Adult Dosing **1 tablet (25 mg TAF / 200 mg FTC) orally once daily.** ## Pediatric Dosing **Patients aged 12 years and older AND weighing at least 35 kg:** **1 tablet (25 mg TAF / 200 mg FTC) orally once daily.** Dosing for pediatric patients below 35 kg is not established. ## Dose Adjustments No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance [CrCl] ≥ 30 mL/min). **Severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis:** Current recommendations suggest avoiding use or using with caution due to TAF accumulation. Data on safety and efficacy is limited in this population. **Hepatic Impairment:** No dose adjustment is recommended for patients with mild to moderate hepatic impairment. Data is insufficient to recommend a dose for patients with severe hepatic impairment. ## Contraindications None specific to the combination, beyond hypersensitivity to any component. ## Adverse Effects Common adverse effects include nausea, diarrhea, headache, abdominal pain, and rash. Less common but serious adverse effects can include: * **Lactic Acidosis:** Particularly in patients with risk factors like obesity or prolonged NRTI exposure. * **Hepatic Steatosis and Steatohepatitis:** May occur with TAF-containing regimens. * **Immune Reconstitution Inflammatory Syndrome (IRIS):** May develop after initiation of combination antiretroviral therapy. * **Bone Mineral Density:** TAF has a lower impact on bone mineral density compared to tenofovir disoproxil fumarate (TDF). * **Renal Impairment:** TAF has a lower impact on renal function compared to TDF. ## Key Drug Interactions * **Strong CYP3A4 Inducers:** (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) may decrease plasma concentrations of TAF and FTC, reducing efficacy. Avoid co-administration. * **Certain Anticonvulsants:** (e.g., oxcarbazepine) may also induce CYP3A4. * **Didanosine:** Co-administration with TAF may increase the risk of pancreatitis and mitochondrial dysfunction. Avoid co-administration. ## Monitoring * **HIV-1 RNA and CD4+ T-cell count:** Regularly to assess treatment efficacy. * **Renal Function:** Baseline and periodically, especially in patients with pre-existing renal disease. * **Hepatic Function:** Baseline and periodically. * **Bone Mineral Density:** Consider if risk factors are present. * **Lipid Profile:** May be affected. ## Clinical Pearls * Tabvolhep is a complete regimen for treatment-naive patients and may be used in switch strategies for virologically suppressed patients. * TAF has a more favorable renal and bone safety profile compared to TDF due to lower plasma tenofovir levels and higher intracellular TAF concentrations. * Ensure adherence to minimize the risk of resistance. *** *This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines for complete details and to verify information before making clinical decisions.*