Table 1.
Currently available Tenofovir Alafenamide (TAF) Fixed dose drug combinations and their use during pregnancy.
| Drug Name | Formulation | Company | FDA Approval date |
Relevant Clinical PK studies in pregnancy |
Use in Pregnancy |
|---|---|---|---|---|---|
| TAF/FTC/RPV (Odefsey) | TAF – 25 mg FTC – 200 mg RPV – 25 mg |
Gilead Sciences | March 2016 | *IMPAACT P1026 s (Momper et al.) [63] | Insufficient data to use during pregnancy. Monitor renal function in pregnancy |
| TAF/FTC (Descovy) | TAF – 25 mg FTC – 200 mg |
Gilead Sciences | April 2016 | *IMPAACT P1026 s (Brooks et al.) [64] | Insufficient data to use during pregnancy. Monitor renal function in pregnancy |
| TAF/FTC/EVG/COBI (Genvoya) | TAF – 10 mg FTC – 200 mg EVG – 25 mg COBI – 150 mg |
Gilead Sciences | November 2015 | IMPAACT P1026 s (Momper et al) [63] #PANNA (Schalkwijk et al.) [36] | Not currently recommended for use during pregnancy due to low cobicistat exposures during the second and third trimester of pregnancy [33–37] |
| TAF/FTC/DTG | TAF – 25 mg FTC – 200 mg DTG – 50 mg |
Mylan | February 2018 | IMPAACT 1026s | Insufficient data to use during pregnancy. |
| TAF/FTC/DRV/COBI (Symtuza) | TAF – 10 mg FTC – 200 mg DRV – 800 mg COBI – 150 mg |
Janssen | July 2018 | IMPAACT P1026 | Not currently recommended for use during pregnancy due to low cobicistat exposures during the second and third trimester of pregnancy[33–37] |
| TAF/FTC/BIC (Biktarvy) | TAF – 25 mg FTC – 200 mg BIC – 50 mg |
Gilead Sciences | March 2019 | IMPAACT 2026 s and Gilead GS-US-380-5310 (NCT03960645) | Insufficient data to use during pregnancy. Data to be studied in ^IMPAACT P2026s. Monitor renal function in pregnancy |
International Maternal Pediatric Adolescent AIDS Clinical Trials – IMPAACT P1026 s, an ongoing, non-randomized, open-label, multi-center study of antiretroviral PK in pregnant women living with HIV in the United States, Brazil, Thailand, and Africa.
International Maternal Pediatric Adolescent AIDS Clinical Trials – IMPAACT P2026 s, a non-randomized, open-label, multi-center study of antiretroviral PK in pregnant women living with HIV in the United States, Brazil, Thailand, and Africa. The PK study arms will open in 2020.
Pharmacokinetics of newly developed ANtiretroviral agents in HIV-positive pregNAnt women (PANNA), an ongoing, non-randomized, open-label, multi-center study of antiretroviral PK in pregnant women living with HIV in Europe.