Table 2.
Currently Available Ritonavir (RTV) and Cobicistat (COBI) 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 |
|---|---|---|---|---|---|
| TDF/FTC/EVG/COBI (Stribild) | TDF 300 mg FTC 200 mg EVG 25 mg COBI 150 mg |
Gilead Sciences | August 2012 | PANNAa (Colbers et al)92 | Not currently recommended for use during pregnancy due to low cobicistat exposures during the second and third trimesters of pregnancy8,55,66 |
| TAF/FTC/EVG/COBI (Genvoya) | TAF 10 mg FTC 200 mg EVG 25 mg COBI 150 mg |
Gilead Sciences | November 2015 | IMPAACT P1026sb (Momper et al)61 PANNA (Schalkwijk et al)88 |
Not currently recommended for use during pregnancy due to low cobicistat exposures during the second and third trimesters of pregnancy8,55,66 |
| TAF/FTC/DRV/COBI (Symtuza) | TAF 10 mg FTC 200 mg DRV 800 mg COBI 150 mg |
Janssen | July 2018 | IMPAACT P1026 (Momper et al)64 | Not currently recommended for use during pregnancy due to low cobicistat exposures during the second and third trimesters of pregnancy8,55,66 |
| ATV/COBI (Evotaz) | ATV 300 mg COBI 150 mg |
Bristol-Myers Squibb | January 2015 | IMPAACT P1026s (Momper et al)9 | Not currently recommended for use during pregnancy due to low cobicistat exposures during the second and third trimester of pregnancy8,55,66 |
| DRV/COBI (Prezcobix) | DRV 800 mg COBI 150 mg |
Janssen | January 2015 | IMPAACT P1026s (Momper et al)64 | Not currently recommended for use during pregnancy due to low cobicistat exposures during the second and third trimesters of pregnancy 8,55,66 |
| LPV/RTV (Kaletra) | LPV 100 mg RTV 25 mg or LPV 200 mg RTV 50 mg |
Abbvie | September 2000 | PACTG (IMPAACT) 1026s (Stek et al)89 (Mirochnick et al)37 (Best et al)36 | With standard 400 mg/100 mg twice daily dosing, reduction of LPV plasma concentrations during pregnancy of ~30% compared to nonpregnant adults. 89–91 May increase LPV/r to 600 mg/150 mg twice daily.36,37 |
ATV, atazanavir; DRV, darunavir; EVG, elvitegravir; FTC, emtricitabine; LPV, lopinavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
Pharmacokinetics of Newly Developed Antiretroviral Agents in HIV-Positive Pregnant Women (PANNA), an ongoing, nonrandomized, open-label, multicenter study of antiretroviral pharmacokinetics in pregnant women with HIV in Europe.
International Maternal Pediatric Adolescent AIDS Clinical Trials (formerly Pediatric AIDS Clinical Trials Group) (IMPAACT P1026s), an ongoing, nonrandomized, open-label, multicenter study of antiretroviral pharmacokinetics in pregnant women with HIV in the United States, Brazil, Thailand, and Africa.