Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate
Class: HIV Integrase Inhibitors
ATC Class: J05AX08
Chemical Name: 6-[(3-Chloro-2-fluorophenyl)methycypl]-1,4-dihydro-1-[(1S)-1-(hydroxymethyl)-2-methylpropyl]-7-methoxy-4-oxo-3-quinolinecarboxylic acid
Molecular Formula: C23H23ClFNO5C40H53N7O5S2C8H10FN3O3SC9H14N5O4P • H2O
CAS Number: 697761-98-1
Warning
- HBV Infection
Fixed combination of EVG/c/FTC/TDF not indicated for treatment of chronic HBV infection. Safety and efficacy of EVG/c/FTC/TDF not established in HIV-1 infected patients coinfected with HBV.
Severe, acute exacerbations of HBV reported following discontinuance of emtricitabine or tenofovir DF in patients coinfected with HIV and HBV. Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after EVG/c/FTC/TDF discontinued in patients coinfected with HIV and HBV. If appropriate, initiation of HBV treatment may be warranted. (See HIV-infected Individuals Coinfected with HBV under Cautions.)
Introduction
Antiretroviral; fixed combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (tenofovir DF) (EVG/c/FTC/TDF). Elvitegravir (EVG) is an HIV integrase strand transfer inhibitor (INSTI) antiretroviral; cobicistat is a CYP3A inhibitor used as a pharmacokinetic enhancer to decrease metabolism and increase plasma concentrations of EVG; emtricitabine (FTC) and tenofovir DF (TDF) are HIV nucleoside reverse transcriptase inhibitors (NRTIs).
Uses for Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate
Treatment of HIV Infection
Treatment of HIV-1 infection in antiretroviral-naive (have not previously received antiretroviral therapy) or antiretroviral-experienced (previously treated) adults and pediatric patients ≥12 years of age.
Fixed combination of EVG/c/FTC/TDF used alone as a complete regimen for treatment of HIV-1 infection; do not use with other antiretrovirals.
For initial treatment in antiretroviral-naive adults, experts state EVG/c/FTC/TDF is a recommended INSTI-based regimen.
For initial treatment in HIV-infected pediatric patients, experts state that EVG/c/FTC/TDF is not a preferred or alternative regimen and is recommended only for children and adolescents ≥12 years of age who weigh ≥35 kg and are in late puberty (sexual maturity rating [SMR] 4 or 5).
For antiretroviral-experienced adults and pediatric patients ≥12 years of age, manufacturer states EVG/c/FTC/TDF can be used to replace the current antiretroviral regimen in those with plasma HIV-1 RNA levels <50 copies/mL on a stable antiretroviral regimen for ≥6 months who have no history of treatment failure and are infected with HIV-1 with no known substitutions associated with resistance to the antiretroviral components of..
