Doravirine, Lamivudine, and Tenofovir Disoproxil
Class: HIV Nonnucleoside Reverse Transcriptase Inhibitors
Chemical Name: 3-chloro-5-[1-[(4-methyl-5-oxo-1H-1,2,4-triazol-3-yl)methyl]-2-oxo-4-(trifluoromethyl)pyridin-3-yl]oxybenzonitrile
Molecular Formula: C17H11ClF3N5O3C8H11N3O3SC9H14N5O4P • H2O
CAS Number: 1338225-97-0
Warning
- HBV Infection
Severe, acute exacerbations of HBV infection reported following discontinuance of lamivudine 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 doravirine/lamivudine/tenofovir DF is 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 doravirine, lamivudine, and tenofovir disoproxil fumarate (doravirine/lamivudine/tenofovir DF). Doravirine is an HIV nonnucleoside reverse transcriptase inhibitor (NNRTI), lamivudine is an HIV nucleoside reverse transcriptase inhibitor (NRTI), and tenofovir DF is an HIV nucleotide reverse transcriptase inhibitor classified as an NRTI.
Uses for Doravirine, Lamivudine, and Tenofovir Disoproxil
Treatment of HIV Infection
Treatment of HIV-1 infection in antiretroviral-naive (have not previously received antiretroviral therapy) or antiretroviral-experienced (previously treated) adults.
Fixed combination of doravirine/lamivudine/tenofovir DF used alone as a complete regimen for treatment of HIV-1 infection; use with other antiretrovirals not recommended.
For initial treatment in antiretroviral-naive adults, experts state that doravirine/lamivudine/tenofovir DF is a recommended NNRTI-based regimen in certain clinical situations.
For antiretroviral-experienced adults, manufacturer states that doravirine/lamivudine/tenofovir DF 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 who have no history of treatment failure and are infected with HIV-1 with no known substitutions associated with resistance to doravirine, lamivudine, or tenofovir DF.
Most appropriate antiretroviral regimen cannot be defined for every clinical scenario; select regimen based on information regarding antiretroviral potency, potential rate of resistance development, known toxicities, potential for pharmacokinetic interactions, and patient's virologic, immunologic, and clinical characteristics. Guidelines for the management of HIV infection, including specific recommendations for initial treatment in antiretroviral-naive patients and recommendations for changing antiretroviral regimens, are available at [Web].
