What is the role of the NNRTI doravirine in the treatment of HIV infection?

Updated: Jul 01, 2019
  • Author: Nicholas John Bennett, MBBCh, PhD, MA(Cantab), FAAP; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

The FDA approved the NNRTI doravirine in August 2018. Also with this new drug, a complete regimen combination containing doravirine/lamivudine (3TC)/tenofovir DF (TDF) was also approved. Approval was based on the DRIVE-FORWARD clinical trial (n=766). Patients who were antiretroviral-naïve were randomly assigned to once-daily treatment with doravirine or darunavir 800 mg plus ritonavir 100 mg (DRV+r), each in combination with emtricitabine (FTC)/TDF or abacavir (ABC)/3TC. Treatment with doravirine led to sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferiority compared with DRV+r, each in combination with FTC/TDF or ABC/3TC. At week 48, 84% of the doravirine group and 80% of the DRV+r group had plasma HIV-1 RNA levels of less than 50 copies/mL. [160]

The doravirine/3TC/TDF combination was approved based on data from the DRIVE-AHEAD trial (n=728). Patients who were antiretroviral-naïve were randomly assigned to once-daily treatment with doravirine/3TC/TDF or efavirenz (EFV)/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg). The doravirine/3TC/TDF combination provided sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferiority compared with EFV/FTC/TDF. At week 48, 84% of the doravirine/3TC/TDF group had plasma HIV-1 RNA levels of less than 50 copies/mL, as did 81% of the EFV/FTC/TDF group. [161]


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