The effectiveness of doravirine in combination with other ARVTs is not inferior to DRV + r / EFV
The drug doravirin (DOR) as part of the 3-component HIV-1 therapy regimen is comparable in effectiveness to the combination of darunavir plus ritonavir (DRV + r) and efavirenza (EFV), follows from preliminary results of two ongoing clinical trials of phase III DRIVE-FORWARD (NCT02275780 ) and DRIVE-AHEAD (NCT02403674) presented at CROI-2019.
Doravirin, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is designed to treat wild-type HIV infection and the most common NNRTI-resistant variants of the virus (K103N, Y181C, G190A).
The DRIVE-FORWARD and DRIVE-AHEAD research data presented in Seattle included information on the antiviral activity of doravirine (DOR) in comparison with three-part therapy at 48 weeks of observation.
CI DOR groups were reported to be combined: 747 participants received doravirin in combination: DOR (doravirin) / 3TC (lamivudine) / TDF (tenofovir) or DOR (doravirin) (100 mg, 1 time per day) / FTC (emtricitabine ) / TDF (tenofovir), or ABC (abacavir) / 3TC (lamivudine).
Control groups were analyzed separately. In them, 383 participants received DRV + r (darunavir + ritonavir) (800/100 mg, 1 time per day) / FTC (emtricitabine) / TDF (tenofovir) or ABC (abacavir) / 3TC (lamivudine), and 364 - EFV ( efavirenz) / FTC (emtricitabine) / TDF (tenofovir) (600/200/300 mg, 1 time per day).
Efficiency was assessed by the proportion of participants with HIV-1 RNA <50 copies / ml (primary) and change in CD4 + T cells (secondary) after 48 weeks of treatment.
An analysis of the data showed that by the planned date, 84.1% of the participants taking DOR had reached undetectable viral load, against 79.9% of DRV + r and 80.8% in the EFV / FTC / TDF group.
At the same time, scientists did not reveal significant differences in the ratio of patient shares by demographic, gender, race and ethnicity.
Moreover, according to experts, doravirin, not inferior in effectiveness to efavirenz and darunavir, did not have clinically significant side effects and could be used without a booster.
The mean increase in CD4 + T cells by week 48 compared to baseline was 195.5 cells / mm3 for DOR, 185.6 cells / mm3 for DRV + r and 188.4 cells / mm3 for EFV / FTC / TDF.
Thus, according to the researchers, the DOR drug, administered in combination therapy with other antiretroviral drugs, including as part of a fixed dosage of DOR / 3TC / TDF, demonstrated a higher efficiency of suppressing viral load in blood and plasma in comparison with DRV + r and EFV.