Doravirin suppresses HIV more effectively than the combination of darunavir / ritonavir
An experimental non-nucleoside reverse transcriptase inhibitor (NNRTI), Doravirin, showed greater efficacy in suppressing the viral load of HIV than that of darunavir / ritonavir. These are the results of clinical studies of the 3 phases obtained after 96 weeks of observation and presented last week in Amsterdam at the 22nd International AIDS Conference (AIDS 2018).
According to specialists, after almost two years of therapy, a suppressed viral load (less than 50 copies / ml) was observed in 73% of people receiving Doravirin, while only 66% of those who used darunavir / ritonavir achieved such VN.
Scientists added that for the entire time of observation only two people developed resistance to Doravirin.
Doravirin is the newest NNRTI. Laboratory studies have shown that the drug is effective against both the wild type virus and against HIV with mutations that give it resistance to other NNRTI drugs.
The results of the phase 3 study presented at the IAS 2017 conference showed that a fixed dose regimen containing doravirin, tenofovir and lamivudine is not inferior to efavirenz, tenofovir and emtricitabine.
In turn, the DRIVE-FORWARD study (phase 3), which included "naive" HIV-positive patients, was to show whether Doravirin is effective in the efficacy of the duranavir / ritonavir-based protease inhibitor when used in combination with two nucleoside reverse transcriptase inhibitors (NRTIs).
After 48 weeks of therapy, 83% of patients receiving doravirin had undetectable viral load. In comparison, only 80% of people taking darunavir / ritonavir achieved the same results.
Researchers continued to monitor the drug until 96 weeks. In addition to data on virological suppression, scientists were also interested in indicators of cessation of treatment, safety and changes in lipid profiles.
CI was multicenter, randomized and double-blind. A total of 766 people took part in it (383 for each drug). Approximately three quarters of them were white, and the average age was 35 years. At baseline, the average number of CD4 cells was 422 cells / mm3, and the average viral load was slightly more than 25,000 copies / ml.
At week 96, 73% of the patients receiving Doravirin and 66% of the people in the darunavir / ritonavir group had a viral load of less than 50 copies / ml. In this case, the effectiveness of Doravirin was not related to the initial viral load.
Only two people stopped taking the drug because of the developed resistance. The profile of side effects was also quite mild (digestive tract disorders, headaches were observed only in a third of those taking Doravirin).
Changes in blood lipids also showed the benefit of the newest NNRTI. LDL cholesterol moderately decreased in people taking Doravirin, compared with participants using a protease inhibitor. Here the index showed an increase of 14 mg / dl.