New NNRTI Doravirine as Effective as Efavirenz in People New to HIV Treatment
July 21, 2015
An oral presentation at the 2015 International AIDS Conference in Vancouver this week reported 24-week results comparing the new NNRTI doravirine to efavirenz. Both drugs were combined with emtricitabine/tenofovir (Truvada).
The new NNRTI doravirine may offer benefits compared with the other approved NNRTIs, rilpivirine (Edurant, Complera) and efavirenz (Sustiva, Atripla), neither of which are recommended as first line treatment in the US. Efavirenz tends to have neurological side effects for some people while rilpivirine is only recommended for people starting treatment with viral loads <100,000 and CD4 counts >200 cells.
A total of 108 people enrolled in each group: doravirine + Truvada or efavirenz + Truvada. All were new to treatment. The great majority (>90%) who enrolled were men, average age was 35, and nearly 80% were white. A little over 35% had viral loads >100,000 and median CD4 counts ranged from 402 to 430. Less than 10% had 100200 CD4s cells.
After 24 weeks, 88.9% on doravirine and 87.0% on efavirenz reached a viral load <200 copies. As for viral loads <40 copies, 73.1% on doravirine and 72.2% on efavirenz reached this level. The mean increase in CD4 counts was +154 cells for doravirine and +146 cells for efavirenz.
The rate of experiencing any adverse event was similar between the groups (75.9% on doravirine, 84.3% on efavirenz), although more serious adverse events occurred in the efavirenz group (0.9% vs. 4.6%). Higher rates of diarrhea, dizziness, abnormal dreams, nightmares and sleep disorders occurred with efavirenz.
As for lab abnormalities, doravirine appears less likely to increase LDL cholesterol (1.0% vs. 12.6%) and total cholesterol (3.8% vs. 17.3%). However, bilirubin levels were slightly higher in those on doravirine (3.7% vs. 0.9%).
Of those who stopped the study, 5% came from the doravirine group while 12% came from the efavirenz group.
So far, it appears doravirine suppresses HIV at high levels equal to efavirenz. If it continues to do well in study, we may see doravirine come to market within several years.
Read our earlier coverage of doravirine here.
Alan McCord is the director of education for Project Inform.
JM Gatell, et. al. Efficacy and Safety of Doravirine 100mg QD vs Efavirenz 600mg QD with TDF/FTC in ART-Naive HIV-Infected Patients: Week 24 Results. IAS 2015, Vancouver, Canada. July 1922, 2015.
This article was provided by Project Inform. Visit Project Inform's website to find out more about their activities, publications and services.
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