Cenicriviroc effective, led to fewer discontinuations in HIV patients
ATLANTA — Preliminary results from an ongoing, phase 2b, 48-week trial comparing cenicriviroc with efavirenz, combined with emtricitabine/tenofovir, and efavirenz alone suggest the combination therapy is effective and led to fewer discontinuations from adverse events.
Joseph Gathe, MD, of Therapeutic Concepts in Houston, presented the 24-week data during an oral abstract session at the 2013 Conference on Retroviruses and Opportunistic Infections.
“Importantly, the endpoints of this study are not just virologic control or increases in CD4, but whether or not we are having action and activity against the inflammatory pathways, whether or not we are having action against the metabolic side effects we are seeing in our patients and whether or not we can make a significant impact on some of these other endpoints that are not simply control of HIV viral load,” Gathe said.
For the randomized, double blind, double dummy, comparative study, Gathe and colleagues assigned 143 adults (94% male; 62% white) in a 2:2:1 fashion to either 100 mg or 200 mg cenicriviroc (Tobira Therapeutics) after breakfast or standard of care 600 mg efavirenz with emtricitabine/tenofovir (Truvada, Gilead) at bedtime. Primary endpoint was percentage of patients with HIV-1 RNA <50 copies/mL at week 24 and assessment of safety.
Virologic success at week 24 was achieved in 76% of patients assigned 100 mg cenicriviroc, in 73% of those assigned 200 mg cenicriviroc and in 71% of those assigned efavirenz. The virologic non-response rate was 14% for 200 mg cenicriviroc, 12% for 100 mg cenicriviroc and 4% for efavirenz. CD4 cell counts increased across all groups from baseline.
Total and LDL cholesterol decreased in the cenicriviroc arms, whereas HDL, LDL and total cholesterol increased in the efavirenz arm.
“The reason why we need new drugs is because the mortality rate in HIV patients is still higher than in the age-matched population,” Gathe said. “For this study, patients had to take four pills in the morning with breakfast and another pill at bedtime. Compared with modern day HAART, this was a difficult regimen for patients to adhere to. Based upon this study, we will move forward with phase 3 studies where cenicriviroc will be administered in a single tablet regimen in combination with some of the other [antiretroviral] agents available.”
For more information:
Gathe J. #106LB. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6; Atlanta.
Disclosure: Gathe reports no relevant financial disclosures.