Safety, Pharmacokinetics and_Antiviral Activity of a Novel HIV Antiviral, ABX464, in Treatment- Naïve HIV Infected Subjects: a Phase II Randomized, Controlled Study [PublishAheadOfPrint]

We investigated the safety and anti-viral effects of an anti-HIV compound (ABX464) with a unique mechanism of viral replication inhibition. This was a randomized, double blind, placebo controlled, dose- ranging study in treatment naïve HIV infected patients. Participants were assigned to eight groups; each group included 8 subjects receiving either the study compound, ABX464 (n=6) or corresponding placebo (n=2), according to a randomization code. The first dose administered was 25 mg, given once or 3 times a day over a 2 to 3-week period. Ascending doses up to 150 mg were delivered after review of the safety data. The primary objective of the study was to assess safety and tolerability of ABX464 after repeated oral administrations in subjects infected by HIV. Sixty-six (66) subjects were enrolled and were randomized. Sixty-three (63) subjects completed the study according to the study protocol. Twenty-one (21) AEs were reported by 7 subjects out of 16 (44%) who received placebo and 158 AEs were reported by 39 subjects out of 50 (78%) who received the study drug. In the ABX464 treatment group, all of these adverse events were mild to moderate. No subjects discontinued treatment due to drug related AE's. Administration of ABX464 up to 150 mg, once a day was safe and well tolerated in HIV infected subjects. An efficacy signal with respect to reduction of viral load by ABX464 was detected, mainly in subjects treated at the highest dose. Further studies will be required to demonstrate anti-viral effects in HIV- infected subjects in combination with other anti-retroviral therapies.

http://ift.tt/2rkXpU9