AVANTI 1 Shows Immunological Benefit for Loviride

Results from a multicenter clinical trial called AVANTI-1 conducted in Europe, Canada and Australia were presented by Professor Rozenbaum at the National Conference on Retroviruses and Opportunistic Infections in Washington, D.C. Loviride, a new nonnucleoside reverse transcriptase inhibitor manufactured by Janssen Pharmaceuticals at a dose of 100 mg three times daily in combination with AZT and 3TC was compared to AZT and 3TC in a double blind, randomized trial which enrolled 106 antiretroviral naive patients with CDC Group A or B/C stage disease.The average HIV viral loads were 4.8-4.9 and CD4 counts were 270 in each group. The primary endpoint was the degree and duration of the reduction in HIV viral load and safety and tolerance of the regimens. After 52 weeks of follow-up the average viral load reduction was 1.3 logs in the AZT + 3TC group and 1.6 logs in the triple combination group; a statistically significant difference, as was the median rise in CD4 counts (55 versus 98 cells, respectively). Although at 8 weeks of follow-up >50% of the patients in the triple drug arm had viral loads below the level of detection (< 500 copies/ml), the effect was not sustained, and after 52 weeks 11% versus 20% of the patients in each arm were undetectable, a non-significant difference. The CD4 response however was more durable; with a median rise of 127 cells from baseline in the triple drug arm, compared to 69 cell rise in the double drug arm. The only adverse effect that was more common in the 3 drug group was nausea which occurred in 20% versus 10% in the AZT + 3TC + loviride and AZT + 3TC arms, respectively. Withdrawal rates for serious adverse effects were similar (15% versus 11%). The authors of the study concluded that the immunological effects of the triple combination were superior although the viral load reductions were similar.