Dual nucleoside regimens in nonadvanced HIV infection: Prospective follow-up of 130 patients, Aquitaine Cohort, 1996 to 1998

Objective: To describe the response to combinations of two nucleoside rever se transcriptase inhibitors (NRTIs) initiated early in the course of HIV in fection under routine circumstances and to research prognostic factors indi cating good virologic response. Setting: Patients of the Aquitaine Cohort, a hospital-based open cohort tha t had been recruiting since 1987 in five public hospitals of the Aquitaine region in southwestern France. Methods: Prospective cohort study of antiretroviral-naive patients with CD4 (+) cell counts >0.350 x 10(9)/L who started dual NRTI therapy between Janu ary 1996 and June 1997. Intent-to-treat analysis and multivariate logistic regression were used with data collected up to March 31, 1998. Results: In this study, 130 patients were enrolled with a median follow-up of 14 months. At the time of first prescription, 79% were in U. S. Centers for Disease Control and Prevention (CDC) group A, 16% in group B, and 5% in group C; median CD4(+) cell count was 0.466 x 10(9)/L and median HIV RNA l evel was 4.52 log(10) copies/ml. The two main combinations used were zidovu dine (AZT) plus zalcitabine (ddC; 38%) and AZT plus didanosine (ddI; 37%). At week 52, median CD4(+) and HN RNA responses were, respectively, +80 cell s and -1.6 log; the proportions of patients with HIV RNA level <5000 and <5 00 copies/ml were 70% and 45%, respectively, and 96% of the patients had a CD4(+) cell count >0.350 x 10(9)/L at that time. At their last follow-up, 3 patients had reached been diagnosed with full-blown AIDS and the AIDS-free survival probability at 1 year was 98.2% (95% confidence interval [CI], 93 .1-99.6); 1 death had occurred. The only significant variable associated wi th an undetectable HIV RNA level at 1 year was a lower HIV RNA level at the first prescription of dual therapy. Conclusion: Our data indicate that dual nucleoside combinations could be a therapeutic option for patients diagnosed and observed during follow-up in the early course of HIV infection.