Effect of Randomized HAART on Viral Suppression off Therapy in Patients with Acute/Early HIV Infection
Joseph Margolick*1, L Apuzzo1, H Tossonian2, J Singer3, C Fraser4, M Loutfy5, A Rachlis6, P El-Helou7, K Kasper8, and B Conway2
1Johns Hopkins Univ Bloomberg Sch of Publ Hlth, Baltimore, MD, US; 2Univ of British Columbia, Vancouver, Canada; 3Canadian Inst of Hlth Res Canadian HIV Trials Network, Vancouver; 4Cool Aid Community Hlth Ctr, Victoria, Canada; 5Maple Leaf Med Clin, Toronto, Canada; 6Sunnybrook Hlth Sci Ctr, Toronto, Canada; 7Hamilton Hlth Sci, McMaster Univ Med Ctr, Canada; and 8Hlth Sci Ctr, Winnipeg, Canada
Background: The optimal treatment for acute/early HIV infection is still controversial. Early treatment with HAART may allow more effective immune suppression of viral replication, a possibility that has been supported in recent randomized trials in acute infection. Little is known about the natural history of acute/early HIV infection in this group or the response to HAART if initiated at this stage of disease.
Methods: We studied viral suppression in patients randomized to immediate treatment with HAART for 12 months or deferred treatment, in patients diagnosed within the first year of HIV infection. We evaluate the number of patients in each arm who had not initiated HAART (based on CD4 cell count <350/µL) at 24 months after study entry in the deferred treatment arm or 24 months after cessation of HAART (i.e., 36 months after study entry) in the immediate treatment arm, and the distributions of viral load in each group at this time point. The hypotheses tested were that viral load would be lower and CD4 cell count greater in the immediate treatment group. Statistical significance of differences was assessed by Fisher’s exact test, 2-sided.
Results: One hundred and thirteen patients were enrolled (57 in the immediate treatment arm, 56 in the deferred treatment arm). The arms did not differ in proportion of those infected within 2 months of study entry. Eleven (19.2%) patients in the immediate treatment arm had not reinitiated HAART at 24 months off treatment, while only 4 (7.1%) patients in the deferred treatment arm had not initiated HAART by 24 months on study (p = 0.09). Viral load set point at 24 months in those who had not (re)initiated HAART was <10,000 copies/mL in 10 (17.5%) patients in the immediate treatment arm, compared to 3 (5.4%) in the deferred treatment arm (p = 0.07).
Conclusions: The group randomized to immediate HAART for 12 months had more people who remained off therapy, and more with low viral loads (<10,000 copies/mL) at 24 months without treatment than did the group randomized to deferred therapy. This suggests a benefit of immediate HAART to the immune response that controls HIV replication in patients treated within the first year of HIV infection. Whether a clinical benefit exists will require further follow up.