519 Is HAART for Primary/Early HIV Infection Associated with Improved Outcomes After Treatment Discontinuation? F. M. Hecht*1, L. Wang2, A. Collier3, J. Margolick4, S. Little5, M. Kilby6, C. Benson7, B. Conway8, E. Daar9, M. Markowitz10, S. Holte2 1Univ of California at San Francisco; 2Fred Hutchinson Cancer Res Ctr, Seattle, WA; 3Univ of Washington, Seattle; 4Johns Hopkins, Baltimore, MD; 5Univ of California at San Diego; 6Univ of Alabama, Birmingham; 7Univ of Colorado, Denver; 8Univ of British Columbia, Vancouver, Canada; 9Univ of California at Los Angeles; and 10Aaron Diamond AIDS Res Ctr, New York, NY
Background: It is unknown whether HAART in primary/early HIV is associated with lower HIV RNA and higher CD4 cell counts once treatment is discontinued compared with untreated persons.
Methods: Participants in centers of the Acute Infection Early Disease Research Program were enrolled within 6 months (mos) of HIV seroconversion; they elected to start HAART with one of a variety of regimens or not to start treatment. We defined the treatment (Tx) group as persons who started HAART and continued for > 12 wks, then chose to stop Tx for > 4 wks. The untreated (UT) group consisted of persons who chose not to start HAART and had > 24 wks of f/u. The primary outcomes were defined as HIV viral load (VL) and CD4 count 24 wks from enrollment in the UT group compared to these measures 24 wks after Tx discontinuation in the Tx group. If there were < 24 wks of f/u off Tx in the Tx group, the last observations were carried forward.
Results: There were 61 persons in the Tx group and 134 in the UT group. The groups were similar in age, race, and sex. The estimated median time from infection to enrollment was 8 wks in the Tx group vs 12.7 wks in the UT group (p < 0.001). Compared with the UT group, the Tx group had a higher baseline mean logVL (4.9 vs 3.9, p < 0.001) and lower median CD4 count (519 vs 593, p = 0.006). The median duration of HAART was 78 wks in the Tx group (range 14-227). At the 24 wk outcome, the mean logVL was 3.86 for the Tx group and 3.91 for UT group (p > 0.1). After adjusting for baseline VL and estimated wks from infection, the adjusted mean logVL was 3.29 for Tx group compared to 4.14 for UT group (p < 0.0001). Five (5) persons treated pre-seroconversion had a mean pre-Tx logVL of 5.41; post-Tx it was 3.72 unadjusted, 2.81 adjusted. The unadjusted and adjusted CD4 counts at 24 wks in the Tx group were 656 and 704, respectively, compared with 594 (p = 0.06) and 595 (p = 0.10) in the UT group.
Conclusions: After controlling for baseline differences, the data suggest treating very early HIV was associated with lower VL and higher CD4 counts 24 wks after stopping treatment. However, the lack of clear benefit in unadjusted analyses and limitations of statistical adjustments to compensate for baseline differences suggest that randomized controlled trials would be useful to definitively assess the role of treatment in primary HIV infection.
