• Is HAART for Primary/Early HIV Infection Associated With Improved Outcomes After Treatment Discontinuation? (Poster 519)
  Authored by F.M. Hecht, L. Wang, A. Collier, J. Margolick, S. Little, M. Kilby, C. Benson, B. Conway, E. Daar, M. Markowitz, S. Holte
  View the original abstract

I perused the posters on treatment of primary infection and choose this one as the most interesting for clinicians. Though many treatment guidelines suggest that persons should be treated with HAART during primary infection, that recommendation does not have a strong evidence basis. In this study, Hecht and colleagues assembled an impressive data set involving 231 persons identified within 52 weeks of their seroconversion. For this study they compared the key surrogate marker parameters once off therapy for study subjects treated with HAART versus no treatment. Treatment was defined as >12 weeks of HAART and treatment then had to be stopped for >4 weeks. The primary endpoint was the CD4 T-cell and viral load data 24 weeks off treatment versus the 24 week data for the untreated sub-group. This analysis thus asks the important question "Does treatment early in infection result in a benefit observable once treatment is stopped?"

The median duration of HAART was 77 weeks. The average age of the study subjects was 34 with 91 percent being male and >66 percent Caucasian. Other key baseline features of the two groups are summarized below:

For this analysis, data from 62 patients in the Rx group for whom 24-week-off-HAART data was available was compared with 24-week observational data for 59 of the no Rx group study subjects. That comparison is summarized (adjustments made for initial viral load and time from infection to study enrollment) below:

In the absence of a randomized clinical trial, this study attempts to compare how well recently infected patients are doing either after 24 weeks of a no-treatment observation period, or 24 weeks after stopping HAART with an average treatment duration of 77 weeks. The treatment group had an overall 0.5 log lower RNA level and a 100 higher CD4 count. The benefit of treatment was greatest among those starting treatment within six weeks of enrollment. The difference is even more impressive when one considers that the no-treatment group had lower RNA levels and higher CD4 counts at baseline (which may have influenced their decision to not receive treatment). So how does this study influence the debate as to whether patients seen early after HIV infection should be routinely offered HAART? It is not surprising that the Rx group had more favorable surrogate marker parameters at their presumed set-point off treatment.

Although that more favorable status likely will translate into a significant delay in reaching the threshold when treatment would be restarted, long-term data is lacking. Furthermore, that cohort likely was composed of a group of largely gay white males who were highly motivated to take their medications under the auspices of careful monitoring in a clinical trial setting. During the >1.5 years of HAART, they were exposed to the potential for side effects and resistance but had minimal increased protection against AIDS progression given the high overall CD4 count range. The no-Rx group could well match the surrogate marker status of the Rx group if they wait until their CD4 count reached 350 cells/mm³ and then take 77 weeks of HAART.

From my perspective this is a nice study that provides reassurance that both approaches may be reasonable but that there may be some modest initial benefit to early therapy in motivated and well monitored patients.

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