Objective: To investigate the effect of a short course of HAART during primary HIV infection (PHI) on rate of CD4 cell and viral load change.
Methods: Data following HAART cessation from 89 individuals (seroconverting 1999–2003) who chose to take a 3 month course of HAART at PHI were compared with 179 untreated controls in CASCADE, using linear and nonlinear random effects models. Participants were non-randomized but frequency matched for age, sex, risk factor, year of seroconversion and presentation within the first 6 months of seroconversion. Time to CD4 cell count < 350 cells/μl and initiation of clinically indicated antiretroviral therapy (ART) were also compared as competing risks.
Results: The rate of CD4 cell decline following therapy cessation appeared significantly slower among treated participants than untreated controls: losses of 51 cells/μl [95% confidence interval (CI), 32–69] and 77 cells/μl (95% CI, 65–89), respectively, 3 years after seroconversion (P = 0.011). Based on extrapolated data, viral loads also differed significantly at this point (4.09 and 4.53 copies/ml, respectively). At 2 years, there was no significant difference in mean viral load levels: 4.31 copies/ml (95% CI, 4.14–4.48) and 4.47 copies/ml (95% CI, 4.28–4.66), respectively. CASCADE seroconverters were more likely to reach CD4 cell count < 350 cells/μl or initiate clinically indicated ART (hazard ratio, 1.45; 95% CI, 1.02–2.05; P = 0.039).
Conclusion: A short course of ART at PHI may delay CD4 cell decline. Confirmation of this requires a randomized clinical trial powered to address definitively the role of ART intervention in PHI (currently underway through SPARTAC).