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).
From the aImperial College, St Mary's Hospital, London, UK
bAthens University Medical School, Greece
cMRC Clinical Trials Unit, London, UK.
Received 26 September, 2006
Revised 4 December, 2006
Accepted 18 January, 2007
Correspondence to Dr S. Fidler, Imperial College, St Mary's Hospital, London, UK. E-mail: email@example.com