Objectives: To compare immunological, virological and clinical outcomes in persons initiating combination antiretroviral therapy (cART of different durations within 6 months of seroconversion (early treated) with those who deferred therapy (deferred group).
Design: CD4 cell and HIV-RNA measurements for ‘early treated’ individuals following treatment cessation were compared with the corresponding ART-free period for the ‘deferred’ group using piecewise linear mixed models. Individuals identified during primary HIV infection were included if they seroconverted from 1st January 1996 and were at least 15 years of age at seroconversion. Those with at least 2 CD4 less than 350 cells/μl or AIDS within the first 6 months following seroconversion were excluded.
Results: Of 348 ‘early treated’ patients, 147 stopped cART following treatment for at least 6 (n = 38), more than 6–12 (n = 40) or more than 12 months (n = 69). CD4 cell loss was steeper for the first 6 months following cART cessation, but subsequent loss rate was similar to the ‘deferred’ group (n = 675, P = 0.26). Although those treated for more than 12 months appeared to maintain higher CD4 cell counts following cART cessation, those treated for 12 months or less had CD4 cell counts 6 months after cessation comparable to those in the ‘deferred’ group. There was no difference in HIV-RNA set points between the ‘early’ and ‘deferred’ groups (P = 0.57). AIDS rates were similar but death rates, mainly due to non-AIDS causes, were higher in the ‘deferred’ group (P = 0.05).
Conclusion: Transient cART, initiated within 6 months of seroconversion, seems to have no effect on viral load set point and limited beneficial effect on CD4 cell levels in individuals treated for more than 12 months. Its long-term effects remain inconclusive and need further investigation.
aDepartment of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece
bHôpital Edouard Herriot, France
cUniversité de Lyon, Lyon, France
dSouthern Alberta HIV Clinic, Calgary, Alberta, Canada
eBasel Institute for Clinical Epidemiology University Hospital, Basel, CH-4031 Basel, Switzerland
fMRC Clinical Trials Unit, London, UK.
* Members of CASCADE Collaboration are listed in the section ‘Acknowledgement’.
Received 13 June, 2008
Revised 9 September, 2008
Accepted 12 September, 2008
Correspondence to Dr Nikos Pantazis, Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, M Asias 75, Athens 11527, Greece. Tel: +30 210 7462088; fax: +30 210 7462205; e-mail: firstname.lastname@example.org