Background: In patients with HIV, immune reconstitution after antiretroviral therapy (ART) is often incomplete. We assessed the probability of patients reaching a CD4/CD8 ratio of 1 or more after the start of ART and its association with the onset of non-AIDS-defining events and death. Methods: We did an analysis of the ICONA cohort, which recruited treatment-naive patients with HIV in Italy. We included participants in the cohort who started ART, reached an undetectable viral load (â¤80 copies per mL), and had a CD4/CD8 ratio of less than 0Â·8 at the time of an undetectable viral load. We defined ratio normalisation in patients as two consecutive values of 1 or more. We used Kaplan-Meier curves to estimate the cumulative probability of ratio normalisation. We then used Poisson regression models to identify factors independently associated with normalisation and with progression to non-AIDS-defining events or death. Findings: We included 3236 participants, enrolled between Jan 22, 1997, and Feb 25, 2013. At the start of ART, median CD4/CD8 ratio in our population was 0Â·39 (IQR 0Â·26-0Â·55). 458 (14%) patients reached a CD4/CD8 ratio of 1 or more; the estimated probability of normalisation was 4Â·4% (95% CI 3Â·7-5Â·2) by 1 year from baseline, 11Â·5% (10Â·2-13Â·0) by 2 years, and 29Â·4% (26Â·7-32Â·4) by 5 years. Factors associated with normalisation were high pre-ART CD4 cell counts, a high CD4/CD8 ratio at baseline, and negative cytomegalovirus serological findings. The incidence rate of non-AIDS-defining events for patients with a CD4/CD8 ratio of less than 0Â·30 (4Â·2 per 100 patient-years, 95% CI 3Â·4-5Â·3) was double that for those with a ratio of 0Â·30-0Â·45 (2Â·3, 2Â·1-2Â·5) or more than 0Â·45 (2Â·2, 1Â·7-2Â·9). A ratio of less than 0Â·30 was independently associated with an increased risk of non-AIDS-defining events or death compared with one of more than 0Â·45. Interpretation: Few patients had normalised CD4/CD8 ratios, even though they had viral suppression. Low ratios were associated with increased risk of serious events and deaths. The CD4/CD8 ratio could be used by clinicians to identity patients at risk of non-AIDS-related events. Funding: AbbVie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp & Dohme, ViiV Italy.
|Titolo:||CD4/CD8 ratio normalisation and non-AIDS-related events in individuals with HIV who achieve viral load suppression with antiretroviral therapy: An observational cohort study|
|Data di pubblicazione:||2015|
|Appare nelle tipologie:||01.01 - Articolo su rivista|