Evaluation of Haemostatic and Inflammatory Parameters in Treatment-Naïve and Non-Naïve HIV-Positive Subjects: Demographic Characteristics and Exploratory Analysis by Marital Status

Aims: This study evaluated and compared prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-α) among treatment-naïve HIV-positive subjects, non-naïve HIV-positive subjects and HIV-negative controls, and explored these parameters in relation to marital status. Study Design: A cross-sectional comparative study. Methodology: One hundred and fifty adults aged 20–60 years were recruited from clinical and community sources. They comprised 35 treatment-naïve HIV-positive subjects, 50 non-naïve HIV-positive subjects who had received first-line antiretroviral therapy, mainly tenofovir/lamivudine/dolutegravir, for at least six months, and 65 apparently healthy HIV-negative controls. PT and APTT were determined manually, fibrinogen was measured by the Clauss method using an STA-Compact coagulation analyser, and IL-6 and TNF-α were measured by sandwich ELISA. Overall group summaries were reconciled from the reported marital-status subgroup counts, means and standard deviations. One-way ANOVA and Bonferroni-adjusted pairwise comparisons were applied. Results: After internal reconciliation, significant overall group differences were present for PT (F = 70.327, p < 0.001), fibrinogen (F = 566.548, p < 0.001), IL-6 (F = 468.598, p < 0.001) and TNF-α (F = 441.026, p < 0.001), but not APTT (F = 2.494, p = 0.086). For PT, fibrinogen, IL-6 and TNF-α, all three group pairs differed after Bonferroni adjustment (all adjusted p < 0.001). No APTT pairwise comparison was significant. The marital-status analysis was exploratory; an unadjusted group-by-marital-status interaction was detected for fibrinogen (F = 4.516, p = 0.013) but not for PT, APTT, IL-6 or TNF-α. Conclusion: The three study groups differed in PT, fibrinogen, IL-6 and TNF-α, whereas the reconciled APTT analysis did not show a statistically significant group difference. Because this was a cross-sectional comparison of distinct participants, the observed differences cannot be attributed causally to antiretroviral therapy. The marital-status findings do not establish independence from, or modification by, marital status and require confirmation in adequately powered analyses with relevant clinical covariates.