Evaluation of Haemostatic and Inflammatory Parameters in Treatment-Naïve and Non-Naïve HIV-Positive Subjects: Demographic Characteristics and Exploratory Analysis by Marital Status
I. Okon, Betini *
Department of Medical Laboratory Science (Haematology and Blood Transfusion Science), Faculty of Health Sciences, Madonna University Nigeria, Elele, Rivers State, Nigeria.
I. Eze, Richard
Department of Medical Laboratory Science (Haematology and Blood Transfusion Science), Faculty of Health Sciences, Madonna University Nigeria, Elele, Rivers State, Nigeria.
Eledo, Benjamin
Department of Medical Laboratory Science (Haematology and Blood Transfusion Science), Faculty of Health Sciences, Madonna University Nigeria, Elele, Rivers State, Nigeria.
*Author to whom correspondence should be addressed.
Abstract
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.
Keywords: HIV, antiretroviral therapy, treatment-naïve, haemostasis, inflammation, prothrombin time, fibrinogen, interleukin-6, tumour necrosis factor-alpha, marital status