Prevalence of Dyslipidemia and Its Association with HAART Regimens among HIV-Positive Patients at Machakos Level V Hospital

Introduction

Human Immunodeficiency Virus (HIV) infection remains a leading global health concern, affecting over 38 million individuals worldwide and continuing to challenge healthcare systems, especially in sub-Saharan Africa [1]. The introduction of Highly Active Antiretroviral Therapy (HAART) has transformed HIV infection from a fatal disease into a chronic, manageable condition [2]. Despite its success, long-term HAART use has been linked to metabolic complications, notably dyslipidemia, which increases cardiovascular disease (CVD) risk and compromises overall health outcomes [3,5].

Dyslipidemia is defined by abnormalities in serum lipid levels — elevated total cholesterol (TC), triglycerides (TG), or low- density lipoprotein cholesterol (LDL-C), and/or reduced high- density lipoprotein cholesterol (HDL-C) [6]. In HIV-infected individuals, dyslipidemia arises from both viral effects and drug- induced metabolic alterations. HIV infection promotes chronic inflammation and cytokine dysregulation, which affect lipid metabolism. HAART compounds these effects through direct biochemical interference with lipid synthesis, transport, and clearance [7]. Different antiretroviral drug classes influence lipid metabolism through specific mechanisms. Protease inhibitors (PIs) alter lipid regulation by inhibiting hepatic sterol regulatory element- binding proteins (SREBPs), disrupting triglyceride synthesis and LDL receptor recycling, and increasing circulating LDL-C and TG [8,9]. Non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, induce hepatic cytochrome P450 enzymes that may enhance cholesterol production [10]. Conversely, integrase strand transfer inhibitors (INSTIs), like dolutegravir, generally show neutral or favorable lipid effects [11]. These drug-induced alterations elevate atherogenic indices, including the total cholesterol to HDL-C (TC/HDL-C) ratio, and contribute to early- onset cardiovascular complications [12]. Therefore, monitoring lipid profiles in HAART-treated patients is essential for detecting metabolic disturbances and preventing adverse outcomes.

In sub-Saharan Africa, dyslipidemia prevalence among HAART users ranges between 60–80% [13–15], with Kenyan studies reporting similar figures [16]. However, there remains limited data on regimen-specific lipid effects in semi-urban populations such as Machakos County. Beyond clinical implications, this issue has substantial relevance to clinical chemistry education and practice. Laboratory professionals play a critical role in lipid testing, quality assurance, result interpretation, and communication with clinicians. Enhancing awareness of HAART-induced biochemical changes among medical laboratory scientists can improve diagnostic accuracy and patient management. This study therefore aimed to determine the prevalence of dyslipidemia and its association with HAART regimens among HIV-positive patients attending Machakos Level V Hospital, Kenya, while drawing practical insights for laboratory practice and clinical chemistry education.

Materials & Methods

Study Design and Setting

A cross-sectional study was conducted at the Comprehensive Care Clinic (CCC) of Machakos Level V Hospital, a major referral facility serving Machakos County and neighboring regions.

Study Population

The study population comprised HIV-positive adult patients on HAART for at least three months. Participants with diabetes, acute illness, or those on lipid-lowering medication were excluded.

Sample Size and Sampling Technique

A total of 406 participants were selected using systematic random sampling from the CCC registry.

Data and Sample Collection

Structured questionnaires were used to gather demographic and clinical data. After overnight fasting, 5 mL of venous blood was collected, serum separated, and analyzed immediately or stored at −20 °C until testing.

Laboratory Analysis

Lipid parameters (TC, TG, HDL-C, and LDL-C) were analyzed using enzymatic colorimetric methods with the H600 autoanalyzer system. LDL-C was calculated using the Friedewald formula. Internal quality control was maintained using commercial control sera before every analytical run.

Definition of Dyslipidemia

Dyslipidemia in this study was defined according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP- ATP III) criteria. It was characterized by one or more abnormalities in serum lipid levels, including total cholesterol (TC) greater than 5.2 mmol/L, triglycerides (TG) greater than 1.7 mmol/L, or low- density lipoprotein cholesterol (LDL-C) greater than 3.4 mmol/L. High-density lipoprotein cholesterol (HDL-C) levels less than 1.0 mmol/L for males or less than 1.3 mmol/L for females were also considered abnormal. Participants who exhibited any one or more of these lipid abnormalities were classified as having dyslipidemia.

Data Analysis

Data were analyzed using SPSS v28. Descriptive statistics sum- marized demographic and lipid data. Associations between dyslip- idemia and HAART regimens were tested using Chi-square, and odds ratios (ORs) were estimated at 95% confidence intervals. A p-value < 0.05 denoted statistical significance.

Ethical Considerations

Ethical approval was obtained from Kenyatta University Ethics Review Committee (KU-ERC). Permission was granted by the National Commission for Science, Technology, and Innovation (NACOSTI). Written informed consent was obtained from all participants.

Results

A total of 406 HIV-positive participants were included, with a female majority and most aged between 35–54 years. The mean duration on HAART was 7.3 years, and a large proportion were on first-line regimens. 3.1. Lipid Profiles by HAART Regimen Participants were categorized into NNRTI-, PI-, and INSTI-based regimen groups. The TDF/3TC/DTG (INSTI-based) regimen accounted for the largest proportion (approximately 89.7%). Across all regimens, the mean serum concentrations for TC, TG, LDL-C, and HDL-C varied, but patients on PI-based regimens consistently displayed higher mean TC and LDL-C levels compared to NNRTI or INSTI users. The mean TC/HDL-C ratio also differed significantly among regimen groups (p = 0.046), indicating an elevated atherogenic risk among PI users. Logistic regression confirmed that PI users were four times more likely to present with high TC/HDL-C ratios (OR = 4.19, 95% CI = 1.03– 17.02). Other lipid parameters showed no statistically significant difference across HAART regimens (see Table 1).

Table 1: Lipid Profiles According to Haart for Hiv-Positive Patients on Haart at Machakos Level V Hospital

Prevalence of Dyslipidemia

The overall prevalence of dyslipidemia was 74.1% (301/406). Dyslipidemia was more frequent among males (75.9%) than females (73.4%), although the difference was not statistically significant (p = 0.707). Prevalence increased with age, peaking at 79.7% among participants aged ≥60 years, and was highest among obese participants (79.4%) compared to those with normal BMI (70.1%). By regimen, dyslipidemia was present in 79.3% of PI users, 73.1% of INSTI users, and 100% of NNRTI users, though not statistically significant (see Table 2). Hypertensive participants recorded a significantly higher prevalence (84.6%) compared to non-hypertensive ones (p = 0.044).

Discussion

This study established that 74.1% of HIV-positive patients on HAART at Machakos Level V Hospital exhibited dyslipidemia. This finding aligns with studies in Kenya [13,16]. Ethiopia , and Cameroon, which report prevalence rates of 60–80% [17]. The consistently high burden of lipid abnormalities among HAART users across Africa reflects the dual influence of prolonged therapy and emerging non-communicable disease risks in this population [18]. Patients on protease inhibitor (PI) regimens had significantly higher mean TC and LDL-C levels and elevated TC/HDL-C ratios compared to those on NNRTI or INSTI regimens. The TC/HDL-C ratio was a significant marker of atherogenic risk (p = 0.046). These findings support earlier observations by Taramasso et al., Ji et al. , and Su et al., who linked PI therapy with elevated cholesterol and triglycerides due to hepatic lipid dysregulation [19, 20].

Biochemically, PIs disrupt lipid homeostasis by inhibiting SREBPs and LDL receptor recycling, increasing VLDL secretion and TG synthesis. They also reduce peripheral lipolysis, promote insulin resistance, and induce lipodystrophy. These mechanisms collec- tively explain the high dyslipidemia prevalence observed in PI users. Conversely, INSTI-based regimensparticularly dolutegra- vir-based combinationsshowed more favorable lipid patterns, consistent with Bahar et al. and other multicenter studies that found INSTIs metabolically safer. Although differences by sex and age were not statistically significant, dyslipidemia tended to be higher among males and older adults (≥60 years), consistent with reports by Lloyd-Jones et al.. Obesity and hypertension were also posi tively associated, suggesting clustering of CVD risk factors in this population. The strong link between hypertension and dyslipid- emia (p = 0.044) highlights the importance of integrated metabolic screening in HIV care.

From a clinical chemistry perspective, these results emphasize the importance of routine lipid monitoring for patients on HAART, particularly those on PI-based regimens. Accurate lipid analysis requires adherence to pre-analytical standards (e.g., fasting sam- ples, proper centrifugation) and validated enzymatic colorimetric methods. Laboratories must maintain rigorous internal and exter- nal quality control, use traceable calibrators, and adhere to stan- dardized reporting formats to ensure diagnostic accuracy. Result interpretation should not stop at numerical reporting. Laboratory professionals should flag atherogenic ratios and provide interpre- tive comments guiding clinicians toward patient-centered man- agement. Integration of biochemical and clinical data enhances multidisciplinary decision-making and aligns with evidence-based care principles. This study also holds significance for medical laboratory education and capacity building. Training programs should integrate HAART-related metabolic case studies into clinical chemistry curricula to strengthen understanding of drug-lipid interactions. Laboratory trainees should be exposed to interpretive reporting, cardiovascular risk assessment, and communication skills to support clinical teams. Continuing Professional Develop- ment (CPD) workshops can further improve competence in lipid testing and result interpretation.

These educational efforts would not only improve diagnostic ser- vices but also foster critical thinking among laboratory profes- sionals. Given Kenya’s growing population of PLHIV on lifelong therapy, HAART-related dyslipidemia represents an emerging public health challenge. Integrating routine lipid testing into HIV programs could facilitate early identification of high-risk individu- als and reduce long-term CVD burden. Public health interventions should emphasize lifestyle modification, periodic biochemical screening, and regimen adjustment where feasible.

In summary, the high dyslipidemia prevalence found underscores the metabolic toll of HAART, especially PI-based therapy. INSTI regimens appear more lipid-friendly, offering safer long-term options. Strengthening laboratory systems, ensuring analytical reliability, and embedding clinical interpretation in laboratory education are essential to addressing this biochemical complication of HIV therapy.

Conclusion and Recommendations

Dyslipidemia is prevalent among HIV-positive patients on HAART at Machakos Level V Hospital, particularly in those on PI-based regimens. The TC/HDL-C ratio serves as a practical indicator of atherogenic risk.

Recommendations:

1. Integrate regular lipid profiling into HIV management protocols.

2. Provide continuous laboratory staff training on lipid testing and interpretation.

3. Include HAART-induced metabolic monitoring in undergraduate and CPD curricula.

4. Conduct longitudinal research linking lipid changes with cardiovascular outcomes.

Acknowledgement

The authors wish to express their sincere gratitude to the manage- ment of Machakos Level V Hospital and the staff of the Compre- hensive Care Clinic for their invaluable support and cooperation during data collection. Special appreciation goes to Dr. Scholastica G. Mathenge and Dr. Nelson C. Menza for their dedicated supervi- sion, insightful guidance, and continuous encouragement through- out the research process. We also extend our thanks to Kenyatta University for providing ethical approval and academic mentor- ship, and to all the study participants for their willingness to take part in this work.

Conflict of Interest and Funding Declaration

The authors declare no conflict of interest.

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

References

1. Global, H. I. V. (2021). AIDS statistics—Fact sheet.
2. Eggleton,J.S.,&Nagalli,S.(2020).HighlyActiveAntiretroviral Therapy (HAART) StatPearls Publishing. Treasure Island, FL, USA.
3. Feeney, E. R., & Mallon, P. W. (2011). HIV and HAART- associated dyslipidemia. The open cardiovascular medicine journal, 5, 49.
4. Syengo, S. M. (2023). Lipid Profiles, Cardiovascular Disease Risk and Dyslipidemia in HIV-Positive Patients on HAART at Machakos Level Five Hospital, Machakos County, Kenya. KENYATTA UNIVERSITY.
5. Vargas Pacherrez, D. (2018). Fatores associados a hipertensão arterial em portadores de HIV/AIDS num centro de referência em Bahia, Brasil.
6. Hmiel, L., Zhang, S., Obare, L. M., Santana, M. A. D. O.,Wanjalla, C. N., Titanji, B. K., ... & Bagchi, S. (2024). Inflammatory and immune mechanisms for atherosclerotic cardiovascular disease in HIV. International journal of molecular sciences, 25(13), 7266.
7. SapuÅ?a, M., Suchacz, M., ZaÅ?Ä?ski, A., & WierciÅ?ska-DrapaÅ?o,A. (2022). Impact of combined antiretroviral therapy on metabolic syndrome components in adult people living with HIV: A literature review. Viruses, 14(1), 122.
8. Li, Y., Ji, Y., & Li, F. (2023). A review: Mechanism and prospect of gastrodin in prevention and treatment of T2DM and COVID-19. Heliyon, 9(11).
9. Moyo-Chilufya, M., Maluleke, K., Kgarosi, K., Muyoyeta, M., Hongoro, C., & Musekiwa, A. (2023). The burden of non-communicable diseases among people living with HIV in Sub-Saharan Africa: a systematic review and meta- analysis. EClinicalMedicine, 65.
10. Comte, B., Monnerie, S., Brandolini-Bunlon, M., Canlet,C., Castelli, F., Chu-Van, E., ... & Pujos-Guillot, E. (2021). Multiplatform metabolomics for an integrative exploration of metabolic syndrome in older men. EBioMedicine, 69.
11. Sever, B., Otsuka, M., Fujita, M., & Ciftci, H. (2024). A review of FDA-approved anti-HIV-1 drugs, anti-gag compounds, and potential strategies for HIV-1 eradication. International journal of molecular sciences, 25(7), 3659.
12. Papantoniou, E., Arvanitakis, K., Markakis, K., Papadakos, S. P., Tsachouridou, O., Popovic, D. S., ... & Kotsa, K. (2024). Pathophysiology and clinical management of dyslipidemia in people living with HIV: sailing through rough seas. Life, 14(4), 449.
13. Magara, G. M. (2022). Prevalence of Uncontrolled Hypertension and Associated Factors among Hypertensive Patients Attending Medical Outpatient Clinic, Thika Level 5 Hospital, Kiambu County, Kenya (Doctoral dissertation, JKUAT-COHES).
14. Kemal, A., Teshome, M. S., Ahmed, M., Molla, M., Malik, T., Mohammed, J., & Abate, K. H. (2020). Dyslipidemia and associated factors among adult patients on antiretroviral therapy in armed force comprehensive and specialized hospital, Addis Ababa, Ethiopia. HIV/AIDS-Research and Palliative Care, 221-231.
15. Dimala, C. A., Blencowe, H., & Choukem, S. P. (2018). The association between antiretroviral therapy and selected cardiovascular disease risk factors in sub-Saharan Africa: A systematic review and meta-analysis. PloS one, 13(7),e0201404.
16. Ji, C. (2023). Molecular factors and pathways of hepatotoxicity associated with HIV/SARS-CoV-2 protease inhibitors. International Journal of Molecular Sciences, 24(9), 7938.
17. Savinelli, S., Heeney, A., Tinago, W., Garcia Leon, A. A., McGettrick, P., Cotter, A. G., ... & HIV UPBEAT study group. (2025). People living with HIV on modern antiretrovirals do not display a pro�atherogenic lipid profile and have similar body composition compared to healthy controls. HIV medicine.
18. Kolovou, G. D., Kolovou, V., Kostakou, P. M., & Mavrogeni,S. (2014). Body mass index, lipid metabolism and estrogens: their impact on coronary heart disease. Current Medicinal Chemistry, 21(30), 3455-3465.
19. Lim, S. Y., Chin, B., Kim, M. K., Kim, G., & Kim, Y.(2025). Comparative analysis of lipid profile changes in treatment-naïve people living with HIV on INSTI-based single-tablet regimens, BIC/FTC/TAF and DTG/3TC: real- world evidence from South Korea. Journal of Antimicrobial Chemotherapy, 80(9), 2384-2390.
20. Lu, E., Chidambaram, V., Kumar, A., Aparicio, H. G. C., Golzar, Y., Pyslar, N., ... & Karakousis, P. C. (2025). Cholesterol efflux in HIV-associated atherosclerosis: mechanisms and targets. Trends in Molecular Medicine.