Dolutegravir-based antiretroviral therapy-associated hyperglycemia in persons living with human immunodeficiency virus in Niger: a multicentric cross-sectional study

Background: Growing evidence from clinical and experimental research suggests that dolutegravir is associated with hyperglycemia. This study aimed to determine the prevalence of hyperglycemia and its associated factors among persons living with human immunodeficiency virus (PLWH) on dolutegravir-based antiretroviral therapy in Niger.

Methodology: This was a retrospective multicentric cross-sectional study carried out using data from PLWH who had been examined between January 2022 and June 2024. Data were collected from July to September 2024. PLWH aged 18 years or older who had been on dolutegravir-based antiretroviral therapy for more than three months were enrolled in the study. Hyperglycemia was defined as a fasting plasma glucose level ≥7.0 mmol/L. A multivariable logistic regression analysis was conducted in RStudio version 4.4.1 to identify factors associated with hyperglycemia. Variables with a p-value less than 0.05 were considered statistically significant.

Results: A total of 633 records were reviewed during the study period, of which 39.0% (n = 247) had baseline blood glucose levels and were included in this analysis. The mean age of patients was 38.9 ± 11.8 years. More than half of the patients (60.5%; n = 101) had a normal body mass index. The mean duration of the dolutegravir-based regimen was 13.9 ± 7.05 months. The prevalence of hyperglycemia was 36.4% (n = 51). In multivariate analysis, patients with primary (adjusted Odds ratio (aOR): 8.26; 95% CI: 1.47-62.00, p=0.024), secondary (aOR: 6.29; 95%CI: 1.12-48.28; p=0.051), and tertiary (aOR: 9.39; 95%CI: 1.34-89.92; p=0.034) educational levels, patients with a history of personal hypertension (aOR: 4.24; 95% CI: 1.17-17.18; p = 0.033) were significantly associated with hyperglycemia among PLWH on dolutegravir-based ART regimens.

Conclusion: The prevalence of hyperglycemia among PLWH on dolutegravir-based antiretroviral therapy regimens was relatively high in Niger. Educated PLWH and hypertension were identified as risk factors for hyperglycemia. Baseline and periodic monitoring of plasma glucose might be required in antiretroviral therapy containing dolutegravir care in Niger.

Introduction

The advent of antiretroviral therapy (ART) has significantly improved the prognosis of persons living with HIV (PLWH), transforming it from a fatal illness into a manageable chronic condition (1). Among widely used ART regimens, dolutegravir (DTG), an integrase strand transfer inhibitor (INSTI), has gained prominence for its potent antiviral activity, favorable safety profile, and high barrier to resistance (2). The World Health Organization (WHO) has endorsed DTG as the preferred first-line and second-line treatment for HIV, including for pregnant women and those of childbearing potential (3). This recommendation is based on evidence evaluating the benefits and risks of DTG, and it has been adopted by many countries in sub-Saharan Africa, including Niger (4).

However, several studies have investigated the relationship between people with HIV’s use of DTG and weight gain (5–7). DTG induces considerable weight gain in ART-naive individuals initiating DTG for the first time, according to recent studies including randomized trials conducted in sub-Saharan Africa (4, 8, 9). Additionally, ART-experienced patients tend to gain weight when transitioning from a protease inhibitor or non-nucleoside reverse transcriptase inhibitor-based regimen to a DTG-based regimen (7, 10). The exact mechanism of hyperglycemia in DTG-based therapy is not fully understood. One proposed mechanism involves magnesium interference, which could affect glucose transport and insulin signaling (11). Adiponectin expression was reduced in subcutaneous adipose tissue of macaques (12, 13). Despite DTG’s proadipogenic effect in vitro, it can impair adipocyte function, leading to insulin resistance and decreased secretion of leptin and adiponectin (14). Long-term DTG exposure can also reduce insulin-stimulated glucose transport and induce insulin resistance in adipocyte-differentiated adipose stem cells (12). DTG increases reactive oxygen species production, leading to mitochondrial dysfunction characterized by increased mitochondrial mass and decreased membrane potential in proliferating adipose stem cells and adipocytes (12). Elevated oxidative stress levels have been associated with insulin resistance in vitro and in obese individuals (15, 16).

According to a study performed in Uganda, more than 1 in 10 PLWH on DTG-based ART developed hyperglycemia (17). Hyperglycemia is a significant concern in PLWH, as it increases the risk of cardiovascular disease, diabetes mellitus, and other metabolic complications (18, 19). Hyperglycemia risk factors among PLWH on DTG-based ART were widely described in the literature. It has been reported that age (20), duration of DTG-based ART (21), hypertension (17), and obesity (22) were significantly associated with hyperglycemia among PLWH on DTG-based ART.

In Niger, where approximately 0,20% of adults live with HIV (23), DTG-based regimens have been widely used since 2020. However, to the best of our knowledge, no data are available concerning the effect of DTG-based ART regimens on hyperglycemia and its associated factors in the Nigerien population.

Thus, this study aimed to determine the prevalence of hyperglycemia and its associated factors among PLWH on DTG-based ART at four different HIV treatment centers in Niamey, Niger.

Methods and materials

Study design, period, and setting

This was a retrospective multicentric cross-sectional study carried out using data of PLWH who had been examined between January 2022 and June 2024. There are six public tertiary care hospitals in Niger. These public tertiary hospitals include general, national, and specialist hospitals. Tertiary hospitals provide comprehensive and specialized healthcare to the general population, serving as centers for postgraduate medical training and health research. Niamey is the capital and largest city of Niger, with a population of about 1.4 million inhabitants. The city of Niamey alone has five of the country’s seven HIV treatment centers. The study was carried out in four HIV treatment centers, including two tertiary care hospitals (Hôpital National de Niamey and Hôpital National Amirou Boubacar Diallo), and two regional centers (Centre de Traitement Ambulatoire and Mieux Vivre avec le SIDA). These centers have been serving 6515 PLWH in 2023.

Study population and sampling technique

The study’s target population consisted of all patients acquiring HIV who received DTG-based ART, since its introduction in 2020 in Niger. The source population included patients acquiring HIV who received DTG-based ART for at least three months in four HIV care centers in Niamey from 2022 to 2024.

Purposive sampling was used to collect exhaustive data of PLWH under treatment seen in consultation in the four HIV treatment centers in Niamey. Participants were enrolled from centers serving PLWH as follows: 109 at Hôpital National de Niamey, 35 at Hôpital National Amirou Boubacar Diallo, 57 at Centre de Traitement Ambulatoire, and 46 at Mieux Vivre avec le SIDA.

Inclusion and exclusion criteria

PLWH aged 18 years or older who had been on DTG-based ART for more than three months were included in this study. PLWH with known diabetes mellitus, thyroid dysfunction, renal damage, and chronic liver disease were excluded (Figure 1).

Figure 1

Figure 1. Study design.

Treatment protocol

During the period of this study, two DTG-based regimens were in use in Niger: Tenofovir/Lamivudine/Dolutegravir and Abacavir/Lamivudine/Dolutegravir.

Study variables

The dependent variable was hyperglycemia in PLWH receiving DTG-based ART, with the modalities coded as 1 (Yes) and 0 (No). Independent variables were sociodemographic data such as age, sex, marital status, level of education, socioeconomic level, place of residence and occupational status. Using a survey form, clinical and biological data including duration of being HIV-positive, WHO clinical stage of AIDS, body mass index, comorbidities, history of personal hypertension, history of hyperglycemia, viral load, lipid profile, current ART regimen type and duration of treatment, were also collected from the patient’s medical record.

Data collection and analysis

Data were collected from July to September 2024 using a pre-established individual survey form and entered into KoboToolbox v2021.2.4, and then exported to RStudio version 4.4.0 for analysis. Descriptive analysis was conducted, and the results were presented in tables. Categorical and discrete variables were described using frequencies and percentages. Continuous variables were described using means and standard deviation if normally distributed, and median and interquartile range (IQR) if not normally distributed. Using the chi-square test, categorical variables were compared. The independent t-test was used to assess differences between groups for continuous variables that met normality assumptions. In contrast, the Mann-Whitney U test was used for continuous variables that did not meet the normality assumptions. The normality of the data distribution was assessed using the Shapiro–Wilk test. The relationships between outcome variables and potential associated factors were investigated using bivariable and multivariable binary logistic regression models. Variables with p-values ≤ 0.2 in the univariate analysis were included in a multivariable logistic regression model. The results are presented as odds ratios, along with 95% confidence intervals. A p-value < 0.05 was considered statistically significant. Multicollinearity among selected independent variables was checked, and the variance inflation factor was found to be acceptable (less than 5). The Hosmer-Lemeshow test was used to assess the model’s goodness-of-fit.

Definition of terms

Hyperglycemia was defined as a fasting plasma glucose level (FPG) ≥7.0 mmol/L or a random plasma glucose ≥11.1 mmol/L in an individual with classic symptoms of hyperglycemia. Hyperglycemia thresholds were based on the 2024 American Diabetes Association (ADA) guidelines (24). Hypertension was defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. BMI was classified as underweight (<18.5 kg/m²), normal weight (18.5–24.9 kg/m²), overweight (25–29.9 kg/m²), and obese (≥ 30 kg/m²). Dyslipidemia was defined according to the National Cholesterol Education Program Adult Treatment Panel III guidelines as having total cholesterol (TC) levels of ≥ 5.2 mmol/L, low-density lipoprotein cholesterol (LDL-C) levels of ≥ 3.4 mmol/L, triglycerides (TG) of ≥ 1.7 mmol/L, and high-density lipoprotein cholesterol (HDL-C) levels of < 1.03 mmol/L for men and < 1.29 mmol/L for women, either in isolation or in combination (25).

Results

Baseline characteristics of patients enrolled

The mean age of patients was 38.9 ± 11.8 years, with a range of 18–75 years. The majority of patients were female (53.0%; n = 131), with an age range of 18 to 40 years (58.0%; n = 142). More than half of the patients (60.5%; n = 101) had a normal body mass index, while 65.7% (n = 130) and 34.5% (n = 69) had a history of familial and personal hypertension, respectively. Patients at the WHO clinical stage 3 were more represented (38.9%; n = 63). The mean duration of DTG-based regimen was 13.9 ± 7.05 months, with 52.6% (n=130) of patients using DTG-based ART for 12–24 months (Table 1).

Table 1

Table 1. Socio-demographic and clinical characteristics of patients.

Prevalence of hyperglycemia among PLWH on DTG-based ART

Between January 1st, 2022, and June 30th, 2024, 633 individuals were screened for inclusion, of which 247 (39.0%) were enrolled. Among patients with baseline blood glucose levels (n=247), 56.7% (n = 140) had a last blood glucose level. Among patients with a last blood glucose level, 36.4% (n = 51; 95% CI: 24.50–44.40) had hyperglycemia (Figure 2).

Figure 2

Figure 2. Flow diagram of inclusions.

Factors associated with hyperglycemia among PLWH on DTG-based ART

In the univariate analysis, age over 40 years (OR = 3.06; 95%CI=1.50-6.39; p=0.002), primary educational level (OR = 3.13; 95%CI=1.11-9.56; p=0.036), and a history of personal hypertension (OR = 2.67; 95%CI=1.22-5.94; p=0.015) were significantly associated with hyperglycemia (Table 2).

Table 2

Table 2. Univariate analysis of factors predicting hyperglycemia in PLWH.

In the multivariate analysis, patients with primary, secondary, and tertiary educational levels had 8.26 (95%CI=1.47– 62.00), 6.29 (95%CI=1.12– 48.28), and 9.39 (95%CI=1.34– 89.92) times higher risk of hyperglycemia, respectively, compared to individuals with an informal educational level. Patients with a history of personal hypertension had a 4.24 (95%CI=1.17– 17.18)-fold increased risk of hyperglycemia compared to those without such a history (Figure 3).

Figure 3

Figure 3. Predictors of hyperglycemia in persons living with HIV using multivariate logistic regression analysis. The blue square indicates the adjusted odds ratio (OR) for the listed variable, and the black lines indicate 95% confidence intervals (95% CI). The vertical dotted line indicates the limit of no effect; that is, the OR of the factors that overlap this line has no effect. To the right of it are the factors that increase the OR, and to the left, the factors that reduce the OR. DTG = Dolutegravir; WHO= World health organization.

Discussion

Hyperglycemia poses a considerable risk for PLHIV, as it heightens the likelihood of developing cardiovascular disease, diabetes mellitus, and various other metabolic complications (18, 19). The DTG-based ART regimen was adopted as the preferred treatment option in sub-Saharan Africa, including Niger. Recently, growing evidence from clinical and experimental research suggests that INSTIs are associated with hyperglycemia (26–29). This study aimed to determine the prevalence of hyperglycemia and its associated factors among PLWH on DTG-based ART in Niger. To the best of our knowledge, this is the first-ever study to assess this issue in Niger.

Diabetes may be diagnosed based on glycated hemoglobin (A1C) or plasma glucose criteria. Plasma glucose criteria include either the FPG, 2-h plasma glucose during a 75-g oral glucose tolerance test, or random glucose accompanied by classic hyperglycemic symptoms (e.g., polyuria, polydipsia, and unexplained weight loss) or hyperglycemic crises (i.e., diabetic ketoacidosis and/or hyperglycemic hyperosmolar state) (30). PLWH are at higher risk for developing prediabetes and diabetes, with certain ART potentially exacerbating the risk. Therefore, a screening protocol for prediabetes and type 2 diabetes is recommended (31). As the glycated hemoglobin test may not accurately reflect blood glucose levels in PLWH, plasma glucose criteria are preferred for diagnosing hyperglycemia in PLWH (32).

In the present study, the proportion of hyperglycemia (FPG ≥ 7.0 mmol/L (126 mg/dL)) found among DTG-based PLWH (36.4%) was higher than that reported in studies conducted in other parts of Africa, 12.8% (17), and 26.5% (33) in Uganda, 12.1% (20), and 17,2% (34) in Ethiopia. However, our finding was lower than that of a study conducted in Kenya (22), which showed a higher prevalence of FPG ≥ 126 mg/dL in patients treated with DTG-based ART (55.9%). Differences in sample collection state (fasting in our study vs. random), ART exposure (ART-naïve vs. ART-experienced), sample size, study design, and participants’ sociodemographic characteristics may contribute to these incongruous findings. The effect of DTG on insulin sensitivity remains a topic of debate (35). Some studies have not shown any influence of DTG on insulin resistance or blood sugar levels (36, 37). However, other studies (38, 39) have reported that DTG can lead to insulin resistance and reduced adiponectin levels.

Our finding suggests that hyperglycemia is relatively prevalent among PLWH in Niger. At present, the number of PLWH on DTG-based treatment is still on the rise in Niger. With the growing number of PLWH on DTG-based therapy, the number of persons with hyperglycemia is expected to increase. Therefore, baseline and periodic monitoring of plasma glucose might be required in ART treatment containing DTG care in Niger.

In this study, risk factors associated with hyperglycemia in DTG-based ART regimens include primary, secondary, and tertiary educational levels, and a history of personal hypertension. Regionally, reports of the determinants of hyperglycemia among PLWH on DTG–based regimen are summarized in Table 3. Age (17, 20–22, 33), hypertension (17, 33), duration of DTG-based ART (21), study site (21), triglyceride level (20), prior DTG use, male sex (27), abnormal waist-hip ratio (27), abnormal total serum cholesterol (27), being overweight (22), obesity (22) were significant factors for hyperglycemia in Africa. In this study, age >40 years was associated with hyperglycemia at univariate analysis, but this association lost significance after adjustment for confounders.

Table 3

Table 3. Predictors of hyperglycemia among PLWH on DTG-based ART regimen in Africa.

Regarding educational level, the strong association between education and hyperglycemia observed in this study is intriguing. This association is unexpected and may reflect residual confounding (e.g., urbanization, diet, socioeconomic differences). Education serves as a reliable indicator of health-related knowledge and behaviors, which may influence the observed relationship. Previous studies have indicated that HIV prevalence is higher among more educated individuals (40). In HIV and AIDS patients, the level of schooling influences protective behaviors like condom usage, seeking counseling and testing, discussing AIDS with partners, and understanding HIV and AIDS. However, it also correlates with an increased likelihood of infidelity and a decreased likelihood of abstaining from sexual activity (41). Accordingly, educational attainment is a significant predictor of HIV risk in Africa, in part because of risk behaviors and other characteristics among better-educated individuals (42). More interestingly, there is a strong association between years of education and diabetes self-management behaviors in low - and middle-income countries (43). Preventive interventions should focus on diabetes risk in educated PLWH and school-aged populations on DTG-based ART regimens.

This study also revealed an increased risk of hyperglycemia with a history of personal hypertension. Apart from HIV, hypertension is a known risk factor for developing type 2 diabetes, with individuals with hypertension having a significantly higher likelihood of developing diabetes compared to those with normal blood pressure (44, 45).

Several limitations of our study should be acknowledged. First, the cross-sectional design of the study limits our ability to establish causality between DTG exposure and hyperglycemia. Second, we did not assess factors such as physical activity, dietary habits, use of any other medicines, lifestyle, and abnormal waist-to-hip ratio, which could have been associated with hyperglycemia in PLWH on DTG-based regimens. Third, our sample may not be representative of the general population. In Niger, HIV prevalence is disproportionately concentrated among key populations, such as men who have sex with men, people who inject drugs, sex workers, and transgender individuals (46). Variations in demographic characteristics and lifestyle factors across these groups could influence the prevalence of hyperglycemia. Finally, impaired glucose tolerance (IGT) (47) and insulin resistance (48) are commonly observed in PLWH. However, we did not perform oral glucose tolerance tests in this study, which limits our ability to assess the prevalence of IGT in this population. Additionally, hyperglycemia was diagnosed based on a single fasting glucose measurement, which may have led to an overestimation of its actual prevalence. Future longitudinal studies are warranted to clarify the temporal relationships between DTG exposure and the development of hyperglycemia.

Conclusion

The prevalence of hyperglycemia among PLWH on DTG-based ART regimens was high in Niger. Educated HIV-positive patients and hypertension were identified as risk factors for hyperglycemia. Screening for hyperglycemia should be considered for PLWH, especially those with primary, secondary, and tertiary educational levels, and hypertension, to prevent diabetes. Therapeutic education for HIV patients on DTG-based therapy may focus on the risk of diabetes and the importance of careful dietary management. Future studies should assess the association between hyperglycemia and impaired glucose tolerance in this population.

Data availability statement

The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author.

Ethics statement

The studies involving humans were approved by Faculty of Health Sciences, Abdou Moumouni University ethical review committee. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.

Author contributions

AY: Conceptualization, Formal Analysis, Methodology, Software, Writing – original draft. RS: Methodology, Writing – original draft. A-SD: Data curation, Formal Analysis, Investigation, Writing – original draft. AI: Supervision, Validation, Visualization, Writing – review & editing. SS: Supervision, Validation, Writing – review & editing. OT: Formal Analysis, Writing – review & editing. AB: Writing – review & editing. MD: Conceptualization, Supervision, Validation, Writing – review & editing. SB: Conceptualization, Supervision, Validation, Writing – review & editing. IA: Investigation, Methodology, Writing – review & editing. YN: Writing – review & editing. O-RA: Writing – review & editing. SM: Project administration, Supervision, Validation, Writing – review & editing.

Funding

The author(s) declared that financial support was not received for this work and/or its publication.

Conflict of interest

The authors declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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The author(s) declared that generative AI was not used in the creation of this manuscript.

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