Baseline demographic and clinical characteristics of the study participants

Of the 63 patients analyzed, 37 (58%) were female. The median age of the participants was 31 years (Interquartile range (IQR):28,37) with a median CD4 cell count of 284 cells/mm3 (IQR 158,518). Fifty-two (83%) of the patients had a normal blood pressure, 8 (12%) had pre-hypertension and 3 (4%) had hypertension. Sixty-one (97%) of the participants were in WHO HIV clinical stage 1, one patient in clinical stage 2 and one in clinical stage 3. Fifty-two (83%) of the patients had no tuberculosis (TB) symptoms, 10 (16%) had symptoms suggestive of TB but were found not to have active TB disease on evaluation and one patient had an established diagnosis of TB at baseline and treatment was initiated. On weight evaluation, 41 (65%) had a normal body mass index (BMI), 7 (11%) were underweight, 14 (22%) were overweight and one, obese. Fifty-five (87%) met the WHO physical activity requirements [26]. All patients were anti- glutamic acid decarboxylase (anti-GAD) antibody negative while 2 (3%) were positive for anti- Islet cell antigen-2 (anti-IA2) antibodies. All evaluated patients had virologic suppression at 24 weeks. The median serum creatine, fasting LDL, fasting HDL and fasting total cholesterol at baseline were: 0.86 (IQR; 0.77, 0.98), 75.2 (IQR; 53.8, 90.3), 29.6 (IQR: 24.9, 35.8) and 130.9 (IQR:111.2, 158.7) respectively. (Table 1)

Table 1 Baseline clinical and demographic characteristics of the study participants Changes in mean fasting blood glucose and 2-hour blood glucose from baseline

There was an initial significant drop in fasting blood glucose at week 12 (difference in mean fasting blood glucose from baseline (FBG): -3.3, 95%CI: -6.0, -0.5), p = 0.020). There after blood glucose leveled off with insignificant changes through 24 and 36 weeks. Fasting blood glucose at 48 weeks was not significantly different from fasting blood glucose at baseline (FBG: 0.4, 95%CI: -2.2, 3.1, p = 0.742) (Table 2).

Table 2 Changes in blood glucose, pancreatic beta cell function and insulin resistance over 48 weeks on dolutegravir in the study participants

There was significant reduction in 2hBG at 12 weeks (difference in mean 2hBG from baseline (2hBG): -14.6, 95%CI: -22.1, -7.0, p = 0.0003). thereafter there was an insignificant increase in 2hBG to week 36. 2hBG at 36 weeks was not significantly different from baseline (2Hbg: -5.1, 95%CI: -12.4, 2.1, p = 0.163) (Table 2).

Changes in mean pancreatic beta cell function determined by homeostatic modeling (HOMA %β) from baseline

There was a significant increase in HOMA %β at 12 weeks (difference in mean HOMA %β from baseline (HOMA %β): 24.9, 95%CI: 6.3, 43.6, p = 0.01) with subsequent reduction through 36 to 48 weeks but not reaching baseline values. There was no significant difference between HOMA %β at 36 and 48 weeks from baseline i.e. (HOMA %β: 8.8, 95%CI: -13.2, 30.7, p = 0.427) and (HOMA %β: 6.7, 95%CI: -13.4, 26.8, p = 0.506) respectively (Table 2; Fig. 1). Changes in HOMA %β over 48 weeks were independent of factors known to influence glucose metabolism such as: Age, Baseline CD4, Waist circumference, Sex, BMI and physical activity (Table S1- supplementary material).

Changes in mean insulin resistance determined by homeostatic modeling (HOMA IR) from baseline

There was a trend towards an increase in HOMA IR at 12 weeks with subsequent reduction thereafter through 36 weeks to 48 weeks without reaching baseline values. However, HOMA IR at 12, 36 and 48 weeks was not significantly different from that at baseline i.e. (difference in mean HOMA IR from baseline (HOMA IR):0.27, 95%CI: -0.24, 0.79, p = 0.294), (HOMA IR:0.22, 95%CI: -0.44, 0.87, p = 0.511) and (HOMA IR: 0.14, 95%CI: -0.46, 0.733, p = 0.648) respectively. (Table 2; Fig. 2). Changes in HOMA IR over 48 weeks were as well not influenced by baseline age, baseline CD4, Waist circumference, Sex, BMI and physical activity (Table S1- supplementary material).

Fig. 1

Changes in mean pancreatic beta cell function (HOMA%β) over 48 weeks

Fig. 2

Changes in mean insulin resistance (HOMA IR) over 48 weeks