TABLE 2.
Characteristics of the study population, total and stratified by HBsAg status
| Parameter | Total N = 329 | HBsAg negative n = 239 | HBsAg positive n = 90 | p value | |
|---|---|---|---|---|---|
| Female, n (%) | 238 (72.3) | 179 (74.9) | 59 (65.6) | 0.09 | |
| Age | Median years (IQR) | 47 (42–53) | 48 (41–54) | 47 (42–52) | 0.90 |
| CD4 count | Median cells/mm3 (IQR) | 619 (358–830) | 602 (349–829) | 663 (390–840) | 0.32 |
| ART regimen, n (%) | Tenofovir/lamivudine | 180 (54.7) | 106 (44.4) | 74 (82.2) | <0.0001 |
| Zidovudine/lamivudine | 137 (41.6) | 123 (51.5) | 14 (15.6) | ||
| Other NRTI a | 5 (1.5) | 4 (1.7) | 1 (1.1) | ||
| NNRTI, efavirenz | 208 (63.2) | 137 (58.8) | 71 (79.8) | 0.002 | |
| NNRTI, nevirapine | 79 (24.0) | 68 (29.2) | 11 (12.4) | ||
| PI/b, lopinavir/ritonavir | 31 (9.4) | 24 (10.3) | 7 (7.9) | ||
| PI/b, atazanavir/ritonavir | 4 (1.2) | 4 (1.7) | 0 (0) | ||
| None b | 7 (2.1) | 6 (2.5) | 1 (1.1) | ||
| Cumulative ART exposure, median years (IQR) | Total | 8.9 (5.7–11.3) | 8.7 (4.9–11.2) | 9.6 (6.9–11.3) | 0.07 |
| Tenofovir | 0.7 (0–5.9) | 0 (0–1.9) | 6.1 (1.6–6.4) | <0.0001 | |
| Zidovudine | 3.0 (0–8.0) | 5.2 (0–8.4) | 2.0 (0–4.8) | 0.006 | |
| Stavudine | 0 (0–1.3) | 0 (0–0.7) | 0 (0–1.8) | 0.08 | |
| Efavirenz | 3.1 (0–8.0) | 1.7 (0.‐7.2) | 5.9 (2.4–9.1) | 0.0001 | |
| Nevirapine | 0 (0–5.6) | 0 (0–6.3) | 0 (0–4.6) | 0.61 | |
| Lopinavir/ritonavir [range] | 0 [0–7.1] | 0 [0–6.8] | 0 [0–8.1] | 0.19 | |
| HIV‐1 RNA load | Median log10 copies/ml (IQR) | 1.3 (1.3–2.6) | 1.6 (1.3–2.7) | 1.3 (1.3–2.4) | 0.67 |
| <40 copies/ml, n (%) | 162 (49.2) | 144 (48.7) | 48 (53.3) | 0.46 | |
| HBV DNA load c | Median log10 IU/ml (IQR) | – | – | 0.30 (0.30–1.30) | – |
| <40 IU/ml, n (%) | – | – | 74 (82.2) | ||
| 40–2000 IU/ml, n (%) | – | – | 9 (10.0) | ||
| >2000 IU/ml, n (%) | – | – | 2 (2.2) | ||
| >20,000 IU/ml, n (%) | – | – | 5 (5.6) | ||
| Cigarette smoking, n (%) | 20 (6.1) | 14 (5.9) | 6 (6.7) | 0.80 | |
| Excessive alcohol, n (%) | 6 (1.8) | 4 (1.7) | 2 (2.2) | 0.67 | |
| Herbal or traditional remedies, n (%) | 11 (3.3) | 7 (2.9) | 4 (4.4) | 0.50 | |
| Metabolic syndrome d , n (%) | 87 (26.4) | 68 (28.6) | 19 (21.1) | 0.17 | |
| BMI | Median kg/m2 (IQR) | 23.9 (20.8–27.1) | 23.9 (21.0–26.9) | 23.8 (20.8–27.9) | 0.96 |
| Underweight | 31 (9.4) | 22 (9.2) | 9 (10.0) | 0.90 | |
| Overweight | 92 (28.0) | 68 (28.5) | 24 (26.7) | ||
| Obese | 41 (12.5) | 28 (11.7) | 13 (14.4) | ||
| Waist circumference | Male, median cm (IQR) | 82 (76–88) | 82 (77–88) | 82 (75–88) | 0.94 |
| Female, median cm (IQR) | 88 (80–96) | 89 (80–96) | 86 (77–98) | 0.74 | |
| Central obesity, n (%) | 198 (60.2) | 150 (62.8) | 48 (53.3) | 0.12 | |
| Blood pressure | Median systolic mm Hg (IQR) | 128 (113–144) | 130 (113–147) | 125 (110–140) | 0.14 |
| Median diastolic mm Hg (IQR) | 82 (71–91) | 82 (72–92) | 82 (71–90) | 0.88 | |
| Grade 1 elevation, n (%) e | 119 (36.2) | 87 (36.4) | 32 (35.6) | 0.66 | |
| Grade 2 elevation, n (%) | 33 (10.0) | 25 (10.5) | 8 (8.9) | ||
| Grade 3 elevation, n (%) | 27 (8.2) | 22 (9.2) | 5 (5.6) | ||
| No data, n (%) | 7 (2.1) | 5 (2.1) | 2 (2.2) | ||
| Total cholesterol | Median mmol/L (IQR) | 4.7 (4.1–5.4) | 4.8 (4.1–5.5) | 4.4 (4.0–5.1) | 0.011 |
| Grade 1 elevation, n (%) | 78 (23.7) | 58 (24.3) | 20 (22.2) | 0.05 | |
| Grade 2 elevation, n (%) | 27 (8.2) | 25 (10.5) | 2 (2.2) | ||
| Grade 3 elevation, n (%) | 6 (1.8) | 5 (2.1) | 1 (1.1) | ||
| LDL | Median mmol/L (IQR) | 2.7 (2.2–3.4) | 2.8 (2.2–3.4) | 2.6 (2.2–3.2) | 0.12 |
| Grade 1 elevation, n (%) | 54 (16.4) | 39 (16.3) | 15 (16.7) | 0.09 | |
| Grade 2 elevation, n (%) | 18 (5.5) | 16 (6.7) | 2 (2.2) | ||
| Grade 3 elevation, n (%) | 9 (2.7) | 9 (3.8) | 0 (0) | ||
| No data, n (%) | 6 (1.8) | 5 (2.1) | 1 (1.1) | ||
| HDL | Median mmol/L (IQR) | 1.3 (1.1–1.6) | 1.3 (1.0–1.6) | 1.3 (1.1–1.6) | 0.74 |
| Low, n (%) | 132 (40.1) | 98 (41.0) | 34 (37.8) | 0.65 | |
| Triglycerides | Median mmol/L (IQR) | 1.2 (0.9–1.6) | 1.2 (0.9–1.7) | 1.1 (0.8–1.4) | 0.004 |
| Grade 1 elevation, n (%) | 46 (14.0) | 36 (15.1) | 10 (11.1) | 0.024 | |
| Grade 2 elevation, n (%) | 30 (9.1) | 28 (11.7) | 2 (2.2) | ||
| Grade 3 elevation, n (%) | 2 (0.6) | 2 (0.8) | 0 (0) | ||
| No data, n (%) | 1 (0.3) | 0 (0) | 1 (1.1) | ||
| HbA1c | Median mmol/mol (IQR) | 33 (29–37) | 33 (29–37) | 34 (31–37) | 0.20 |
| Impaired glucose tolerance, n (%) | 15 (4.6) | 12 (5.0) | 3 (3.3) | ||
| Hyperglycemia, n (%) | 17 (5.2) | 14 (5.9) | 3 (3.3) | ||
| No data, n (%) | 2 (0.6) | 2 (0.8) | 0 (0) | ||
| Platelet count | Median ×109/L (IQR) | 231 (195–277) | 237 (204–285) | 209 (168–255) | 0.001 |
| ALT | Median IU/L (IQR) | 18 (14–24) | 17 (13–22) | 21 (15–29) | <0.0001 |
| AST | Median IU/L (IQR) | 27 (23–34) | 26 (22–33) | 30 (25–37) | 0.001 |
| APRI score | Median (IQR) | 0.27 (0.20–0.36) | 0.25 (0.19–0.34) | 0.37 (0.25–0.47) | <0.0001 |
| FIB‐4 score | Median (IQR) | 1.35 (1.00–1.81) | 1.30 (0.97–1.69) | 1.58 (1.18–2.16) | <0.0001 |
| Liver stiffness | Median kPa (IQR) | 4.9 (4.0–6.0) | 4.9 (3.9–5.9) | 4.9 (4.2–6.4) | 0.18 |
| Fibrosis grade, n (%) | F0–F1 | 274 (83.3) | 217 (90.8) | 57 (63.3) | <0.0001 |
| F2–F4 | 55 (16.7) | 22 (9.3) | 33 (36.7) | ||
| F2 | 38 (11.6) | 17 (7.1) | 21 (23.3) | ||
| F3 | 12 (3.7) | 4 (1.7) | 8 (8.9) | ||
| F4 f | 5 (1.5) | 1 (0.4) | 4 (4.4) | ||
| CAP | Median dB/m (IQR) | 207 (175–240) | 206 (172–239) | 214 (181–242) | 0.33 |
| Steatosis grade, n (%) | S0 | 260 (79.0) | 189 (79.1) | 71 (78.9) | 0.97 |
| S1–S3 | 69 (21.0) | 50 (20.9) | 19 (21.1) | ||
| S1 | 26 (7.9) | 20 (8.4) | 6 (6.7) | ||
| S2 | 20 (6.1) | 14 (5.9) | 6 (6.7) | ||
| S3 | 23 (7.0) | 16 (6.7) | 7 (7.8) | ||
Abbreviations: ALT, alanine aminotransferase; APRI, aspartate aminotransferase to platelet ratio index; ART, antiretroviral treatment; AST, aspartate aminotransferase; BMI, body mass index; CAP, controlled attenuation parameter; FIB‐4, fibrosis‐4; HbA1c, glycated hemoglobin; HBsAg, hepatitis B virus surface antigen; HBV, hepatitis B virus; HDL, high‐density lipoprotein; HIV, human immunodeficiency virus; IQR, interquartile range; LDL, low‐density lipoprotein; NNRTI, non‐nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI/b, boosted.
Other NRTI combinations comprised one each of tenofovir + abacavir; tenofovir/lamivudine + abacavir; tenofovir + zidovudine; tenofovir + zidovudine/lamivudine; and abacavir/lamivudine.
Comprised 4/329 (1.2%) patients who were ART naive and 3/329 (0.9%) patients who had discontinued ART ≥3 months earlier.
Among patients with detectable HBV DNA, 11 were on tenofovir/lamivudine (median HBV DNA load, 344 IU/ml; range, 60–548,000,000), four were on lamivudine without tenofovir (median HBV DNA load, 7084 IU/ml; range, 72–4,080,000), and one was off ART (HBV DNA load, 123,200 IU/ml).
One female meeting two metabolic syndrome criteria (hypertension and low HDL) but lacking HbA1C results was classified in the group without metabolic syndrome.
Included eight patients with normal blood pressure while on antihypertensive medication.
Patients with liver stiffness values indicative of F4 fibrosis/cirrhosis did not show signs of clinical decompensation, and all underwent a liver ultrasound scan to exclude ascites and focal lesions. Liver steatosis by CAP value (dB/m): none (S0) <248; mild (S1) 248–268; moderate (S2) 268–280; severe (S3) >280. Liver fibrosis by stiffness value: HBsAg positive (kPa) none (F0/F1) <5.9; mild (F2) ≥5.9 to 7.5; moderate (F3) ≥7.6 to 9.3; severe (F4) ≥9.4; HBsAg negative (kPa): F0/F1 <7.1; F2 ≥7.1 to 9.3; F3 ≥9.4 to 13.9; F4 ≥14.