Study population
A prospective cohort study was conducted on sixty-one male patients with HIV who were treatment-naive with the TDF plus 3TC plus EFV regimen at the Public and Health Clinic Centre of Chengdu from October 1, 2012, to December 31, 2017.
The inclusion criteria were as follows: age from 18 to 65 years old; gender is not limited; HIV-1 antibody positive according to enzyme-linked immune-sorbent assay and confirmed by Western blotting; CD4+ T cell count 500 µL within 30 days before enrollment; voluntarily signed informed consent and agreed to undergo follow-up analyses; no plan to move away from current address during the trial; no history of antiretroviral therapy.
The following exclusion criteria were used in this study: patients with acute infections; patients with opportunistic infections or AIDS-related malignant tumors at the time of enrollment; patients with opportunistic infection occurring within 3 months before enrollment and still in unstable condition within 2 weeks before enrollment; patients with hemoglobin <9 g/dL, white blood cell count < 2000/µL, neutrophil count < 1000/µL, platelet count < 75,000/µL, serum creatinine > 1.5-fold upper limit of the normal value (ULN), aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase > threefold ULN, total bilirubin > twofold ULN, serum creatine phosphokinase > twofold ULN, or creatinine clearance rate < 60 mL/min; women who were pregnant or lactating; current drug users; patients with severe mental or neurological diseases; patients with a history of alcoholism; and patients with severe digestive tract ulcers.
AIDS, dyslipidemia and hyperacidemia diagnostic criteria were applied according to the corresponding guidelines [13,14,15]. According to guidelines, the cutoff values for determining hypercholesterolemia, hyper-low-density lipoprotein cholesterolemia, hypo-high-density lipoprotein cholesterolemia, hypertriglyceridemia and hyperuricemia were as follows: total cholesterol (TC) > 5.18 mmol/L, low-density lipoprotein cholesterol (LDL-c) > 3.37 mmol/L, high-density lipoprotein cholesterol (HDL-c) < 1.0 mmol/L, triglyceride > 1.7 mmol/L, and uric acid (UA) > 420 µmol/L, respectively.
The participants were divided into three groups according to their baseline CD4 T cell counts: there were 26, 12, and 23 patients in the < 200, from 200 to 350 and > 350 cells/µL groups [4, 5, 13], respectively.
Measurement of anthropometric parameters
The subjects fasted overnight for at least 12 h. At 8:00 a.m. the next day after emptying stool and urine, anthropometric parameters, including height, body weight (BW), body fat weight, lean body mass weight, body mass index (BMI) and body fat percentage, were measured by specially trained researchers using a body fat measuring instrument.
Detection of laboratory indicators
The subjects fasted overnight for at least 12 h. At 8:00 a.m. the next day, the venous blood of those patients was drawn to measure TC, LDL-c, HDL-c, TG, UA, HIV viral nucleic acid (HIVRNA), and T lymphocyte subsets.
TC, TG, HDL-c, LDL-c and UA levels were measured by the enzymatic method of an automatic biochemical analyzer purchased from Zhejiang Eastern European Biological Products Company. HIVRNA was detected by fluorescent quantitative PCR; T lymphocyte subsets (including CD3+ count, CD4+ count, CD8+ count, CD3+%, CD4+%, CD8+%) were measured by flow cytometry using a Beckman flow cytometer.
The follow-up time points were 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 144 weeks after patients underwent ART with the TDF plus 3TC plus EFV regimen [13]. UA levels were measured at each follow-up time point, and TC, LDL-c, HDL-c and TG levels were detected at 0, 24, 48, 96, 120, and 144 weeks [13].
Databases were established according to the needs of the research by two researchers simultaneously collecting and entering data. All of the data were checked by the researchers to assess data integrity, authenticity, and accuracy.
Patient and public involvement
Patients and the public were involved in the development of the research question or in the design of the study. Patients received oral and written information about this study; however, they were not involved in the recruitment and implementation of the study. In addition, the burden of the intervention was assessed by the investigators. After signing an informed consent form by the participants, they were assessed for eligibility prior to data collection.
Statistical methods
The Statistical Package for the Social Sciences software version 17.0 (IBM Inc., Armonk, NY, USA) and GraphPad Prism 8 (GraphPad) software were used for statistical analysis. TC, LDL-c, HDL-c, TG and UA levels normally distributed, and statistical analysis was conducted directly. Nonnormally distributed HIVRNA levels were subjected to natural logarithmic transformation before statistical analysis. Quantitative data were expressed as χ ± SD, and categorical data were expressed as rates or percentages. One-way ANOVA was used to compare metabolism parameters from baseline to 144 weeks, and a paired t-test was used to compare metabolism parameters between baseline and some follow-up time points. The Kruskal-Wallis H (K) test for K independent samples was used to compare the percentage of dyslipidemia and hyperuricemia from baseline to 144 weeks. The Mann-Whitney test for two independent samples was used to compare the percentage of dyslipidemia and hyperuricemia between baseline and some follow-up time points. One-way ANOVA was used to compare metabolism parameters between the three different CD4+ T cell count groups at the same time point. Two-way ANOVA was used to compare metabolism parameters between the three different CD4+ T cell count groups from baseline to 144 weeks. A p value < 0.05 was considered statistically significant.
Ethical consideration
The study was approved by the hospital ethics committee of the Public and Health Clinic Centre of Chengdu (PJ-K2012-012-01). All patients gave written informed consent.