Methods: HIV treatment-naïve AA males and females between the ages of 18-50 were included. Subjects with chronic renal insufficiency (GFR <50 ml/min), alcoholism, phenytoin use, and hypogonadism were excluded. Patients were randomized to TEE or RDr in a 1:1 manner. All subjects received cholecalciferol 1000 IU/day and calcium citrate 1000 mg/day. CD4 counts, HIV RNA, complete blood counts, chemistry profiles, testosterone levels (in male patients), and 25[OH]D levels were obtained at baseline and at weeks 8, 24, 36, and 48. Dual-energy X-ray absorptiometry (DEXA) scans of the spine and hip were performed at baseline and at week 48. Differences in the two groups were assessed using Mann-Whitney test.
Results: Ten patients on each regimen completed the study. Baseline characteristics, including age, body mass index (BMI), cigarette and alcohol use, CD4 count, and HIV RNA were similar in the two groups. Mean baseline 25[OH]D levels were decreased and similar in both groups, (TEE 15.7 ng/ml vs. RDr 19.5 ng/ml, p=0.48). All patients had plasma HIV RNA <50 copies/ml by week 24, and HIV RNA remained <50 copies/ml of plasma through week 48. By week 48, there was a sustained increase in 25[OH]D levels of the RDr but not in the TEE group (TEE 20 ng/ml vs. RDr 35 ng/ml, p=0.002). At week 48 there was a larger decrease in the percentage change in BMD of the hip in the TEE group compared to the RDr group (TEE -2.8% vs. RDr -0.15%, p=0.01).
Conclusion: Treatment of AA HIV subjects with TEE is associated with a reduction in BMD of the hip and sustained reductions of 25[OH]D levels not seen in the group that did not receive tenofovir or efavirenz. This phenomenon may have long-term consequences on bone integrity and immune function in AA HIV patients.
P. Cook, Merck: Grant Investigator and Speaker's Bureau , Grant recipient , Research grant , Research support and Speaker honorarium
Gilead: Grant Investigator , Grant recipient and Research grant
Pfizer: Grant Investigator and Shareholder , Grant recipient and Research grant