Effect of Vitamin D Supplementation on Bone Turnover Markers During HIV Pre-Exposure Prophylaxis Using Tenofovir Disoproxil Fumarate-Emtricitabine in Men Who Have Sex with Men.

Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) reduces bone mineral density in HIV-uninfected men who have sex with men (MSM). We hypothesized that PrEP with TDF-FTC would increase bone turnover markers (BTMs) at week 24 and that vitamin D supplementation from weeks 24 to 48 would blunt this increase. Participants were from a cohort of 398 MSM and transgender women who received daily TDF-FTC for PrEP. At week 24, a prospective intervention group initiated vitamin D3 4,000 IU daily. Concurrent controls were selected from the cohort who took ≤400 IU/day of vitamin D3 matched by age, race, and body mass index. The primary endpoint was the change in procollagen-I N-terminal propeptide (P1NP) from weeks 24 to 48. Paired t-tests were used to compare changes in BTMs between intervention and controls. Among 48 intervention-control pairs, median age was 33 years. At baseline, 68.9% of the intervention group and 77.3% of controls were vitamin D sufficient (≥20 ng/mL, p = .94). P1NP, C-telopeptide, parathyroid hormone (PTH), and 25-OH vitamin D3 did not increase significantly at week 24. P1NP fell by a mean ± SD of -27.6 ± 49.9 pg/mL from weeks 24 to 48 with vitamin D and -2.5 ± 40.2 pg/mL in controls (p = .01). There were no significant between-group differences in the weeks 24-48 change in C-telopeptide, PTH, or 25-OH vitamin D3. Vitamin D3 supplementation with 4,000 IU/day resulted in a significant reduction in the BTM P1NP compared with controls, suggesting that this intervention has potential to improve bone health during PrEP.

Effect of rectal douching/enema on rectal gonorrhoea and chlamydia among a cohort of men who have sex with men on HIV pre-exposure prophylaxis.

OBJECTIVES: Rectal douching/enema (RD) is a common practice among men who have sex with men (MSM) in preparation for sex. RD can break down the rectal mucosal barrier and potentially affect the rectal microbiome. The objective of this study was to understand if RD is associated with acquiring rectal infections (RI) with rectal gonorrhoea (NG) and/or chlamydia (CT). METHODS: From 2013 to 2015, 395 adult HIV-uninfected MSM were enrolled in a randomised controlled study for pre-exposure prophylaxis (PrEP) adherence with routine sexual risk survey and testing. Using data from this cohort, baseline differences by RI were assessed using Pearson's χ² and Wilcoxon-Mann-Whitney test. Association between RD and RI was modelled using multivariable logistic regression adjusted for potential confounders (sexual behaviour, substance use and age) selected a priori. Effect modification by number of male partners and sensitivity analysis to rule out reverse causality were also conducted. RESULTS: Of 395 participants, 261 (66%) performed RD and 133 (33%) had at least one NG/CT RI over 48 weeks. Number of condomless anal receptive sex (med: 4, p<0.001), male partners (med:6, p<0.001) and substance use (any of methamphetamine/hallucinogens/dissociative/poppers) (p<0.001) were associated with increased odds of RI. Controlling for potential confounders, odds of prevalent RI were 3.59 (p<0.001, 95% CI 1.90 to 6.78) and incident RI 3.87 (p=0.001, 95% CI 1.78 to 8.39) when douching weekly or more compared with not douching. MSM with more than six male partners had 5.34 (p=0.002, 95% CI 1.87 to 15.31) increased odds of RI when douching weekly or more compared with not douching. CONCLUSION: Rectal hygiene with RD is a common practice (66%) among HIV-uninfected MSM on PrEP in this study, which increases the odds of acquiring rectal NG and/or CT independent of sexual risk behaviour, substance use and other factors. This suggests interventional approaches targeting rectal hygiene products and practices could reduce sexually transmitted infections.

Probiotics, soluble fiber, and L-Glutamine (GLN) reduce nelfinavir (NFV)- or lopinavir/ritonavir (LPV/r)-related diarrhea.

PURPOSE: Highly active antiretroviral therapy (HAART) can be associated with diarrhea and other gastrointestinal (GI) side effects. Reducing these side effects may improve treatment durability and quality of life (QOL). This study assessed the impact of nutritional co-therapies known to reduce diarrhea in HIV-positive men treated with nelfinavir (NFV)- or lopinavir/ritonavir (LPV/r)-containing regimens. METHODS: Thirty-five HIV-positive men treated with NFV (n = 27) or LPV/r (n = 8) with diarrhea (> or = two liquid stools/day [d]) participated in a 12-week prospective study. Twenty-eight subjects were randomly assigned supplements (S), seven received standard of care (C). Group S received probiotics (1.2g/d) and soluble fiber (11g/d). If diarrhea persisted at week 4, 30g/d L-Glutamine (GLN) was added. Diarrhea incidence, as well as supplement and antidiarrheal use, was assessed monthly. RESULTS: Weight, CD4 count, and HIV RNA were unchanged in both groups. Diarrhea completely resolved in 10 of 28 (36 percent) S subjects. The mean (+/-SD) number of stools/d declined [3.40+/-1.25 to 2.54+/-1.34 (p < 0.01)]. Diarrhea (loose, watery stools/d) lessened in S from 2.84+/-1.42 to 0.74+/-1.03 (p < 0.0001). Fifteen S subjects did not obtain full relief with probiotics and fiber, but stools/d decreased from 4.08+/-1.35 to 3.06+/-1.68 (p < 0.05) after starting GLN. In C, stools/d, 4.14+/-4.86 to 3.44+/-1.68(p = 0.678) and incidence of diarrhea/d, 3.00+/-4.82 to 1.36+/-1.29 (p= 0.361) was unchanged. In S, loperamide use decreased from 1.69+/-2.34 to 0.31+/-0.69 mg/d (p < 0.01); 18 versus eight subjects used loperamide at 0 and 12 weeks, respectively. CONCLUSION: Probiotics, soluble fiber, and GLN significantly reduced diarrhea for subjects receiving NFV or LPV/r. Nutritional co-therapies show clinical benefit in HIV-positive men with diarrhea.