scholarly journals Changes in Bone Mass After Discontinuation of Preexposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine in Young Men Who Have Sex With Men: Extension Phase Results of Adolescent Trials Network Protocols 110 and 113

2019 ◽  
Vol 70 (4) ◽  
pp. 687-691 ◽  
Author(s):  
Peter L Havens ◽  
Suzanne E Perumean-Chaney ◽  
Amit Patki ◽  
Stacey S Cofield ◽  
Craig M Wilson ◽  
...  

AbstractHuman immunodeficiency virus–seronegative men aged 15–22 years who lost bone mineral density (BMD) during tenofovir disoproxil fumarate/emtricitabine preexposure prophylaxis (PrEP) showed BMD recovery 48 weeks following PrEP discontinuation. Lumbar spine and whole body BMD z-scores remained below baseline 48 weeks off PrEP in participants aged 15–19 years.Clinical Trials Registration. NCT01772823 (ATN 110) and NCT01769456 (ATN 113).

2019 ◽  
Vol 71 (5) ◽  
pp. 1281-1288 ◽  
Author(s):  
Denise L Jacobson ◽  
Jane C Lindsey ◽  
Catherine Gordon ◽  
Rohan Hazra ◽  
Hans Spiegel ◽  
...  

Abstract Background Children and adolescents with perinatal human immunodeficiency virus (HIV) infection and with low bone mineral density (BMD) may be at higher risk of osteoporosis and fractures in later life than their uninfected peers. Bisphosphonate therapy has been shown to reduce fractures in adults with osteoporosis, but has not been formally studied in youths living with HIV. Methods Fifty-two children and adolescents (aged 11–24 years) perinatally infected with HIV with low lumbar spine (LS) BMD (Z score < −1.5) were randomized to receive once-weekly alendronate or placebo in a double-blind cross-over study designed to assess the safety and efficacy of 48 and 96 weeks of alendronate in the United States and Brazil. All participants received daily calcium carbonate and vitamin D supplementation and were asked to engage in regular weight-bearing exercise. Safety and efficacy are summarized for the initial 48 weeks of the trial. Results Grade 3 or higher abnormal laboratory values, signs, or symptoms developed in 5 of 32 (16%) participants on alendronate and 2 of 18 (11%) on placebo (P > .99). No cases of jaw osteonecrosis, atrial fibrillation, or nonhealing fractures were reported. Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate (20% [14%–25%]) than placebo (7% [5%–9%]) (P < .001). Similar improvements were seen for whole body BMD. Conclusions In this small study in children and adolescents perinatally infected with HIV with low LS BMD, 48 weeks of alendronate was well-tolerated, showed no safety concerns, and significantly improved LS and whole body BMD compared to participants on vitamin D/calcium supplementation and exercise alone. Clinical Trials Registration NCT00921557.


2003 ◽  
Vol 36 (4) ◽  
pp. 482-490 ◽  
Author(s):  
Kristin Mondy ◽  
Kevin Yarasheski ◽  
William G. Powderly ◽  
Michael Whyte ◽  
Sherry Claxton ◽  
...  

2020 ◽  
Vol 223 (1) ◽  
pp. 72-82
Author(s):  
Kevin M Maloney ◽  
Adrien Le Guillou ◽  
Robert A Driggers ◽  
Supriya Sarkar ◽  
Emeli J Anderson ◽  
...  

Abstract Background Long-acting injectable (LAI) human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) is reportedly efficacious, although full trial results have not been published. We used a dynamic network model of HIV transmission among men who have sex with men to assess the population impact of LAI-PrEP when available concurrently with daily-oral (DO) PrEP. Methods The reference model represents the current HIV epidemiology and DO-PrEP coverage (15% among those with behavioral indications for PrEP) among men who have sex with men in the southeastern United States. Primary analyses investigated varied PrEP uptake and proportion selecting LAI-PrEP. Secondary analyses evaluated uncertainty in pharmacokinetic efficacy and LAI-PrEP persistence relative to DO-PrEP. Results Compared with the reference scenario, if 50% chose LAI-PrEP, 4.3% (95% simulation interval, −7.3% to 14.5%) of infections would be averted over 10 years. The impact of LAI-PrEP is slightly greater than that of the DO-PrEP–only regimen, based on assumptions of higher adherence and partial protection after discontinuation. If the total PrEP initiation rate doubled, 17.1% (95% simulation interval, 6.7%–26.4%) of infections would be averted. The highest population-level impact occurred when LAI-PrEP uptake and persistence improved. Conclusions If LAI-PrEP replaces DO-PrEP, its availability will modestly improve the population impact. LAI-PrEP will make a more substantial impact if its availability drives higher total PrEP coverage, or if persistence is greater for LAI-PrEP.


2019 ◽  
Vol 6 (9) ◽  
Author(s):  
Ralph-Sydney Mboumba Bouassa ◽  
Laurent Bélec ◽  
Camelia Gubavu ◽  
Hélène Péré ◽  
Mathieu Matta ◽  
...  

Abstract Background We assessed the prevalence and risk factors of anal and oral high-risk (HR) human papillomavirus (HPV) infection in human immunodeficiency virus–uninfected men who have sex with men (MSM) and take preexposure prophylaxis (PrEP) in France. Methods Anal and oral samples were screened by multiplex real-time polymerase chain reaction (Anyplex II HPV 28; Seegene) for HPV DNA. Results A total of 61 unvaccinated MSM (mean age, 36.1 years) were enrolled. Anal HPV and HR-HPV prevalences were 93.4% and 81.9%, respectively, and oral HPV and HR-HPV prevalences, 33.9% and 19.6%, respectively. HR-HPV type 33 was the most detected genotype, in both anal and oral samples. Among MSM, 68.8% carried ≥1 anal HPV type targeted by the 9-valent Gardasil-9 vaccine; all oral HPV-positive samples carried ≥1 strain included in the vaccine. Condomless receptive anal intercourse and history of anal gonorrhea were the main factors associated with increased risk for anal HPV infection (adjusted odds ratio, 10.4) and anal infection with multiple HR-HPV genotypes (5.77), respectively. Conversely, having had <10 partners in the last 12 months was associated with decreased risk for anal carriage of both multiple HPV (adjusted odds ratio, 0.19) and HR-HPV (0.17) types. Conclusion French MSM using PrEP are at high risk for both anal and oral carriage of HR-HPV that could lead to HPV-related cancers.


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