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Tenofovir disoproxil fumarate as pre-exposure prophylaxis for HIV prevention in women with osteoporosis: a case report and review of the literature.

ABSTRACT: Pre-exposure prophylaxis (PrEP), using tenofovir disoproxil fumarate (TDF), can effectively prevent HIV acquisition. However, TDF can cause changes in bone mineral density (BMD). There is little information on the use of PrEP among patients with bone disease. We present a case report of a female with pre-existing osteoporosis who was prescribed PrEP. Over the course of 9 months of consistent PrEP use, verified by dried blood spot testing, we report a lack of BMD changes on serial dual-emission X-ray absorptiometry scans in this patient. This case can inform PrEP care for patients with pre-existing bone disease.

SUBMITTER: Patel RR

PROVIDER: S-EPMC6003884 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Tenofovir disoproxil fumarate as pre-exposure prophylaxis for HIV prevention in women with osteoporosis: a case report and review of the literature.

Patel Rupa R RR Presti Rachel R Harrison Laura C LC Powderly William G WG Chan Philip A PA

Antiviral therapy 20180101 4

Pre-exposure prophylaxis (PrEP), using tenofovir disoproxil fumarate (TDF), can effectively prevent HIV acquisition. However, TDF can cause changes in bone mineral density (BMD). There is little information on the use of PrEP among patients with bone disease. We present a case report of a female with pre-existing osteoporosis who was prescribed PrEP. Over the course of 9 months of consistent PrEP use, verified by dried blood spot testing, we report a lack of BMD changes on serial dual-emission X ...[more]

PMID: 29168695

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Project description:Safety of tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) has been studied more extensively among HIV-infected patients than among HIV-uninfected people. Using data from a pre-exposure trial - FEM-PrEP -, we determined the cumulative probabilities of grade 1+ ALT, AST and creatinine and grade 2+ phosphorus toxicities; ALT/AST toxicities by baseline hepatitis B status; and change in mean creatinine, phosphorus, ALT and AST levels controlling for TDF-FTC adherence.FEM-PrEP was a randomized, blinded, placebo-controlled trial of daily TDF-FTC among women in Africa. Enrolled women were in general good health, HIV antibody negative, 18 to 35 years old, hepatitis B surface antigen negative, and had normal hepatic and renal function at baseline. AST, ALT, phosphorus and serum creatinine were measured regularly throughout the trial. TDF-FTC concentrations were measured to assess adherence to TDF-FTC. The cumulative probabilities of grade 1+ creatininemia and grade 2+ phosphatemia toxicities were not statistically different between TDF-FTC and placebo arms. The cumulative probabilities of grade 1+ ALT and AST toxicities were higher among participants in the TDF-FTC arm than in the placebo arm (p = 0.03 for both). The proportions of grade 1+ and grade 2+ ALT or AST toxicities were significantly higher in participants who were hepatitis B virus surface antibody (HBsAb) positive than in those who were HBsAb-negative. Women with good adherence had higher mean change from baseline to week 4 in their AST levels (2.90 (0.37, 5.42); p = 0.025) than women with less than good adherence.We did not observe a significant relationship between randomization to TDF-FTC and creatinine or phosphorus toxicities. Women randomized to TDF-FTC had higher rates of mild to moderate ALT/AST toxicities, especially women with prior hepatitis B virus exposure. We also observed a significant increase in AST from baseline to week 4 among women who had higher adherence to TDF-FTC during that interval.#NCT00625404, February 19, 2008.

Project description:BACKGROUND:An intravaginal ring that releases the tenofovir prodrug, tenofovir disoproxil fumarate, provided 100% protection in macaques against simian HIV and was safe in a 14-day clinical trial in sexually abstinent women. We aimed to assess the safety and pharmacokinetics of this intravaginal ring over 90 days in sexually active women. METHODS:We did a phase 1, single-blind, randomised, placebo-controlled trial to assess safety, pharmacokinetics, and acceptability of a tenofovir disoproxil fumarate intravaginal ring used continuously with monthly ring changes for 3 months. Sexually active women who were HIV negative were randomly assigned (3:1) to a tenofovir disoproxil fumarate ring or placebo ring. Primary safety endpoint was the proportion of women who had grade 2 or higher genitourinary adverse events judged related to study product and any grade 2 or higher adverse event as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. We quantified tenofovir disoproxil fumarate and tenofovir concentrations in cervicovaginal fluid, tenofovir in plasma, and tenofovir diphosphate, the active metabolite, in cervical tissue and dried blood spots 1 month after each ring insertion. We compared changes over time in cervicovaginal fluid cytokine and chemokine concentrations and vaginal microbiota. The study was electively stopped early and is registered with ClinicalTrials.gov, number NCT02762617. FINDINGS:Between Feb 24 and July 20, 2017, 17 women were enrolled before study termination. 12 were assigned to receive the tenofovir disoproxil fumarate ring and five were assigned to receive the placebo ring. Two participants in the tenofovir disoproxil fumarate ring group completed 3 months of continuous ring use; eight were asked to discontinue ring use early because of ulcerations (grade 1) near the ring; in the remaining two women, rings were electively removed by study staff on day 20 and day 23. Ulcers were detected a mean of 32 days after ring use (range 23-56). Four of eight participants with ulcers were symptomatic with vaginal discharge; four had ulcers identified when examined; three had two ulcers; all ulcers resolved after ring removal. No participants in the placebo group developed ulcers. No grade 2 product-related adverse events were reported in either group and four non-product-related grade 2 adverse events were reported in the tenofovir disoproxil fumarate ring group. Cervicovaginal fluid tenofovir concentrations did not differ at day 14 (p=0·14) comparing the eight patients who did (median 1·0?×?105 ng/mL [IQR 9·1?×?104-1·1?×?105]) with the four who did not (6·0?×?104 ng/mL [5·6?×?104-1·1?×?105]) develop ulcers. No significant changes in vaginal microbiota were detected in either group. Concentrations of multiple inflammatory cytokines and chemokines were significantly higher at days 14 and 28 compared with baseline in the tenofovir disoproxil fumarate ring group but not the placebo group. INTERPRETATION:Future studies are needed to establish whether the unanticipated finding of ulcerations is specific to this tenofovir disoproxil fumarate ring or generalisable to other sustained topical release formulations of tenofovir or its prodrugs. FUNDING:National Institutes of Health.

Dataset Information

Tenofovir disoproxil fumarate as pre-exposure prophylaxis for HIV prevention in women with osteoporosis: a case report and review of the literature.

Publications

Tenofovir disoproxil fumarate as pre-exposure prophylaxis for HIV prevention in women with osteoporosis: a case report and review of the literature.

Similar Datasets

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