Less impact on BMD¹

48 & 96 Weeks

Significantly less impact on BMD^1-4

24% to 29% of participants in this substudy had osteopenia or osteoporosis at baseline

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96 by DXA scans

The long-term clinical significance of changes in BMD is not known.

BMD declines of ≥5% at the lumbar spine were experienced by 4% of participants in both treatment arms at Week 48, and in 4% of DESCOVY participants and 16% of FTC/TDF participants at Week 96. BMD declines of ≥7% at the total hip were experienced by 1% in both treatment arms at Week 48, and in 0% of DESCOVY participants and 1% of FTC/TDF participants at Week 96
Analysis of these parameters was conducted in a subset of the study population (n=383)

Median age for the substudy was 37 years, with participants ranging from 19 to 74 years of age.

144 Weeks

Changes in BMD were consistent over 144 weeks^3-5

A separate analysis of this substudy from baseline to ≥144 weeks (DESCOVY^®, n=191)

Mean % change in lumbar spine and hip BMD at Weeks 48, 96, and 144 by DXA scans

The long-term clinical significance of changes in BMD is not known.

Analysis of these parameters was conducted in a subset of the study population (n=191)

Median age for the substudy was 37 years, with participants ranging from 19 to 74 years of age./

^aDue to timing of the analysis and participant visits, 1 additional participant was included in the 144-week analysis.

Participants <25

DESCOVY^® had less long-term impact on BMD in participants <25 years of age^3,4,6

Males can continue to develop bone mass up to about age 30, highlighting the need to consider BMD loss in this group

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96

The long-term clinical significance of changes in BMD is not known.

Significantly less impact on BMD^1-4

24% to 29% of participants in this substudy had osteopenia or osteoporosis at baseline

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96 by DXA scans

Lumbar spine

Hip

The long-term clinical significance of changes in BMD is not known.

BMD declines of ≥5% at the lumbar spine were experienced by 4% of participants in both treatment arms at Week 48, and in 4% of DESCOVY participants and 16% of FTC/TDF participants at Week 96. BMD declines of ≥7% at the total hip were experienced by 1% in both treatment arms at Week 48, and in 0% of DESCOVY participants and 1% of FTC/TDF participants at Week 96
Analysis of these parameters was conducted in a subset of the study population (n=383)

Median age for the substudy was 37 years, with participants ranging from 19 to 74 years of age.

Changes in BMD were consistent over 144 weeks^2,3,7

A separate analysis of this substudy from baseline to ≥144 weeks (DESCOVY^®, n=191)

Mean % change in lumbar spine and hip BMD at Weeks 48, 96, and 144 by DXA scans

Two graphs showing lumbar spine and hip bone mineral density safety data of DESCOVY® (emtricitabine/tenofovir alafenamide) through week 144. See BOXED WARNING.

The long-term clinical significance of changes in BMD is not known.

Analysis of these parameters was conducted in a subset of the study population (n=191)

Median age for the substudy was 37 years, with participants ranging from 19 to 74 years of age.

^aDue to timing of the analysis and participant visits, 1 additional participant was included in the 144-week analysis.

DESCOVY^® had less long-term impact on BMD in participants <25 years of age^3,4

Males can continue to develop bone mass up to about age 30, highlighting the need to consider BMD loss in this group

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96

Lumbar spine

Hip

The long-term clinical significance of changes in BMD is not known.

Resource

Bone Risk Factor Brochure

A resource with information about why BMD is an important consideration when prescribing PrEP medication. Includes risk factors that may impact BMD.

Download

People may be staying on a PrEP medication for extended periods of time.² Consider BMD when prescribing a PrEP medication.

BMD=bone mineral density; CI=confidence interval; DXA=dual-energy X-ray absorptiometry; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; SEM=standard error of the mean.

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INDICATION & LIMITATION OF USE

DESCOVY^® for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Limitation of Use: DESCOVY FOR PrEP^® is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

INDICATION & LIMITATION OF USE

Limitation of Use: DESCOVY FOR PrEP^® is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Less impact on BMD1

Significantly less impact on BMD1-4

24% to 29% of participants in this substudy had osteopenia or osteoporosis at baseline

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96 by DXA scans

The long-term clinical significance of changes in BMD is not known.

Changes in BMD were consistent over 144 weeks3-5

A separate analysis of this substudy from baseline to ≥144 weeks (DESCOVY®, n=191)

Mean % change in lumbar spine and hip BMD at Weeks 48, 96, and 144 by DXA scans

The long-term clinical significance of changes in BMD is not known.

DESCOVY® had less long-term impact on BMD in participants <25 years of age3,4,6

Males can continue to develop bone mass up to about age 30, highlighting the need to consider BMD loss in this group

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96

The long-term clinical significance of changes in BMD is not known.

Significantly less impact on BMD1-4

24% to 29% of participants in this substudy had osteopenia or osteoporosis at baseline

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96 by DXA scans

Lumbar spine

Hip

The long-term clinical significance of changes in BMD is not known.

Changes in BMD were consistent over 144 weeks2,3,7

A separate analysis of this substudy from baseline to ≥144 weeks (DESCOVY®, n=191)

Mean % change in lumbar spine and hip BMD at Weeks 48, 96, and 144 by DXA scans

The long-term clinical significance of changes in BMD is not known.

DESCOVY® had less long-term impact on BMD in participants <25 years of age3,4

Males can continue to develop bone mass up to about age 30, highlighting the need to consider BMD loss in this group

Mean % change in lumbar spine and hip BMD at Weeks 48 and 96

Lumbar spine

Hip

The long-term clinical significance of changes in BMD is not known.

People may be staying on a PrEP medication for extended periods of time.2 Consider BMD when prescribing a PrEP medication.

You may also be interested in:

This site is intended for US healthcare professionals

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Impact of PrEP on new HIV diagnoses

Contents

Transcript

Introduction

PrEP: An effective HIV prevention strategy

Regional disparities in PrEP uptake and HIV diagnoses

Normalizing PrEP use

PrEP: A potential gateway to routine care

Helping end the HIV epidemic

Introduction [0:02]

PrEP: An effective HIV prevention strategy [0:17]

Regional disparities in PrEP uptake and HIV diagnoses [1:10]

Normalizing PrEP use [1:50]

PrEP: A potential gateway to routine care [2:38]

Helping end the HIV epidemic [3:08]

PrEP use in the Black community

Contents

Transcript

Introduction

PrEP use is lowest amongst Black MSM and transgender women

Helping to support PrEP uptake in the Black community

Raising awareness of programs that increase access to HIV prevention

Reframing HIV prevention and emphasizing its importance to sexual health

Introduction [0:02]

PrEP use is lowest amongst Black MSM and transgender women [0:24]

Helping to support PrEP uptake in the Black community [1:19]

Raising awareness of programs that increase access to HIV prevention [2:20]

Reframing HIV prevention and emphasizing its importance to sexual health [3:07]

PrEP use in the Latinx/o community

Contents

Transcript

Introduction

The Latinx/o community has low PrEP uptake despite high rates of HIV diagnoses

The impact of cultural perceptions and sex in the Latinx/o community

Creating a safe space is the first step in initiating sexual health conversations

Addressing barriers to PrEP uptake in Latinx/o communities

Representation is crucial to increasing PrEP use in the Latinx/o community

Introduction [0:02]

The Latinx/o community has low PrEP uptake despite high rates of HIV diagnoses [0:24]

The impact of cultural perceptions and sex in the Latinx/o community [0:58]

Creating a safe space is the first step in initiating sexual health conversations [1:58]

Addressing barriers to PrEP uptake in Latinx/o communities [2:50]

Representation is crucial to increasing PrEP use in the Latinx/o community [4:20]

PrEP use in young MSM

Contents

Transcript

Less impact on BMD¹

Significantly less impact on BMD^1-4

Changes in BMD were consistent over 144 weeks^3-5

A separate analysis of this substudy from baseline to ≥144 weeks (DESCOVY^®, n=191)

DESCOVY^® had less long-term impact on BMD in participants <25 years of age^3,4,6

Significantly less impact on BMD^1-4

Changes in BMD were consistent over 144 weeks^2,3,7

A separate analysis of this substudy from baseline to ≥144 weeks (DESCOVY^®, n=191)

DESCOVY^® had less long-term impact on BMD in participants <25 years of age^3,4

People may be staying on a PrEP medication for extended periods of time.² Consider BMD when prescribing a PrEP medication.

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B