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.

Please see below for Important Safety Information for DESCOVY.

PrEP use can be long term1

A real-world study looked at ~14,000 people* who received PrEP care during a 6-year period1

(July 2012-March 2019; N=13,906)

Individuals engaged with PrEP care at any point during the retrospective study period1:

52.2% of those initiating PrEP discontinued at least once during the study

60.2% of those who discontinued reinitiated PrEP before the end of follow-up

(Hojilla JC, et al; 2017. Study used electronic health records from Integrated Health in Northern California)

*Prescriptions were filled for FTC/TDF or FTC/TAF for individuals aged ≥18 years with an indication for PrEP.

PrEP was first approved by the FDA in 2012. DESCOVY FOR PrEP® was approved in October 2019.2

When prescribing a potential long-term medication, such as PrEP, consider that3:

  • Renal function may change over time
  • Bone density is crucial for individuals of any age

81%

81% of PrEP users had at least one renal or bone risk factor.

of oral PrEP users had ≥1 renal or bone risk factor

in a retrospective study analyzing EHR data of over 40,000 people prescribed oral PrEP between 01/01/2015 and 02/29/2020.3

Renal function may decline over time due to age and other factors4

Consider the age of PrEP users

39% of men on a PrEP medication are forty years or older.
~

39

%

of men on a PrEP medication are aged ≥40 years,
an age when renal function may be declining.†

†Source: IQVIA® LAAD Weekly, through April 2023.‡

‡This information is an estimate derived from the use of information under license from the following IQVIA information service: IQVIA LAAD Weekly data through April 2023. IQVIA expressly reserves all rights, including rights of copying, distribution, and republication.

Markers of renal function that can be affected by exposure to certain drugs include5:

  • eGFR
  • Serum creatinine

Renal risk factors may be more prevalent than you think: 62% of oral PrEP users had ≥1 renal risk factor.3

Source: Retrospective US observational study, January 2015-February 2020; N=40,621.

These risk factors may impact renal function

NSAIDs

Taking ≥7 doses of NSAIDs per month can significantly increase the risk of kidney disease, according to a 2011-2014 cohort study of US Army soldiers6

(Nelson DA, et al; 2019; N=764,228)

Proton pump inhibitors

PPI use was shown to causally increase the risk for incident CKD, CKD progression, and ESKD, according to a 2020 review of 12 large-cohort studies7,§

(Al-Aly Z, et al; 2020)
§Sampling period between 1993-2012.

Excessive alcohol consumption

According to the National Kidney Foundation, regular heavy drinking may double the risk of chronic kidney disease8

(National Kidney Foundation, 2021)

Diabetes

According to the CDC, diabetes is the leading cause of kidney failure; ~1 in 3 adults with diabetes may have CKD9,10

(CDC; 2021)

Stimulant use

Stimulants, such as methamphetamines and cocaine, have been associated with a negative effect on kidney health11

(Fields SD, et al; 2021. Narrative review of patient-focused selection of PrEP medication for individuals at risk of HIV)

Hypertension

According to the CDC, hypertension is the second leading cause of kidney failure. Men are at greater risk for CKD and ESRD than women9,12

(CDC; 2021. Weldegiorgis M, et al; 2020; N=2,382,712)

Additional risk factors13-21:

  • Anabolic steroid use
  • CKD or declining renal function
  • Obesity
  • Comorbidities in adolescents (eg, prediabetes, hypertension)
  • Smoking

BMD may be impacted by age and other risk factors22-24

Bone density develops through about age 30 and decreases as people age22-24

28% of men on a PrEP medication are thirty years or younger.

28

%

of men on a PrEP medication
are aged 30 and under†

†Source: IQVIA® LAAD Weekly, through April 2023.‡

‡This information is an estimate derived from the use of information under license from the following IQVIA information service: IQVIA LAAD Weekly data through April 2023. IQVIA expressly reserves all rights, including rights of copying, distribution, and republication.

Lifestyle factors influence 20% to 40% of adult peak bone mass, according to the National Osteoporosis Foundation.22

Bone risk factors may be more prevalent than you think: 68% of oral PrEP users had ≥1 bone risk factor.3

Source: Retrospective US observational study, January 2015-February 2020; N=40,621.

These risk factors may impact bone mineral density

Excessive alcohol consumption

Excessive alcohol intake could significantly increase the risk of osteoporosis-related fractures11

(Fields SD, et al; 2021. Narrative review of patient-focused selection of PrEP medication for individuals at risk of HIV)

Antidepressants

In a 2012 review of 19 studies, an association between use of SSRIs and reduced BMD was observed25

(Sansone RA, et al; 2012. Review of 19 studies related to bone fractures and osteoporosis in patients on SSRIs)

ADHD medications

Stimulant ADHD medication usage was associated with a statistically significant decrease in BMD in the skull and spine,§ according to DXA data from 2013-2018 NHANES of individuals aged 18 to 50 years26

ADHD medications reported in NHANES included amphetamine, methylphenidate, dextroamphetamine, amphetamine/dextroamphetamine, and lisdexamfetamine.
(Lawson MJ, et al; 2022; N=7961 [ADHD medication users, n=79; and controls, n=7871])
§No differences in BMD were seen in any other skeletal region.

Methamphetamine use

Low BMD was associated with the use of methamphetamines and inhalants (eg, poppers) in MSM enrolled (n=210) at the San Francisco Department of Public Health site of the US CDC PrEP study from 2005-200727

(Liu AY, et al; 2011)

Vaping

46% higher prevalence of self-reported fragility fractures among e-cigarette users** vs nonusers, according to 2017-2018 NHANES data28

(Agoons DD, et al; 2021. Data on 5569 individuals aged ≥20 years. 1050 [18.8%] were past or present e-cigarette users)
In hip, spine, or wrist. **Past or present users.

Proton pump inhibitors

Chronic PPI use may increase the risk of vertebral fracture by 40% to 60%, according to a 2012 review of 14 observational studies from 1980-201129

(Lau YT, et al; 2012)

Additional risk factors27,30-32:

  • Low bone mass observed in TGW prior to/during GAHT; low baseline levels prior to GAHT may be attributed to lifestyle factors (eg, low physical activity)

    (Rothman MS and Iwamoto SJ; 2019)
  • Popper use
  • Smoking
  • Osteopenia/osteoporosis (younger males)

Consider the long-term view when choosing a PrEP option, including impact on markers of renal function and BMD.

ADHD=attention-deficit/hyperactivity disorder; BMD=bone mineral density; CDC=Centers for Disease Control and Prevention; CKD=chronic kidney disease; DXA=dual-energy X-ray absorptiometry; eGFR=estimated glomerular filtration rate; EHR=electronic health record; ESKD=end-stage kidney disease; ESRD=end-stage renal disease; FDA=US Food and Drug Administration; FTC/TAF=emtricitabine/tenofovir alafenamide fumarate; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; GAHT=gender-affirming hormone therapy; GFR=glomerular filtration rate; LAAD=Longitudinal Access and Adjudication Data; MSM=men who have sex with men; NHANES=National Health and Nutrition Examination Survey; NSAID=nonsteroidal anti-inflammatory drug; PPI=proton pump inhibitor; SSRI=selective serotonin reuptake inhibitor (SSRI is one class of drugs used to treat depression); TGW=transgender women (who have sex with men).

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