Why Are Patients Switching from Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada) to Tenofovir Alafenamide/Emtricitabine (Descovy) for Pre-Exposure Prophylaxis?

D’Angelo, Alexa B; Westmoreland, Drew; Carneiro, Pedro B.; Johnson, Jeremiah; Grov, Christian

doi:10.1089/apc.2021.0033

Cited by 23 publications

(10 citation statements)

References 27 publications

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“…We found an elevated risk of hypertension and statin initiation among TAF users especially among those who initiated PrEP at age 40 years and older. TAF has been a welcome addition to the products for PrEP due to its benefits on kidney and bone health and smaller pill size . However, it may have unwanted impact on cardiometabolic health.…”

Section: Discussionmentioning

confidence: 99%

Use of Tenofovir Alafenamide Fumarate for HIV Pre-Exposure Prophylaxis and Incidence of Hypertension and Initiation of Statins

Rivera,

Pak,

Mefford

et al. 2023

JAMA Netw Open

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ImportancePre-exposure prophylaxis (PrEP) is an important tool for preventing HIV infection. However, PrEP’s impact on cardiometabolic health is understudied.ObjectiveTo examine the risk of incident hypertension and statin initiation among adult (age ≥18 years) health plan members starting PrEP with tenofovir alafenamide fumarate (TAF) compared with propensity score–matched adults taking tenofovir disoproxil fumarate (TDF).Design, Setting, and ParticipantsThis retrospective cohort study used electronic health records (EHRs) from Kaiser Permanente Southern California. Adult members starting PrEP in Kaiser Permanente Southern California between October 2019 and May 2022 were included. Propensity score matching with multiple imputation (50 matched data sets) was conducted to generate 1 TAF:4 TDF matched data sets with balanced baseline covariates.ExposuresPrEP initiation with either TAF or TDF during the study period.Main Outcomes and MeasuresIncident hypertension and statin initiation within 2 years of PrEP initiation were ascertained through blood pressure and outpatient pharmacy records, respectively. Risk differences and odds ratios (ORs) were estimated using logistic regression and g-computation.ResultsA total of 6824 eligible individuals were identified (mean [SD] age, 33.9 [10.3] years; 6618 [97%] male). This pool was used to generate 2 cohorts without baseline hypertension or statin use for matching (hypertension: n = 5523; statin: n = 6149) In both cohorts, those starting PrEP with TAF were older and were more likely to be non-Hispanic White compared with those starting with TDF. In matched analysis adjusting for baseline covariates, TAF use was associated with elevated risk of incident hypertension (TAF: n = 371; risk difference, 0.81 [95% CI, 0.12-1.50]; OR, 1.64 [95% CI, 1.05-2.56]). TAF use was also associated with elevated risk of statin initiation (TAF: n = 382; risk difference, 0.85 [95% CI, 0.37-1.33]; OR, 2.33 [95% CI, 1.41-3.85]). Subgroup analyses restricted to individuals 40 years and older at PrEP initiation showed similar results with larger risk difference in statin initiation (risk difference, 4.24 [95% CI, 1.82-6.26]; OR, 3.05 [95% CI, 1.64-5.67]).Conclusions and RelevanceIn this study of people taking PrEP, TAF use was found to be associated with higher incident hypertension and statin initiation compared with TDF use, especially in those 40 years or older. Continued monitoring of blood pressure and lipids for TAF users is warranted.

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Section: Discussionmentioning

confidence: 99%

Use of Tenofovir Alafenamide Fumarate for HIV Pre-Exposure Prophylaxis and Incidence of Hypertension and Initiation of Statins

Rivera,

Pak,

Mefford

et al. 2023

JAMA Netw Open

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“…6 For PrEP, there is evidence to suggest that providers continue to prescribe high-cost brand-name medications, even when lower cost generic TDF/FTC is the appropriate regimen and may be covered in full by the insurer. 7 Pivoting entirely to the latest biomedical interventions instead of staying focused on efforts to increase initial uptake of PrEP and support needs for PrEP adherence among racial and sexual minorities may be short-sighted and contribute to stagnating progress on PrEP scale up. Instead, federal partners should explore national approaches that provide widespread access, through programs like the federal Vaccines for Children program (VFC) model.…”

Section: Reasons People Are Not Using Prepmentioning

confidence: 99%

Health Departments and PrEP:A Missed Opportunity for Public Health

Comer¹,

Fernández²

2022

J. Law. Med. Ethics

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The paper identifies common barriers and challenges to Pre-Exposure Prophylaxis (PrEP) uptake and offers considerations for state and local public health departments to address barriers and retool infrastructure to increase access to PrEP to new users. Authors identify synergistic opportunities with federal agencies and funders to advance PrEP-related HIV prevention efforts, that prioritize strategies and investments to provide PrEP to people who could benefit from the intervention but are unaware of PrEP or struggle to access it. Barriers discussed and examined include financing strategies to reduce financial burden of PrEP medication, expanding PrEP access and outreach beyond clinical settings, and increasing the network and reach of the provider community to serve people we oppress through policy choices and discourses of racial and socioeconomic inferiority.

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“…A potential impact of sex-aware drug repurposing (and sex-aware drug discovery not discussed in this review) would be more drugs being approved for only one sex for non-sex-specific conditions due to the difference in therapeutic effectiveness or to avoid an adverse event. Several drugs are only FDA-approved for a condition that occurs in one sex (i.e., ovarian or testicular cancer), but in 2019, an HIV prevention medication, Descovy, was approved for cisgender men and transgender women due to a large clinical trial with just cisgender men and transgender women (177). While there is justified criticism for the approval of a drug for a specific gender/sex due to the underrepresentation of females in a clinical trial, this case highlights that the FDA can approve drugs in a sex and gender -specific manner even though the condition is not sex or gender -specific (177).…”

Section: Perspectives and Significancementioning

confidence: 99%

“…Several drugs are only FDA-approved for a condition that occurs in one sex (i.e., ovarian or testicular cancer), but in 2019, an HIV prevention medication, Descovy, was approved for cisgender men and transgender women due to a large clinical trial with just cisgender men and transgender women (177). While there is justified criticism for the approval of a drug for a specific gender/sex due to the underrepresentation of females in a clinical trial, this case highlights that the FDA can approve drugs in a sex and gender -specific manner even though the condition is not sex or gender -specific (177). Another future consequence of sex-aware drug repurposing is the practice of adjusting dosage based on sex-specific pharmacokinetic or pharmacodynamics, as suggested for the FDA Ambien example discussed earlier (56).…”

Section: Perspectives and Significancementioning

confidence: 99%

Considerations and Challenges for Sex-Aware Drug Repurposing

Fisher¹,

Jones²,

Flanary³

et al. 2022

Preprint

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Sex differences are essential factors in disease etiology and manifestation in many diseases such as cardiovascular disease, cancer, and neurodegeneration (1). The biological influence of sex differences (including genomic, epigenetic, hormonal, immunological, and metabolic differences between males and females) and the lack of biomedical studies considering sex differences in their study design has led to several policies. For example, the National Institute of Health’s (NIH) sex as a biological variable (SABV) and Sex and Gender Equity in Research (SAGER)) policies to motivate researchers to consider sex differences (2). However, drug repurposing, a promising alternative to traditional drug discovery by identifying novel uses for FDA-approved drugs, lacks sex-aware methods that can improve the identification of drugs that have sex-specific responses (1,3–5). Sex-aware drug repurposing methods either select drug candidates that are more efficacious in one sex or deprioritize drug candidates based on if they are predicted to cause a sex-bias adverse event (SBAE), unintended therapeutic effects that are more likely to occur in one sex. Computational drug repurposing methods are encouraging approaches to develop for sex-aware drug repurposing because they can prioritize sex-specific drug candidates or SBAEs at lower cost and time than traditional drug discovery. Sex-aware methods currently exist for clinical, genomic, and transcriptomic information (3,6,7). They have not expanded to other data types, such as DNA variation, which has been beneficial in other drug repurposing methods that do not consider sex (8). Additionally, some sex-aware methods suffer from poorer performance because a disproportionate number of male and female samples are available to train computational methods (3). However, there is development potential for several different categories (i.e., data mining, ligand binding predictions, molecular associations, and networks). Low-dimensional representations of molecular association and network approaches are also especially promising candidates for future sex-aware drug repurposing methodologies because they reduce the multiple hypothesis testing burden and capture sex-specific variation better than the other methods (9,10). Here we review how sex influences drug response, the current state of drug repurposing including with respect to sex-bias drug response, and how model organism study design choices influence drug repurposing validation.

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Why Are Patients Switching from Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada) to Tenofovir Alafenamide/Emtricitabine (Descovy) for Pre-Exposure Prophylaxis?

Cited by 23 publications

References 27 publications

Use of Tenofovir Alafenamide Fumarate for HIV Pre-Exposure Prophylaxis and Incidence of Hypertension and Initiation of Statins

Use of Tenofovir Alafenamide Fumarate for HIV Pre-Exposure Prophylaxis and Incidence of Hypertension and Initiation of Statins

Health Departments and PrEP:A Missed Opportunity for Public Health

Considerations and Challenges for Sex-Aware Drug Repurposing

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