Effects of emtricitabine and tenofovir: A Synthesis of Findings from 14 Studies

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Original Abstract of the Article

Main research findings

Emtricitabine and tenofovir combination drugs are widely used as oral pre-exposure prophylaxis (PrEP) to prevent HIV infection. 3 found that long-acting injectable cabotegravir (CAB-LA) was superior to oral emtricitabine-tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP).

A study 6 showed that switching from F/TDF to emtricitabine/tenofovir alafenamide (F/TAF) might improve renal function. This was especially evident in HIV-positive individuals with reduced renal function at baseline, where a significant improvement was observed after switching to F/TAF.

The study 8 found that bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), a new HIV treatment drug, has been confirmed to be effective in clinical trials and is widely used in actual medical practice.

However, a study 9 showed that the pharmacokinetics of F/TDF might differ in transgender women compared to cisgender men. Transgender women may experience changes in renal function due to hormone therapy, potentially impacting F/TDF metabolism.

The study 2 reviewed the safety of TDF-based PrEP for pregnant women. Results indicated that using TDF-based PrEP during pregnancy did not show any increased risk of adverse pregnancy or early infant growth outcomes.

A meta-analysis 12 examined the efficacy and safety of BIC/FTC/TAF. This meta-analysis demonstrated that BIC/FTC/TAF is effective and safe for people living with HIV.

The study reported the potential for pill-related esophagitis due to tenofovir disproxil fumarate/emtricitabine (Truvada) HIV pre-exposure prophylaxis.

7 studied the efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in HIV-1-infected adults, both those with and without prior treatment experience. The results confirmed the effectiveness and safety of this new HIV treatment drug.

The study 5 showed that combination antiretroviral drugs (cART) can affect hippocampal neuroplasticity in female mice. Specifically, cART might decrease hippocampal neuroplasticity and impair cognitive function.

14 evaluated the safety and efficacy of using F/TAF as PrEP. This study confirmed the safety and efficacy of F/TAF compared to TDF-based PrEP.

The study 11 investigated lipid profile changes in a real-world cohort treated with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine. The study found that these medications could affect lipid profiles.

A study 4 explored the ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in participants with M184V and/or M184I resistance mutations when switching from a tenofovir disoproxil fumarate-based or abacavir (ABC)-based regimen. Results showed that E/C/F/TAF could maintain virologic suppression even in patients with these resistance mutations.

The study 1 compared the effectiveness of doravirine-lamivudine-tenofovir disoproxil fumarate (DOR/3TC/TDF) and elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide (EVG/c/FTC/TAF) for HIV post-exposure prophylaxis (PEP). Results indicated that DOR/3TC/TDF exhibited similar safety and efficacy as EVG/c/FTC/TAF and might be cost-effective.

The study 13 evaluated the efficacy, safety, and central nervous system effects after switching from efavirenz/tenofovir/emtricitabine to doravirine/tenofovir/lamivudine. Results confirmed the effectiveness and safety of doravirine-based treatment compared to efavirenz-based treatment, potentially reducing central nervous system side effects.

Benefits and risks

Benefits summary

Emtricitabine and tenofovir combination drugs are effective in preventing HIV infection and might help improve renal function. 3 , 6 BIC/FTC/TAF and D/C/F/TAF, new HIV treatment drugs, have been confirmed to be effective in clinical trials. 8 , 7 Doravirine/lamivudine/tenofovir disoproxil fumarate appears to have a similar safety profile to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for HIV post-exposure prophylaxis (PEP) and may be more cost-effective. 1 Switching from efavirenz-based to doravirine-based treatment appears to be effective and safe, potentially reducing central nervous system side effects. 13

Risks summary

Emtricitabine and tenofovir combination drugs could lead to side effects such as esophagitis. There may be differences in the pharmacokinetics of F/TDF in transgender women. 9 Combination antiretroviral drugs (cART) may affect hippocampal neuroplasticity. 5 Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine could affect lipid profiles. 11

Comparison of studies

Commonalities

Most studies confirm the high effectiveness and safety of emtricitabine and tenofovir combination drugs in preventing HIV infection. The development of new HIV treatment drugs is progressing, and their effectiveness and safety are being confirmed.

Differences

The studies differ in the target population and research design. For example, some studies target pregnant women, while others focus on transgender women. The types of drugs used and the methods of administration vary depending on the study.

Consistency and discrepancies of results

Most studies confirm that emtricitabine and tenofovir combination drugs are highly effective and safe in preventing HIV infection. However, some studies report side effects such as esophagitis. There is also evidence that the pharmacokinetics of F/TDF may differ in transgender women. Based on these findings, emtricitabine and tenofovir combination drugs are considered effective for many patients, but it is crucial to understand that some patients may experience side effects.

Considerations for real-life application

While emtricitabine and tenofovir combination drugs are effective and safe for preventing HIV infection, there are important points to consider, such as side effects and individual variations in pharmacokinetics. Therefore, it is essential to follow the doctor's instructions and take the medication safely. For individuals in specific situations, like transgender women or pregnant women, consulting a doctor to choose the right medication is crucial.

Limitations of current research

Current research lacks sufficient studies on the long-term effects of emtricitabine and tenofovir combination drugs and their pharmacokinetics in specific populations. Furthermore, although new HIV treatment drugs are being developed, research is insufficient to assess their long-term effectiveness and safety.

Directions for future research

Future research should further investigate the long-term effects of emtricitabine and tenofovir combination drugs and their pharmacokinetics in specific populations. Additionally, research on the long-term effectiveness and safety of new HIV treatment drugs is essential. Moreover, research on PrEP dissemination strategies and improving adherence is crucial for HIV infection prevention.

Conclusion

Emtricitabine and tenofovir combination drugs are effective and safe medications for preventing HIV infection. However, important considerations include side effects and individual variations in pharmacokinetics. It is vital to follow the doctor's instructions, take the medication safely, and consult a doctor if needed. Future research should focus on investigating the long-term effects of emtricitabine and tenofovir combination drugs, studying their pharmacokinetics in specific populations, and assessing the long-term effectiveness and safety of new HIV treatment drugs.

Literature analysis of 14 papers
Positive Content
12
Neutral Content
1
Negative Content
1
Article Type
2
0
0
2
14
1.

Prophylaxis by doravirine-lamivudine-tenofovir disoproxil fumarate or elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide after sexual exposure to HIV.

Author: DevredInès, KayembeKick, ValinNadia, RougierHayette, ShingaBruce Wuembulua, Lambert-NiclotSidonie, ChiarabiniThibault, MeyohasMarie-Caroline, LacombeKarine

HIV PEP

This study compares the completion rates of doravirine/tenofovir disoproxil fumarate/lamivudine (DOR/3TC/TDF) and elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/c/FTC/TAF) for HIV post-exposure prophylaxis (PEP). The study found that DOR/3TC/TDF had a similar safety profile to EVG/c/FTC/TAF, with a comparable completion rate and no cases of seroconversion. DOR/3TC/TDF may be a cost-effective treatment option for PEP in the context of HIV-exposure accidents.

Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Safety review of tenofovir disoproxil fumarate/emtricitabine pre-exposure prophylaxis for pregnant women at risk of HIV infection.

Author: StalterRandy M, PintyeJillian, MugwanyaKenneth K

HIV prevention
Safe for pregnant women

This review discusses the safety and efficacy of TDF-based PrEP for HIV prevention during pregnancy. Current evidence suggests that TDF/FTC PrEP is not associated with increased risk of adverse pregnancy or early infant growth outcomes. However, more research is needed to further support these findings and understand the drug's effects on pregnant women.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Cost-Effectiveness of Long-Acting Injectable HIV Preexposure Prophylaxis in the United States : A Cost-Effectiveness Analysis.

Author: NeilanAnne M, LandovitzRaphael J, LeMylinh H, GrinsztejnBeatriz, FreedbergKenneth A, McCauleyMarybeth, WattananimitgulNattanicha, CohenMyron S, CiaranelloAndrea L, ClementMeredith E, ReddyKrishna P, HyleEmily P, PaltielA David, WalenskyRochelle P

CAB-LA
HIV prevention
Price premium

Long-acting injectable cabotegravir (CAB-LA) for HIV preexposure prophylaxis (PrEP) could achieve an incremental cost-effectiveness ratio (ICER) of at most $100,000 per quality-adjusted life-year (QALY) compared with generic emtricitabine-tenofovir disoproxil fumarate (F/TDF).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Adults With HIV and M184V/I Mutation.

Author: Perez-ValeroIgnacio, LlibreJosep M, CastagnaAntonella, PulidoFederico, MolinaJean-Michel, EsserStefan, MargotNicolas, ShaoYongwu, TemmeLauren, PiontkowskyDavid, McNichollIan R, HaubrichRichard

HIV treatment

This study investigated the ability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) to maintain virologic suppression in individuals with specific resistance mutations when switching from other HIV treatment regimens. The study aimed to assess the effectiveness of E/C/F/TAF in individuals with resistance mutations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

eGFR-EPI changes among HIV patients who switch from F/TDF to F/TAF while maintaining the same third agent in the Spanish VACH cohort.

Author: TeiraRamón, Diaz-CuervoHelena, AragãoFilipa, MuñozJosefa, GalindoPepa, MerinoMaríaDolores, de la FuenteBelén, SepúlvedaMaría Antonia, DomingoPere, GarcíaJosefina, CastañoManuel, RiberaEsteve, GeijoPaloma, RomeroAlberto, PeraireJoaquim, DeigElisabeth, RocaBernardino, MartínezElisa, EstradaVicente, MonteroMarta, BerenguerJuan, EspinosaNuria

Renal function improvement

Switching from emtricitabine/tenofovir disoproxil fumarate (F/TDF) to emtricitabine/tenofovir alafenamide (F/TAF)-based triple-therapy regimens resulted in numerical improvements in eGFR-EPI for people living with HIV (PLWH) with baseline eGFR-EPI <90 ml/min/1.73m<sup>2</sup>. Switching to F/TAF demonstrated beneficial renal effects in a clinical practice setting.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1.

Author: HuhnGregory D, WilkinAimee, MussiniCristina, SpinnerChristoph D, JezorwskiJohn, El GhaziMohsine, Van LanduytErika, LathouwersErkki, BrownKimberley, BaughBryan,

Bone/renal safety
High virologic response
Low VF rate
AE discontinuation

This study found that darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) was effective in treatment-naïve and treatment-experienced, virologically-suppressed adults, regardless of demographic or clinical characteristics. The regimen demonstrated a high barrier to resistance and bone/renal safety benefits.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre.

Author: AmbrosioniJuan, Rojas LiévanoJhon, BerrocalLeire, InciarteAlexy, de la MoraLorena, González-CordónAna, Martínez-RebollarMaría, LagunoMontserrat, TorresBerta, UgarteAinoa, ChiviteIván, LealLorna, de LazzariElisa, MiróJosé M, BlancoJosé L, MartinezEsteban, MallolasJosep

BIC/FTC/TAF
Virological suppression
Toxicity

This observational, retrospective study evaluated the real-world effectiveness, tolerability, and safety of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in adults with HIV. The study found that BIC/FTC/TAF achieved high rates of virological suppression in both treatment-naive and treatment-experienced patients. The medication was well-tolerated and safe, with high persistence observed at 6 months.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Population pharmacokinetics of tenofovir, emtricitabine and intracellular metabolites in transgender women.

Author: TanaudommongkonAsama, ChaturvedulaAyyappa, HendrixCraig W, FuchsEdward J, ShiehEugenie, BakshiRahul P, MarzinkeMark A

Renal function alteration

This study focuses on the need for better understanding of how gender-affirming hormonal therapies affect the pharmacokinetics of emtricitabine/tenofovir disproxil fumarate in transgender women compared to cisgender men, considering the underrepresentation of transgender women in clinical trials.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

10.

Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection.

Author: BrowneSara H, VaidaFlorin, UmlaufAnya, TuckerAmanda J, BlaschkeTerrence F, BensonConstance A

PrEP adherence
Prophylaxis choice

This study evaluated a Food and Drug Administration (FDA)-approved digital health feedback system (DHFS) with ingestible-sensor-enabled (IS) tenofovir-disoproxil-fumarate plus emtricitabine (Truvada®) in persons starting oral PrEP.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

11.

Lipid profile changes associated with antiretroviral therapies in a real-world cohort.

Author: Rotea-SalvoSandra, Giménez-ArufeVíctor, Martínez-PradedaAlejandro, Fernández-OliveiraCarla, Mena-de-CeaÁlvaro, Margusino-FramiñánLuis, Martín-HerranzIsabel, Cid-SilvaPurificación

Cardiovascular events
Lipid profile worsening

A retrospective cohort study of 457 patients with HIV who received either elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate or dolutegravir/abacavir/lamivudine found that the lipid profile worsened in the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate group but not as significantly in the dolutegravir/abacavir/lamivudine group.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Efficacy, safety and central nervous system effects after switch from efavirenz/tenofovir/emtricitabine to doravirine/tenofovir/lamivudine.

Author: NelsonMark, WinstonAlan, HillAndrew, MngqibisaRosie, BassaAyesha, OrkinChloe, RassoolMohammed, RodgersAnthony, TealValerie, KumarSushma, TepplerHedy

Lipid improvement
Virologic suppression
CNS toxicity

Switching from an efavirenz-based regimen to a doravirine-based regimen did not significantly improve CNS toxicities attributable to efavirenz, but maintained virologic efficacy and improved lipid profiles.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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