Side Effects of etravirine: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Key Findings

Etravirine has shown sustained virologic efficacy in clinical trials involving over 1,000 treatment-experienced HIV-1 infected patients who were resistant to NNRTIs. 13 Etravirine has a favorable safety profile compared to other antiretrovirals, including NNRTIs. 13 Etravirine is a good option for use with chemotherapy for Hodgkin's lymphoma due to its moderate inducing effect on drug-metabolizing enzymes. 24 Etravirine is a highly flexible diarylpyrimidine compound with favorable binding interactions towards mutant HIV strains as well as wild-type virus. 17 Etravirine has a high genetic barrier to resistance, requiring multiple mutations before a decrease in susceptibility occurs. 17 Etravirine was used successfully in a rescue therapy for a child with vertically-acquired multidrug-resistant HIV-1. 16 Etravirine is a potential alternative to efavirenz, with advantages regarding patient preference, sleep, anxiety, and lipid levels. 10 Etravirine has significantly improved water solubility and a favorable safety profile compared to other DAPYs. 20 Long-term administration of etravirine and abacavir may impair semen quality and affect the redox system and bone metabolism in growing male rats. 19 Antiretroviral drugs such as etravirine, raltegravir, and darunavir can cause allergic hypersensitivity. 3 Etravirine is a potential option for patients who are switching therapy due to adverse events. 5 Raltegravir has shown comparable long-term outcomes to other third-line drugs in salvage therapy for highly experienced HIV individuals. 18 Etravirine is a valuable treatment option for a wide range of treatment-experienced HIV-1 infected patients. 11 A combination of raltegravir, etravirine, and r-darunavir has shown promising results in adolescents with multidrug-resistant virus. 14 Etravirine-based therapy has shown clinical benefits for treatment-experienced HIV-1 infected patients. 1 Antiretroviral treatment with efavirenz can disrupt the blood-brain barrier integrity and increase stroke severity. 21 Efavirenz is a preferred NNRTI for first-line treatment of children over 3 years old. 4 Etravirine dosage can be switched from twice daily to once daily for patients with suppressed viremia and prior resistance to first-generation NNRTIs. 7 Maraviroc utilization has increased with the inclusion of routine tropism testing. 8 Etravirine plays a vital role in managing treatment-experienced patients with HIV-1. 9 Etravirine in combination with optimized background regimen (OBR) shows superior antiviral activity compared to control OBR. 9 There are gastrointestinal side effects associated with HIV infection and antiretroviral treatment. 15 Etravirine is a novel NNRTI designed to suppress the replication of viruses resistant to efavirenz, nevirapine, and delavirdine. 12 Dual therapy is a potential alternative for HIV-pretreated patients, helping prevent side effects and improve adherence. 2 Etravirine has shown to be well-tolerated with minimal clinically significant drug interactions. 26 Hepatotoxicity, a common side effect of early antiretrovirals, is less frequent with newer drugs. 6 Telaprevir-based therapy has been evaluated for its efficacy, safety, and pharmacokinetics in patients with HCV-1/HIV-1 coinfection. 22 Etravirine has a lower risk of brain side effects compared to efavirenz. There are potential drug-drug interactions between etravirine and DAA agents. 23

Reasons for Side Effects

Etravirine is a substrate of and a weak inducer of CYP3A4. 26 It's also a substrate and a weak inhibitor of CYP2C9 and CYP2C19. 26 Etravirine is also a weak inhibitor of P-glycoprotein. 26 These pharmacokinetic properties mean etravirine may affect the metabolism and movement of other drugs in the body, potentially leading to side effects.

Common Side Effects

Rash

Rash has been shown to occur with a higher incidence in etravirine-treated patients versus placebo, but cases are generally mild to moderate, occur within the first few weeks, and resolve with continued use. 13 There were no major differences in frequency or severity of side effects between etravirine and placebo groups, with the exception of rash. 17

Nausea

Nausea is one of the most common side effects reported with etravirine treatment. 17

Neuropsychiatric Side Effects

Etravirine has fewer neuropsychiatric side effects compared to efavirenz. 11

Hepatotoxicity

Etravirine has a low risk of hepatotoxicity. 11 Etravirine has fewer hepatic side effects compared to nevirapine. 11

Effects on Semen Quality

Etravirine and abacavir may impair semen quality and alter the redox system and bone metabolism in growing male rats. 19

Allergic Hypersensitivity

Antiretroviral drugs such as etravirine, raltegravir, and darunavir can cause allergic hypersensitivity. 3

Side Effects Management

Rash

In many cases, rash resolves with continued use if it's mild to moderate. 13

Nausea

Eating small, frequent meals may help alleviate nausea. 15

Neuropsychiatric Side Effects

Consult with your doctor if you experience any neuropsychiatric side effects. 11

Hepatotoxicity

Regular liver function tests are important to monitor for hepatotoxicity risk. 11

Effects on Semen Quality

Etravirine and abacavir may impair semen quality in rats. 19 Adjusting the dosage or route of administration of etravirine may be necessary to minimize this side effect. 19

Allergic Hypersensitivity

Seek immediate medical attention if you experience any allergic reactions. 3

Comparison Between Studies

Commonalities

Many studies have shown etravirine to be a viable treatment option for treatment-experienced HIV-1 infected patients. 13 Etravirine has the potential for improved tolerability compared to other NNRTIs. 13 Also, etravirine can be combined with a variety of other medications. 26

Differences

Side effects may vary in their frequency and severity depending on the route of administration, dosage, and concomitant medications. 11 The age and health status of the study participants can also influence the manifestation of side effects. 15

Considerations for Real-World Applications

Etravirine has the potential to effectively suppress viral load in treatment-experienced HIV-1 infected patients. 13 However, etravirine can interact with other medications, making it crucial to consult with your doctor to determine the appropriate dosage and combination of medications. 26 Additionally, be aware that etravirine can cause side effects. 13 If you have concerns about side effects, consult your doctor. 13

Limitations of Current Research

The long-term safety of etravirine hasn't been fully elucidated yet. 6 Therefore, further research on the long-term side effects of etravirine is required. 6 More extensive research is also needed to understand the pharmacokinetic profile and drug interactions of etravirine. 26

Future Research Directions

Further research is needed to understand the long-term safety of etravirine. 6 Additional research into the pharmacokinetic profile and drug interactions of etravirine is also necessary. 26 Furthermore, studies evaluating the efficacy and safety of etravirine when combined with other antiretroviral drugs are crucial. 11

Conclusion

Etravirine is a potential effective treatment option for treatment-experienced HIV-1 infected patients. 13 However, it's essential to remember that etravirine can cause side effects. 13 If you're considering using etravirine, consult your doctor to determine the appropriate dosage and combination of medications. 26

Literature analysis of 26 papers
Positive Content
25
Neutral Content
0
Negative Content
1
Article Type
1
0
1
7
26
1.

Effectiveness of etravirine-based therapy for treatment-experienced HIV-infected patients.

Author: Huerta GarcíaGloria, Mata-MarínJosé Antonio, Domínguez-HermosilloJuan Carlos, Chavez-GarcíaMarcelino, Banda-LaraMarco Issac, Nuñez-RodríguezNohemi, Cruz-HerreraJavier Enrique, Sandoval-RamírezJorge Luis, Villagómez-RuizAlfredo, Manjarrez-TellezBulmaro, Gaytan-MartínezJesús Enrique

HIV treatment

This study evaluated the effectiveness of efavirenz (ETV) plus an optimized background regimen in a cohort of highly treatment-experienced HIV-1 patients. ETV has shown significant clinical benefits in patients with antiretroviral resistance.

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

Language : English

2.

[Dual therapy as an alternative treatment in HIV pretreated patients: experience in a tertiary hospital].

Author: Yunquera-RomeroLucia, Asensi-DíezRocío, Gajardo-ÁlvarezMacarena, Muñoz-CastilloIsabel

Improved adherence
Reduced side effects

Dual therapy regimens for HIV may provide an effective alternative to prevent side effects and comorbidities associated with prolonged antiretroviral therapy.

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

Language : Spanish

3.

[Allergic hypersensitivity to antiretroviral drugs: etravirine, raltegravir and darunavir].

Author: Sánchez-OlivasManuel Anastacio, Valencia-ZavalaMartha Patricia, Vega-RobledoGloria Bertha, Sánchez-OlivasJesús Alberto, Velázquez-SámanoGuillermo, Sepúlveda-VelázquezGuadalupe

Early recognition
Reduce drug interactions
Allergic reactions
Long-term adverse events
Short-term adverse events

Antiretroviral drugs can cause both short-term and long-term side effects. While each drug has its own specific side effects, the risk can vary from person to person. This review discusses the adverse effects of highly active antiretroviral therapy (HAART) in the treatment of HIV and aims to increase awareness for early recognition and reversal of potentially serious side effects.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Spanish

5.

Switching to an etravirine-containing regimen due to drug intolerance in clinical practice.

Author: Martín-CarboneroL, MorenoV, Ramírez-OlivenzaG, ValenciaE

Virologic suppression
Adverse events

Switching to an etravirine (ETR)-containing regimen is a safe strategy for HIV patients experiencing drug side effects.

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

Language : English

6.

Hepatoxicity of new antiretrovirals: a systematic review.

Author: SurgersLaure, LacombeKarine

More efficient antiretrovirals
Safer antiretrovirals
Hepatic events
Hepatotoxicity

The management of HIV has shifted towards earlier initiation of antiretroviral therapy, leading to lifelong drug exposure and concerns about long-term safety. Recent advances have introduced newer, safer, and more effective drugs. While initial antiretrovirals were associated with hepatotoxicity, newer drugs show reassuring liver tolerance in phase II/III trials. However, long-term data are needed, as case reports suggest rare but potentially life-threatening hepatic events in patients with co-infections or taking other hepatotoxic drugs.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

7.

Switch from etravirine twice daily to once daily in non-nucleoside reverse transcriptase inhibitor (NNRTI)-resistant HIV-infected patients with suppressed viremia: the Monetra study.

Author: SchneiderL, KtorzaN, FouratiS, AssoumouL, CourbonE, CabyF, BlancC, TindelM, AgherR, MarcelinA G, CalvezV, PeytavinG, KatlamaC

HIV treatment
Side effects
Virological failure

Etravirine (ETR) once daily was effective in maintaining suppressed viremia over 48 weeks in HIV-experienced patients with prior resistance to first-generation NNRTIs.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Maraviroc observational study: the impact of expanded resistance testing and clinical considerations for antiretroviral regimen selection in treatment-experienced patients.

Author: WilligJames H, WilkinsSara-Anne, TamhaneAshutosh, NevinChrista R, MugaveroMichael J, RaperJames L, NapolitanoLaura A, SaagMichael S

Increased MVC utilization

This study investigated the impact of free tropism testing on maraviroc (MVC) utilization in HIV-positive patients. Routine tropism testing led to a statistically significant increase in MVC use, but additional barriers to MVC utilization remain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

A randomized crossover study to compare efavirenz and etravirine treatment.

Author: NguyenAlain, CalmyAlexandra, DelhumeauCécile, MercierIsabelle K, CavassiniMatthias, Fayet-MelloAurélie, ElziLuigia, GennéDaniel, RauchAndri, BernasconiEnos, HirschelBernard,

Reduced cholesterol

This study found that patients did not express a significant preference for etravirine over efavirenz after substitution. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol levels decreased after replacing efavirenz with etravirine.

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

11.

Etravirine in the treatment of HIV-1: a clinical overview for healthcare professionals.

Author: YeniPatrick, MillsAnthony, PeetersMonika, VingerhoetsJohan, KakudaThomas N, De SmedtGoedele, WoodfallBrian

HIV treatment
Rash

The study found that etravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is a valuable treatment option for a wide range of treatment-experienced HIV-1-infected patients. Etravirine demonstrated durable, superior virologic efficacy over placebo and has a favorable safety and tolerability profile.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

A review of the safety and tolerability profile of the next-generation NNRTI etravirine.

Author: GrinsztejnBeatriz, Di PerriGiovanni, TownerWilliam, WoodfallBrian, De SmedtGoedele, PeetersMonika

HIV-1 treatment
Improved tolerability
Virologic efficacy
Rash

Etravirine is a well-tolerated next-generation nonnucleoside reverse transcriptase inhibitor (NNRTI) with a proven safety record. It may offer improved tolerability over existing antiretrovirals, including NNRTIs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Raltegravir, etravirine and r-darunavir combination in adolescents with multidrug-resistant virus.

Author: ThuretIsabelle, ChaixMarie-Laure, TamaletCatherine, ReliquetVéronique, FirtionGhislaine, TricoireJoëlle, RabaudChristian, FrangePierre, AumaîtreHugues, BlancheStéphane

HIV Treatment
Multidrug Resistant Virus Treatment

This study evaluated the effectiveness of a combination therapy of raltegravir, r-darunavir, and etravirine in twelve adolescents with multidrug-resistant HIV infection. The combination therapy resulted in a significant decrease in viral load in most patients, with no significant side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Successful rescue therapy with a darunavir/ritonavir and etravirine antiretroviral regimen in a child with vertically acquired multidrug-resistant HIV-1.

Author: ViganòAlessandra, MeroniLuca, MarchettiGiulia, VanzulliAngelo, GiacometVania, FasanSilvia, PradellaAndrea, CeriniChiara, ZuccottiGian V

Multidrug-resistant HIV-1 treatment

This report describes a case of a child with vertically-acquired multidrug-resistant HIV-1, successfully treated with a darunavir/ritonavir- and etravirine-containing regimen. This case highlights the growing challenge of managing multidrug-resistant HIV-1 in children and the potential need for experimental agents in such cases.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Long-Term Administration of Abacavir and Etravirine Impairs Semen Quality and Alters Redox System and Bone Metabolism in Growing Male Wistar Rats.

Author: MatuszewskaAgnieszka, NowakBeata, NiżańskiWojciech, EberhardtMaria, DomrazekKinga, NikodemAnna, WiatrakBenita, ZduniakKrzysztof, OlejnikKamil, Merwid-LądAnna, TomkalskiTomasz, JędrzejukDiana, SzelągEwa, Podhorska-OkołówMarzenna, PiotrowskaAleksandra, JęśkowiakIzabela, HeinrichAgata, RutkowskaMaria, DziewiszekWojciech, SozańskiTomasz, KwiatkowskaJoanna, JawieńPaulina, BolanowskiMarek, SzelągAdam

Bone formation
Decreased fertility
Oxidative stress

This study evaluated the toxicity of abacavir and etravirine, two antiretroviral drugs, in monotherapy on the reproductive system, liver, kidneys, and bones in male rats. Both drugs disturbed oxidative stress and affected bone formation, with etravirine also disturbing vitamin D metabolism.

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

Language : English

20.

Exploiting the Tolerant Region I of the Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Binding Pocket: Discovery of Potent Diarylpyrimidine-Typed HIV-1 NNRTIs against Wild-Type and E138K Mutant Virus with Significantly Improved Water Solubility and Favorable Safety Profiles.

Author: HuangBoshi, ChenWenmin, ZhaoTong, LiZhenyu, JiangXiangyi, GinexTiziana, VílchezDavid, LuqueFrancisco Javier, KangDongwei, GaoPing, ZhangJian, TianYe, DaelemansDirk, De ClercqErik, PannecouqueChristophe, ZhanPeng, LiuXinyong

Anti-HIV-1 activity
Cytotoxicity
Side-effects

This study developed new diarylpyrimidine derivatives (DAPYs) with improved anti-HIV-1 activity and water solubility. The new compounds showed comparable or better potency against wild-type and E138K mutant HIV-1 compared to the lead etravirine, with low cytotoxicity. These findings suggest the new compounds hold promise for further development as anti-HIV-1 agents.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Antiretroviral Treatment with Efavirenz Disrupts the Blood-Brain Barrier Integrity and Increases Stroke Severity.

Author: BertrandLuc, DygertLevi, ToborekMichal

HIV treatment
Cerebrovascular complications

This study evaluated the impact of several non-nucleoside reverse transcriptase inhibitors (NNRTI) on the integrity of the blood-brain barrier and their impact on severity of stroke. The study found that Efavirenz, but not other NNRTIs, altered claudin-5 expression, increased endothelial permeability, and disrupted the blood-brain barrier integrity, increasing the severity of stroke in a model of middle cerebral artery occlusion in mice.

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

22.

Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.

Author: MontesMaria Luisa, NelsonMark, GirardPierre-Marie, SasadeuszJoe, HorbanAndrzej, GrinsztejnBeatriz, ZakharovaNatalia, RiveroAntonio, DurantJacques, Ortega-GonzalezEnrique, LathouwersErkki, JanssenKatrien, Ouwerkerk-MahadevanSivi, WitekJames, González-GarcíaJuan

Higher SVR rates
Adverse events

A Phase IIIb, multicenter study of 162 patients with hepatitis C virus genotype 1 (HCV-1)/HIV-1 co-infection found that telaprevir-based therapy plus pegylated-IFN α2a and ribavirin resulted in significantly higher sustained virological response (SVR) rates compared with pre-specified historical controls. The safety profile was comparable to that in HCV-monoinfected patients.

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.
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

24.

Etravirine: a good option for concomitant use with chemotherapy for Hodgkin's lymphoma.

Author: KurzMario, StoeckleMarcel, KrasniqiFatime, BattegayManuel, MarzoliniCatia

Etravirine effective with chemo
Hodgkin's lymphoma treatment
Drug-drug interactions
Side effects increase

This article describes a successful case of using an etravirine-based regimen in a patient with advanced Hodgkin's lymphoma who was also receiving BEACOPP chemotherapy. The authors highlight the value of etravirine for concomitant use with chemotherapy due to its moderate effect on drug-metabolizing enzymes.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

25.

Dual therapy with etravirine plus raltegravir for virologically suppressed HIV-infected patients: a pilot study.

Author: MonteiroPolyana, PerezIñaki, LagunoMontserrat, Martínez-RebollarMaria, González-CordonAna, LoncaMontserrat, MallolasJosep, BlancoJose L, GatellJose M, MartínezEsteban

Durable viral suppression
Intolerance

Dual therapy with etravirine plus raltegravir was well tolerated and maintained durable viral suppression in selected virologically suppressed patients for whom both protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor (NRTI) therapy was challenging.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

26.

Pharmacokinetic interactions between etravirine and non-antiretroviral drugs.

Author: KakudaThomas N, Schöller-GyüreMonika, HoetelmansRichard M W

Few drug interactions
HIV-1 inhibition
Increased exposure

Etravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) used for HIV-1 treatment, has been extensively studied for potential drug-drug interactions. Overall, etravirine is generally safe and well tolerated when co-administered with a variety of non-antiretroviral agents.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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