Effects of doravirine: A Synthesis of Findings from 12 Studies

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Original Abstract of the Article

Major Research Findings

Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the treatment of HIV-1 infection. Doravirine has been shown to have a robust safety and efficacy profile when used in combination with other antiretroviral drugs. 2 Doravirine has been reported to be an alternative treatment option for individuals who do not tolerate efavirenz. 2 Doravirine has demonstrated a better safety profile in embryo development compared to efavirenz. 9 Doravirine has been shown to be non-genotoxic and exhibits no developmental toxicity or effects on fertility in rats. 9 Doravirine has a better safety profile than efavirenz in zebrafish embryos. 9 However, doravirine may affect neurogenesis, angiogenesis, and lipid metabolism in zebrafish embryos. 9 Doravirine exposure may be decreased by dialysis in HIV patients with chronic renal failure. 11 Doravirine has shown potential efficacy as non-occupational HIV-1 post-exposure prophylaxis (PEP). Doravirine has demonstrated good safety and tolerability in adolescents with HIV-1. 12 Doravirine may cause hypertriglyceridemia in HIV-1 patients. Doravirine has shown potential efficacy as maintenance therapy in HIV-1 patients. 10 Doravirine has demonstrated good efficacy, safety, and tolerability in HIV-1 patients. 5 Doravirine shows promise for achieving high therapeutic effect when combined with other antiretroviral drugs in HIV-1 patients. 4

Benefits and Risks

Benefit Summary

Doravirine has demonstrated high efficacy and safety in the treatment of HIV-1 infection. It may serve as an alternative treatment option for individuals who do not tolerate efavirenz. 2 It has shown promise for achieving high therapeutic effect when combined with other antiretroviral drugs. 4 Doravirine has shown good safety and tolerability in adolescents with HIV-1. 12 Doravirine has shown potential efficacy as non-occupational HIV-1 post-exposure prophylaxis (PEP). Doravirine has demonstrated a better safety profile in embryo development compared to efavirenz. 9 Doravirine has shown potential efficacy as maintenance therapy in HIV-1 patients. 10

Risk Summary

Doravirine may cause hypertriglyceridemia in HIV-1 patients. Doravirine exposure may be decreased by dialysis in HIV patients with chronic renal failure. 11 Doravirine may affect neurogenesis, angiogenesis, and lipid metabolism in zebrafish embryos. 9

Comparison of Studies

Similarities Across Studies

Multiple studies have shown that doravirine is effective and safe in HIV-1 patients. 2 12 5 4 Additionally, doravirine has shown promise as an alternative treatment option for individuals who do not tolerate efavirenz. 2 Doravirine shows promise for achieving high therapeutic effect when combined with other antiretroviral drugs. 4

Differences Across Studies

Studies on doravirine’s safety have yielded conflicting results. A study using zebrafish embryos demonstrated that doravirine is safer than efavirenz. 9 On the other hand, a study using rats showed that doravirine is non-genotoxic and exhibits no developmental toxicity or effects on fertility. 9 These differences in results might stem from interspecies variability or methodological variations.

Consistency and Contradictions in Results

While doravirine has shown promise for efficacy and safety in HIV-1 patients, some studies have reported potential side effects. 11 9 These contradictions might be attributed to factors such as dosage variations or patient characteristics.

Considerations for Real-World Application

While doravirine presents a viable treatment option for HIV-1 infection, it’s not a one-size-fits-all solution. Doravirine exposure may be decreased by dialysis in patients with renal insufficiency, necessitating potential dosage or administration interval adjustments. 11 Doravirine may cause hypertriglyceridemia, thus warranting regular blood tests. It’s crucial to consult with a doctor before taking doravirine to fully understand the risks and benefits.

Limitations of Current Research

Further research on doravirine is warranted. Research on the effects of doravirine in pregnant women requires further investigation. Additionally, a deeper understanding of the interactions between doravirine and other antiretroviral drugs is necessary.

Future Research Directions

To delve deeper into the safety and efficacy of doravirine, further research is crucial. This includes detailed studies on the effects in pregnant women, interactions with other antiretroviral drugs, and the long-term effects of doravirine administration.

Conclusion

Doravirine has shown promise for efficacy and safety in HIV-1 treatment. However, as doravirine may cause side effects, it’s essential to consult with a doctor and fully understand the associated risks and benefits. Future research is anticipated to provide a more comprehensive understanding of doravirine’s safety and efficacy.

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

A Randomized Trial to Assess the Effect of Doravirine on the QTc Interval Using a Single Supratherapeutic Dose in Healthy Adult Volunteers.

Author: KhaliliehSauzanne G, YeeKa Lai, FanLi, LiuRachael, HeberWalter, DunzoElise, TriantafyllouIlias, HussainiAzra, IwamotoMarian

HIV treatment
QTc prolongation

Doravirine, a novel HIV-1 non-nucleoside reverse transcriptase inhibitor, had no significant effects on the heart-rate corrected QT (QTc) interval in healthy adults when administered at a supratherapeutic dose.

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.

Language : English

2.

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

4.

Current insights and molecular docking studies of HIV-1 reverse transcriptase inhibitors.

Author: SinghAnkit Kumar, KumarAdarsh, AroraSahil, KumarRaj, VermaAmita, KhalilullahHabibullah, JaremkoMariusz, EmwasAbdul-Hamid, KumarPradeep

HIV drug targets
NRTI and NNRTI efficacy
HIV drug resistance
HIV drug side effects

This review provides an overview of HIV-1 structure, replication cycle, and drug targets. It focuses on nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs), including their binding sites, mechanisms of action, FDA-approved drugs, drugs in clinical trials, resistance, adverse effects, molecular docking studies, and highly active antiretroviral therapy (HAART).

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

5.

Efficacy, safety, and tolerability of doravirine/lamivudine/tenofovir disoproxil fumarate fixed dose combination tablets in adolescents living with HIV: results through week 96 from IMPAACT 2014.

Author: RungmaitreeSupattra, AurpibulLinda, BestBrookie M, LiXiang, WarshawMeredith G, WanHong, TobinNicole H, JumesPatricia, LeavittRandi, McCarthyKatie, ScheckterRachel, OunchanumPradthana, ViolariAvy, TepplerHedy, CampbellHavilland, KrotjeChelsea, TownleyEllen, MoyeJack, MelvinAnn J,

Efficacy
Safety
Tolerability

This study reports the efficacy, safety, and tolerability of doravirine (DOR) co-formulated with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) as a fixed dose combination (DOR FDC) in adolescents with HIV-1.

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

Language : English

6.

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

8.

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP).

Author: InciarteAlexy, UgarteAinoa, Martínez-RebollarMaría, TorresBerta, FernándezEmma, BerrocalLeire, LagunoMontserrat, De la MoraLorena, De LazzariElisa, CallauPilar, ChiviteIván, González-CordónAna, SolbesEstela, RicoVerónica, BarreroLaura, BlancoJosé Luis, MartínezEsteban, AmbrosioniJuan, MallolasJosep,

PEP treatment
Well-tolerated

This prospective, open-label, single-arm trial evaluated the single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for nonoccupational human immunodeficiency virus (HIV) postexposure prophylaxis (PEP). Noncompletion of PEP was 29% and 20% per modified intention-to-treat. The main reasons for noncompletion were loss to follow-up and intolerance. The study concludes that DOR/3TC/TDF is a well-tolerated option for nonoccupational PEP.

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

Language : English

9.

Comparison of Efavirenz and Doravirine Developmental Toxicity in an Embryo Animal Model.

Author: ZizioliDaniela, FerrettiSara, TieccoGiorgio, MignaniLuca, MontiEugenio, CastelliFrancesco, Quiros-RoldanEugenia, ZanellaIsabella

HIV treatment

Doravirine (DOR) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used to treat HIV infection. This study compared the developmental toxicity of DOR to efavirenz (EFV) using zebrafish embryos. DOR demonstrated a better safety profile than EFV in terms of survival, morphology, hatching rate, and other developmental parameters.

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

Language : English

10.

Doravirine plus lamivudine two-drug regimen as maintenance antiretroviral therapy in people living with HIV: a French observational study.

Author: PerfezouPascale, HallNolwenn, DutheJean-Charles, AbdiBasma, SeangSophie, ArvieuxCédric, LamauryIsabelle, MenardAmélie, MarcelinAnne-Geneviève, KatlamaChristine, PalichRomain,

Effective maintenance therapy

This study reports the experience of using doravirine/lamivudine as maintenance therapy in people living with HIV (PLWH) in French HIV settings.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Doravirine Exposure Decreased by Dialysis in a HIV Patient: A Grand Round.

Author: FromageYeleen, CoddeCyrielle, MonchaudCaroline, LabriffeMarc, LêMinh P, FaucherJean-François, WoillardJean-Baptiste

HIV-1 treatment
doravirine exposure
renal failure

This case report describes a 66-year-old male patient with chronic renal failure who received doravirine for HIV-1. No dose adjustment is needed for doravirine in severe renal injury, but the effect of dialysis on its exposure is poorly understood.

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

12.

Pharmacokinetics, Tolerability, and Safety of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Week 24 Results From IMPAACT 2014.

Author: MelvinAnn J, YeeKa Lai, GrayKathryn P, YedlaMounika, WanHong, TobinNicole H, TepplerHedy, CampbellHavilland, McCarthyKatie, ScheckterRachel, AurpibulLinda, OunchanumPradthana, RungmaitreeSupattra, CassimHassena, McFarlandElizabeth, FlynnPatricia, CooperEllen, KrotjeChelsea, TownleyEllen, MoyeJack, BestBrookie M,

Effective HIV-1 treatment
Well-tolerated

This study evaluated the pharmacokinetics (PK) and safety of doravirine and a fixed-dose combination of doravirine, lamivudine, and tenofovir disoproxil fumarate in adolescents with HIV-1. The study found that both doravirine and the fixed-dose combination achieved target PK levels in adolescents and were well-tolerated. The fixed-dose combination maintained excellent virologic efficacy through 24 weeks, suggesting that it may be a favorable option for adolescents with HIV-1.

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

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