Effects of darunavir: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Main Research Findings

Darunavir is a protease inhibitor used to treat HIV-1 infection. It works by blocking the activity of HIV-1 protease, an enzyme that is essential for the virus to replicate. 11 investigated the effects of drug-resistant mutations on the dynamic properties of HIV-1 protease and its inhibition by Amprenavir and Darunavir. They found that Darunavir binds to HIV-1 protease through both hydrophobic and hydrogen bonding interactions, which further stabilize the closed conformation of flaps. reported a serious neuropsychiatric adverse effect related to the interaction between itraconazole and darunavir/ritonavir in an HIV-infected patient. Darunavir also has metabolic effects, as shown in , which investigated the post-prandial lipid effects of raltegravir versus darunavir/ritonavir. 10 explored a reduction grade of lipodystrophy and limited side effects after HAART regimen with Raltegravir, Lamivudine, Darunavir and Ritonavir in an HIV-1 infected patient. 13 compared the metabolic effects of ritonavir-boosted darunavir or atazanavir versus raltegravir, and the impact of ritonavir plasma exposure. Darunavir did not affect telomerase activity in vitro, according to 6 . 15 compared the effects of once-daily darunavir/ritonavir versus lopinavir/ritonavir on metabolic parameters in treatment-naive HIV-1-infected patients, finding a more favorable lipid profile with Darunavir. The ARTEMIS study ( 1 ) also showed that darunavir/ritonavir was not inferior to lopinavir/ritonavir in treatment-naive patients. reported an unrecognized drug interaction where ranolazine adverse effects were intensified by Darunavir-Cobicistat. 4 compared the effects of atazanavir, darunavir, and raltegravir on fat and muscle among persons living with HIV, highlighting the impact of ART on fat and muscle quality. 3 investigated the effects of Dolutegravir, Darunavir and Atazanavir on osteogenesis to understand the basis of antiretroviral therapy-induced osteopenia. 8 studied the chronic effects of ethanol and/or darunavir/ritonavir on U937 monocytic cells. 7 compared the effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons. 16 assessed metabolic changes for darunavir/ritonavir versus atazanavir/ritonavir in treatment-naive, HIV type 1-infected subjects over 48 weeks. 2 focused on early lipid changes with atazanavir/ritonavir or darunavir/ritonavir. 14 compared the incidence and health care costs of medically attended adverse effects among U.S. Medicaid HIV patients on atazanavir- or darunavir-based antiretroviral therapy. explored the different effects of glucocorticoids on darunavir plasma concentrations. 5 investigated the inflammatory effects of atazanavir/ritonavir versus darunavir/ritonavir in treatment-naive, HIV-1-infected patients. 12 examined the differential effects of viremia and microbial translocation on immune activation in HIV-infected patients on ritonavir-boosted darunavir monotherapy. 9 explored the effects of switching from fixed-dose tenofovir disoproxil fumarate/emtricitabine/efavirenz to darunavir/ritonavir monotherapy on vitamin D, bone, and kidney function.

Benefits and Risks

Benefits Summary

Darunavir is effective in suppressing HIV-1 replication, leading to an increase in CD4 counts, and may have fewer side effects compared to other protease inhibitors. 15 , 1 It is particularly effective in patients with high viral loads. 1 Darunavir may also be an option for first-line antiretroviral therapy due to its effectiveness and a reduced dose of ritonavir. 1

Risks Summary

While effective, darunavir has potential risks and side effects. It may interact with other medications, leading to serious neuropsychiatric adverse effects. , It can also influence metabolism, potentially causing lipodystrophy and other metabolic disorders. 10 , 13 , 16 , 2 Darunavir may also impact bone health, potentially increasing the risk of osteopenia. 3

Comparison Across Studies

Commonalities

Multiple studies have confirmed the effectiveness of darunavir as an HIV-1 protease inhibitor. 15 , 1 Several studies have also noted the potential for darunavir to cause metabolic side effects, specifically lipodystrophy. 10 , 13 , 16 , 2

Differences

Some studies have shown that darunavir may have fewer metabolic side effects compared to other protease inhibitors, like a favorable lipid profile compared to lopinavir/ritonavir. 15 , 1 However, other studies suggest that darunavir might increase the risk of lipodystrophy. 10 , 13 , 16 , 2 These differences may be due to factors such as study design, participant populations, and specific metabolic parameters investigated.

Consistency and Contradictions in Findings

Some contradictions exist in the findings regarding darunavir's effects. Some studies indicate that darunavir may have a lower risk of metabolic side effects compared to other protease inhibitors. 15 , 1 However, other studies suggest a potential for darunavir to increase the risk of lipodystrophy. 10 , 13 , 16 , 2 These discrepancies could be explained by differences in study design, participant populations, and specific metabolic parameters investigated.

Implications for Daily Life

Darunavir is a valuable treatment option for HIV-1 infection, but it is important to consider its potential risks and interactions with other medications. , Darunavir can influence metabolism, possibly leading to lipodystrophy. 10 , 13 , 16 , 2 Regular monitoring by a healthcare professional is crucial to manage potential side effects and optimize treatment outcomes.

Limitations of Current Research

Research on darunavir has certain limitations. Many studies are small and focus on specific populations, making it difficult to generalize findings to other groups. Some studies focus on specific side effects or metabolic parameters, leaving the impact of darunavir on other aspects unclear.

Future Research Directions

To gain a deeper understanding of darunavir's effects, further research is needed. Investigating how darunavir affects diverse populations, its long-term side effects, and optimal strategies for its use are important. Further research into drug interactions involving darunavir is also crucial.

Conclusion

Darunavir is an effective antiretroviral drug for treating HIV-1 infection but comes with potential risks and side effects. It is crucial to be aware of these risks, and regular monitoring by a healthcare professional is essential to manage potential side effects and optimize treatment outcomes. Continued research will help us understand darunavir's effects better, ensuring its safe and effective use for HIV-infected individuals.

Literature analysis of 16 papers
Positive Content
11
Neutral Content
2
Negative Content
3
Article Type
7
0
0
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16
1.

[Darunavir in treatment-naïve patients. The ARTEMIS study].

Author: EstradaVicente, FusterMónica

HIV treatment efficacy
Increased CD4 count
Reduced adverse effects

The ARTEMIS study compared the effectiveness of darunavir/ritonavir and lopinavir/ritonavir for treating HIV in people who had never taken HIV medications before. Both medications were effective, but darunavir/ritonavir was more effective in patients with higher levels of HIV in their blood. Darunavir/ritonavir also had fewer side effects, particularly digestive problems and changes in lipid levels.

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.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
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.
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.

Language : Spanish

2.

Early lipid changes with atazanavir/ritonavir or darunavir/ritonavir.

Author: MartinezE, Gonzalez-CordonA, FerrerE, DomingoP, NegredoE, GutierrezF, PortillaJ, CurranA, PodzamczerD, MurillasJ, BernardinoJ I, SantosI, CartonJ A, PeraireJ, PichJ, PerezI, GatellJ M,

Lipid effects
Tolerability
Hyperbilirubinaemia

This study examines the lipid effects and overall tolerability of ritonavir-boosted atazanavir and darunavir compared to ritonavir-boosted lopinavir in patients with HIV infection.

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

3.

Unveiling the basis of antiretroviral therapy-induced osteopenia: the effects of Dolutegravir, Darunavir and Atazanavir on osteogenesis.

Author: CazzanigaAlessandra, ScrimieriRoberta, GalliMassimo, MaierJeanette, RusconiStefano

Impaired osteogenesis

Atazanavir and Dolutegravir, two commonly used antiretroviral drugs, were found to impair osteogenesis in human mesenchymal stem cells and osteoblasts, while Darunavir had no effect. This finding highlights the importance of early diagnosis and therapeutic interventions to preserve bone health in ART-treated HIV patients.

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

4.

Effects of atazanavir, darunavir, and raltegravir on fat and muscle among persons living with HIV.

Author: AdrianStefan, MiaoHongyu, FengHan, ScherzingerAnn, NardiniGiulia, BeghettoBarbara, RoncagliaEnrica, LigabueGuido, MilicJovana, GuaraldiGiovanni, LakeJordan E, ErlandsonKristine M

Fat gain
Muscle gain

This study compares fat and muscle density among people with HIV on different antiretroviral therapies (ARTs), exploring implications for muscle function.

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

5.

Inflammatory effects of atazanavir/ritonavir versus darunavir/ritonavir in treatment naïve, HIV-1-infected patients.

Author: DentoneChiara, Di BiagioAntonio, Cozzi LepriAlessandro, FenoglioDaniela, FilaciGilberto, LichtnerMiriam, CarraraStefania, GiacomettiAndrea, SighinolfiLaura, MarchettiGiulia, AntinoriAndrea, D'arminio MonforteAntonella,

There was little evidence for an association between antiretroviral regimens and modulation of vascular inflammatory and activation markers over one year of exposure. The analysis of soluble markers of inflammation in treatment-naive HIV-1-infected patients showed a difference in ox-LDL between the atazanavir/ritonavir and darunavir/ritonavir groups, but overall, antiretroviral regimens had generally poor efficiency in downregulating these markers.

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

Language : English

6.

Brief Report: Differential Effects of Tenofovir, Abacavir, Emtricitabine, and Darunavir on Telomerase Activity In Vitro.

Author: Stella-AscarizNatalia, MontejanoRocío, Pintado-BerninchesLaura, MongeSusana, BernardinoJosé I, Pérez-ValeroIgnacio, MontesMaría L, MingoranceJesús, PeronaRosario, ArribasJosé R

Inhibition of telomerase activity

This study investigated the effects of tenofovir and abacavir on telomerase activity in peripheral blood mononuclear cells of healthy subjects. The results showed that both drugs significantly inhibited telomerase activity at therapeutic concentrations, while emtricitabine and darunavir did not affect telomerase activity.

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

7.

Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial.

Author: OvertonEdgar Turner, TebasPablo, CoateBruce, RyanRobert, PerniciaroAmy, DayaramYaswant K, De La RosaGuy, BaughBryan P

Darunavir with low-dose ritonavir (DRV/r) and atazanavir with low-dose ritonavir (ATV/r) are antiretroviral medications. This study assessed the effects of these agents on insulin sensitivity.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
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.

Chronic Effects of Ethanol and/or Darunavir/Ritonavir on U937 Monocytic Cells: Regulation of Cytochrome P450 and Antioxidant Enzymes, Oxidative Stress, and Cytotoxicity.

Author: RaoP S S, KumarSantosh

Cytotoxicity
Oxidative stress

This abstract discusses the potential interactions between ethanol and antiretroviral therapy in monocytes, which are important for understanding the health risks associated with alcohol use in HIV-infected individuals.

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

9.

Effects on vitamin D, bone and the kidney of switching from fixed-dose tenofovir disoproxil fumarate/emtricitabine/efavirenz to darunavir/ritonavir monotherapy: a randomized, controlled trial (MIDAS).

Author: HamzahLisa, TiraboschiJuan M, IvesonHelen, TobyMartina, MantChristine, CasonJohn, BurlingKeith, WandoloEmily, JendrulekIsabelle, TaylorChris, IbrahimFowzia, KulasegaramRanjababu, TeagueAlastair, PostFrank A, FoxJulie

Improved bone density
Increased Vitamin D
Renal dysfunction

This study investigated the potential of switching from fixed-dose tenofovir/emtricitabine/efavirenz to darunavir/ritonavir monotherapy to improve vitamin D levels, bone mineral density, and renal tubular function.

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

12.

Differential effects of viremia and microbial translocation on immune activation in HIV-infected patients throughout ritonavir-boosted darunavir monotherapy.

Author: BenMarzouk-HidalgoOmar J, Torres-CornejoAlmudena, Gutiérrez-ValenciaAlicia, Ruiz-ValderasRosa, VicianaPompeyo, López-CortésLuis F

T-cell activation reduction
Viral suppression
Viremic episodes

This study evaluated the role of microbial translocation (MT) in CD4 and CD8 T cells immune activation (IA) in HIV-1-infected patients on ritonavir-boosted darunavir monotherapy (mtDRV/rtv). Results show that MT does not have a pivotal role in T-cell activation in patients with long-term viral suppression.

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

13.

Comparison of the metabolic effects of ritonavir-boosted darunavir or atazanavir versus raltegravir, and the impact of ritonavir plasma exposure: ACTG 5257.

Author: OfotokunIghovwerha, NaLumine H, LandovitzRaphael J, RibaudoHeather J, McComseyGrace A, GodfreyCatherine, AweekaFrancesca, CohnSusan E, SagarManish, KuritzkesDaniel R, BrownTodd T, PattersonKristine B, ParaMichael F, LeavittRandi Y, Villasis-KeeverAngelina, BaughBryan P, LennoxJeffrey L, CurrierJudith S,

Improved lipid profile
Increased LDL cholesterol
Increased total cholesterol
Increased triglycerides

Raltegravir-based combination antiretroviral therapy (cART) produced the most favorable lipid profile compared to ritonavir-boosted atazanavir or darunavir. The metabolic syndrome rates were high at baseline and increased to the same degree in all arms.

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, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

14.

Comparative incidence and health care costs of medically attended adverse effects among U.S. Medicaid HIV patients on atazanavir- or darunavir-based antiretroviral therapy.

Author: JohnstonStephen S, JudayTimothy, EskerStephen, EspindleDerek, ChuBong-Chul, HebdenTony, UyJonathan

Lower healthcare costs
Gastrointestinal issues
Jaundice

The study compared the incidence and health care costs of adverse effects in atazanavir- and darunavir-based antiretroviral therapy (ART). Atazanavir-treated patients had fewer gastrointestinal issues and more jaundice compared to darunavir-treated patients. Atazanavir-treated patients also incurred significantly lower health care costs.

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.

Language : English

15.

Effects of once-daily darunavir/ritonavir versus lopinavir/ritonavir on metabolic parameters in treatment-naive HIV-1-infected patients at week 96: ARTEMIS.

Author: ArathoonE, SchneiderS, BaraldiE, LimP L, OpravilM, Van De CasteeleT, LavreysL

Favorable lipid profile
HIV treatment efficacy
Glucose increase
Insulin increase

Darunavir/ritonavir (DRV/r) had a more favorable lipid profile than lopinavir/ritonavir (LPV/r) in treatment-naïve HIV-infected patients. Both DRV/r and LPV/r had a similar effect on glucose and insulin levels.

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

16.

Metabolic effects of darunavir/ritonavir versus atazanavir/ritonavir in treatment-naive, HIV type 1-infected subjects over 48 weeks.

Author: AbergJudith A, TebasPablo, OvertonEdgar Turner, GuptaSamir K, SaxPaul E, LandayAlan, FalconRon, RyanRobert, De La RosaGuy

Metabolic profile similar to ATV/r

The study compared the metabolic effects of darunavir/ritonavir (DRV/r) and atazanavir/ritonavir (ATV/r) in HIV-1-infected patients. Both regimens showed similar metabolic profiles over 48 weeks, with small changes in lipid parameters and no clinically significant differences in fasting glucose or insulin sensitivity. Further studies are needed to confirm these findings.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
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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