Effects of darunavir and cobicistat: A Synthesis of Findings from 20 Studies

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Original Abstract of the Article

Main research findings

Darunavir/cobicistat is a protease inhibitor that is widely used to treat HIV infection. 3 investigated the pharmacokinetics of darunavir in a cohort of adult patients, revealing significant inter-individual variability. This study aimed to understand the pharmacokinetics of darunavir and identify factors contributing to this variability, ultimately aiming to optimize dosing regimens. 1 compared darunavir/ritonavir with lopinavir/ritonavir in treatment-naive HIV patients. The study found that darunavir/ritonavir was non-inferior to lopinavir/ritonavir, showing similar increases in CD4 counts. Furthermore, darunavir/ritonavir demonstrated greater effectiveness than lopinavir/ritonavir, particularly in patients with high viral loads. 11 investigated the pharmacokinetics, safety, and tolerability of darunavir/cobicistat in conjunction with a weekly regimen of isoniazid/rifapentine for latent tuberculosis infection in HIV-positive individuals. The study showed that while darunavir/cobicistat exposures were reduced when combined with isoniazid/rifapentine, the combination remained safe and well-tolerated. 13 compared the tolerability and metabolic impact of antiretroviral regimens containing darunavir/ritonavir and darunavir/cobicistat in Romanian patients with HIV infection. The study indicated that darunavir/cobicistat was better tolerated and had a lower impact on metabolic profiles compared to darunavir/ritonavir. 12 highlights the approval of a fixed-dose combination of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide by the European Medicines Agency, marking the first protease-inhibitor-based single-tablet regimen for HIV treatment. The study delves into the pharmacokinetic profile and safety of this combination, emphasizing the advantages of cobicistat compared to ritonavir in terms of CYP3A4 inhibition and lack of enzyme-inducing properties. 19 reviews the efficacy of this single-tablet regimen, emphasizing its convenient dosing, favorable safety profile, and potent antiviral efficacy, even in patients with resistance to other antiretrovirals.

Benefits and Risks

Benefit Summary

Darunavir/cobicistat offers several advantages for HIV treatment. 1 demonstrated that darunavir/ritonavir is a more effective and well-tolerated regimen compared to lopinavir/ritonavir, with a lower incidence of gastrointestinal side effects like diarrhea and lipid-related adverse events such as elevated triglyceride and cholesterol levels. 13 found that darunavir/cobicistat is better tolerated and has a less disruptive effect on metabolic profiles compared to darunavir/ritonavir. 6 suggested that switching from darunavir/ritonavir monotherapy to darunavir/cobicistat monotherapy is a safe and effective strategy for simplifying antiretroviral treatment. 19 highlights the benefit of a fixed-dose combination regimen of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in a single tablet, simplifying treatment adherence and reducing pill burden for patients. 20 emphasizes the high genetic barrier to resistance and good tolerability of this combination regimen, making it a promising option for HIV treatment.

Risk Summary

Darunavir/cobicistat is not without potential risks. 3 emphasizes the need for individualized dosing due to the significant inter-individual variability in darunavir pharmacokinetics. 18 highlights a case of a kidney transplant patient who experienced severe drug-drug interactions, emphasizing the importance of cautious use in patients taking multiple medications, especially those with compromised renal function. reports a case of Cushing's syndrome resulting from the interaction between darunavir/cobicistat and topical betamethasone dipropionate, demonstrating the potential for drug-drug interactions. 4 underscores the need for caution when using darunavir/cobicistat in pregnant women, highlighting the importance of further research to determine its safety during pregnancy. 14 details various potential adverse events associated with darunavir and its boosted agents, including impacts on liver, endocrine, cardiovascular, musculoskeletal, gastrointestinal, metabolic, and nutritional systems. The study also suggests potential risks for pregnant women, highlighting the need for prospective monitoring.

Comparison Across Studies

Commonalities

All of these studies contribute to the growing body of knowledge on darunavir/cobicistat, exploring its efficacy and safety in treating HIV infection. A consistent theme emerges: darunavir/cobicistat demonstrates effectiveness in controlling HIV viral load and is generally well-tolerated.

Differences

The studies reviewed vary in their focus, populations, and methodologies. For instance, 3 utilizes population pharmacokinetic modeling and simulations to explore dosing regimen optimization, while 1 employs a clinical trial design to compare darunavir/ritonavir against lopinavir/ritonavir. 6 explores the safety and effectiveness of switching from darunavir/ritonavir monotherapy to darunavir/cobicistat monotherapy, while 19 reviews the efficacy of a single-tablet regimen containing darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. This diversity in focus and methodology underscores the ongoing research efforts to understand the nuances of darunavir/cobicistat.

Consistency and Discrepancies

These studies collectively suggest that darunavir/cobicistat is a valuable treatment option for HIV infection, generally effective and well-tolerated. However, the range of reported adverse events highlights the importance of individualizing treatment and closely monitoring patients for potential side effects. Further research is needed to clarify the exact nature and extent of these risks, particularly for specific patient populations like pregnant women and individuals with compromised renal function.

Implications for Everyday Life

For individuals living with HIV who are considering darunavir/cobicistat treatment, it is crucial to engage in open and honest conversations with their healthcare provider. They should discuss individual health history, potential drug interactions, and any concerns regarding potential side effects. Close monitoring is essential to ensure the optimal benefits of the medication while minimizing the risk of adverse events.

Limitations of Current Research

The reviewed studies, while valuable, have certain limitations. Several studies are short-term, limiting the understanding of long-term effects. Additionally, many studies focus on specific populations, limiting the generalizability of the findings to the broader HIV patient population. Further research with larger, diverse cohorts and longer durations is needed to comprehensively evaluate the long-term safety and effectiveness of darunavir/cobicistat.

Future Research Directions

Future research efforts should prioritize addressing the limitations of existing studies. Long-term studies are needed to evaluate the long-term safety and effectiveness of darunavir/cobicistat in different patient populations. Additional research is required to understand the potential impact of darunavir/cobicistat on specific populations like pregnant women, children, and individuals with renal impairment. Furthermore, more in-depth exploration of drug-drug interactions, particularly in patients taking multiple medications, is essential.

Conclusion

Darunavir/cobicistat has emerged as a valuable tool in the fight against HIV infection, demonstrating efficacy and generally good tolerability. However, it is crucial to acknowledge potential risks and individualize treatment strategies, particularly in vulnerable populations and those with pre-existing conditions. Ongoing research is essential to refine our understanding of darunavir/cobicistat's long-term impact and to develop safer and more personalized treatment approaches for HIV patients.

Literature analysis of 20 papers
Positive Content
17
Neutral Content
2
Negative Content
1
Article Type
5
0
0
4
20
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.

Exploration of Reduced Doses and Short-Cycle Therapy for Darunavir/Cobicistat in Patients with HIV Using Population Pharmacokinetic Modeling and Simulations.

Author: StillemansGabriel, BelkhirLeila, VandercamBernard, VincentAnne, HaufroidVincent, ElensLaure

Pharmacokinetic variability

This study investigated the pharmacokinetics of darunavir, a protease inhibitor used to treat HIV, and analyzed the sources of inter-individual variability. The findings suggest that current dosing guidelines may not be optimal for all patients, and alternative dosing regimens could be explored to optimize treatment effectiveness.

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

5.

Pharmacokinetics of darunavir/cobicistat and etravirine alone and co-administered in HIV-infected patients.

Author: MoltóJosé, CurranAdrian, MirandaCristina, ChallengerElizabeth, SantosJosé Ramón, RiberaEsteban, KhooSaye, ValleMarta, ClotetBonaventura

Reduced cobicistat exposure

The study found that etravirine co-administration decreased cobicistat exposure and in darunavir C24 when darunavir/cobicistat was co-administered with etravirine.

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

Language : English

6.

Simplification of Antiretroviral Treatment from Darunavir/Ritonavir Monotherapy to Darunavir/Cobicistat Monotherapy: Effectiveness and Safety in Routine Clinical Practice.

Author: SantosJosé R, CurranAdrian, Navarro-MercadeJordi, AmpueroMario F, PelaezPablo, Pérez-AlvarezNuria, ClotetBonaventura, ParedesRoger, MoltóJosé

Treatment simplification
Virological failure

This study evaluated the effectiveness and safety of switching from darunavir/ritonavir to darunavir/cobicistat monotherapy in HIV-infected patients. The results showed that the switch was safe and effective in patients with well-controlled HIV infection, with a high rate of patients remaining free of treatment failure.

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.
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

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.

Darunavir/cobicistat once daily for the treatment of HIV.

Author: KakudaThomas N, CrauwelsHerta, OpsomerMagda, TomakaFrank, van de CasteeleTom, VanveggelSimon, IterbekeKoen, de SmedtGoedele

Improved adherence
Reduced pill burden

Cobicistat, a newer agent for boosting plasma drug levels of darunavir, is a more specific cytochrome P450 3A inhibitor than ritonavir without enzyme-inducing properties. This review discusses the differing effects of cobicistat and ritonavir on metabolic enzymes, their drug-drug interactions, and the clinical development and data for a once-daily darunavir/cobicistat fixed-dose combination (FDC).

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

9.

Low Incidence and Brief Duration of Gastrointestinal Adverse Events with Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Over 96 Weeks: Post hoc Analyses of AMBER and EMERALD.

Author: DunnKeith, BaughBryan, BejouNika, LuoDonghan, CampbellJennifer, SeyedkazemiSareh, AndersonDavid

Low GI AEOIs
Gastrointestinal intolerance

This post-hoc analysis evaluated gastrointestinal adverse events of interest in patients receiving darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF). The findings suggest that the incidence and prevalence of these events were low and tended to present early.

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

Language : English

10.

Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients.

Author: OrkinChloe, EronJoseph J, RockstrohJürgen, PodzamczerDaniel, EsserStefan, VandekerckhoveLinos, Van LanduytErika, LathouwersErkki, HufkensVeerle, JezorwskiJohn, OpsomerMagda,

Bone/renal safety
High virologic response
Low virologic failure
Resistance development

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) resulted in high virologic response and low virologic failure rates in treatment-naive HIV-1-positive adults over 96 weeks. No resistance development to darunavir or TAF/TDF was observed. Bone, renal, and lipid safety were consistent with known D/C/F/TAF component profiles.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

11.

Pharmacokinetics, Safety, and Tolerability of Once-Daily Darunavir With Cobicistat and Weekly Isoniazid/Rifapentine.

Author: BrooksKristina M, PauAlice K, SwaimDoris, BunnHaden T, AdeojoLilian, PeloquinCharles A, KumarParag, KovacsJoseph A, GeorgeJomy M

HIV treatment
Drug interactions

This study examined the pharmacokinetics, safety, and tolerability of darunavir/cobicistat, an antiretroviral medication, in patients receiving once-weekly isoniazid with rifapentine for latent tuberculosis infection.

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, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.

Language : English

12.

Darunavir-cobicistat-emtricitabine-tenofovir alafenamide: safety and efficacy of a protease inhibitor in the modern era.

Author: SquillaceNicola, BozziGiorgio, ColellaElisa, GoriAndrea, BanderaAlessandra

HIV treatment
Kidney safety

This article provides a detailed description of the pharmacokinetic, efficacy, and safety profile of a fixed-dose combination of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide for the treatment of HIV infection.

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

15.

Pharmacogenomics of COVID-19 therapies.

Author: TakahashiTakuto, LuzumJasmine A, NicolMelanie R, JacobsonPamala A

Improved efficacy
Improved safety
QT prolongation

This review examines the pharmacogenomic literature available for drugs used to treat COVID-19, including hydroxychloroquine, chloroquine, azithromycin, remdesivir, and others. It identifies several drug-gene variant pairs that could alter drug pharmacokinetics and increase the risk of adverse effects. This research suggests that pharmacogenomic testing may be beneficial for individualizing drug therapies and improving their safety and efficacy in treating COVID-19.

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

16.

COVID-19 Outbreak in Italy: Report on the First 124 Consecutive Patients Treated at Home.

Author: CavannaLuigi, CremonaGabriele, CitterioChiara, NunzioCamilla Di, MuroniMonica, AndenaAnna Maria, CattadoriEvelina, GubbeliniMirella, MuroniLara, SchiavoRoberta, NolliMassimo, CodeluppiMauro, ManiscalcoPietro, PedrazziniGuido

No deaths
Reduced hospitalization rate

Early home treatment of COVID-19 patients with low-dose hydroxychloroquine resulted in a low hospitalization rate (3.2%) and no deaths at day 30 and 60.

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

Language : English

17.

Week 96 resistance analyses of the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the phase 3 randomized AMBER and EMERALD trials.

Author: LathouwersErkki, WeinsteigerShirley, BaughBryan, GhysAnne, JezorwskiJohn, MohsineEl Ghazi, Van LanduytErika, De MeyerSandra

HIV treatment

This study examined the resistance profiles of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in two clinical trials (AMBER and EMERALD) after 96 weeks of treatment. The results indicate that D/C/F/TAF has a high barrier to resistance, with few emerging mutations. Even with pre-existing resistance mutations, D/C/F/TAF demonstrated sustained virologic suppression.

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.
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

18.

Threatening drug-drug interaction in a kidney transplant patient with coronavirus disease 2019 (COVID-19).

Author: BartiromoMarilù, BorchiBeatrice, BottaAnnarita, BagalàAlfredo, LugliGianmarco, TilliMarta, CavalloAnnalisa, XhaferiBrunilda, CutruzzulàRoberta, VaglioAugusto, BresciSilvia, LartiAida, BartoloniAlessandro, CiramiCalogero

COVID-19 treatment
Immunosuppressant levels
Management difficulties

Organ transplant recipients are highly vulnerable to COVID-19 infection due to immunosuppressive therapy. This case report highlights the unique clinical presentation and challenges in managing COVID-19 in a kidney-transplanted woman. The need for guidelines specific to transplant recipients with COVID-19 is emphasized.

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

20.

A four-drug combination oral tablet of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide for the treatment of HIV-1 infection in adults.

Author: MucciniCamilla, CastagnaAntonella

Effective regimen
High genetic barrier
Well tolerated
None mentioned

The study highlighted the efficacy and tolerability of darunavir (DRV)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir alafenamide (TAF), the only protease inhibitor-based single-tablet regimen (STR) approved for the treatment of HIV infection in adults and pediatric patients.

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

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