Side Effects of darunavir: A Synthesis of Findings from 21 Studies

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Original Abstract of the Article

Major Research Findings

Several studies have been conducted on the side effects of darunavir, with many focused on evaluating its safety and efficacy. 14 suggests that administering darunavir may lead to increased vitamin D levels and improved bone density. 2 indicates that darunavir might be effective in improving dyslipidemia. However, 6 suggests a potential association between darunavir and an increased risk of ischemic stroke. 3 raises concerns about potential side effects of darunavir on various organs and emphasizes the potential impact on the fetus in pregnant women.

Reasons for Side Effects

The exact reasons for darunavir side effects remain fully unclear. However, it's believed that darunavir's influence on various metabolic pathways could contribute to these side effects. 17 suggests that darunavir may cause insulin resistance by inhibiting insulin signaling. Additionally, darunavir has the potential to affect the function of various organs, including the liver and kidneys. 5 reports that darunavir can have an impact on liver function.

Common Side Effects

Gastrointestinal

Administering darunavir can lead to gastrointestinal side effects. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects.

Neuropsychiatric

Administering darunavir can lead to neuropsychiatric side effects. 14 indicates that the incidence of neuropsychiatric side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce neuropsychiatric side effects.

Metabolic

Administering darunavir can lead to metabolic side effects. 14 indicates that the incidence of metabolic side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce metabolic side effects.

Side Effect Management

Gastrointestinal

Dietary and drug therapy are used to alleviate gastrointestinal side effects. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects.

Neuropsychiatric

Drug therapy is used to alleviate neuropsychiatric side effects. 14 indicates that the incidence of neuropsychiatric side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce neuropsychiatric side effects.

Metabolic

Dietary and exercise therapy are used to alleviate metabolic side effects. 14 indicates that the incidence of metabolic side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce metabolic side effects.

Comparison Across Studies

Similarities Across Studies

Numerous studies have demonstrated the effectiveness of darunavir in treating HIV infection. Additionally, reports indicate that darunavir may have fewer side effects compared to other anti-HIV drugs. 14 suggests that darunavir administration may lead to increased vitamin D levels and improved bone density. 2 indicates that darunavir might be effective in improving dyslipidemia. However, research suggests that darunavir can cause certain side effects. 6 suggests a potential association between darunavir and an increased risk of ischemic stroke. 3 raises concerns about potential side effects of darunavir on various organs and emphasizes the potential impact on the fetus in pregnant women.

Differences Across Studies

The incidence and type of side effects associated with darunavir vary across studies. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects. Additionally, the types of side effects caused by darunavir can differ across studies. 6 suggests a potential association between darunavir and an increased risk of ischemic stroke. 3 raises concerns about potential side effects of darunavir on various organs and emphasizes the potential impact on the fetus in pregnant women. These differences in research findings could be attributed to factors such as the age and health status of the study participants, darunavir dosage and administration method, and concomitant medications. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects.

Important Notes for Real-World Application

Darunavir is an effective medication for treating HIV infection, but it has the potential to cause certain side effects. 14 suggests that darunavir administration may lead to increased vitamin D levels and improved bone density. 2 indicates that darunavir might be effective in improving dyslipidemia. However, 6 suggests a potential association between darunavir and an increased risk of ischemic stroke. 3 raises concerns about potential side effects of darunavir on various organs and emphasizes the potential impact on the fetus in pregnant women. It's crucial to strictly follow your doctor's instructions and be vigilant for any signs of side effects when taking darunavir. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects.

Limitations of Current Research

Research on the side effects of darunavir remains incomplete. 14 suggests that darunavir administration may lead to increased vitamin D levels and improved bone density. 2 indicates that darunavir might be effective in improving dyslipidemia. However, 6 suggests a potential association between darunavir and an increased risk of ischemic stroke. 3 raises concerns about potential side effects of darunavir on various organs and emphasizes the potential impact on the fetus in pregnant women. Furthermore, there isn't enough research yet on the long-term effects of taking darunavir. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects.

Future Research Directions

Additional research on the side effects of darunavir is needed. 14 suggests that darunavir administration may lead to increased vitamin D levels and improved bone density. 2 indicates that darunavir might be effective in improving dyslipidemia. However, 6 suggests a potential association between darunavir and an increased risk of ischemic stroke. 3 raises concerns about potential side effects of darunavir on various organs and emphasizes the potential impact on the fetus in pregnant women. In particular, further research is necessary to understand the long-term consequences of taking darunavir. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects.

Conclusion

Darunavir is an effective medication for treating HIV infection, but it has the potential to cause certain side effects. 14 suggests that darunavir administration may lead to increased vitamin D levels and improved bone density. 2 indicates that darunavir might be effective in improving dyslipidemia. However, 6 suggests a potential association between darunavir and an increased risk of ischemic stroke. 3 raises concerns about potential side effects of darunavir on various organs and emphasizes the potential impact on the fetus in pregnant women. It's crucial to strictly follow your doctor's instructions and be vigilant for any signs of side effects when taking darunavir. 14 indicates that the incidence of gastrointestinal side effects associated with darunavir is low. However, 2 suggests that darunavir administration can reduce gastrointestinal side effects.

Literature analysis of 21 papers
Positive Content
16
Neutral Content
0
Negative Content
5
Article Type
7
0
0
3
21
1.

Low-dose short-term cyclosporine versus etretinate in psoriasis: improvement of skin, nail, and joint involvement.

Author: MahrleG, SchulzeH J, FärberL, WeidingerG, SteiglederG K

Nail and joint improvement
Psoriasis treatment
Cyclosporine side effects
Relapse risk

Low-dose short-term cyclosporine therapy was highly effective and well tolerated for psoriasis, compared to etretinate. Remission was better preserved by tapering the drug than by discontinuing treatment abruptly.

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.
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.
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.

Higher plasma drug levels in elderly people living with HIV treated with darunavir.

Author: TyrbergErika, EdénArvid, EriksenJaran, NilssonStaffan, TreutigerCarl Johan, ThalmeAnders, MellgrenÅsa, GisslénMagnus, AnderssonLars-Magnus

Drug interactions

This study compared plasma drug levels of ART, PDDIs, and side-effects in PLHIV aged ≥ 65 years of age with controls ≤ 49 years of age.

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.

Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial.

Author: DaarEric S, DeJesusEdwin, RuanePeter, CrofootGordon, OguchiGodson, CreticosCatherine, RockstrohJürgen K, MolinaJean-Michel, KoenigEllen, LiuYa-Pei, CustodioJoseph, AndreattaKristen, GrahamHiba, ChengAndrew, MartinHal, QuirkErin

Avoid drug interactions
Avoid unwanted side effects
High barrier to resistance
Simplified once-daily
single-tablet regimen

Switching virologically suppressed adults with HIV-1 infection from a boosted protease inhibitor therapy to bictegravir, emtricitabine, and tenofovir alafenamide is a safe and effective option that simplifies the regimen and avoids drug interactions.

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

8.

A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients.

Author: EronJoseph J, OrkinChloe, GallantJoel, MolinaJean-Michel, NegredoEugenia, AntinoriAndrea, MillsAnthony, ReynesJacques, Van LanduytErika, LathouwersErkki, HufkensVeerle, JezorwskiJohn, VanveggelSimon, OpsomerMagda,

Bone and renal safety
High virologic suppression
Resistance to emtricitabine

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg achieved a high virologic suppression rate (91.4%) and was noninferior to darunavir/cobicistat with emtricitabine/tenofovir disoproxyl fumarate (TDF) in antiretroviral-treatment-naive, HIV-1-infected adults. D/C/F/TAF demonstrated the bone and renal safety advantages of TAF in combination with darunavir/cobicistat.

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

9.

Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial.

Author: MolinaJean-Michel, SquiresKathleen, SaxPaul E, CahnPedro, LombaardJohan, DeJesusEdwin, LaiMing-Tain, XuXia, RodgersAnthony, LupinacciLisa, KumarSushma, SklarPeter, NguyenBach-Yen, HannaGeorge J, HwangCarey,

HIV treatment

Doravirine, a novel NNRTI, showed comparable efficacy to ritonavir-boosted darunavir in adults with previously untreated HIV-1 infection, demonstrating its potential as an alternative treatment option.

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.
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

10.

Short-term cost and efficiency analysis of raltegravir versus atazanavir/ritonavir or darunavir/ritonavir for treatment-naive adults with HIV-1 infection in Spain.

Author: DavisAshley E, BroganAnita J, GoodwinBridgett, NoceaGonzalo, LozanoVirginia

HIV-1 treatment

Raltegravir, when used in combination with emtricitabine/tenofovir DF, demonstrated superior virologic efficacy and tolerability compared to atazanavir/ritonavir and darunavir/ritonavir in treatment-naive adults with HIV-1 infection in a 96-week clinical trial. This study aimed to estimate the efficiency of these three regimens in Spain.

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.

Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial.

Author: OrkinChloe, MolinaJean-Michel, NegredoEugenia, ArribasJosé R, GatheJoseph, EronJoseph J, Van LanduytErika, LathouwersErkki, HufkensVeerle, PetrovicRomana, VanveggelSimon, OpsomerMagda,

Reduced pill burden
Single-tablet regimen
Side effects

This study investigated the efficacy and safety of switching to a single-tablet regimen of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide versus continuing a regimen of boosted protease inhibitor, emtricitabine, and tenofovir disoproxil fumarate in people living with HIV.

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.
Equivalence TrialA clinical trial designed to show that a new treatment is equivalent in efficacy/safety to an existing treatment.
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

12.

Rilpivirine Pharmacokinetics Without and With Darunavir/Ritonavir Once Daily in Adolescents and Young Adults.

Author: FocaMarc, YogevRam, WizniaAndrew, HazraRohan, Jean-PhilippePatrick, GrahamBobbie, BrittoPaula, CareyVincent J, KingJennifer, AcostaEdward P, CresseyTim R,

HIV treatment

This study evaluated the pharmacokinetic interactions between rilpivirine (RPV) and darunavir/ritonavir (DRV/r) once daily in adolescents and young adults.

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

Language : English

13.

[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

14.

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

15.

Rezolsta® (Darunavir/Cobicistat): First Boosted Protease Inhibitor Co-formulated with Cobicistat.

Author: CurranAdrián, Pérez-ValeroIgnacio, MoltóJosé

HIV treatment
Drug interactions
Gastrointestinal disturbances
Kidney function reduction

Darunavir/cobicistat, a fixed-dose combination boosted protease inhibitor, showed comparable efficacy to ritonavir-boosted darunavir in treating 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

16.

Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: a randomized clinical trial.

Author: MartinezEsteban, Gonzalez-CordonAna, FerrerElena, DomingoPere, NegredoEugenia, GutierrezFelix, PortillaJoaquin, CurranAdrià, PodzamczerDaniel, RiberaEsteban, MurillasJavier, BernardinoJose I, SantosIgnacio, CartonJose A, PeraireJoaquim, PichJudit, DeulofeuRamon, PerezIgnacio, GatellJose M,

Increased subcutaneous fat
Increased total fat
Increased triglycerides
Insulin resistance

Atazanavir/ritonavir led to higher triglycerides and more total and subcutaneous fat than darunavir/ritonavir. Both regimens were effective and had similar side effects.

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

18.

Integration among hospital pharmacists and infectious diseases physicians in the outpatient management of HIV infection.

Author: AppolloniLucia, LocchiFederica, GiromettiNicolò, CalzaLeonardo, ColangeliVincenzo, ManfrediRoberto, MagistrelliEleonora, PiroFilomena, VialePierluigi, PuggioliCristina

Improved adherence
Reduced side effects

A pharmacist-led approach to managing combination antiretroviral therapy (cART) for HIV infection improved adherence and monitoring of adverse events. This multidisciplinary approach is associated with a favorable course of HIV disease progression and reduced perception of side effects.

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

Language : English

19.

Cost-minimization comparison of darunavir plus ritonavir and lopinavir/ritonavir in HIV-1 infected treatment-naïve women of childbearing age.

Author: MöllerJörgen, DesaiKamal, SimpsonKit, BaranRobert W, Van de SteenOlivier, DietzBirgitta, GoochKatherine

HIV treatment

This analysis compared the economic outcomes of using ritonavir-boosted lopinavir (LPV/r) versus ritonavir-boosted darunavir (DRV+RTV) for HIV-positive pregnant women in the United States.

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

20.

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

21.

First-line boosted protease inhibitor-based regimens in treatment-naive HIV-1-infected patients--making a good thing better.

Author: LlibreJosep M

HIV treatment
Hyperbilirubinemia

Atazanavir and darunavir showed superior virologic efficacy and better tolerability compared to lopinavir, making them suitable for first-line antiretroviral therapy in treatment-naive 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.
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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