Side Effects of darunavir and cobicistat: A Synthesis of Findings from 7 Studies

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Original Abstract of the Article

Major research findings

Darunavir/cobicistat combination therapy is effective in treating HIV infection, but there are a number of side effects. 7 、 3 、 1 、 4 、 5 、 6 、 2 Studies have shown that darunavir/cobicistat combination therapy has been observed to cause side effects related to the liver, endocrine, cardiovascular, musculoskeletal, gastrointestinal, metabolic, and nutritional systems. In pregnant women, side effects such as umbilical cord abnormalities, fetal growth restriction, low birth weight, stillbirth, preterm birth, premature rupture of membranes, and spontaneous abortion have been reported. Furthermore, darunavir/cobicistat combination therapy has been shown to potentially cause serious side effects such as progressive extraocular muscle paralysis, acute pancreatitis, exfoliative dermatitis, acquired lipodystrophy, and mitochondrial toxicity. 3

Reasons for side effects

The side effects of darunavir/cobicistat combination therapy are mainly due to the inhibitory effect of cobicistat on CYP3A4. CYP3A4 is an enzyme involved in the metabolism of many drugs in the body. When cobicistat inhibits CYP3A4, drug metabolism is slowed and blood concentrations increase, making side effects more likely. 7

Common side effects

Gastrointestinal system

Gastrointestinal side effects are the most commonly reported with darunavir/cobicistat combination therapy. The main side effects include diarrhea, nausea, vomiting, and abdominal pain. 3 、 7

Metabolism

Metabolic-related side effects have also been reported with darunavir/cobicistat combination therapy. The main side effects include elevated cholesterol levels, elevated triglyceride levels, and elevated blood sugar levels. 2 、 5

Kidney

Cobicistat can slightly reduce glomerular filtration rate in the kidneys. 7 、 5

Bone

Darunavir/cobicistat combination therapy may cause a decrease in bone mineral density. 5

Countermeasures for side effects

Gastrointestinal side effects

Dietary and drug therapy can be effective in reducing gastrointestinal side effects. Dietary therapy involves avoiding fatty foods and irritants. Drug therapy may include antiemetics and antidiarrheals. 3 、 7

Metabolic side effects

Lifestyle changes are important to reduce metabolic-related side effects. Dietary therapy involves avoiding foods high in cholesterol and triglycerides. Exercise therapy involves getting moderate exercise. 2 、 5

Kidney side effects

Kidney side effects from cobicistat are usually mild and reversible. However, if you have impaired kidney function, you should consult your doctor. 7 、 5

Bone side effects

To prevent bone loss, it is important to consume calcium and vitamin D. It is also important to have regular bone density tests. 5

Comparison between studies

Common points in research

Multiple studies have shown that darunavir/cobicistat combination therapy is effective in treating HIV infection. 7 、 3 、 1 、 4 、 5 、 6 、 2

Differences between studies

There were differences in the frequency and severity of side effects between studies. This is thought to be due to differences in study design and subject characteristics. 7 、 3 、 1 、 4 、 5 、 6 、 2

Precautions for application to real life

Darunavir/cobicistat combination therapy is an effective treatment for HIV infection, but it is important to remember that there is a risk of side effects. It is important to see a doctor regularly to detect side effects early and to manage them appropriately. In addition, you can reduce the risk of side effects by improving your lifestyle. 7 、 3 、 1 、 4 、 5 、 6 、 2

Limitations of current research

There is still not enough research on the side effects of darunavir/cobicistat combination therapy. In particular, further research is needed on long-term side effects. 7 、 3 、 1 、 4 、 5 、 6 、 2

Future research directions

Further research is needed to clarify the long-term side effects of darunavir/cobicistat combination therapy. It is also important to develop more effective ways to reduce the risk of side effects. 7 、 3 、 1 、 4 、 5 、 6 、 2

Conclusion

Darunavir/cobicistat combination therapy is an effective treatment for HIV infection, but it is important to remember that there is a risk of side effects. It is important to see a doctor regularly to detect side effects early and to manage them appropriately. In addition, you can reduce the risk of side effects by improving your lifestyle. 7 、 3 、 1 、 4 、 5 、 6 、 2

Literature analysis of 7 papers
Positive Content
6
Neutral Content
0
Negative Content
1
Article Type
4
0
0
1
7
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.

Pharmacokinetics of dolutegravir with and without darunavir/cobicistat in healthy volunteers.

Author: ElliotEmilie R, CerroneMaddalena, ChallengerElizabeth, ElseLaura, AmaraAlieu, BisdominiElisa, KhooSaye, OwenAndrew, BoffitoMarta

Dolutegravir and darunavir, when boosted with cobicistat, can be safely prescribed together for the treatment of HIV-1 without dosage adjustments.

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.
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

5.

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

6.

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

7.

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

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