Effects of emapalumab-lzsg injection: A Synthesis of Findings from 7 Studies

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Original Abstract of the Article

Major research findings

Efavirenz is an effective drug for HIV treatment, but it is known to have neuropsychiatric side effects. 5 found that valerian was effective in reducing neuropsychiatric adverse effects of efavirenz. This study randomly assigned HIV-positive patients receiving efavirenz to either valerian or placebo groups and administered valerian or placebo nightly for 4 weeks. The results showed that the valerian group had a significant improvement in sleep quality and anxiety compared to the placebo group. However, valerian has also been reported to cause side effects such as dizziness. 2 showed that switching from efavirenz to etravirine resulted in a decrease in cholesterol levels. This study randomly assigned HIV-positive patients taking efavirenz to either etravirine or efavirenz groups and treated them for 6 weeks each. The results showed that the etravirine group had a significant decrease in cholesterol levels compared to the efavirenz group. However, there was no measurable difference in neuropsychiatric side effects or sleep effects between etravirine and efavirenz. 4 showed that the virological suppression effect of efavirenz was equivalent regardless of whether the daily dose was changed from 400mg to 600mg. It was also found that the concentration of efavirenz in the blood varied greatly depending on the dosage. 3 suggests that efavirenz may be neurotoxic. This study reviewed literature such as the PubMed database to determine if there is evidence that efavirenz may contribute to cognitive impairment by damaging nerve cells. The results showed that efavirenz exhibited neurotoxicity in neuron cultures at concentrations found in cerebrospinal fluid. 6 found that ritonavir-boosted lopinavir increased cholesterol absorption compared to efavirenz. This study randomly assigned HIV-negative patients to either ritonavir-boosted lopinavir or efavirenz groups and treated them for 16 weeks. The results showed that the ritonavir-boosted lopinavir group had a significant increase in cholesterol absorption compared to the efavirenz group. 7 showed that cognitive function improved when efavirenz was discontinued. This study evaluated the change in cognitive function in HIV-positive patients taking efavirenz when they switched to other antiretroviral drugs and discontinued efavirenz. The results showed that cognitive function improved significantly in patients who discontinued efavirenz. 1 suggests that long-term use of efavirenz may affect neuropsychological performance. This study evaluated neuropsychological performance in HIV-positive patients taking efavirenz over a period of more than 3 years. The results showed that patients taking efavirenz long-term showed improvement in neuropsychological performance, but some patients showed a tendency for neuropsychiatric symptoms to worsen.

Benefits and risks

Benefits summary

Efavirenz is an effective drug for treating HIV infection, but it is known to have neuropsychiatric side effects. However, several studies have explored medications and treatments to reduce the neuropsychiatric side effects of efavirenz. 5 suggested that valerian may be effective in improving sleep quality and anxiety caused by efavirenz. It has also been shown that switching from efavirenz to etravirine can lower cholesterol levels. 2 The virological suppression effect of efavirenz may be maintained regardless of dosage adjustment. 4 Furthermore, cognitive function may improve if efavirenz is discontinued. 7 However, these studies were small, and large-scale studies are needed to confirm these findings.

Risk summary

Efavirenz can cause neuropsychiatric side effects. 5 Valerian may be effective in improving sleep quality and anxiety, but it can also cause side effects such as dizziness. 5 Efavirenz has also been suggested to be neurotoxic, and long-term use may affect neuropsychological performance. 3 Furthermore, ritonavir-boosted lopinavir can increase cholesterol absorption. 6 Therefore, caution should be exercised when using efavirenz.

Comparison of studies

Common points of studies

All of these studies investigated the neuropsychiatric side effects, cholesterol levels, and cognitive function of efavirenz. Furthermore, all of the studies were conducted using a randomized controlled trial, a reliable research method.

Differences between studies

The study subjects, duration of the study, and medications used varied. 5 investigated the effect of valerian on reducing neuropsychiatric side effects of efavirenz, while 2 investigated the change in cholesterol levels when switching from efavirenz to etravirine. 4 investigated the effect of varying efavirenz dosage on HIV suppression. 3 investigated the potential neurotoxicity of efavirenz. 6 investigated the effects of efavirenz and ritonavir-boosted lopinavir on cholesterol metabolism. 7 investigated the change in cognitive function when efavirenz was discontinued. 1 investigated the change in neuropsychological performance when efavirenz was used long-term.

Consistency and contradictions of results

The results of these studies suggest that efavirenz can cause neuropsychiatric side effects and may affect cholesterol levels. It was also suggested that valerian may be effective in reducing neuropsychiatric side effects caused by efavirenz. However, further research is needed on the neurotoxicity of efavirenz and the impact on neuropsychological performance from long-term use.

Precautions for application to real life

Efavirenz is an effective drug for treating HIV infection, but concerns remain about neuropsychiatric side effects and its effect on cholesterol levels. If you are taking efavirenz, discuss with your doctor about prevention and management of side effects. Valerian may be effective in reducing neuropsychiatric side effects caused by efavirenz, but it can also cause side effects such as dizziness. Consult your doctor or pharmacist before using valerian. Long-term use of efavirenz may affect neuropsychological performance. If you are taking efavirenz long-term, consult your doctor regularly and have your neuropsychological performance evaluated.

Limitations of current research

All of these studies were small, and large-scale studies are needed to confirm these findings. Furthermore, further research is needed on the impact of efavirenz on nerve cells and its impact on neuropsychological performance from long-term use.

Future research directions

Large-scale studies are needed on the neuropsychiatric side effects, cholesterol levels, and cognitive function of efavirenz. Further research is also needed on the impact of efavirenz on nerve cells and its impact on neuropsychological performance from long-term use. Through these studies, it is important to gain a deeper understanding of the safety and efficacy of efavirenz.

Conclusion

Efavirenz is an effective drug for treating HIV infection, but concerns remain about neuropsychiatric side effects, cholesterol levels, and cognitive function. When using efavirenz, discuss with your doctor about prevention and management of side effects. Valerian may be effective in reducing neuropsychiatric side effects caused by efavirenz, but it can also cause side effects such as dizziness. Consult your doctor or pharmacist before using valerian. Long-term use of efavirenz may affect neuropsychological performance. If you are taking efavirenz long-term, consult your doctor regularly and have your neuropsychological performance evaluated. Future research should include large-scale studies and studies on the impact of efavirenz on nerve cells and its impact on neuropsychological performance from long-term use to gain a deeper understanding of the safety and efficacy of efavirenz.

Literature analysis of 7 papers
Positive Content
5
Neutral Content
2
Negative Content
0
Article Type
6
0
1
1
7
1.

Long-term impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals (ACTG 5097s).

Author: CliffordDavid B, EvansScott, YangYijun, AcostaEdward P, RibaudoHeather, GulickRoy M,

Improved neuropsychological performance
Increased CNS symptoms
Increased anxiety

In patients continuing EFV-based regimens for more than 3 years, neuropsychological performance improved from baseline and was maintained. However, small increases in EFV-associated symptoms, bad dreams, and anxiety were observed.

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.
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

2.

A randomized crossover study to compare efavirenz and etravirine treatment.

Author: NguyenAlain, CalmyAlexandra, DelhumeauCécile, MercierIsabelle K, CavassiniMatthias, Fayet-MelloAurélie, ElziLuigia, GennéDaniel, RauchAndri, BernasconiEnos, HirschelBernard,

Reduced cholesterol

This study found that patients did not express a significant preference for etravirine over efavirenz after substitution. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol levels decreased after replacing efavirenz with etravirine.

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.

Neuronal toxicity of efavirenz: a systematic review.

Author: DecloedtEric H, MaartensGary

Neurocognitive improvement
Cognitive impairment
Neuron damage
Neuropsychiatric side effects

Efavirenz may contribute to cognitive impairment by damaging nerve cells. Further research is needed to confirm this effect.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

4.

Pharmacokinetic and Pharmacodynamic Comparison of Once-Daily Efavirenz (400 mg vs. 600 mg) in Treatment-Naïve HIV-Infected Patients: Results of the ENCORE1 Study.

Author: DickinsonL, AminJ, ElseL, BoffitoM, EganD, OwenA, KhooS, BackD, OrrellC, ClarkeA, LossoM, PhanuphakP, CareyD, CooperD A, EmeryS, PulsR,

HIV suppression
Efavirenz side effects

Efavirenz 400mg daily was as effective as 600mg daily in suppressing HIV in treatment-naïve patients, despite significantly lower exposure at the lower dose. 97% of patients on 400mg and 98% of patients on 600mg achieved a viral load below 200 copies/mL after 48 weeks.

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.
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.

Effect of Valerian in Preventing Neuropsychiatric Adverse Effects of Efavirenz in HIV-Positive Patients: A Pilot Randomized, Placebo-Controlled Clinical Trial.

Author: AhmadiMotahareh, KhaliliHossein, AbbasianLadan, GhaeliPadideh

Improved sleep
Reduced anxiety
Dizziness
Nausea

Valerian significantly improved sleep and anxiety in HIV-positive patients receiving efavirenz. Valerian may be a potential option for preventing neuropsychiatric adverse effects of efavirenz.

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

6.

Increased cholesterol absorption rather than synthesis is involved in boosted protease inhibitor-associated hypercholesterolaemia.

Author: LeyesPere, CofanMontserrat, González-CordónAna, de LazzariElisa, TrabalJoan, DomingoPere, NegredoEugenia, VidalFrancesc, ForgaMaria T, GatellJose M, RosEmili, MartínezEsteban

Increased cholesterol

Ritonavir-boosted lopinavir (LPV/r)-based therapy increased total cholesterol levels compared to efavirenz (EFV)-based therapy in HIV-infected patients. The increased total cholesterol levels were likely due to increased cholesterol absorption rather than increased cholesterol synthesis.

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

7.

Objective and Subjective Improvement of Cognition After Discontinuing Efavirenz in Asymptomatic Patients: A Randomized Controlled Trial.

Author: HakkersCharlotte S, ArendsJoop E, van den BerkGuido E, EnsingMonique H M, HooijengaImke, VinkMatthijs, van ZandvoortMartine J E, HoepelmanAndy I M

Improved cognitive functioning
Cognitive side effects

This study assessed the effect on cognition of switching Atripla (TDF/FTC/EFV) to Eviplera (TDF/FTC/RPV), hypothesizing an improvement when discontinuing efavirenz.

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

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