Side Effects of elbasvir and grazoprevir: A Synthesis of Findings from 12 Studies

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Original Abstract of the Article

Main Research Findings

The C-SCAPE study found that elbasvir/grazoprevir, with or without ribavirin, was effective in suppressing the virus in participants with hepatitis C virus (HCV) genotype 2, 4, 5, or 6 infection after 12 weeks of administration. 6

Several studies have suggested that efavirenz may affect neuropsychological performance in HIV-infected individuals. 1 2

Reasons for Side Effects

Efavirenz may be toxic to nerve cells and could contribute to impaired neurocognitive performance. 2

Common Side Effects

Sleep Disturbances

Efavirenz administration may increase bad dreams. 1

Neurological Symptoms

Efavirenz administration may cause neurological symptoms. 1

Countermeasures for Side Effects

Sleep Disturbances

For sleep disturbances, measures such as ensuring sufficient sleep, limiting caffeine intake, and taking relaxing baths can be effective. 1

Neurological Symptoms

For neurological symptoms, it is necessary to adjust the medication or consider other therapies as instructed by your doctor. 1

Comparison between Studies

Common Points of Studies

Multiple studies have shown that efavirenz may cause neurological symptoms. 1 2

Differences in Studies

The effects of efavirenz on neurocognitive function vary depending on the study. 1 2

Notes on Application in Daily Life

When taking efavirenz, it is necessary to be aware of neurological symptoms. It is important to be cautious when performing tasks that require concentration, such as driving or operating machinery. 1

Limitations of Current Research

The long-term effects of efavirenz are not yet fully understood. 2

Future Research Directions

Further research is needed on the long-term effects of efavirenz, particularly on its impact on neurocognitive function. 2

Conclusion

Elbasvir and grazoprevir combination therapy is effective for treating hepatitis C virus, but research has shown that efavirenz may cause neurological symptoms. When taking efavirenz, it is important to be aware of neurological symptoms and to proceed with treatment in consultation with your doctor. 1 2 6

Literature analysis of 12 papers
Positive Content
10
Neutral Content
2
Negative Content
0
Article Type
2
0
2
4
11
1.

Impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals.

Author: CliffordDavid B, EvansScott, YangYijun, AcostaEdward P, GoodkinKarl, TashimaKaren, SimpsonDavid, DorfmanDavid, RibaudoHeather, GulickRoy M

Improve neuropsychological performance
Neurological symptoms

Efavirenz is an antiretroviral drug that can cause neurologic side effects. A study found that these side effects were more common in the first week of treatment but resolved by week 4. Neuropsychological performance improved in both the efavirenz and the control groups.

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

Language : English

2.

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

3.

A review of trials investigating efavirenz-induced neuropsychiatric side effects and the implications.

Author: GaidaRazia, TruterIlse, GroblerChristoffel, KotzeTheunis, GodmanBrian

Neuropsychiatric side effects

This review analyzed the neuropsychiatric side effects associated with efavirenz in HIV patients. Common side effects included sleep problems, depression, dizziness, and anxiety, which were generally mild and did not require discontinuation of the drug.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

5.

The efficacy and safety of elbasvir/grazoprevir treatment in HCV genotype 1 patients in Taiwan.

Author: TsaiTzu-Cheng, DengShin-Tarng, HsuChao-Wei

High SVR12 rate
Rapid virologic response
Elevated alanine transaminase

Elbasvir/grazoprevir (EBR/GZR) is safe and effective for treating patients with chronic hepatitis C virus (HCV) genotype (GT) 1, exhibiting excellent overall clinical efficacy in Taiwan. The therapeutic effects were unrelated to factors such as sex, HCV RNA level before treatment, and history of liver cirrhosis.

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

6.

Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C-SCAPE study.

Author: BrownA, HézodeC, ZuckermanE, FosterG R, ZekryA, RobertsS K, LahserF, DurkanC, BadshahC, ZhangB, RobertsonM, WahlJ, BarrE, HaberB,

Treat HCV infection
Adverse events

This phase 2 C-SCAPE study evaluated elbasvir/grazoprevir (EBR/GZR), with or without ribavirin (RBV), in participants with hepatitis C virus (HCV) genotype 2, 4, 5, or 6 infection. SVR12 rates were high in participants with HCV genotype 4 infection receiving EBR/GZR with and without RBV. The addition of RBV to EBR/GZR appeared to increase SVR12 in participants with genotype 5 infection.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number 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, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Elbasvir/Grazoprevir, an Alternative in Antiviral Hepatitis C Therapy in Patients under Amiodarone Treatment.

Author: WeissLina, WustmannKerstin, SemmoMariam, SchwerzmannMarkus, SemmoNasser

Hepatitis C treatment
Cardiac side effects

While a sofosbuvir/ledipasvir combination is a first-line treatment for hepatitis C, its use is contraindicated in patients taking amiodarone due to potential cardiac side effects. However, elbasvir/grazoprevir may be a safe and effective treatment alternative for hepatitis C patients receiving amiodarone therapy.

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.

Language : English

8.

Efficacy of Elbasvir/Grazoprevir in Early Chronic G1/G4 Hepatitis C infection in HIV/HCV co-infected patients with mild fibrosis.

Author: Laguno CentenoMontserrat, AlvarezBeatriz, Martínez-RebollarMaria, de la MoraLorena, PrietoLaura, de LazzariElisa, González-CordónAna, TorresBerta, CabelloAlfonso, GorgolasMiguel, MallolasJosep

AHC treatment

This study highlights the growing prevalence of acute hepatitis C virus (AHC) infection among HIV+ men who have sex with men (MSM). Prior to the advent of effective Direct-Acting-Antivirals (DAAs), the recommended treatment for AHC was pegylated-interferon plus ribavirin, which was often rejected due to its side effects. This study underscores the importance of accessible and effective treatment options for AHC in this population.

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.

Language : English

9.

Direct acting anti-viral medications for hepatitis C: Clinical trials in patients with advanced chronic kidney disease.

Author: BruchfeldAnnette, LindahlKarin

CKD treatment
HCV cure

Direct-acting antiviral (DAA) therapies have proven highly effective in treating hepatitis C in patients with chronic kidney disease (CKD) including end-stage renal disease (ESRD). Cure rates of over 90% have been achieved with minimal side effects, highlighting the need to raise awareness of these treatment options.

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

10.

Management of hepatitis C viral infection in chronic kidney disease patients on hemodialysis in the era of direct-acting antivirals.

Author: KoSoon Young, ChoeWon Hyeok

HCV infection treatment
HCV transmission
Renal impairment

Direct-acting antiviral (DAA) regimens have revolutionized hepatitis C virus (HCV) treatment, but ideal regimens have not been available for patients with severe renal impairment and end-stage renal disease. Recent studies suggest that several DAA combinations are effective in treating HCV infection in these 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

11.

Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.

Author: EvonDonna M, GolinCarol E, StewartPaul, FriedMichael W, AlstonShani, ReeveBryce, LokAnna S, SterlingRichard K, LimJoseph K, ReauNancy, SarkarSouvik, NelsonDavid R, ReddyK R, Di BisceglieAdrian M

Effective treatment for HCV

This study is an observational study that will enroll 1600 patients starting treatment with recently-approved direct-acting antiviral (DAA) therapies for hepatitis C. The study will focus on patient-reported outcomes, including side effects, medication adherence, and long-term impacts of 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.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

12.

Improvement of Gut Diversity and Composition After Direct-Acting Antivirals in Hepatitis C Virus-Infected Patients With or Without Human Immunodeficiency Virus Coinfection.

Author: ChuaypenNatthaya, JinatoThananya, AvihingsanonAnchalee, ChirapongsathornSakkarin, CheevadhanarakSupapon, NookaewIntawat, TanakaYasuhito, TangkijvanichPisit

Microbial restoration
Viral eradication

This study found that direct-acting antivirals (DAAs) used to treat hepatitis C virus (HCV) infection had a short-term effect on restoring microbial dysbiosis in the gut. The gut microbiota of HCV-infected patients, both with and without HIV coinfection, was less diverse and distinct from healthy controls before treatment. However, after successful treatment, responders experienced improvement in microbial dysbiosis, especially those with low fibrosis. This suggests that DAA treatment may contribute to reducing HCV-related complications.

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

Language : English

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