Drug safety evaluation of maraviroc for the treatment of HIV infection.

Abstract:

INTRODUCTION:Maraviroc is the only C-chemokine receptor 5 (CCR5) antagonist approved for the treatment of infection with HIV. This article reviews the safety and efficacy of maraviroc in the treatment of HIV infection. AREAS COVERED:The PubMed database was searched using the keywords 'maraviroc' and 'HIV'. In addition, conference proceedings from CROI, IAS and EACS meetings were searched for maraviroc clinical trials. The PubMed search revealed one Phase IIb - III clinical trial in treatment-naive HIV(+) patients (MERIT) and three Phase IIb - III randomized clinical trials (RCTs) in treatment-experienced patients (MOTIVATE 1 and 2, A4001029). All RCTs showed an excellent safety profile for maraviroc in the treatment of HIV-1 infection. However, long-term (> 3 years) safety data generated on maraviroc therapy are still scarce. Based on the findings from RCTs so far, no relevant toxicities and co-morbidities such as coronary heart disease or hepatotoxicity have been described. The overall CD4(+) cell count increase resulting from a maraviroc-containing regimen appears to be higher than those seen with other antiretroviral regimens. However, the significance remains controversial. To date, maraviroc has shown a potent and durable virological efficacy profile for the treatment of HIV-1 infection. The only use of maraviroc depends on pretreatment testing for CCR5 tropism. EXPERT OPINION:Maraviroc is a generally safe and well-tolerated medication for the treatment of HIV-1 infection with a unique mechanism of action. Long-term (i.e., > 5 years) risks are not known and have to be carefully monitored.

journal_name

Expert Opin Drug Saf

authors

Wasmuth JC,Rockstroh JK,Hardy WD

doi

10.1517/14740338.2012.640670

subject

Has Abstract

pub_date

2012-01-01 00:00:00

pages

161-74

issue

1

eissn

1474-0338

issn

1744-764X

journal_volume

11

pub_type

杂志文章,评审
  • Efficacy and safety of mipomersen sodium (Kynamro).

    abstract:INTRODUCTION:Mipomersen is a first-in-class drug indicated as an adjunct to lipid-lowering medications and diet to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), total cholesterol (TC) and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholes...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2013.793670

    authors: Hovingh K,Besseling J,Kastelein J

    更新日期:2013-07-01 00:00:00

  • A drug safety evaluation of atezolizumab in locally advanced or metastatic urothelial carcinoma.

    abstract:INTRODUCTION:Immune checkpoint inhibitors (ICIs) have rapidly changed the treatment landscape, demonstrating dramatic clinical efficacy in various cancers. AREAS COVERED:In urothelial cancer (UC), several ICIs have been approved in platinum refractory disease and also as first-line therapy in patients that fulfill the...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2020.1792442

    authors: Economopoulou P,Kotsantis I,Bamias A

    更新日期:2020-08-01 00:00:00

  • Statin administration and risk of cholecystectomy: a population-based case-control study.

    abstract:BACKGROUND:Gallstone disease is common in Western countries. Statins reduce biliary cholesterol secretion and have anti-inflammatory effects, suggesting that they may play a role in reducing the incidence of surgically treated gallstone disease. AIM:To examine a potential association between statin administration and ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章

    doi:10.1517/14740338.2010.485190

    authors: Merzon E,Weiss NS,Lustman AJ,Elhayani A,Dresner J,Vinker S

    更新日期:2010-07-01 00:00:00

  • Safety of GnRH agonists and antagonists.

    abstract::The widespread application of protocols using gonadotropin-releasing hormone (GnRH) agonists or antagonists in assisted reproduction treatment has led to an increasing number of pregnancies exposed to these drugs. This issue has raised scepticism as to the safety of these medications, concerning both pregnant women an...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.3.1.39

    authors: Tarlatzis BC,Bili H

    更新日期:2004-01-01 00:00:00

  • Monitoring self-medication.

    abstract::Self-medication, using non-prescription drugs, is beneficial to patients, healthcare professionals, the pharmaceutical industry and governments. Although many non-prescription medications are effective, misuse and abuse of these products can arise. Monitoring of specific populations and products, in addition to data r...

    journal_title:Expert opinion on drug safety

    pub_type: 社论

    doi:10.1517/14740338.2.1.1

    authors: Hughes CM

    更新日期:2003-01-01 00:00:00

  • Tazarotene foam, 0.1%, for the treatment of acne.

    abstract:INTRODUCTION:Acne is a common skin condition of the pilosebaceous units that affects the young and old, ranges from moderate to severe and can be treated with an array of options. Topical retinoids are the initial treatment for acne due to their ability to treat comedones, the starting point of acne. AREAS COVERED:Taz...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章

    doi:10.1517/14740338.2016.1117605

    authors: Smith JA,Narahari S,Hill D,Feldman SR

    更新日期:2016-01-01 00:00:00

  • Safety of secukinumab in the treatment of psoriasis.

    abstract:INTRODUCTION:Secukinumab is a human monoclonal antibody that selectively targets and neutralizes interleukin (IL)-17A, a cytokine that is normally involved in mucocutaneous defense against extracellular organisms and is abnormally expressed in psoriasis. In 2015, secukinumab was the first IL-17A inhibitor approved for ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2016.1221923

    authors: Blauvelt A

    更新日期:2016-10-01 00:00:00

  • Molecular profiling approaches for identifying novel biomarkers.

    abstract::An unprecedented interest in biomarker development has arisen from the increasing use of genomic information and high-throughput technologies in the field of drug development. Monitoring global cellular responses to perturbation due to disease, drug treatment or toxicity is achieved using molecular profiling methods s...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/eods.3.2.137.27344

    authors: Bailey WJ,Ulrich R

    更新日期:2004-03-01 00:00:00

  • The safety of rosiglitazone in the treatment of type 2 diabetes.

    abstract:BACKGROUND:Cardiovascular disease is the leading cause of mortality among adults with Type 2 diabetes. The thiazolidinediones including rosiglitazone are approved for the treatment of Type 2 diabetes on the basis of their ability to lower blood sugar and surrogate markers of cardiovascular disease. OBJECTIVES:To ascer...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.7.5.579

    authors: Singh S,Loke YK

    更新日期:2008-09-01 00:00:00

  • The safety of treatment options for acute bacterial skin and skin structure infections.

    abstract:INTRODUCTION:Acute bacterial skin and skin-structure infections (ABSSSI) may develop in both in-patients and out-patients, possibly with a severe clinical presentation. Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2019.1621288

    authors: Bassetti M,Peghin M,Castaldo N,Giacobbe DR

    更新日期:2019-08-01 00:00:00

  • The safety of bortezomib for the treatment of multiple myeloma.

    abstract:INTRODUCTION:There is now 16 years' worth of established results of various trials demonstrating the bortezomib efficiency in the treatment of multiple myeloma. Over this time, the introduction of bortezomib has been a major break through in the treatment of multiple myeloma. Bortezomib can be administered in the outpa...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2018.1513487

    authors: Cengiz Seval G,Beksac M

    更新日期:2018-09-01 00:00:00

  • The safety and effectiveness of vonoprazan-based Helicobacter pylori eradication therapy; a prospective post-marketing surveillance.

    abstract::Background: The safety and effectiveness of vonoprazan-based Helicobacter pylori (H. pylori) eradication therapy in routine clinical practice, and patient characteristics that influence safety and effectiveness, have not been well investigated.Methods: H. pylori-positive patients with gastric ulcer, duodenal ulcer, id...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章

    doi:10.1080/14740338.2019.1676722

    authors: Ashida K,Honda Y,Sanada K,Takemura Y,Sakamoto S

    更新日期:2019-12-01 00:00:00

  • Safety of pembrolizumab in recurrent or advanced gastric cancer expressing PD-L1 refractory to platinum and fluoropyrimidine.

    abstract:INTRODUCTION:Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC). AREA COVERED:Pembrolizumab was appr...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章

    doi:10.1080/14740338.2020.1805428

    authors: Mishima S,Kawazoe A,Shitara K

    更新日期:2020-09-01 00:00:00

  • Thrombotic microangiopathy associated with gemcitabine: rare but real.

    abstract::Gemcitabine-associated thrombotic thrombocytopenic purpura is a rare complication of gemcitabine treatment with an incidence ranging from 0.015 to 1.4%. Clinically, this disease manifests as haemolytic anaemia, thrombocytopenia and renal insufficiency; hypertension and neurological and pulmonary symptoms are also know...

    journal_title:Expert opinion on drug safety

    pub_type: 社论

    doi:10.1517/14740330902942299

    authors: Saif MW,Xyla V,Makrilia N,Bliziotis I,Syrigos K

    更新日期:2009-05-01 00:00:00

  • The cardiac safety of trastuzumab in the treatment of breast cancer.

    abstract:IMPORTANCE OF THE FIELD:Trastuzumab has become a mainstay in the treatment of women with human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer in the metastatic and adjuvant settings. Although trastuzumab is generally well tolerated, cardiac toxicity has emerged as a rare but potentially serious ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740331003627441

    authors: Chien AJ,Rugo HS

    更新日期:2010-03-01 00:00:00

  • Celecoxib and cardiovascular risks.

    abstract::In a very short time, COX-2 enzyme inhibitors have gone from the darlings to the pariahs of the pharmaceutical industry. These drugs were developed based on the hypothesis whereby selective inhibition of the COX enzyme would lead to reduction in pain and inflammation without associated gastrointestinal and bleeding ri...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.4.6.1005

    authors: Brophy JM

    更新日期:2005-11-01 00:00:00

  • Safety evaluation of cephalosporins based on utilization and adverse drug events: analysis of two databases in China.

    abstract:OBJECTIVE:The aim of this study is to evaluate the safety of cephalosporins, based on utilization and adverse drug events (ADEs). METHODS:This is a retrospective study using data on cephalosporins, obtained from Yangtze River hospital drug information and the Wuhan adverse drug reactions monitoring center database, fr...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,多中心研究

    doi:10.1517/14740338.2012.699037

    authors: Ren X,Liu D,Ding N,Huang K,Xiong Y,Du G,Zeng F

    更新日期:2012-09-01 00:00:00

  • Rationale for administering beta-blocker therapy to patients undergoing coronary artery bypass surgery: a systematic review.

    abstract:INTRODUCTION:Secondary preventative therapies are essential for patients undergoing coronary artery bypass graft (CABG) surgery to optimize perioperative and long-term outcomes. Beta-blockers are commonly used to treat patients with coronary artery disease and congestive heart failure (CHF), but their role for CABG pat...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2018.1504019

    authors: Thaper A,Kulik A

    更新日期:2018-08-01 00:00:00

  • Gender differences on benefits and risks associated with oral antithrombotic medications for coronary artery disease.

    abstract:INTRODUCTION:Despite the significant advances in the pharmacological and interventional management of patients with cardiovascular disease (CVD) over the last decades, cardiovascular mortality remains the leading cause of death. Large randomized clinical trials have investigated the efficacy and safety of different ant...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1080/14740338.2018.1524869

    authors: Romano S,Buccheri S,Mehran R,Angiolillo DJ,Capodanno D

    更新日期:2018-10-01 00:00:00

  • Adverse events associated with somatostatin analogs in acromegaly.

    abstract:INTRODUCTION:In patients with acromegaly, somatostatin analogs (SSA) represent the first choice medical treatment. The long-acting SSA have been found to be effective in controlling growth hormone and IGF-I levels in a high percentage of patients, resulting in an improvement in the quality of life; moreover, these pept...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2015.1059817

    authors: Grasso LF,Auriemma RS,Pivonello R,Colao A

    更新日期:2015-08-01 00:00:00

  • The safety of pomalidomide for the treatment of multiple myeloma.

    abstract:INTRODUCTION:Pomalidomide, a derivative of thalidomide and member of the immunomodulatory drugs is licenced for use in relapsed and refractory multiple myeloma (RRMM) in Europe, USA, Canada and Japan. AREAS COVERED:This review details all published trials in which pomalidomide has been used in the treatment of myeloma...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2016.1154039

    authors: Jones JR,Pawlyn C,Davies FE,Morgan GJ

    更新日期:2016-01-01 00:00:00

  • CGRP inhibitors for migraine prophylaxis: a safety review.

    abstract:INTRODUCTION:Since calcitonin gene-related peptide (CGRP) plays an important role in the pathophysiology of migraine via the activation of the trigeminovascular system, the newest prophylactic treatments directly block CGRP or its receptor. However, the safety of these novel antimigraine drugs is not yet sufficiently e...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章

    doi:10.1080/14740338.2020.1811229

    authors: Rivera-Mancilla E,Villalón CM,MaassenVanDenBrink A

    更新日期:2020-10-01 00:00:00

  • Typical toxic components in traditional Chinese medicine.

    abstract:INTRODUCTION:Traditional Chinese medicine (TCM) is widely used around the world. However, with its wide use has been the identification of a number of toxicological issues that have severely restricted its use in clinical treatment. The identification of these toxic substances within TCM has become somewhat of a hot to...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2012.726610

    authors: Lv W,Piao JH,Jiang JG

    更新日期:2012-11-01 00:00:00

  • The safety of clopidogrel.

    abstract:IMPORTANCE OF THE FIELD:Clopidogrel is an antiplatelet prodrug widely used in acute coronary syndromes and after intravascular stent placement. Acute or chronic use can cause bleeding, a major adverse effect, which can lead to drug discontinuation or noncompliance with therapy. AREAS COVERED IN THIS REVIEW:The mechani...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2011.532485

    authors: Mangalpally KK,Kleiman NS

    更新日期:2011-01-01 00:00:00

  • The rational use of potentially hepatotoxic medications in patients with underlying liver disease.

    abstract::Given the fact that as many as 9% of all adverse drug reactions involve toxic effects on the liver and with upwards of 50% of all cases of fulminant hepatic failure being ascribed to acetaminophen and other agents, the safe use of medications takes on an even greater importance whenever the prescription of potentially...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.1.2.159

    authors: Lewis JH

    更新日期:2002-07-01 00:00:00

  • Adverse effects of golimumab in the treatment of rheumatologic diseases.

    abstract:INTRODUCTION:A number of new biological immune modulators have become available as treatments for inflammatory diseases over the past two decades. Most prominent among them are TNF-α inhibitors (TNFi) which have been available in the clinic since the late 1990s. TNFi have demonstrated efficacy in various rheumatologic ...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2013.831403

    authors: Yang H,Kavanaugh A

    更新日期:2014-01-01 00:00:00

  • Acute mycophenolate overdose: case series and systematic literature analysis.

    abstract:BACKGROUND:Literature regarding acute human toxicity of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) is limited. OBJECTIVES:Our objectives were to describe all cases of overdose with MMF or EC-MPS reported to the Swiss Toxicological Information Centre (STIC) or in the literature between...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,meta分析,评审

    doi:10.1517/14740338.2014.903032

    authors: Ceschi A,Gregoriano C,Rauber-Lüthy C,Kupferschmidt H,Banner NR,Krähenbühl S,Taegtmeyer AB

    更新日期:2014-05-01 00:00:00

  • Metabolic complications associated with antiretroviral therapy in HIV-infected and HIV-exposed uninfected paediatric patients.

    abstract:IMPORTANCE OF THE FIELD:HIV-infection has become a chronic disease in paediatric patients with the potential for long-term survival and exposure to antiretroviral (ARV) therapies for 2 decades longer than HIV-infected adults. On the other hand, the administration of ARV to HIV-infected pregnant women has greatly increa...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740330903579991

    authors: Viganò A,Cerini C,Pattarino G,Fasan S,Zuccotti GV

    更新日期:2010-05-01 00:00:00

  • Application of bone morphogenetic proteins in orthopaedic practice: their efficacy and side effects.

    abstract::Bone morphogenetic proteins (BMPs) have been extensively studied since the discovery of agents within bone that could induce bone formation at ectopic sites by Urist in the 1960s. Extensive preclinical research has been carried out showing the efficacy of these products in promoting bone healing. Clinical trials are e...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.4.1.75

    authors: Harwood PJ,Giannoudis PV

    更新日期:2005-01-01 00:00:00

  • Safety evaluation of trabectedin in treatment of soft-tissue sarcomas.

    abstract:INTRODUCTION:Trabectedin gained the approval by the European Medicines Agency (EMA) in 2007 for the treatment of patients affected by soft-tissue sarcomas (STS). Its safety and activity profiles have been assessed in many clinical trials as well as in standard clinical practice for > 10 years. AREAS COVERED:This artic...

    journal_title:Expert opinion on drug safety

    pub_type: 杂志文章,评审

    doi:10.1517/14740338.2013.829037

    authors: Martin-Liberal J,Judson I

    更新日期:2013-11-01 00:00:00