New therapeutic agents in the management of HIV: an overview of darunavir for clinicians

Sexual Health ◽  
2008 ◽  
Vol 5 (3) ◽  
pp. 235 ◽  
Author(s):  
Jessica Rotty ◽  
Jennifer Hoy
Keyword(s):  
Side Effects ◽  
Hiv Infection ◽  
Protease Inhibitor ◽  
Drug Interactions ◽  
Clinical Efficacy ◽  
Safety Profile ◽  
Therapeutic Agents ◽  
Drug Resistant ◽  
Efficacy Data ◽  
Resistance Profile

This overview will provide the reader with summarised information about darunavir, a new protease inhibitor licenced for the treatment of drug resistant HIV-infection. Darunavir is a promising new drug with good clinical efficacy data and safety profile. In this overview clinicians will be updated on clinical efficacy data, side-effects, resistance profile and drug interactions. The overview should give clinicians a sound understanding of when and how to use this new protease inhibitor in the treatment of HIV-infection.

scholarly journals Current Approaches to the Treatment of Gastrointestinal Infections: Focus on Nitazoxanide

2009 ◽  
Vol 1 ◽  
pp. CMT.S2297 ◽  
Author(s):  
Jennifer L. Halsey
Keyword(s):  
Side Effects ◽  
Drug Interactions ◽  
Broad Spectrum ◽  
Safety Profile ◽  
Taenia Saginata ◽  
Gastrointestinal Infections ◽  
Oral Tablet ◽  
Acceptable Safety Profile ◽  
H Pylori ◽  
Immunocompetent Patients

Nitazoxanide is a broad-spectrum agent active against several protozoa, helminths, and bacteria, including C. difficile and H. pylori. It is available as an oral tablet and suspension, both with adequate bioavailability. Nitazoxanide is associated with minimal side effects, has an acceptable safety profile, and has been classified as a pregnancy category B agent. It is 99% protein bound, which could result in drug interactions. It is the preferred agent for the treatment of Cryptospordiosis and Giardiasis in immunocompetent patients and has shown promise for the treatment of rotavirus, mild to moderate initial C. difficile infection, refractory C. difficile infection, Amoebiasis, Blastocystosis, and Taenia saginata.

Mexiletine therapy in patients with chronic drug-resistant malignant ventricular arrhythmias: Clinical efficacy, safety, and side effects

1986 ◽  
Vol 53 (2) ◽  
pp. 171-179 ◽  
Author(s):  
D. L. Haggman ◽  
J. D. Maloney ◽  
V. A. Morant ◽  
L. W. Castle ◽  
M. King-Rankine ◽  
...  
Keyword(s):  
Side Effects ◽  
Clinical Efficacy ◽  
Ventricular Arrhythmias ◽  
Drug Resistant

Invasive Mycoses in High-Risk Cancer Patients - a Prospective Analysis of Clinical Parameters, Side Effects, Drug Interactions and Costs for the Safe and Economically Appropriate Use of Systemic Antifungal Agents.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2487-2487
Author(s):  
Werner Neubauer ◽  
Alf Zerweck ◽  
Alexandra Goebel ◽  
Beate Lubrich ◽  
Hartmut Bertz ◽  
...  
Keyword(s):  
Side Effects ◽  
High Risk ◽  
Drug Interactions ◽  
Safety Profile ◽  
Research Funding ◽  
Empirical Therapy ◽  
Preemptive Therapy ◽  
Appropriate Use ◽  
Line Therapy ◽  
Invasive Mycoses

Abstract Abstract 2487 Poster Board II-464 Introduction: Invasive mycoses (IM) show high morbidity and mortality rates among immunocompromised patients (pts). Especially allogeneic stem cell transplant (allo-SCT) recipients and acute leukemia pts under induction chemotherapy are at risk and benefit from early systemic antifungal drug (SAD) interventions. Nevertheless, the increasing use of SADs has led to considerable costs and represents a substantial burden for public health systems. Available SADs differ in their antifungal properties, side effects (SE), potential drug interactions (PDI) and costs. Efficacy and safety profiles of SAD have been derived from clinical trials, which, however, may not reflect ‘everyday clinics' and true SAD efficacy due to tight inclusion and exclusion study criteria. Aim of our analysis was to prevent SAD application errors and to assure their economically appropriate use. Methods: Since 11/06, we prospectively analysed the SAD usage on a general hematology ward (n=42) and SCT-unit (n=158) within our department. Pt characteristics, organ function, SE, PDI, treatment outcome and costs were assessed. Data was obtained by daily participation on ward rounds, consultation of ward physicians and review of pts' medication charts. SAD were given according to EORTC-adapted guidelines, with fluconazole given as primary prophylaxis in allo-SCT recipients and posaconazole for AML/MDS pts under induction chemotherapy. Empirical therapy was implemented with liposomal amphotericin B (lip. AmphoB) or caspofungin, preemptive therapy and therapy of aspergillus infections with voriconazole, caspofungin or lip. AmphoB. Results: 200 consecutive pts under SAD treatment showed pt characteristics as displayed in Table 1, with leukemia (n=125) and lymphoma (n=51) as predominant diseases. Transplant (especially allo-SCT) pts were treated more frequently with intravenous (iv) SAD and with two or more consecutively applied SAD. Allo-SCT recipients received SAD earlier with higher pt numbers being treated prophylactically and empirically. The mortality rate due to fungal infections was significantly higher in allo-SCT recipients compared to other subgroups. The median duration of SAD use was considerably longer and median SAD costs exceeded those of auto-SCT and non-transplant pts (Table 1). Lip. AmphoB was primarily applied as empirical therapy and showed an unfavorable safety profile with more SE (predominantly nephrotoxicity) and PDI compared to other SAD (Table 2). Voriconazole (mainly applied as preemptive therapy) and posaconazole displayed hepatotoxicity and numerous pharmacokinetic PDI, whereas caspofungin showed a favorable safety profile, with least SE and PDI. The echinocandin was primarily applied as 2-line therapy, whereas all other SAD were commonly given as 1-line therapy. Conclusions: Earlier onset and longer duration of SAD as well as their increased i.v.-use lead to substantial costs among allo-SCT pts who are at high risk of developing invasive mycoses. SE and PDI frequently arise from the use of lip. AmphoB, whereas caspofungin appears to be well-tolerated. Our detection of frequent SE and PDI with SAD as well as the cost analysis should help us to avoid application errors, thereby enhancing pts' safety, and to assure economically appropriate SAD use. Enrollment of additional pts is ongoing, which will be presented at the meeting. Disclosures: Neubauer: MSD Merck Sharp & Dohme GmbH: Research Funding. Engelhardt:MSD Merck Sharp & Dohme GmbH: Research Funding.

scholarly journals Clinical Efficacy and Toxicity of Anti-EGFR Therapy in Common Cancers

2009 ◽  
Vol 2009 ◽  
pp. 1-14 ◽  
Author(s):  
Amir Harandi ◽  
Aisha S. Zaidi ◽  
Abigail M. Stocker ◽  
Damian A. Laber
Keyword(s):  
Clinical Efficacy ◽  
Tyrosine Kinases ◽  
Kinase Inhibitors ◽  
Growth Factor Receptor ◽  
Therapeutic Agents ◽  
Efficacy Data ◽  
Cell Surface Molecule ◽  
Solid Malignancies ◽  
A Cell ◽  
Epidermal Growth

Epidermal growth factor receptor (EGFR) is a cell surface molecule and member of the ErbB family of receptor tyrosine kinases. Its activation leads to proliferation, antiapoptosis, and metastatic spread, making inhibition of this pathway a compelling target. In recent years, an increasing number of clinical trials in the management of solid malignancies have become available indicating the clinical efficacy of anti-EGFR monoclonal antibodies and oral small molecule tyrosine kinase inhibitors (TKIs). This review addresses frequently used EGFR inhibitors, summarizes clinical efficacy data of these new therapeutic agents, and discusses their associated toxicity and management.

EVALUATION OF CLINICAL EFFICACY AND SIDE EFFECTS OF ROTAVIRUS VACCINE

2020 ◽  
Vol 76 (1) ◽  
Author(s):  
Ali Ulas TUGCU ◽  
Figen Sahin ◽  
Gulendam Bozdayi ◽  
Fatma Nur Aksakal ◽  
Gulcin Alp ◽  
...  
Keyword(s):  
Side Effects ◽  
Clinical Efficacy ◽  
Rotavirus Vaccine

Review on the Clinical Pharmacology of Hydroxychloroquine Sulfate for the Treatment of COVID-19

2020 ◽  
Vol 21 (6) ◽  
pp. 427-435 ◽  
Author(s):  
Cheng Cui ◽  
Siqi Tu ◽  
Valerie Sia Jie En ◽  
Xiaobei Li ◽  
Xueting Yao ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Clinical Efficacy ◽  
Relevant Literature ◽  
The United States ◽  
Efficacy And Safety ◽  
Open Label ◽  
Infected People ◽  
Treatment Regimens ◽  
Therapeutic Drugs

Background: As the number of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infected people is greatly increasing worldwide, the international medical situation becomes very serious. Potential therapeutic drugs, vaccine and stem cell replacement methods are emerging, so it is urgent to find specific therapeutic drugs and the best treatment regimens. After the publications on hydroxychloroquine (HCQ) with anti- SARS-COV-2 activity in vitro, a small, non-randomized, open-label clinical trial showed that HCQ treatment was significantly associated with reduced viral load in patients with coronavirus disease-19 (COVID-19). Meanwhile, a large prophylaxis study of HCQ sulfate for COVID-19 has been initiated in the United States. HCQ offered a promising efficacy in the treatment of COVID-19, but the optimal administration is still being explored. Methods: We used the keyword "hydroxychloroquine" to conduct a literature search in PubMed to collect relevant literature on the mechanism of action of HCQ, its clinical efficacy and safety, pharmacokinetic characteristics, precautions for clinical use and drug interactions to extract and organize information. Results: This paper reviews the mechanism, clinical efficacy and safety, pharmacokinetic characteristics, exposureresponse relationship and precautions and drug interactions of HCQ, and summarizes dosage recommendations for HCQ sulfate. Conclusion: It has been proved that HCQ, which has an established safety profile, is effective against SARS-CoV-2 with sufficient pre-clinical rationale and evidence. Data from high-quality clinical trials are urgently needed worldwide.

P20 Triple protease inhibitor combinations in patients with multidrug resistant HIV infection

HIV Medicine ◽  
2000 ◽  
Vol 1 (3) ◽  
pp. 179-179 ◽  
Author(s):  
B Dragovic ◽  
G Moyle ◽  
M Youle ◽  
Na Smith
Keyword(s):  
Hiv Infection ◽  
Protease Inhibitor ◽  
Multidrug Resistant

scholarly journals Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110026
Author(s):  
Chinar R. Parikh ◽  
Jaya K. Ponnampalam ◽  
George Seligmann ◽  
Leda Coelewij ◽  
Ines Pineda-Torra ◽  
...  
Keyword(s):  
Side Effects ◽  
Clinical Efficacy ◽  
Inflammatory Arthritis ◽  
Biologic Agents ◽  
Adult Patients ◽  
Therapeutic Drug ◽  
Biologic Drugs ◽  
Therapeutic Implications ◽  
The Impact ◽  
First Time

The treatment of inflammatory arthritis has been revolutionised by the introduction of biologic treatments. Many biologic agents are currently licensed for use in both paediatric and adult patients with inflammatory arthritis and contribute to improved disease outcomes compared with the pre-biologic era. However, immunogenicity to biologic agents, characterised by an immune reaction leading to the production of anti-drug antibodies (ADAs), can negatively impact the therapeutic efficacy of biologic drugs and induce side effects to treatment. This review explores for the first time the impact of immunogenicity against all licensed biologic treatments currently used in inflammatory arthritis across age, and will examine any significant differences between ADA prevalence, titres and timing of development, as well as ADA impact on therapeutic drug levels, clinical efficacy and side effects between paediatric and adult patients. In addition, we will investigate factors associated with differences in immunogenicity across biologic agents used in inflammatory arthritis, and their potential therapeutic implications.

scholarly journals Baroreflex activation therapy for resistant hypertension: results from mid-term prospective ambulatory blood pressure registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Sindt ◽  
T Madej ◽  
S Grimm ◽  
M Knaut
Keyword(s):  
Blood Pressure ◽  
Side Effects ◽  
Pressure Drop ◽  
Arterial Hypertension ◽  
Antihypertensive Drugs ◽  
Drug Resistant ◽  
Baroreflex Activation Therapy ◽  
Activation Therapy ◽  
Resistant Arterial Hypertension

Abstract Objectives First generation baroreflex activation therapy (BAT) devices showed clinical efficacy in patients with drug-resistant arterial hypertension (AHT), but the safety profile was insufficient. Data regarding efficacy of second-generation devices were generated mostly from office blood pressure (BP) measurements or short-term 24-hour ambulatory blood pressure measurements (ABPM). We present a mid-term prospective registry to evaluate the efficacy and safety of recent BAT devices. Purpose The purpose of our study was to find a method that helps patients with drug-resistant arterial hypertension to control their blood pressure. Further we sought to reduce the overall amount of antihypertensive drugs to lessen side effects, as well as the effects of polypharmacy. Methods All patients receiving Barostim neo between November 2013 and June 2019 for resistant AHT were prospectively included into this observational study. ABPM was performed at baseline, in 3-month intervals in the first year after BAT implantation and in 6-month intervals afterwards for up to 42 months. Patients were assigned into two groups of responders and non-responders. Non-responders had a mean blood pressure drop (BPD) below 5mmHg. Responders in turn were categorized into 3 sub-groups (low-BPD between 5–9 mmHg, medium-BPD between 10–19 mmHg and high-BPD ≥20 mmHg). The primary efficacy end-points were changes in systolic and diastolic BP and number of antihypertensive medications. The primary safety end point was BAT-related major adverse events (MAE). Results 64 patients (mean age 63 years, 67% males) were included. Only patients who completed a 24-hour ABPM during a follow up were counted in the statistical analysis. We had an overall responder rate of 67.8%. Out of those 15.4% had low-BPD, 38.4% medium-BPD and 46.2% had a high-BPD. Systolic BP decreased over the 3.5-years period from 168±17 mmHg to 149±19 mmHg (n=19, mean change −18.8 mmHg; 95% confidence interval [CI]: −29.32 to −8.36; p<0.0007). Diastolic BP decreased from 97±16 to 85±12 mmHg (n=19, mean change −11.7 mmHg; 95% CI: −19.2 to −4.2; p<0.0021). The mean number of antihypertensive drugs was reduced from 6.9±1.3 to 5.2±1.5 (n=19, mean change −1.7; 95% CI: −0.8 to −0.27; p<0.0009). The time course of primary end-points is shown in Fig.1. Freedom from BAT-related MAE was 93.5%. 4 perioperative complications (1 pocket bleeding, 1 pocket infection, 1 N. hypoglossus palsy, 1 hoarseness) resolved without residual side effects. There were five non BAT related deaths (7,8%) in the follow up period. Conclusion Systolic and diastolic ABP, as well as number and dosage of antihypertensive drugs decreased significantly during 3.5-years follow-up after Barostim neo implantation in 64 consecutive patients (of whom 62 completed at least one follow-up). No MAE associated with BAT were observed after the perioperative period. However, further controlled trials are needed to confirm the long-term efficacy of BAT. Figure 1. Mean blood pressure drop Funding Acknowledgement Type of funding source: None

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