PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Tenofovir" RSS

04:58 EDT 24th August 2019 | BioPortfolio

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Showing "Human medicines European public assessment report EPAR Tenofovir" PubMed Articles 1–25 of 44,000+

Guides Concerning Tenofovir Exposure via Breastfeeding: A Comparison of Drug Dosages by Developmental Stage.

Tenofovir disoproxil fumarate (TDF) is a prodrug of tenofovir, and after being administrated orally, it converts to tenofovir in the blood. With the increasing use of TDF in women for treatment and prevention of mother-to-child transmission (MTCT) of both human immunodeficiency virus (HIV) and hepatitis B virus (HBV), or the pre-exposure prophylaxis (PrEP) for HIV, many nursing mothers have to understand the risk of exposure to tenofovir via breastmilk and make the decision about breastfeeding while on TDF ...

Cost-effectiveness of public health interventions against human influenza pandemics in France: a methodological contribution from the FLURESP European Commission project.

The FLURESP project is a public health project funded by the European Commission with the objective to design a methodological approach in order to compare the cost-effectiveness of existing public health measures against human influenza pandemics in four target countries: France, Italy, Poland and Romania. This article presents the results relevant to the French health system using a data set specifically collected for this purpose.

Tenofovir alafenamide for hepatitis B virus infection including switching therapy from tenofovir disoproxil fumarate.

Tenofovir alafenamide (TAF) is a new prodrug of tenofovir, enabling treatment of patients with hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF), via more efficient delivery of tenofovir to the hepatocytes. We compared the efficacy and safety of TDF and TAF and investigated switching from TDF to TAF therapy.

Rapid assessment of enhanced safety surveillance for influenza vaccine.

The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.

European Medicines Agency-Health Technology Assessment Parallel Consultation Platform: An Industry Perspective.

The financial burden of non-communicable diseases in the European Union: a systematic review.

Non-communicable diseases (NCDs) impose a significant and growing burden on the health care system and overall economy of developed (and developing) countries. Nevertheless, an up-to-date assessment of this cost for the European Union (EU) is missing from the literature. Such an analysis could however have an important impact by motivating policymakers and by informing effective public health policies.

Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV.

Two drugs under consideration for inclusion in antiretroviral therapy (ART) regimens for human immunodeficiency virus (HIV) infection are dolutegravir (DTG) and tenofovir alafenamide fumarate (TAF). There are limited data on their use in low- and middle-income countries.

Corrigendum to: Assessment of developmental risk information on medicines for inclusion on the WHO's Essential Medicines List.

Prediction model for hepatocellular carcinoma risk in treatment-naive chronic hepatitis B patients receiving entecavir/tenofovir.

Accurate assessment of hepatocellular carcinoma (HCC) risk in chronic hepatitis B (CHB) patients receiving entecavir (ETV)/tenofovir disoproxil fumarate (TDF) is likely to play a pivotal role in post-treatment follow-up strategy. We aimed to develop a simple and reliable predictive model for HCC risk in these patients.

Does public report card matter? A 10-year interrupted time series analysis on total knee replacement.

There is a lack of evidence that shows whether a report card can improve health outcomes in terms of infection rates or unscheduled readmission by using rigorous methods to evaluate its impact.

The Impact of Price Negotiations on Public Procurement Prices and Access to 8 Innovative Cancer Medicines in a Middle-Income Country-The Case of Mexico.

To mitigate the effect of high prices, in 2008 Mexico established a commission that negotiates single procurement prices for patented medicines in the public sector.

Added value of human biomonitoring in assessment of general population exposure to xenobiotics.

Human biomonitoring (HBM) has a wide range of applications and long tradition both in health care and the field of public health. Its major advantage is the integration of all exposure routes and sources. Since HBM information is an integrated exposure finding it offers the opportunity to trace and mimic a realistic exposure scenario. It reduces the number of assumptions that need to be made when estimating exposure and thus helps to reduce the uncertainties in exposure science. In spite of some challenges,...

Assessment of technical efficiency of public hospitals in Turkey.

Turkish public hospitals have been subjected to health care reform because of increasing cost pressure, inequities in access to health care, poor quality of care and limited patient responsiveness in the last three decades. This study investigates the impact of recent hospital reforms on the efficiency of public hospitals.

The European Medicines Agency's scientific opinion on oral fexinidazole for human African trypanosomiasis.

Mutual recognition in the European system: A blueprint for increasing access to medicines?

The European regulatory system for approval of medicinal products is globally recognised as a unique platform for regulatory work-sharing and mutual recognition. As such, it potentially serves as a role model for regulatory capacity building worldwide. While focusing on mutual recognition and decentralised procedures, this paper illustrates key success factors and structures allowing for the reliance-based authorisation of medicines in the European Economic Area from the perspective of a national regulatory...

Evolution of Average European Medicine Prices: Implications for the Methodology of External Price Referencing.

There are indications of staggered market entry of medicines in the national markets, with medicines being marketed first in countries with high prices. This study aimed to analyse the availability and evolution of medicine prices in the European Union (EU).

Increased tenofovir monoester concentrations in patients receiving tenofovir disoproxil fumarate with ledipasvir/sofosbuvir.

Intracellular tenofovir diphosphate concentrations are markedly increased in HIV/HCV coinfected individuals receiving tenofovir disoproxil fumarate (TDF) with sofosbuvir-containing treatment. Sofosbuvir may inhibit the hydrolysis of TDF to tenofovir, resulting in increased concentrations of the disoproxil or monoester forms, which may augment cell loading. We sought to quantify tenofovir disoproxil and monoester concentrations in individuals receiving TDF with and without ledipasvir/sofosbuvir.

Switching tenofovir disoproxil fumarate to tenofovir alafenamide results in a significant decline in parathyroid hormone levels: uncovering the mechanism of tenofovir disoproxil fumarate-related bone loss?

: An increasing number of patients have been switched from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide because of its improved bone safety profile, although the pathophysiological mechanism is not fully understood. We show that serum parathyroid hormone levels drop significantly after the switch from TDF to tenofovir alafenamide. This observation supports the theories that TDF-related bone loss is parathyroid hormone-driven and that this effect is dose-dependent.

Access to and use of medicines in the Annapurna region of Western Nepal and possible impacting factors.

Improving access to medicines is a major healthcare challenge for low-income countries because the problem traverses health systems, society and multiple stakeholders. The Annapurna region of Nepal provides a valuable case study to investigate the interplay between medicines, society and health systems and their effects on access to and use of medicines. Government health facilities and international aid organizations provide some healthcare in the region, communities participate actively in healthcare orga...

Assessment of Drug Interaction Potential Between the Hepatitis C Virus Direct-Acting Antiviral Agents Elbasvir/Grazoprevir and the Nucleotide Analog Reverse-Transcriptase Inhibitor Tenofovir Disoproxil Fumarate.

Treatment of individuals coinfected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) requires careful consideration of potential drug-drug interactions. We evaluated the pharmacokinetic interaction of the direct-acting antiviral agents elbasvir and grazoprevir coadministered with the nucleotide reverse transcriptase inhibitor tenofovir disoproxil fumarate (TDF). Three open-label, multidose studies in healthy adults were conducted. In the first study (N = 10), participants received TDF 3...

Evidence for Use of Tenofovir in Pregnancy to Prevent Perinatal Transmission of Hepatitis B Infection.

Perinatal transmission of hepatitis B virus continues to be a serious global public health concern. Transmission failures are related to high maternal viremia. Several antiviral therapies reduce maternal viremia around the time of delivery and decrease maternal-to-child-transmission. This chapter is a review of current studies that, ultimately, have provided strong evidence for the efficacy and safety of 3 antiviral drugs in pregnancy-lamivudine, telbivudine and tenofovir. The latter drug is the particular ...

Tenofovir causes bone loss via decreased bone formation and increased bone resorption, which can be counteracted by dipyridamole in mice.

Osteopenia and fragility fractures have been associated with HIV infection. Tenofovir, a common antiviral in HIV treatment, also leads to increases in bone catabolism markers and decreased bone mineral density (BMD) in children and young adults. In murine models and human cell lines, tenofovir inhibits ATP release and decreases extracellular adenosine levels. Adenosine, and adenosine A2A receptor, inhibits osteoclast formation, and increasing local adenosine concentration with dipyridamole, an agent that bl...

Identification of a quadruple mutation that confers tenofovir resistance in chronic hepatitis B patients.

Tenofovir disoproxil fumarate (TDF) is one the most potent nucleot(s)ide analogues for treating chronic hepatitis B virus (HBV) infection. Phenotypic resistance caused by genotypic resistance to TDF has not been reported. This study aimed to characterize HBV mutations that confer tenofovir resistance.

Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015.

The introduction provisional approval strategies increases the approval of anticancer drugs with ambiguous benefit-risk profiles. Thus, in many instances, there is lacking evidence about overall survival (OS) at the time of marketing authorisation. Our objective was to monitor and characterise therapies with ambiguous benefit-risk profiles and identify any postapproval updates on median OS after at least 3 years of approval by the European Medicines Agency (EMA).

The availability, prices and affordability of essential medicines in Malawi: A cross-sectional study.

The Malawian government recently introduced cost-covering consultation fees for self-referral patients in tertiary public hospitals. Previously, patients received medicines free of charge in government-owned health facilities, but must pay elsewhere. Before the government implements a payment policy in other areas of health care, it is important to investigate the prices, affordability and availability of essential medicines in Malawi.

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