Archive for June 3, 2011

Approval of Edurant (rilpivirine) a new NNRTI) for the treatment of HIV in treatment naive patients

Food and Drug Administration  May 20, 2011

On Friday, May 20, 2011, FDA approved Edurant (rilpivirine) 25 mg tablets, a new non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. Rilpivirine is an antiviral drug that helps to block reverse transcriptase, an enzyme necessary for HIV replication. The recommended dose of rilpivirine is one 25 mg tablet once daily taken orally with a meal.

Full Text

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm256151.htm

June 3, 2011 at 11:05 pm Leave a comment

HIV Infection and Risk for Incident Pulmonary Diseases in the Combination Antiretroviral Therapy Era.

Am J Respir Crit Care Med. 2011 Feb 1 V.183 N.3  p.388-95.

Crothers K, Huang L, Goulet JL, Goetz MB, Brown ST, Rodriguez-Barradas MC, Oursler KK, Rimland D, Gibert CL, Butt AA, Justice AC.

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Washington School of Medicine, Harborview Medical Center, 325 Ninth Avenue, Box 359762, Seattle, WA 98104. crothk@uw.edu.

Abstract

Rationale

In aging HIV-infected populations comorbid diseases are important determinants of morbidity and mortality. Pulmonary diseases have not been systematically assessed in the combination antiretroviral therapy (ART) era.

Objectives

To determine the incidence of pulmonary diseases in HIV-infected persons compared with HIV-uninfected persons.

Methods

We analyzed data from the Veterans Aging Cohort Study Virtual Cohort, consisting of 33,420 HIV-infected veterans and 66,840 age, sex, race and ethnicity, and site-matched HIV-uninfected veterans. Using Poisson regression, incidence rates and adjusted incidence rate ratios were calculated to determine the association of HIV with pulmonary disease. The Virtual Cohort was merged with the 1999 Veterans Large Health Survey to adjust for self-reported smoking in a nested sample (14%).

Measurements and Main Results

Incident chronic obstructive pulmonary disease, lung cancer, pulmonary hypertension, and pulmonary fibrosis, as well as pulmonary infections, were significantly more likely among HIV-infected patients compared with uninfected patients in adjusted analyses, although rates of asthma did not differ by HIV status. Bacterial pneumonia and chronic obstructive pulmonary disease were the two most common incident pulmonary diseases, whereas opportunistic pneumonias were less common. Absolute rates of most pulmonary diseases increased with age, although the relative differences between those with and without HIV infection were greatest in younger persons. Chronic obstructive pulmonary disease and asthma, as well as pulmonary infections, were less likely in those with lower HIV RNA levels and use of ART at baseline.

Conclusions

Pulmonary diseases among HIV-infected patients receiving care within the Veterans Affairs Healthcare System in the combination ART era reflect a substantial burden of non-AIDS-defining and chronic conditions, many of which are associated with aging.

abstract

http://www.ncbi.nlm.nih.gov/pubmed/20851926?dopt=Abstract

June 3, 2011 at 10:53 pm Leave a comment

Airway microbiota and bronchial hyperresponsiveness in patients with suboptimally controlled asthma

Journal of Allergy and Clinical Immunology  Feb. 2011 V.127 N.2 p.372-381

Yvonne J. Huang, MD

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, Calif

Craig E. Nelson, PhD

Marine Science Institute, University of California, Santa Barbara, Calif

Eoin L. Brodie, PhD

Earth Sciences Division, Lawrence Berkeley National Laboratory, Berkeley, Calif

Todd Z. DeSantis, MS

Earth Sciences Division, Lawrence Berkeley National Laboratory, Berkeley, Calif

Marshall S. Baek, BS

Department of Anesthesia and Perioperative Care, University of California, San Francisco, Calif

Jane Liu, MS

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, Calif

Tanja Woyke, PhD

US Department of Energy, Joint Genome Institute, Walnut Creek, Calif

Martin Allgaier, PhD

Department of Anesthesia and Perioperative Care, University of California, San Francisco, Calif

Jim Bristow, MD

US Department of Energy, Joint Genome Institute, Walnut Creek, Calif

Jeanine P. Wiener-Kronish, MD

Department of Anesthesia and Perioperative Care, University of California, San Francisco, Calif

E. Rand Sutherland, MD, MPH

Division of Pulmonary and Critical Care Medicine, Department of Medicine, National Jewish Health, Denver, Colo

Tonya S. King, PhD

Division of Biostatistics, Department of Public Health Sciences, Pennsylvania State University, Hershey, Pa

Nikolina Icitovic, MAS

Division of Biostatistics, Department of Public Health Sciences, Pennsylvania State University, Hershey, Pa

Richard J. Martin, MD

Division of Pulmonary and Critical Care Medicine, Department of Medicine, National Jewish Health, Denver, Colo

William J. Calhoun, MD

Division of Allergy, Pulmonary, Immunology, Critical Care and Sleep, Department of Internal Medicine, University of Texas Medical Branch at Galveston, Galveston, Tex

Mario Castro, MD

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Washington University, St Louis, Mo

Loren C. Denlinger, MD, PhD

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Wisconsin Schools of Medicine and Public Health, Madison, Wis

Emily DiMango, MD

Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY

Monica Kraft, MD

Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Duke University, Durham, NC

Stephen P. Peters, MD, PhD

Section on Pulmonary, Critical Care, Allergy and Immunological Diseases, Department of Internal Medicine, Wake Forest University Health Sciences, Winston-Salem, NC

Stephen I. Wasserman, MD

Allergy and Immunology Section, Department of Medicine, University of California San Diego, San Diego, Calif

Michael E. Wechsler, MD

Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Mass

Homer A. Boushey, MD

Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Francisco, Calif

Susan V. Lynch, PhD

Division of Gastroenterology, Department of Medicine, University of California, San Francisco, Calif

Reprint requests: Susan V. Lynch, PhD, Colitis and Crohn’s Disease Center, Division of Gastroenterology, Department of Medicine, Box 0538, University of California, San Francisco, CA 94143.

National Heart, Lung, and Blood Institute’s Asthma Clinical Research Network

Background

Improvement in lung function after macrolide antibiotic therapy has been attributed to reduction in bronchial infection by specific bacteria. However, the airway might be populated by a more diverse microbiota, and clinical features of asthma might be associated with characteristics of the airway microbiota present.

Objective

We sought to determine whether relationships exist between the composition of the airway bacterial microbiota and clinical features of asthma using culture-independent tools capable of detecting the presence and relative abundance of most known bacteria.

Methods

In this pilot study bronchial epithelial brushings were collected from 65 adults with suboptimally controlled asthma participating in a multicenter study of the effects of clarithromycin on asthma control and 10 healthy control subjects. A combination of high-density 16S ribosomal RNA microarray and parallel clone library-sequencing analysis was used to profile the microbiota and examine relationships with clinical measurements.

Results

Compared with control subjects, 16S ribosomal RNA amplicon concentrations (a proxy for bacterial burden) and bacterial diversity were significantly higher among asthmatic patients. In multivariate analyses airway microbiota composition and diversity were significantly correlated with bronchial hyperresponsiveness. Specifically, the relative abundance of particular phylotypes, including members of the Comamonadaceae, Sphingomonadaceae, Oxalobacteraceae, and other bacterial families were highly correlated with the degree of bronchial hyperresponsiveness.

Conclusion

The composition of bronchial airway microbiota is associated with the degree of bronchial hyperresponsiveness among patients with suboptimally controlled asthma. These findings support the need for further functional studies to examine the potential contribution of members of the airway microbiota in asthma pathogenesis.

abstract

http://www.jacionline.org/article/S0091-6749(10)01760-4/abstract

PDF

http://download.journals.elsevierhealth.com/pdfs/journals/0091-6749/PIIS0091674910017604.pdf

June 3, 2011 at 10:52 pm Leave a comment

Is cefepime safe for clinical use? A Bayesian viewpoint

JAC June 2011 V.66 N.6 P.1207-1209

Andre C. Kalil*

Infectious Diseases Division, University of Nebraska Medical Center, Omaha, USA

Abstract

Cefepime hydrochloride is approved for pneumonia, empirical therapy for febrile neutropenia, uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections and complicated intra-abdominal infections. A recent meta-analysis by Yahav et al. (Lancet Infect Dis 2007; 7: 338–48) concluded that cefepime was associated with a statistically significant increase in mortality (risk ratio 1.26, 95% confidence interval 1.08–1.49) when compared with other antibiotics. The US FDA decided to re-evaluate the meta-analysis data in collaboration with the drug sponsor. Two years later the FDA Alert summarized that ‘data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications.’ However, a thorough evaluation of the 52-page FDA report still shows that safety remains an unresolved issue. A Bayesian re-appraisal of the findings by the FDA and by Yahav et al. indicates that there is a 90.9% (by FDA trial-level meta-analysis), 80.8% (by FDA patient-level meta-analysis) and 99.2% (by Yahav et al. meta-analysis) probability that cefepime raises mortality in neutropenic fever patients, which translates into the following numbers needed to harm (NNH), i.e. to cause one extra death with the use of cefepime: FDA trial-level meta-analysis, NNH = 109; FDA patient-level meta-analysis, NNH = 76; Yahav et al. meta-analysis, NNH = 54. A similar harmful probability was observed with skin structure infections but not with pneumonias, intra-abdominal infections and urinary tract infections. In conclusion, cefepime should be avoided in patients with neutropenic fever or with skin structure infections.

abstract

http://jac.oxfordjournals.org/content/66/6/1207.abstract

PDF

http://jac.oxfordjournals.org/content/66/6/1207.full.pdf+html

June 3, 2011 at 10:49 pm Leave a comment

HIV treatment as prevention—it works

The Lancet 21 May 2011 V.377 N.9779 P.1719

Editorial

Last week any doubts around treatment as an approach to halt the spread of the HIV epidemic were allayed. An international study showed that antiretroviral treatment can prevent the sexual transmission of HIV among heterosexual couples in whom one partner is HIV-infected and the other is not. UNAIDS described the result as a “serious game changer” for HIV prevention….

Full Text

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960713-7/fulltext?elsca1=TL-200511&elsca2=email&elsca3=segment

PDF

http://download.thelancet.com/pdfs/journals/lancet/PIIS0140673611607137.pdf

June 3, 2011 at 10:46 pm Leave a comment


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