Medical Inspection – Health Blog

Combination PI-Containing Regimen for HIV-Infected, Treatment-Experienced Patients

Speaker: Robert Schooley, MD, Head of Infectious Diseases and Professor of Medicine, University of Colorado, Denver, Colorado.

Based on a preliminary 24-week analysis, amprenavir 600 mg (Agenerase, GlaxoSmithKline)/ritonavir 100 mg (Norvir drug, Abbott) twice daily might be a better treatment regimen than amprenavir 900 mg/ritonavir 100 mg twice daily because the lower amprenavir dose results in a similar efficacy, a lower incidence of adverse events and patient withdrawals, and a lower pill burden.

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Speaker: Steven P. LaRosa, MD, Associate Staff Physician, Department of Infectious Diseases, Cleveland Clinic Foundation, Cleveland, Ohio.

Drotreogin alfa activated (Xigris, Lilly), a recombinant form of protein C recently approved by the FDA for the treatment of severe sepsis, markedly reduces the risk of all-cause mortality in adult patients, according to findings from the PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) clinical trial.

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Speaker: Joseph L. Gugliotta, MD, Infectious Disease Specialist, Hunterdon Medical Center, Flemington, New Jersey.

The combination of quinupristin/dalfopristin (Synercid, Aventis) and vancomycin (Vancocin, Lilly) proved to be highly effective in the treatment of bacteremias caused by oxacillin-resistant Staphylococcus aureus (ORSA) strains, demonstrating enhanced bactericidal activity compared with either antibiotic tested alone.

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Short-Duration Antimicrobial Therapy for AECB

Speaker: Marcus J. Zervos, MD, Clinical Professor of Medicine, Wayne State University School of Medicine, Detroit, Michigan, and William Beaumont Hospital, Royal Oak, Michigan.

Five-day therapy with oral telithromycin (Ketek, Aventis), a new ketolide antimicrobial agent, is as effective as standard 10-day treatment with comparators in adult patients with acute exacerbation of chronic bronchitis. When considered along with its convenience of once-daily dosing and tolerabili-ty, this new antibiotic becomes a first-line treatment option for patients with AECB.

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Several points related to the recent influenza vaccine delays and the influenza vaccine process are worth emphasizing. First, the overall process has worked well for decades despite its many complexities and “fragilities.” Although the recent delays highlight the need to take certain actions to strengthen the system, such major disruptions have been exceptional and the potential benefits of any fundamental changes should be considered carefully against the potential drawbacks.

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The public and private sectors both play extensive and critical roles in the influenza vaccine process. Primary responsibilities of the public sector include monitoring changes among circulating influenza viruses, annually updating the vaccine strains, monitoring the vaccine’s effectiveness and coverage rates, and developing recommendations to guide vaccine use. Primary responsibilities of the private sector include the production, distribution, and administration of the vaccine. Both sectors share the responsibility for ensuring the safety and potency of the vaccine. The manufacturers conduct quality-control checks at all stages of the production process while the FDA conducts safety and potency checks on monovalent and trivalent vaccine lots before they are released. In addition, the FDA conducts inspections of plants to ensure that each manufacturer is adhering to current GMP standards. Although complicated, and to a certain extent “fragile,” the current system has worked remarkably well for several decades and has been able to provide increasing doses of vaccine for the U.S. since the 1980s. Some of the key steps of the process are briefly reviewed.

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Among the current manufacturers, Aventis Pasteur and Wyeth Lederle produce influenza vaccine in manufacturing plants located in the U.S. while Evans Vaccines produces influenza vaccine in the United Kingdom, but distributes a percentage of their production in the U.S. In most years, more doses of influenza vaccine are produced by manufacturers, and are released by the FDA, than are distributed. For example, in 1999, 2000, and 2001, respectively, the manufacturers produced combined totals of approximately 77.2 million, 77.9 million, and 87.7 million doses of influenza vaccine while distributing, in those same years, an estimated 76.7 million, 70.4 million, and 77.7 million doses (Figure 2). However, as was previously discussed, the timing of the release of those doses differed significantly by year.

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