Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

TRIMETHOPRIM/SULFAMETHOXAZOLE FAVORED OVER AEROSOLIZED PENTAMIDINE

Executive Summary

TRIMETHOPRIM/SULFAMETHOXAZOLE FAVORED OVER AEROSOLIZED PENTAMIDINE for prevention of both primary and secondary cases of Pneumocystis carinii pneumonia in people with AIDS in new guidelines that will be issued by the Public Health Service's special task force on PCP, Henry Masur, National Institute of Health Clinical Center, told a recent meeting of the National Institute of Allergy and Infectious Diseases' AIDS Clinical Trials Group. The guidelines are expected to be issued sometime in the next month, Masur said Dec. 3. The guidelines recommend that people with AIDS with an absolute CD4 count of less than 300 cells be treated with 80 mg trimethoprim/40 mg sulfamethoxazole four times daily to prevent onset or recurrence of PCP. Patients with "only a minor intolerance to TMP/SMX should be rechallenged" at least once before switching them to pentamidine, Masur added. Masur explained that the decision to revise the task force's original 1987 guidelines, which recommended primary and secondary treatment with aerosolized pentamidine, "was based on the results of ACTG 021 . . . and a series of other clinical trials" demonstrating the superior efficacy of trimethoprim therapy. A recently completed, head-to-head trial comparing the efficacy of the two PCP treatments, ACTG 021 demonstrated that the risk of recurrent PCP was 3.25 times greater among patients receiving aerosolized pentamidine and AZT than among patients receiving the less expensive TMP/SMX in combination with AZT ("The Pink Sheet" Sept. 9, p. 9). TMP/SMX is marketed by Hoffmann-La Roche as Bactrim, Burroughs Wellcome as Septra and in generic versions. The ACTG's working group on PCP prophylaxis plans to follow up protocol 021 with a series of additional trials (ACTG 081, ACTG 173 and ACTG 108) testing the efficacy of other, less prominent PCP prophylactics. Some of the therapies to be tested include dapsone, steroids and a new compound developed by the Walter Reed Army Medical Center, WR6026. All of these ACTG trials are currently in the protocol planning or enrollment phases.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel