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Follow-up of Patients in a Compassionate Plea Program

Terri Creagh-Kirk, MS; Peggy Doi; Elizabeth Andrews, MPH; Sandra Nusinoff-Lehrman, MD; Hugh Tilson, MD; Dan Hoth, MD; David W. Barry, MD

JAMA. 1988;260(20):3009-3015.

Abstract
Through a compassionate plea program (Treatment Investigational New Drug), 4805 patients with acquired immunodeficiency syndrome who previously had experienced Pneumocystis carinii pneumonia (PCP) received zidovudine (Retrovir, formerly azidothymidine). Overall survival at 44 weeks after initiation of therapy was 73% ( ± 2.1%). A positive association was found between survival and pretherapy clinical status as defined by hemoglobin level, functional ability, and stage of disease as measured by time since diagnosis of PCP. For patients with baseline hemoglobin levels of 120 g/L or greater, Karnofsky scores of 90 or greater, and PCP diagnosis within 90 days prior to initiation of therapy, 44-week survival was 88%. Adverse clinical experiences associated with zidovudine therapy were consistent with those from a double-blind, placebo-controlled trial. Survival experience of this large and diverse cohort is consistent with, and extends data from, this clinical trial. Comparison with available natural history data suggests that zidovudine therapy is associated with increased 44-week survival of post-PCP patients with acquired immunodeficiency syndrome.

(JAMA 1988;260:3009-3015)

Author Affiliations
From the Burroughs Wellcome Co, Research Triangle Park, NC (Drs Nusinoff-Lehrman, Tilson, and Barry and Mss Creagh-Kirk, Doi, and Andrews); and the National Institute of Allergy and Infectious Disease, Bethesda, Md(Dr Hoth).

Footnotes
Reprint requests to Division of EIS, Burroughs wellcome Co, 3030 Cornwallis Rd, Research Triangle Park, NC 27709 (Ms Creagh-Kirk).

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