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Effectiveness of twice-weekly pyrimethamine-sulfadoxine as primary prophylaxis of Pneumocystis carinii pneumonia and toxoplasmic encephalitis in patients with advanced HIV infection.

Abstract

The safety and efficacy of a fixed 25 mg pyrimethamine-500 mg sulfadoxine combination supplemented with 15 mg folinic acid twice a week as primary prophylaxis of Pneumocystis carinii pneumonia (PCP) and toxoplasmic encephalitis was evaluated in 106 patients infected with the human immunodeficiency virus. All patients had a CD4+ T-lymphocyte count of less than 100 cells/microl at study entry. Efficacy in this single-arm open-label prospective study was analyzed on an as-treated basis. No patient received highly active antiretroviral treatment, including protease inhibitors or non-nucleoside reverse transcriptase inhibitors, while on study medication. PCP developed in four patients, one of whom had been noncompliant. No PCP episode occurred in the first year. Probabilities of freedom from PCP were 0.97 (95%CI, 0.92-1) after 24 months and 0.93 (95%CI, 0.84-1) after 36 months. Of 74 (69.8%) patients positive for anti-toxoplasma IgG antibodies, one noncompliant patient developed toxoplasmic encephalitis after 24 months. Allergic reactions were observed in 18 (17%) patients and resulted in permanent discontinuation in 7 (6.6%) patients. One (0.9%) patient who had continued prophylaxis despite progressive hypersensitivity reactions developed a serious adverse reaction (Stevens-Johnson syndrome). The median survival of study participants was 29 months, with relentless progression of AIDS accounting for most deaths. The prophylaxis regimen studied appeared safe and effective for primary prophylaxis of PCP and toxoplasmic encephalitis. Severe adverse events can likely be prevented by discontinuation of prophylaxis at the time allergic reactions are noted. Rechallenge frequently results in tolerance. Efficacy and safety compare favorably with previously studied regimens. This simple prophylactic regimen may provide a convenient alternative for patients failing or intolerant to approved regimens.

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  • Authors+Show Affiliations

    ,

    Department of Infectious Diseases, Charité University Hospital, Campus Virchow-Klinikum, Humboldt University of Berlin, Augustenburger Platz 1, Germany. dirk.schuermann@charite.de

    , , , , , , , , ,

    Source

    MeSH

    AIDS-Related Opportunistic Infections
    Adult
    Aged
    Animals
    Anti-Infective Agents
    Antiretroviral Therapy, Highly Active
    Drug Administration Schedule
    Drug Combinations
    Female
    HIV Infections
    Humans
    Leucovorin
    Male
    Middle Aged
    Pneumocystis
    Pneumonia, Pneumocystis
    Pyrimethamine
    Sulfadoxine
    Toxoplasma
    Toxoplasmosis, Cerebral

    Pub Type(s)

    Clinical Trial
    Journal Article

    Language

    eng

    PubMed ID

    12072919

    Citation

    Schürmann, D, et al. "Effectiveness of Twice-weekly Pyrimethamine-sulfadoxine as Primary Prophylaxis of Pneumocystis Carinii Pneumonia and Toxoplasmic Encephalitis in Patients With Advanced HIV Infection." European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology, vol. 21, no. 5, 2002, pp. 353-61.
    Schürmann D, Bergmann F, Albrecht H, et al. Effectiveness of twice-weekly pyrimethamine-sulfadoxine as primary prophylaxis of Pneumocystis carinii pneumonia and toxoplasmic encephalitis in patients with advanced HIV infection. Eur J Clin Microbiol Infect Dis. 2002;21(5):353-61.
    Schürmann, D., Bergmann, F., Albrecht, H., Padberg, J., Wünsche, T., Grünewald, T., ... Suttorp, N. (2002). Effectiveness of twice-weekly pyrimethamine-sulfadoxine as primary prophylaxis of Pneumocystis carinii pneumonia and toxoplasmic encephalitis in patients with advanced HIV infection. European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology, 21(5), pp. 353-61.
    Schürmann D, et al. Effectiveness of Twice-weekly Pyrimethamine-sulfadoxine as Primary Prophylaxis of Pneumocystis Carinii Pneumonia and Toxoplasmic Encephalitis in Patients With Advanced HIV Infection. Eur J Clin Microbiol Infect Dis. 2002;21(5):353-61. PubMed PMID: 12072919.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effectiveness of twice-weekly pyrimethamine-sulfadoxine as primary prophylaxis of Pneumocystis carinii pneumonia and toxoplasmic encephalitis in patients with advanced HIV infection. AU - Schürmann,D, AU - Bergmann,F, AU - Albrecht,H, AU - Padberg,J, AU - Wünsche,T, AU - Grünewald,T, AU - Schürmann,M, AU - Grobusch,M, AU - Vallée,M, AU - Ruf,B, AU - Suttorp,N, Y1 - 2002/05/18/ PY - 2002/6/20/pubmed PY - 2002/9/19/medline PY - 2002/6/20/entrez SP - 353 EP - 61 JF - European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology JO - Eur. J. Clin. Microbiol. Infect. Dis. VL - 21 IS - 5 N2 - The safety and efficacy of a fixed 25 mg pyrimethamine-500 mg sulfadoxine combination supplemented with 15 mg folinic acid twice a week as primary prophylaxis of Pneumocystis carinii pneumonia (PCP) and toxoplasmic encephalitis was evaluated in 106 patients infected with the human immunodeficiency virus. All patients had a CD4+ T-lymphocyte count of less than 100 cells/microl at study entry. Efficacy in this single-arm open-label prospective study was analyzed on an as-treated basis. No patient received highly active antiretroviral treatment, including protease inhibitors or non-nucleoside reverse transcriptase inhibitors, while on study medication. PCP developed in four patients, one of whom had been noncompliant. No PCP episode occurred in the first year. Probabilities of freedom from PCP were 0.97 (95%CI, 0.92-1) after 24 months and 0.93 (95%CI, 0.84-1) after 36 months. Of 74 (69.8%) patients positive for anti-toxoplasma IgG antibodies, one noncompliant patient developed toxoplasmic encephalitis after 24 months. Allergic reactions were observed in 18 (17%) patients and resulted in permanent discontinuation in 7 (6.6%) patients. One (0.9%) patient who had continued prophylaxis despite progressive hypersensitivity reactions developed a serious adverse reaction (Stevens-Johnson syndrome). The median survival of study participants was 29 months, with relentless progression of AIDS accounting for most deaths. The prophylaxis regimen studied appeared safe and effective for primary prophylaxis of PCP and toxoplasmic encephalitis. Severe adverse events can likely be prevented by discontinuation of prophylaxis at the time allergic reactions are noted. Rechallenge frequently results in tolerance. Efficacy and safety compare favorably with previously studied regimens. This simple prophylactic regimen may provide a convenient alternative for patients failing or intolerant to approved regimens. SN - 0934-9723 UR - https://www.unboundmedicine.com/medline/citation/12072919/Effectiveness_of_twice_weekly_pyrimethamine_sulfadoxine_as_primary_prophylaxis_of_Pneumocystis_carinii_pneumonia_and_toxoplasmic_encephalitis_in_patients_with_advanced_HIV_infection_ L2 - https://dx.doi.org/10.1007/s10096-002-0723-3 DB - PRIME DP - Unbound Medicine ER -