Summary
In a randomized open trial foscarnet 90 mg/kg b.i.d. 5 days for 3 weeks was compared to 90mg/kg b.i.d. daily in severe gastrointestinal cytomegalovirus disease in HIV-infected patients. Thirty-eight patients were randomized, 36 were evaluable (all male, age 24–54 years, median 40 years; CD4/µ10–150, median 10). Treatment efficacy was evaluated based on a score consisting of symptoms, endoscopic and histologic examination. In the 5-day treatment group 10/16 (62%) patients responded to treatment, in the 7-day treatment group 13/20 (65%), with symptoms resolving in most patients after 1 week. Side effects and adverse events were seen in 13 patients in the 5-day treatment group and in 15 patients in the 7-day treatment group. Laboratory abnormalities were common in both groups, in one patient reversible renal insufficiency developed. Efficacy and safety of treatment 5 days a week was comparable to the standard regimen.
Zusammenfassung
In einer offenen randomisierten Studie wurde Foscarnet 90 mg/kg i. v. zweimal täglich über 3 Wochen in zwei verschiedenen Dosierungsschemata bei HIV-infizierten Patienten mit schweren gastrointestinalen CMV-Erkrankungen verglichen. Die erste Gruppe erhielt Foscarnet täglich, die zweite an 5 Tagen jeder Woche. 38 Patienten wurden randomisiert, davon waren 36 auswertbar (alle männlich, Alter 24–54, Median 40 Jahre, CD 4 µl/0–150, Median 10) Der Behandlungserfolg wurde anhand eines Scores von Symptomen, endoskopischem Befund und histologischer Beurteilung gemessen. In der Gruppe, die an 5 Tagen der Woche behandelt wurde, sprachen 10/16 (62%) auf die Therapie an, in der 7-Tage-Gruppe 13/20 (65%). Nebenwirkungen wurden in 13 Patienten der 5-Tage-Gruppe und in 15 der 7-Tage-Gruppe beobachtet. Die häufigsten Nebenwirkungen waren Abweichungen der Serum-Elektrolyte in beiden Gruppen, eine Patient entwickelte einen reversiblen Kreatinin-Anstieg. Wirksamkeit und Nebenwirkungen der 5-Tage-Therapie waren vergleichbar mit der Standardtherapie.
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Salzberger, B., Peters, K., Fätkenheuer, G. et al. Foscarnet 5 versus 7 days a week treatment for severe gastrointestinal CMV disease in HIV-infected patients. Infection 24, 121–124 (1996). https://doi.org/10.1007/BF01713315
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DOI: https://doi.org/10.1007/BF01713315