We have investigated the efficacy of a clarithromycin-containing four-drug
regimen for Mycobacterium avium complex (MAC) pulmonary disease in 46 patie
nts without acquired immunodeficiency syndrome (AIDS). The patients were 14
males and 32 females with a mean age of 60.9 +/- 11.5 yr. Patients receive
d 10 mg/kg/d of clarithromycin plus ethambutol, rifampin, and initial kanam
ycin and subsequent quinolone for 24 mo. Seven patients (15.2%) were droppe
d in the first 6 mo. Among 39 patients who received more than 6 mo of thera
py, 28 patients (71.8%) converted their sputa to negative: 26 of 31 patient
s (83.9%) infected with clarithromycin-susceptible strains and two of eight
patients (25.0%) with resistant or intermediate strains. The timing of spu
tum conversion was 3.6 +/- 1.9 mo, with a range of 2 to 9 mo. The conversio
n rate was significantly lower in patients who were infected with clarithro
mycin-resistant or intermediate strains, who had had prior therapy (55.0% v
ersus 89.5%), or who were acid-fast bacilli (AFB) smear-positive at entry (
60.7% versus 100%). The age and sex of patients, the species of pathogen (M
. avium or M. intracellulare), type and extent of the disease, and the use
of kanamycin did not significantly affect the conversion rate. Although the
regimen was efficacious for newly treated patients, frequent adverse react
ions and a low conversion rate of sputum in retreated patients are problems
that remain to be solved.