Table 1.
Frequency of adverse events reported at any point during MDR-TB treatment
| All patients (n=91) | HIV-positive receiving concomitant MDR-TB treatment and ART (n=74)* | HIV-negative (n=15) | |
|---|---|---|---|
| Adverse Event | Patients reporting event, N (%) | Patients reporting event, N (%) | Patients reporting event, N (%) |
| Clinical Adverse Events † | |||
| Peripheral neuropathy | 66 (73) | 55 (74) | 10 (67) |
| Injection site pain | 57 (66) | 47 (64) | 8 (53) |
| Rash | 48 (53) | 39 (53) | 7 (47) |
| Arthralgia | 39 (43) | 32 (43) | 6 (40) |
| Nausea/vomiting | 38 (42) | 30 (41) | 7 (47) |
| Insomnia | 33 (36) | 26 (35) | 6 (40) |
| Abdominal pain | 32 (35) | 25 (34) | 6 (40) |
| Myalgia | 32 (35) | 26 (35) | 6 (40) |
| Hearing Loss | 31 (34) | 24 (32) | 6 (40) |
| Generalized weakness | 27 (30) | 22 (30) | 4 (27) |
| Tinnitus | 26 (29) | 22 (30) | 3 (20) |
| Depression | 20 (22) | 18 (24) | 1 (7) |
| Diarrhea | 20 (22) | 14 (19) | 4 (27) |
| Confusion/psychosis | 18 (20) | 16 (22) | 2 (13) |
| Seizure | 3 (3) | 3 (4) | 0 (0) |
| Laboratory Adverse Events † | (n=88) | (n=72) | (n=14) |
| Elevated ALT | 43 (49) | 36 (50) | 6 (43) |
| Hypothyroidism‡ | 38 (51) | 34 (57) | 4 (33) |
| Hypokalemia | 35 (40) | 29 (40) | 6 (43) |
| Hyperkalemia | 30 (34) | 24 (33) | 5 (36) |
| Anemia | 29 (33) | 28 (39) | 1 (14) |
| Elevated creatinine | 21 (24) | 18 (25) | 3 (21) |
*
Does not include 2 HIV-infected patients who did not receive ART.
†
comparisons between HIV+/ART and HIV-negative groups non significant (p>0.05) for all clinical and lab AEs.
‡
n=76 with a TSH result (n=60 HIV+/ART+; n=12 HIV-negative; n=2 HIV+/ART-)
ALT=alanine aminotransferase; ART=antiretroviral therapy; MDR-TB: multidrug-resistant TB