Table 4:
Multivariable sub-distribution hazard ratios (sHR) of adverse events, by CD4 count and HIV statusa
| sHR (95% CI)b | sHR (95% CI) | |||
|---|---|---|---|---|
| CD4 ≤100 (n=31) | CD4 101-200 (n=34) | CD4 >200 (n=79) | All HIV-Infected Patients (n=150) | |
| Clinical AEs | ||||
| Presence of at least one AE | 0.9 (0.6, 1.4) | 1.1 (0.7, 1.8) | 1.0 (0.7, 1.4) | 1.0 (0.8, 1.4) |
| Peripheral neuropathy | 1.1 (0.6, 2.0) | 1.1 (0.6, 2.1) | 1.3 (0.8, 2.3) | 1.2 (0.7, 2.0) |
| Difficulty sleeping | 0.9 (0.5, 1.6) | 1.0 (0.5, 1.9) | 0.9 (0.5, 1.5) | 0.9 (0.6, 1.5) |
| Rash or Blisters | 1.7 (0.9, 3.0) | 1.2 (0.6, 2.4) | 1.2 (0.7, 2.2) | 1.3 (0.8, 2.2) |
| Fatigue or weakness | 0.7 (0.4, 1.5) | 1.4 (0.7, 2.7) | 0.9 (0.5, 1.7) | 1.0 (0.6, 1.6) |
| Neuropsychiatricc | 0.8 (0.4, 1.6) | 0.8 (0.4, 1.6) | 1.1 (0.6, 2.0) | 0.9 (0.6, 1.6) |
| Tinnitus | 1.1 (0.5, 2.2) | 1.1 (0.5, 2.1) | 1.0 (0.5, 1.9) | 1.1 (0.6, 1.8) |
| Chest pain | 0.9 (0.4, 1.9) | 1.1 (0.6, 2.2) | 0.8 (0.4, 1.4) | 0.9 (0.5, 1.4) |
| Muscle or joint pain | 1.6 (0.8, 3.1) | 0.8 (0.4, 1.8) | 0.7 (0.4, 1.3) | 0.9 (0.5, 1.5) |
| Abdominal pain | 1.0 (0.4, 2.2) | 1.3 (0.6, 3.0) | 1.0 (0.5, 2.1) | 1.1 (0.6, 2.0) |
| Swelling of legs and feet | 1.2 (0.5, 2.7) | 1.6 (0.7, 3.3) | 0.8 (0.4, 1.6) | 1.1 (0.6, 1.9) |
| Shortness of breath | 1.1 (0.4, 3.0) | 2.2 (0.8, 5.6) | 1.5 (0.7, 3.4) | 1.5 (0.7, 3.1) |
| Diarrhea | 3.3 (1.3, 8.8) | 1.8 (0.6, 5.3) | 2.6 (1.0, 6.4) | 2.6 (1.1, 6.0) |
| Vomiting | 1.4 (0.5, 3.8) | 2.2 (0.9, 5.4) | 1.0 (0.4, 2.4) | 1.4 (0.6, 2.8) |
| Other Clinical Adverse Events | 1.4 (0.8, 2.4) | 0.9 (0.5, 1.6) | 0.9 (0.5, 1.4) | 1.0 (0.6, 1.5) |
| Laboratory AEs | ||||
| Presence of at least one AE | 2.2 (1.5, 3.2) | 1.4 (0.9, 2.2) | 1.4 (1.0, 2.1) | 1.6 (1.1, 2.0) |
| Hypokalemia | 1.8 (1.1, 3.4) | 1.1 (0.6, 2.2) | 1.0 (0.5, 1.8) | 1.2 (0.7, 1.9) |
| Decreased Creatinine Clearance | 1.1 (0.9, 1.2) | 1.1 (0.9, 1.2) | 1.0 (0.9, 1.1) | 1.1 (0.9, 1.2) |
| Elevated Alkaline Phosphatase | 1.3 (0.6, 2.9) | 2.4 (1.1, 5.3) | 1.3 (0.7, 2.6) | 1.6 (0.9, 2.9) |
| Elevated TSH | 1.4 (0.4, 4.1) | 2.0 (0.8, 5.2) | 1.2 (0.5, 3.1) | 1.4 (0.6, 3.0) |
| Elevated ALT | 0.8 (0.2, 2.8) | 0.9 (0.3, 2.6) | 0.9 (0.4, 2.1) | 0.8 (0.4, 1.9) |
| Hyperkalemia | 0.6 (0.2, 2.1) | 0.5 (0.1, 1.8) | 0.7 (0.2, 1.7) | 0.5 (0.2, 1.2) |
| Vision AEs | ||||
| Any color discrimination loss | 1.6 (0.5, 5.4) | 2.3 (0.7, 7.4) | 1.4 (0.5, 4.2) | 1.8 (0.7, 4.7) |
| Sustained loss | 2.7 (0.3, 22.9) | -- | -- | 1.5 (0.2, 10.6) |
| Extended loss | -- | -- | -- | -- |
| Severe loss | 1.7 (0.1, 20.1) | 1.7 (0.2, 18.9) | 1.5 (0.2, 11.5) | 2.0 (0.3, 11.8) |
| Hearing Loss | ||||
| Any hearing loss | 0.9 (0.5, 1.7) | 1.2 (0.7, 2.1) | 1.0 (0.7, 1.6) | 1.1 (0.7, 1.6) |
| Mild/moderate loss | 0.9 (0.5, 1.7) | 1.3 (0.7, 2.3) | 1.1 (0.7, 1.7) | 1.1 (0.7, 1.7) |
| Severe loss | 3.8 (0.7, 20.7) | 0.8 (0.1, 8.5) | 1.9 (0.4, 9.7) | 2.4 (0.5, 10.8) |
a
HIV-uninfected group is the reference for all categories;
b
CD4 category based on CD4 measured at baseline: n=200, 6 HIV-infected participants missing CD4 status at enrolment.
c
Neuropsychiatric is defined as patients experiencing mental confusion, depression, hearing voices, hallucinations, or convulsions/seizures.
Bolded numbers indicate statistical significance (α=0.05). TSH=thyroid stimulating hormone; ALT=alanine aminotransferase