Table 2.
Male (n = 1512) Median (IQR), mean % | Female (n = 460) Median (IQR), mean % | p valuea | |
---|---|---|---|
Median CD4 (cells/μL) at 12 months | 123 (52–207) | 145 (66–210) | 0.033 |
CD4 (cells/μL) at 12 months | NS | ||
<200 | 74% | 71% | |
201–350 | 19% | 19% | |
>350 | 8% | 9% | |
Incident opportunistic infections | |||
Pneumocystis jiroveci pneumonia | 7.5% | 5.2% | 0.05 |
Tuberculosis | 11.3% | 8.0% | 0.026 |
Cryptosporidial diarrhea | 1.5% | 1.3% | NS |
Cytomegalovirus | 1.5% | 1.7% | NS |
Progressive multifocal leukoencephalopathy | 0.3% | 0% | NS |
Herpes simplex | 13.1% | 16.1% | NS |
Toxoplasmosis | 3.4% | 3.0% | NS |
Oral candidiasis | 1.9% | 2.6% | NS |
Reported deaths | 6.2% | 4.0% | 0.033 |
Percent modifying first-line regimen | NS | ||
0 | 45% | 48% | |
1–2 | 45% | 44% | |
≥3 | 10% | 8% | |
Median follow-up time (months) | 32 (6–124) | 34 (6–116) | 0.020 |
Adverse events | |||
Anemia | 6% | 7% | NS |
Nausea | 19% | 27% | <0.001 |
Diarrhea | 0.2% | 0% | NS |
Peripheral neuropathy | 13% | 10% | NS |
Pancreatitis | 1% | 0.4% | NS |
Hepatitis | 4% | 4% | NS |
Rash | 20% | 19% | NS |
Steven Johnson syndrome | 1% | 1% | NS |
Lipodistrophy/lipoatrophy | 4% | 5% | NS |
Immune reconstitution syndrome | 6% | 2% | <0.001 |
Lactic acidosis | 0.7% | 2.8% | <0.001 |
Chi-square test and Mann Whitney test performed as % detectable, % undetectable.