Objective: To develop a human immunodeficiency virus (HIV) staging system for sub-Saharan Africa on the basis of an evaluation of the World Health Organization (WHO) system and predictors of mortality.
Design: Prospective cohort study with 4 years of follow-up.
Setting: Kigali, Rwanda.
Patients: 412 HIV-infected women recruited from prenatal and pediatric clinics.
Measurements: Clinical signs and symptoms of HIV disease, laboratory assays (including complete blood count and erythrocyte sedimentation rate), and cumulative mortality.
Results: The WHO staging system includes a clinical and a laboratory axis. The clinical axis was revised by inclusion of oral candidiasis, chronic oral or genital ulcers, and pulmonary tuberculosis as "severe" disease (clinical stage IV); in addition, body mass index was substituted for weight loss in the definition for the wasting syndrome. The 36-month cumulative mortality was 7% for women in modified clinical stage I ("asymptomatic"), 15% for those in stage II, 19% for those in stage III, and 36% for those in stage IV (P < 0.001). The laboratory axis was revised by replacing lymphocyte count with hematocrit and erythrocyte sedimentation rate. The 36-month mortality was 10% for women in modified stage A ("normal" laboratory results) and 33% for those in stage B (erythrocyte sedimentation rate > 65 mm/h or hematocrit < 0.38) (P < 0.001). A single staging system combining clinical and laboratory criteria is proposed, with a 36-month mortality of 7% for women in combined stage I, 10% for those in stage II, 29% for those in stage III, and 62% for those in stage IV (P < 0.001).
Conclusions: On the basis of this analysis, a staging system relevant for sub-Saharan Africa is proposed that reflects the range of HIV-related outcomes, has strong prognostic significance, includes inexpensive and available laboratory tests, and can be used by both clinicians and researchers.
PIP: In Rwanda, health workers followed 412 HIV infected women attending prenatal and pediatric outpatient clinics in Kigali for 4 years. Researchers used these findings to evaluate WHO's HIV Staging System and predictors of mortality and to produce an HIV staging system for sub-Saharan Africa. The 36-month cumulative mortality was 9% for women originally in stage I, 15% for those in stage II, and 25% for those in stage III, and 27% for those in stage IV (p = 0.001). Significant predictors of mortality at 36 months were oral candidiasis, a low body mass index (=or 19 kg/sq. m), a history of oral or genital ulcers (especially chronic ulcers), a low hematocrit (0.38), and a high erythrocyte sedimentation rate (65 mm/h) (p 0.001). 12 of the 96 women who died by 36 months had developed pulmonary or extrapulmonary tuberculosis (TB). The researchers revised the WHO system by adding oral candidiasis, chronic oral or genital ulcers, and pulmonary TB to clinical stage IV (severe HIV disease). In the laboratory axis of the system, they replaced lymphocyte count with hematocrit and erythrocyte sedimentation rate. Using the modified laboratory axis, the 36-month mortality rate was 10% for women with normal laboratory results (stage A) and 33% for those with low hematocrit and a high erythrocyte sedimentation rate (stage B). Based on the proposed single staging system, the 36-month mortality rate was 7% for women in stage I, 10% for those in stage II, 29% for those in stage III, and 62% for those in stage IV (p 0.001). The researchers used these results to propose a staging system that is relevant for sub-Saharan Africa, considers the extent of HIV-related outcomes, requires only inexpensive and available laboratory tests, and has clear prognostic significance. Both clinicians and researchers can use this modified staging system.