ABSTRACT
With global efforts to scale up the prevention of mother-to-child transmission services and pediatric antiretroviral therapy, there is an urgent need to introduce a simple, low-cost infant human immunodeficiency virus test in the field. We postulated that the p24 antigen capture enzyme-linked immunosorbent assay could be simplified by eliminating signal amplification without compromising diagnostic accuracy.
Subject(s)
Acquired Immunodeficiency Syndrome/diagnosis , HIV Core Protein p24/analysis , HIV-1 , Early Diagnosis , Enzyme-Linked Immunosorbent Assay , Humans , Infant, Newborn , RNA, Viral/blood , Sensitivity and SpecificityABSTRACT
BACKGROUND: Data are limited about the effectiveness of pediatric antiretroviral therapy (ART) in low-income countries. METHODS: We report the outcomes of consecutively treating 236 human immunodeficiency virus type 1 (HIV-1)-infected treatment-naive children with triple ART in Port-au-Prince, Haiti, between 1 May 2003 and 30 April 2006. RESULTS: Kaplan-Meier survival analysis at follow-up demonstrated that 191 children (81%) remained in care, 21 (9%) were dead, and 24 (10%) were lost to follow-up. Independent baseline predictors of mortality were age <18 months, CD4(+) T cell percentage < or =5%, and weight-for-age Z score (WAZ) less than -3. Twelve months into ART, 56% of tested subjects had undetectable HIV-1 RNA loads. Median CD4(+) T cell percentages at 12 months increased by 15%, 11%, and 5% in children with baseline percentages of < or =5%, 6%-24%, and > or =25%, respectively (P<.01). The median WAZ at 12 months increased by 1.0, 0.6, and 0.2 in children with baseline WAZ less than -2, -2 to -1.1, and -1 or more, respectively (P<.01). CONCLUSION: With continuous donor support, trained providers, and the availability of pediatric antiretroviral drug formulations, it proved feasible to deliver pediatric ART in Haiti. The effectiveness of this program should encourage efforts to make ART available for HIV-infected children in poor countries.
Subject(s)
Acquired Immunodeficiency Syndrome/drug therapy , Antiretroviral Therapy, Highly Active , Acquired Immunodeficiency Syndrome/epidemiology , Acquired Immunodeficiency Syndrome/mortality , Child , Follow-Up Studies , HIV-1 , Haiti/epidemiology , Humans , Poverty , Survival Analysis , Treatment Outcome , Viral LoadABSTRACT
BACKGROUND: The one-year survival rate of adults and children with the acquired immunodeficiency syndrome (AIDS), without antiretroviral therapy, has been about 30 percent in Haiti. Antiretroviral therapy has recently become available in Haiti and in other developing countries. Data on the efficacy of antiretroviral therapy in developing countries are limited. High rates of coinfection with tropical diseases and tuberculosis, along with malnutrition and limited laboratory monitoring of therapy, may decrease the efficacy of antiretroviral therapy in these countries. METHODS: We studied the efficacy of antiretroviral therapy in the first 1004 consecutive patients with AIDS and without previous antiretroviral therapy who were treated beginning in March 2003 in Port-au-Prince, Haiti. RESULTS: During a 14-month period, three-drug antiretroviral therapy was initiated in 1004 patients, including 94 children under 13 years of age. At enrollment, the median CD4 T-cell count in adults and adolescents was 131 per cubic millimeter (interquartile range, 55 to 211 per cubic millimeter); in children, a median of 13 percent of T cells were CD4-positive (interquartile range, 8 to 20 percent). According to a Kaplan-Meier survival analysis, 87 percent of adults and adolescents and 98 percent of children were alive one year after beginning treatment. In a subgroup of 100 adult and adolescent patients who were followed for 48 to 56 weeks, 76 patients had fewer than 400 copies of human immunodeficiency virus RNA per milliliter. In adults and adolescents, the median increase in the CD4 T-cell count from baseline to 12 months was 163 per cubic millimeter (interquartile range, 77 to 251 per cubic millimeter). In children, the median percentage of CD4 T cells rose from 13 percent at baseline to 26 percent (interquartile range, 22 to 36 percent) at 12 months. Treatment-limiting toxic effects occurred in 102 of the 910 adults and adolescents (11 percent) and 5 of the 94 children (5 percent). CONCLUSIONS: This report documents the feasibility of effective antiretroviral therapy in a large number of patients in an impoverished country. Overall, the outcomes are similar to those in the United States. These results provide evidence in support of international efforts to make antiretroviral therapy available to patients with AIDS in developing countries.
