Early versus Standard Antiretroviral Therapy for HIV-Infected Adults in Haiti.

Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port au Prince, Haiti.
New England Journal of Medicine (Impact Factor: 54.42). 07/2010; 363(3):257-65. DOI: 10.1056/NEJMoa0910370
Source: PubMed

ABSTRACT For adults with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts that are greater than 200 and less than 350 per cubic millimeter and who live in areas with limited resources, the optimal time to initiate antiretroviral therapy remains uncertain.
We conducted a randomized, open-label trial of early initiation of antiretroviral therapy, as compared with the standard timing for initiation of therapy, among HIV-infected adults in Haiti who had a confirmed CD4+ T-cell count that was greater than 200 and less than 350 per cubic millimeter at baseline and no history of an acquired immunodeficiency syndrome (AIDS) illness. The primary study end point was survival. The early-treatment group began taking zidovudine, lamivudine, and efavirenz therapy within 2 weeks after enrollment. The standard-treatment group started the same regimen of antiretroviral therapy when their CD4+ T-cell count fell to 200 per cubic millimeter or less or when clinical AIDS developed. Participants in both groups underwent monthly follow-up assessments and received isoniazid and trimethoprim-sulfamethoxazole prophylaxis with nutritional support.
Between 2005 and 2008, a total of 816 participants--408 per group--were enrolled and were followed for a median of 21 months. The CD4+ T-cell count at enrollment was approximately 280 per cubic millimeter in both groups. There were 23 deaths in the standard-treatment group, as compared with 6 in the early-treatment group (hazard ratio with standard treatment, 4.0; 95% confidence interval [CI], 1.6 to 9.8; P=0.001). There were 36 incident cases of tuberculosis in the standard-treatment group, as compared with 18 in the early-treatment group (hazard ratio, 2.0; 95% CI, 1.2 to 3.6; P=0.01).
Early initiation of antiretroviral therapy decreased the rates of death and incident tuberculosis. Access to antiretroviral therapy should be expanded to include all HIV-infected adults who have CD4+ T-cell counts of less than 350 per cubic millimeter, including those who live in areas with limited resources. ( number, NCT00120510.)

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Available from: Catherine Godfrey, Dec 12, 2013
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    • "A randomized trial still in progress (START) [16] is randomizing people with a CD4 cell count of greater than 500 per µL to either start antiretroviral therapy (ART) immediately or defer to a CD4 cell count of 350 per µL. However, Severe et al. [17] recommended that access to antiretroviral therapy should be expanded to include all HIV-infected adults who have CD4+ T-cell counts of less than 350 cells/mm 3 in those who live in areas with limited resources. The U.S. Centre for Disease Control (CDC) and the prevention [18] staging system used the CD4 count as a tool to stage HIV into categories A, B, and C based on whether the CD4 count is >500 cells/mm 3 , between 200–499 cells/mm 3 and <200 cells/mm 3 , respectively. "
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    ABSTRACT: Background. CD4 count measures the degree of immunosuppression in HIV-positive patients. It is also used in deciding when to commence therapy, in staging the disease, and in determining treatment failure. Using the CD4 count, this study aimed at determining the percentage of HIV-positives who require antiretroviral therapy at enrollment in an HIV treatment and care centre. Methods. The Baseline CD4 count, age and gender of 4,042 HAART-naïve patients, who registered between December 2006 and June 2010, at Lagos State University Teaching Hospital, Ikeja, were retrospectively studied. Data were analyzed using SPSS version 16.0 (Statistical Package for Social Sciences, Inc., Chicago, Ill). Results. Patients consisted of 2507 (62%) female and 1535 (38%) males. The mean age of males was 37.73 ± 9.48 years and that of females 35.01 ± 9.34 years. Overall, the mean CD4 count was of 298.76 ± 246.93 cells/mm3. The mean CD4 count of males was 268.05 ± 230.44 cells/mm3 and that of females 317.55 ± 254.72 cells/mm3. A total of 72.3% males, 64.3% females and 67.4% overall registered patients had CD4 count <350 cells/mm3, while only 15.1% males , 20.3% females, and 18.3% overall registered patients had CD4 count >500 cells/mm3 at registration. Conclusion. Females account for more than half of registered patients in HIV clinic and have a relatively higher CD4 count than males. About three-quarter of HIV positives require antiretroviral therapy at registration.
    AIDS research and treatment 09/2012; 2012:352753. DOI:10.1155/2012/352753
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    • "Earlier or so-called ''upstream'' ART access may reduce individual mortality, mother-to-child transmission of HIV and the incidence of HIV-associated tuberculosis (TB). A recent study from Haiti (Severe et al. 2010) showed a 75% reduction in mortality and a 50% reduction in TB incidence associated with starting ART earlier. On the ground, there are huge gaps in access to CD4 testing countrywide. "
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