Short-course antiretroviral therapy in primary HIV infection
Autor: | Steve Kaye, Abdel Babiker, Giuseppe Tambussi, Sabine Kinloch, Jonathan Weber, Fiona M. Ewings, Sarah Fidler, Anthony D. Kelleher, Myra McClure, Gita Ramjee, José M. Miró, Martin Fisher, M Gabriel, Helen Rees, Pontiano Kaleebu, Rodney E. Phillips, David A. Cooper, Kholoud Porter, John Frater, Martin T. Schechter |
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Jazyk: | angličtina |
Rok vydání: | 2013 |
Předmět: |
Adult
Male medicine.medical_specialty Randomization Nevirapine HIV Infections Article Drug Administration Schedule RC0109 03 medical and health sciences Young Adult 0302 clinical medicine Acquired immunodeficiency syndrome (AIDS) Internal medicine medicine Humans 030212 general & internal medicine Seroconversion Adverse effect 030304 developmental biology 0303 health sciences business.industry Incidence (epidemiology) Hazard ratio HIV General Medicine Middle Aged medicine.disease Confidence interval 3. Good health CD4 Lymphocyte Count Anti-Retroviral Agents Immunology Disease Progression RNA Viral Female business medicine.drug Follow-Up Studies |
ISSN: | 0028-4793 |
Popis: | Background\ud Short-course antiretroviral therapy (ART) in primary human immunodeficiency virus\ud (HIV) infection may delay disease progression but has not been adequately evaluated.\ud Methods\ud We randomly assigned adults with primary HIV infection to ART for 48 weeks, ART\ud for 12 weeks, or no ART (standard of care), with treatment initiated within 6 months\ud after seroconversion. The primary end point was a CD4+ count of less than 350 cells\ud per cubic millimeter or long-term ART initiation.\ud Results\ud A total of 366 participants (60% men) underwent randomization to 48-week ART\ud (123 participants), 12-week ART (120), or standard care (123), with an average followup\ud of 4.2 years. The primary end point was reached in 50% of the 48-week ART\ud group, as compared with 61% in each of the 12-week ART and standard-care groups.\ud The average hazard ratio was 0.63 (95% confidence interval [CI], 0.45 to 0.90;\ud P = 0.01) for 48-week ART as compared with standard care and was 0.93 (95% CI,\ud 0.67 to 1.29; P = 0.67) for 12-week ART as compared with standard care. The proportion\ud of participants who had a CD4+ count of less than 350 cells per cubic millimeter\ud was 28% in the 48-week ART group, 40% in the 12-week group, and 40% in the\ud standard-care group. Corresponding values for long-term ART initiation were 22%,\ud 21%, and 22%. The median time to the primary end point was 65 weeks (95% CI,\ud 17 to 114) longer with 48-week ART than with standard care. Post hoc analysis\ud identified a trend toward a greater interval between ART initiation and the primary\ud end point the closer that ART was initiated to estimated seroconversion (P = 0.09),\ud and 48-week ART conferred a reduction in the HIV RNA level of 0.44 log10 copies\ud per milliliter (95% CI, 0.25 to 0.64) 36 weeks after the completion of short-course\ud therapy. There were no significant between-group differences in the incidence of the\ud acquired immunodeficiency syndrome, death, or serious adverse events.\ud Conclusions\ud A 48-week course of ART in patients with primary HIV infection delayed disease\ud progression, although not significantly longer than the duration of the treatment.\ud There was no evidence of adverse effects of ART interruption on the clinical outcome.\ud (Funded by the Wellcome Trust; SPARTAC Controlled-Trials.com number,\ud ISRCTN76742797, and EudraCT number, 2004-000446-20.) |
Databáze: | OpenAIRE |
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