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More young people started ART after 2009 guidelines change
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Data from a multicenter study suggest that there was an uptake in recently changed antiretroviral therapy guidelines among adolescents and young adults with HIV in New York City, according to a report in Clinical Infectious Diseases.
In 2009, the Department of Health and Human Services Panel on Antiretroviral Therapy for Adults changed guidelines to recommend that ART-naïve patients with CD4 counts of 350 to 500 cells/mm3 initiate ART, according to Christina Gagliardo, MD, who conducted the study while a fellow at Columbia University. Previously, the recommendation was to initiate ART in patients with a CD4 count of less than 350 cells/mm3.
Christina Gagliardo
“A significant number of patients at the adolescent clinic at Columbia — Project STAY — needed to start ART in response to the new guidelines, so we wanted to look at the baseline immune status in terms of CD4 count of recently infected, ART-naïve adolescents and young adults,” Gagliardo told Infectious Disease News. “The take home message from our study is that these patients are presenting to care with higher CD4 counts which were in the range recommended to begin treatment.”
Gagliardo and colleagues from Columbia evaluated the uptake of the 2009 recommendations among young people aged 13 to 25 years who were recently diagnosed with HIV and presented to care from January 2007 to June 2011. The study included 331 patients from four sites throughout New York City. They had contracted HIV through sexual contact or IV drug use.
The mean CD4 count at presentation to care was 452 cells/mm3. In 2007-2009, 75 patients (33%) presented with a CD4 count of less than 350 cells/mm3 and were eligible for ART. In 2010-2011, 56 patients (57%) had a CD4 count of less than 500 cells/mm3 and were eligible for ART.
Among the entire cohort, 191 patients (58%) started ART. Before the 2009 guideline change, the mean CD4 count at ART initiation was 261 cells/mm3 compared with 363 cells/mm3 after the guideline change. The plasma RNA was similar between both groups. In 2010-2011, ART was more likely to be initiated when the CD4 count was 350 cells/mm3 to 500 cells/mm3 or more than 500 cells/mm3 vs. patients who started ART in 2007-2009.
Six months after ART initiation, 116 (71%) had undetectable plasma RNA, and there was no difference before and after the 2009 guidelines. Among the 212 patients tested for resistance, 50 drug resistance mutations were detected in 38 (18%) of the patients. The proportion of patients with mutations increased from 12% in 2007-2009 to 25% in 2010-2011.
“We found a significant level of ART resistance in these individuals who had never received ART, highlighting the need to perform resistance testing at entry into care,” Gagliardo said. “The high rate of resistance could inform future guideline development for choosing initial regimens in ART-naïve adolescents and young adults.”
Gagliardo said that future studies should assess the uptake of the most recent 2013 guidelines that recommend initiating ART in all HIV-infected individuals and assess the impact on drug resistance. — by Emily Shafer
Christina Gagliardo, MD, can be reached at: Maimonides Infants and Children’s Hospital of Brooklyn, 977 48th Street, Brooklyn, NY 11219-2919; email: cgagliardo@maimonidesmed.org.
Disclosure: The researchers report no relevant disclosures.
Perspective
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Elizabeth Connick, MD
This important study provides concrete data on the treatment of newly-diagnosed adolescents and young adults. Although this population is perceived as more difficult than others to treat, uptake of ART and treatment outcomes were not that different from other populations. The finding that antiretroviral drug resistance increased in this population over time is of major concern. Although new HIV diagnoses may be declining overall, it is likely that drug resistance in newly-diagnosed individuals will continue to increase, as HIV risk behavior is associated with poor drug adherence. These results underscore the importance of drug resistance testing in all newly diagnosed individuals. Furthermore, they highlight one of the major challenges still facing the field, which is to improve antiretroviral medication adherence so that drug resistance does not emerge.
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