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ART among Children with Perinatally Acquired HIV Infection: Temporal Changes in ART and Virologic and Immunologic Outcomes in the Pediatric HIV/AIDS Cohort Study Adolescent Master Protocol
Russell Van Dyke*1, K Patel2, J Read3, M Chernoff2, L Mofenson3, G Siberry3, S Burchett4, H Mendez5, Z Rodriguez6, G Seage2, and the Pediatric HIV/AIDS Cohort Study
1Tulane Univ Hlth Sci Ctr, New Orleans, LA, US; 2Harvard Sch of Publ Hlth, Boston, MA, US; 3Natl Inst of Child Hlth and Human Devt, NIH, Bethesda, MD, US; 4Children`s Hosp, Boston, MA, US; 5State Univ of New York Downstate Med Ctr, Brooklyn, US; and 6Univ of Puerto Rico Med Ctr, San Juan, US
Background: Approximately 8500 US children are
surviving with perinatally acquired HIV; most are 7 to 18 years old. The PHACS
AMP study is a prospective cohort study of outcomes of children with perinatally
acquired HIV.
Methods: AMP is conducted at 12 US sites. Perinatally
HIV-infected children 7 to 16 years old are eligible. Enrollment began in March
2007. Clinical history, including ART, virologic and immunologic testing were
obtained from medical charts and prior studies’ databases. Entry demographic
and clinical characteristics were described and temporal trends in ART, CD4,
and viral load by calendar year evaluated.
Results: Of 291 subjects enrolled in AMP by August
2008, 240 had complete ART data available for analysis. Median age at entry was
12 years (57% were born before 1996); 54% were female; and 76% were African American,
16% Hispanic. Median CD4 count at entry was 718 cells/mm3 (6% <250),
median viral load was <400 copies/mL (65% <400, 6% >50,000) and 28% of
subjects were CDC clinical stage C (AIDS). At entry, 93% were receiving ART and
all previously received ART. ART was initiated at a median age of 0.6 years. Median
duration of ART was 11.2 years. The number of different regimens per child
ranged from 1 to 19 (median 5). Prior to 1998, most subjects received only 1 to
2 NRTI. Over time, use of HAART with PI increased, followed by use of HAART
with PI+NNRTI. Now HAART with NNRTI is as common as HAART with PI+NNRTI. At
entry, 75% were receiving PI-containing HAART, 15% HAART without a PI, 3% non-HAART,
and 7% no ART. 3TC was the most common NRTI at entry (53% of subjects),
followed by zidovudine (ZDV) (29%), stavudine (d4T) (26%), abacavir (ABC) (26%),
and tenofovir (TDF) (23%). Since 2002, the use of d4T has decreased while use
of TDF and ABC has increased. Use of efavirenz (EFV) (18% at entry) has been
stable while nevirapine (NVP) (8% at entry) has decreased since 2000. Ritonavir
(RTV) -boosted lopinavir (LPV) (45% at entry) has been the most common PI since
2004 while the use of nelfinavir (NFV) has decreased (14% at entry). Use of ZDV
has increased (10% at entry). The newer PI and raltegravir were received by
<5% of subjects. Subjects’ mean CD4 percentage has been stable (~ 33%) since
1999 and never below 29%. The median HIV viral load has been <400 copies/mL
since 2002.
Conclusions: Despite changing standards of care over
time, receipt of multiple ART regimens, and sub-optimal therapy in the
pre-HAART era, most children with perinatal HIV in AMP have viral suppression
and normal CD4 counts. Use of newer drugs is limited.
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