This article is more than 5 years old. Information may no longer be current.
CHER trial: Virologic response achieved in infants with early ART
Click Here to Manage Email Alerts
GLASGOW — Six-year follow-up data on the Children with HIV Early Antiretroviral Therapy trial presented here suggest that a significant virologic response was obtained in infants assigned to ART at an early age — treatment interruption did not adversely affect virological outcomes.
“The main results of the trial were presented at this year’s [Conference on Retroviruses and Opportunistic Infections] meeting in Seattle, showing that early, limited ART was superior to deferred therapy in all aspects, including mortality and disease progression,” Avy Violari, MD, of the perinatal HIV research unit, University of the Witwatersrand in Johannesburg, said during a presentation.
The Children with HIV Early Antiretroviral Therapy (CHER) trial compared deferred but continuous ART (arm 1) with early, limited ART (arms 2 and 3) in children with HIV-1 assigned immediate protease inhibitor-based ART after diagnosis. The 6-year follow-up data were based upon virological outcomes and resistance patterns.
By June 2011, 353 children were assigned lopinavir/ritonavir plus zidovudine and lamivudine regimen. Median age at treatment initiation was 26.1 weeks in arm 1, 4.4 weeks in arm 2 and 7.5 weeks in arm 3. ART was then interrupted after 40 weeks of treatment in arm 2 and at 96 weeks in arm 3; treatment reinitiation was based upon immunologic criteria.
A resistant mutation was observed in about 40% of the overall cohort with viral loads >1,000 copies/mL. HIV RNA was <400 copies/mL in 87% of children in arm 1, in 84% in arm 2 and in 83% in arm 3 (P=.96). Of the 22 children with viral loads >1,000 copies/mL, 41% had mutations.
Specifically, seven children had M184V mutations; two children had significant protease inhibitor mutations and two had significant non-nucleoside reverse transcriptase inhibitor mutations.
“Virological response was excellent, with no differences between the three arms,” Violari said. “We didn’t see any detrimental effects of interrupting ART and restarting with the [protease inhibitor]-based regimen. Ongoing work will investigate the impact of length of time with detectable viral load on risk of developing resistance.”
For more information:
Violari A. #224. Presented at: HIV11 Congress; Nov. 11-15, 2012; Glasgow.
Disclosure: Violari reports no relevant financial disclosures.
Perspective
Back to Top
Paul A. Volberding, MD
In resource limited settings, continuous, effective and non-toxic ART begun early in the course of infection remains difficult to implement because of treatment costs. In response, less effective and more toxic, but less expensive approaches have been attempted. In this trial, no study arm offered early and continuous therapy and each arm included zidovudine which as a thymidine analog is more toxic than alternative drugs. While the on treatment viral suppression was, as expected, potent, the study leaves open many questions. In adults, treatment interruption is known to lead to excess mortality and morbidity, but this trial was underpowered to examine these important endpoints. The study leaves open the question of comparison to effective therapy begun early in the infection. We appreciate the complexity of adjusting approaches to resource realities, but hope we can move to treatment strategies shown advantageous in less economically constrained settings. We should certainly not accept the interpretation that this study shows that treatment interruption in children can be recommended.
Click Here to Manage Email Alerts