HIV Treatment Interruptions: A Study on Short Breaks from Antiretroviral Therapy
Author Information
Author(s): Firnhaber Cynthia, Azzoni Livio, Foulkes Andrea S., Gross Robert, Yin Xiangfan, Van Amsterdam Desiree, Schulze Doreen, Glencross Deborah K., Stevens Wendy, Hunt Gillian, Morris Lynn, Fox Lawrence, Sanne Ian, Montaner Luis J.
Primary Institution: Clinical HIV Research Unit, Faculty of Health Sciences, Department of Medicine, University of the Witwatersrand, Johannesburg, South Africa
Hypothesis
Intermittent short cyclic treatment interruptions would be non-inferior to continuous therapy in maintaining ART-mediated immune reconstitution.
Conclusion
Short interruptions of protease inhibitor-based ART did not lead to a greater rate of resistance mutations or adverse events compared to continuous therapy, but they were not shown to be non-inferior in maintaining immune reconstitution.
Supporting Evidence
- The proportions of CD4 counts >350 cells/µl were 82.12% for the intermittent arm and 93.73% for the continuous ART arm.
- No clinically significant differences in opportunistic infections, adverse events, adherence or viral resistance were noted.
- Long-term CD4 rise was observed only in the continuous ART arm.
Takeaway
The study looked at whether taking short breaks from HIV treatment is as good as staying on treatment all the time. It found that while breaks didn't cause more problems, they also didn't keep the immune system as strong.
Methodology
A 2-arm non-inferiority trial was conducted with participants randomized to either ART interruptions or continuous ART, with primary analysis based on CD4 count over 72 weeks.
Potential Biases
The study's conservative definition of non-inferiority may have favored the continuous ART arm.
Limitations
The sample size was limited, making it difficult to compare clinical outcomes against larger studies.
Participant Demographics
69% women, mean age 35 years, mean baseline CD4+ T cell count 270 cells/µl.
Statistical Information
P-Value
p<0.0001
Confidence Interval
Upper limit of 97.5% CI, 24.1%; two-sided CI: −0.16, 23.1
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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