Clinical Outcomes Following the Use of Archived HIV-1 DNA Sequencing to Guide Antiretroviral Therapy Regimen Adjustment and Simplification

Abstract

Abstract Background While favorable new antiretroviral therapy (ART) options are available for HIV disease, the Department of Health and Human Services guidelines recommend against switching suppressive regimens unless there is evidence that the new regimen will be fully active. A new assay analyzes archived HIV pro-viral DNA and can detect resistance mutations when HIV RNA is below the limit of detection, when standard genotyping (GT) is not possible. Small studies have correlated archived DNA GT to historical plasma RNA GT, but there is minimal available data on treatment outcomes when using this assay to determine antiretroviral therapy switch strategies. We evaluated clinical outcomes following ART adjustment based upon results of archived DNA GT testing. Methods A retrospective review of electronic medical records was performed at our medical center from October 2014 to October 2016. Inclusion criteria included age ≥ 18 years, archived DNA GT result available, ART changed after archived GT result, and follow up HIV RNA available after ART switch. Data was collected prior to and after ART switching. McNemar’s test was used for categorical variables and paired t-test for continuous variables. Results A total of 38 patients were included. Most patients were male (89%), Caucasian (66%), had a history of AIDS diagnosis (45%), had HIV for >10 years (74%), and had baseline ART resistance (24% resistant to 1 class, 37% resistant to ≥ 2 classes). Median baseline CD4 was 532 cells/mm3. At baseline, 31 (82%) patients had HIV RNA < 50 copies/mL. Compared with baseline, 35 (92%) patients were undetectable at furthest follow up (P = 0.22). Median time to furthest follow up was 146.5 days (range 12–485). Overall, 36 (95%) patients had at least one undetectable HIV RNA after switching. None of the patients with an initial undetectable HIV RNA became detectable after switching ART. Average number of pills per day and administrations per day decreased from 3.84 to 1.97 (P < 0.001) and 1.47 to 1.05 (P < 0.001) respectively. The number of patients on protease inhibitors (PIs) decreased from 66% to 21% (P < 0.001). Conclusion The use of archived DNA GT to guide ART adjustment may result in maintained viral suppression while allowing for regimens with optimized long-term safety and decreased pill burden. Disclosures All authors: No reported disclosures.