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Optimize Background

DHHS Standard of Care is Optimized Background

The goal of treatment for patients with prior drug exposure and drug resistance is to re-establish maximal virologic suppression.

For some patients with extensive prior drug exposure and drug resistance where viral suppression is difficult or impossible to achieve with currently available drugs, the goal of treatment is preservation of immune function and prevention of clinical progression.

Current U.S. Department of Health and Human Services (DHHS) guidelines stress the importance of having an optimized background therapy by utilizing past and current resistance test. Guidelines suggest utilizing an assay that can define partial activity. The study results presented below show outcomes when optimized background therapy (OBT) is put into practice.

Significant increases in CD4 count in the MOTIVATE 1 and 2 trials with PhenoSense GT™–directed OBT 11, 12


In a combined analysis of the MOTIVATE 1 and 2 trials, viremic, treatment-experienced patients with CCR5-tropic HIV-1 were randomized to receive OBT + placebo (n=209) or OBT + maraviroc 150 mg BID (n=426). "Treatment experienced" was defined as resistance to and/or ≥6 months' experience with ≥1 ARV from three classes (≥2 for Pls). Baseline CD4 count was 171 cells/mm3 for the OBT + placebo group and 167 cells/ mm3 for the OBT + maraviroc 150 QD



The MOTIVATE 1 and 2 trials showed significant viral load reductions with PhenoSense GT™-directed optimized background therapy11, 12

In a combined analysis of the MOTIVATE 1 and 2 trials, viremic, treatment-experienced patients with CCR5-tropic HIV-1 were randomized to receive OBT + placebo (n=209) or OBT + maraviroc 150 mg BID (n=426). "Treatment experienced" was defined as resistance to and/or ≥6 months' experience with ≥1 ARV from three classes (≥2 for Pls). Baseline viral load was 4.86 log10 copies/mL for the OBT + maraviroc 150 mg QD

  • 45.3% of patients receiving OBT = maraviroc 150 mg BID had an undetectable viral load after 24 weeks
  • Optimized background therapy alone was enough to suppress viral load <50 copies/mL in 23.0% of patients


The MOTIVATE 1 & 2 trials demonstrated increased activity with more active drugs in OBT 10, 11

In a combined analysis of the MOTIVATE 1 and 2 trials, viremic, treatment-experienced patients with CCR5-tropic HIV-1 were randomized to receive OBT + placebo (n=209) or OBT + maraviroc 150 mg BID (n=426). “Treatment experienced” was defined as resistance to and/or ≥6 months' experience with ≥1 ARV from three classes (≥2 for PIs). Baseline viral load was 4.86 log10 copies/mL for the OBT + placebo group and 4.85 log10 copies/mL for the OBT + maraviroc 150 mg BID group.



Answers to your Questions

Q: What is optimized background therapy (OBT)?
A: Optimized background therapy is the combination of antiretroviral (ARV) drugs most likely to increase CD4 count and decrease viral load based on patient RV history and resistance testing.

Q: Who needs optimized background therapy?
A: The US Department of Health and Human Services recommends optimized background therapy (OBT) for experienced patients1
Adding a new agent with a novel resistance profile or a new mechanism of action in the context of OBT can provide significant ARV activity1

Q: How do I select optimized background therapy?
A: To create the best possible regimen for your patient, you must have all the information possible, including:

  • Patient history
  • CD4 count
  • ARV treatment history
  • Viral load
  • Past and current resistance tests

Q: Which resistance test provides the most information?
A: PhenoSense GT™ pinpoints a virus's susceptibility to each drug so you can identify all effective treatment options.
Only PhenoSense GT™ combines actual phenotype and genotype information in a single report

For a downloadable version of these answers click here

Click here for more information on PhenoSense GT™ and resistance testing