For patients with extensive treatment and drug resistance:
"The goal is to re-suppress the HIV RNA levels maximally (e.g., to <50 copies/mL). With the availability of multiple new antiretroviral drugs, including some with new mechanisms of action, this goal is now possible in many patients..."
DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, January 29, 2008.1
Patients with R5 virus achieved potent and durable results with Selzentry™ (maraviroc) plus optimized background therapy (OBT)2,3
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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). 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.2 In a second study, viremic, treatment-experienced patients with D/M-tropic HIV-1 were randomized to receive OBT + placebo (n=58) or OBT + maraviroc 150 mg BID (n=52). Baseline viral load was >5 log10 copies/mL for both treatment groups.3
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Dual/mixed tropism is a predictor of disease progression, independent of CD4 count and HIV RNA4
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From a study in 313 treatment-na•ve patients who were enrolled in the Long-Term Monitoring Protocol (LTM). Disease progression was assessed by a composite outcome of CD4 count <350 cells/mcL, treatment initiation, or death.
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D/M virus was associated with a relative doubling of the risk of disease progression
"Ideally, one should design a regimen with at least two, and preferably three, fully active drugs on the basis of drug history, resistance testing, or new mechanistic class."
Ð DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents, January 29, 2008.1
Patients who received more active drugs experienced greater viral suppression in the MOTIVATE 1 and 2 trials6,7
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From a 24-week analysis of the MOTIVATE 1 and 2 trials. 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. P values were not determined in this subanalysis. The number of active agents in OBT was determined by an overall susceptibility score (OSS), measured at the time of patient screening and calculated using results of both genotypic and phenotypic resistance testing (PhenoSense GT).
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Isentress® (raltegravir) demonstrated improved efficacy with more active OBT8
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In the BENCHMRK 1 and 2 trials, treatment-experienced patients with HIV-1 were randomized to receive OBT + placebo (n=237) or OBT + raltegravir 400 mg BID (n=466). "Treatment-experienced" was defined as viral load >1,000 copies/mL and documented genotypic/phenotypic resistance to ³1 drug in each of 3 classes (NNRTI, NRTI, and PI).
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PhenoSense GT was used to determine OBT in the MOTIVATE and BENCHMRK clinical trials