What is the impact of combination antiretroviral therapy (ART) on HIV/AIDS?

Updated: Jul 27, 2020
  • Author: Shelley A Gilroy, MD, FACP, FIDSA; Chief Editor: Michael Stuart Bronze, MD  more...
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A study by Lennox et al in treatment-naive patients from 67 centers on 5 continents demonstrated benefits of raltegravir (another INSTI) over efavirenz (an NNRTI) as part of combination antiretroviral therapy. [122] Participants had viral RNA (vRNA) concentrations greater than 5000 copies/mL and demonstrated no baseline drug resistance to efavirenz, tenofovir, or emtricitabine. They were randomly assigned to receive raltegravir 400 mg bid (n=281) or efavirenz 600 mg daily (n=282).

The primary endpoint was a vRNA concentration of less than 50 copies/mL at week 48. In the raltegravir group, 86.1% achieved the primary endpoint, compared with 81.9% in the efavirenz group (difference 4.2%, 95% CI, -1.9 to 10.3). The time to viral suppression was shorter in the raltegravir group than in the efavirenz group. Significantly fewer adverse drug reactions were reported in the raltegravir group (44.1%) than in the efavirenz group (77%). [122]

Similarly, in a randomized, phase III, noninferiority trial of raltegravir-based treatment versus efavirenz-based therapy, in 563 treatment-naïve HIV-1–infected patients, the addition of raltegravir to tenofovir/emtricitabine, compared with the addition of efavirenz to tenofovir/emtricitabine, resulted in significantly greater vRNA suppression rates and increases in baseline CD4 counts at week 240. In addition, significantly fewer patients in the raltegravir group experienced neuropsychiatric and drug-related adverse events. [123]

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