Roche says combination therapy successful against HIV

Roche said such a high response rate has never been seen in patients who have developed resistance to at least one agent in each of the first three classes of antiretrovirals.

Fuzeon, co-developed by Roche and Trimeris is the first fusion inhibitor available for the treatment of HIV. Raltegravir is a novel investigational integrase inhibitor being developed by Merck & Co, while Prezista (darunavir) is a ritonavir-boosted protease inhibitor, marketed by Tibotec Therapeutics.

However, Roche has said because Fuzeon and/or Prezista were included in a patient’s background regimen only at the judgment of the investigator after consideration of individual patient factors the full meaning of these relative response rates is unclear.

Generally, previous studies have shown that patients who receive Fuzeon as part of the background regimen have more advanced disease and demonstrate a higher degree of drug resistance, with fewer active treatment options, than other treatment-experienced patients. Consequently, these subsets do not represent randomized comparisons of background treatment options with or without raltegravir that permit an accurate assessment of the relative benefits of one treatment strategy over another.

A fuller understanding of these subset analyses will be possible after additional detail describing baseline treatment and disease characteristics of the patients in each subset is available.

“Despite several caveats surrounding the subset analyses, these promising new data herald a new era for HIV patients who are very treatment-experienced and who – with few exceptions – should be able to experience complete virologic suppression with Fuzeon, darunavir and raltegravir,” said James Thommes, senior medical director, Roche.