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The recommended dose for Merck & Co's Isentress (raltegravir) in treatment-naive adult patients is 400mg, twice daily. The drug is already approved for late-stage therapy, where it is widely used in combination with other anti-retrovirals including Tibotec/Johnson & Johnson's protease inhibitor Prezista (darunavir) and non-nucleoside reverse transcriptase inhibitor Intelence (etravirine).
Approval for treatment-naive patients was based on 48-week data from the STARTMRK study in which the safety and efficacy of Isentress was compared to leading first-line agent Sustiva (efavirenz) in this patient population. Isentress met the primary endpoint of non-inferiority, with 86.1% of patients in the Isentress arm achieving undetectable HIV RNA (<50 copies/ml) versus 81.9% in the Sustiva group. Isentress also performed better in terms of safety, with fewer central nervous system related side effects, plus a better lipid profile.
Isentress has experienced a rapid uptake in treatment-experienced patients since its launch in 2007 due to its high efficacy and good safety profile. However, penetration of first-line therapy may prove to be more challenging due to the drug's requirement for twice-daily dosing. Since the majority of first-line drugs are taken only once daily, it will be difficult for Isentress to compete effectively, particularly because of concerns that poor adherence to a twice-daily regimen can lead to development of resistance.
In order to increase Isentress' commercial perspectives in first-line therapy, Merck is investigating a once-daily formulation. However, Datamonitor anticipates that this follow-on product will not reach the market until 2011. The company is also exploring the use of Isentress in combination with various protease inhibitors (i.e. Prezista, Bristol-Myers Squibb's Reyataz and Abbott's Kaletra), without the traditional dual nucleoside reverse transcriptase (NRTI) backbone. Given the growing concerns over toxicity associated with the NRTI class, Datamonitor believes that development of a fixed-dose combination comprising Isentress and a protease inhibitor is the best strategy to counter the increasing competition in first-line.
http://www.datamonitor.com
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