Boston, MA -- (SBWIRE) -- 05/13/2013 -- Cobicistat (HIV) - Forecast and Market Analysis to 2022

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, "Cobicistat (HIV) - Forecast and Market Analysis to 2022". Human Immunodeficiency Virus (HIV), the causative agent of AIDS, has claimed millions of lives since its emergence. However, the advent of antiretroviral therapy (ART) has transformed the face of HIV/AIDS from a deadly disease to a manageable chronic condition for most infected individuals. Antiretroviral treatment not only reduces the viral load and reconstitutes immune function, but also decreases infection incidence rates by limiting viral transmission. The treatment algorithm in HIV has characteristically involved multiple drug regimens designed to tackle the virus on different levels. In the recent past, simplified dosing regimens through the emergence of single tablet regimens (STRs) or fixed dose combination (FDC) therapies have become increasingly popular amongst physicians and patients alike by increasing clinical efficacy thresholds and enabling patient compliance.

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Gilead has developed a novel pharmacokinetic booster, cobicistat (previously known as GS-9350), which acts as an inhibitor of human cytochrome P450 3A (CYP3A) isoforms. The drug increases the systemic exposure of co-administered medications that are metabolized by CYP3A enzymes, such as protease inhibitors. This increases the co-administered drug's bioavailability, thereby enabling less frequent dosing of the co-administered medications (PIs or elvitegravir). Cobicistat's mechanism is similar to AbbVie's Norvir (ritonavir), but cobicistat lacks intrinsic antiretroviral activity. When dosed as a booster, the antiretroviral activity of Norvir is minimal, which positions cobicistat as a threat to Norvir as a PK booster, since neither can claim antiviral activity. Studies that compared cobicistat with Norvir used a CYP3A substrate, midazolam for clearance. Both Norvir and cobicistat potently inhibit midazolam from being cleared. That means that a drug that would be metabolized by CYP3A can have sustained antiviral activity in the presence of cobicistat (Mathias et al., 2010). Cobicistat is already approved for use in the US as a component of Gilead's Stribild (Sax et al., 2012). Gilead also filed for EMA approval in the EU, and Japan Tobacco filed an application with the Pharmaceuticals and Medical Devices (PMDA) in Japan for a drug with Stribild's formulation in November of 2012. In June 2012, Gilead Sciences also filed a New Drug Application (NDA) with the FDA for approval as a standalone booster to be used with pre-existing PIs that are currently used with AbbVie's Norvir (Gilead Sciences, press release, July 24, 2012). GlobalData estimates that cobicistat will be launched in the US and EU in 2013, and in Japan by 2014.

Scope

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