Research and Markets has announced the addition of the “Cobicistat
(HIV) – Forecast and Market Analysis to 2022” report to their
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
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
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
– Overview of HIV, including epidemiology, etiology, symptoms,
diagnosis, pathology and treatment guidelines as well as an overview on
the competitive landscape.
– Detailed information on Cobicistat including product description,
safety and efficacy profiles as well as a SWOT analysis.
– Sales forecast for Cobicistat for the top nine countries from 2012 to
– Sales information covered for the US, France, Germany, Italy, Spain,
the UK, Japan, Brazil and China
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