Boston, MA -- (SBWIRE) -- 06/10/2013 -- Elvitegravir (HIV) - Forecast and Market Analysis to 2022

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, "Elvitegravir (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 obtained the exclusive global marketing rights (excluding Japan) for elvitegravir from Japan Tobacco in 2005. Elvitegravir would be the second INI after Merck's Isentress (raltegravir), which was launched in the US and Europe in 2007, in Japan and Brazil in 2008, and in China 2009 (Merck, 2012a). INI's mechanism of action involves inhibiting the catalytic activity of HIV integrase, an enzyme that is required for viral replication, which blocks HIV from integrating its DNA into the host cell genome. This prevents HIV from replicating (Isentress Highlights of Prescribing Information, 2012). INIs are an attractive antiretroviral class due to their favorable side effect profile compared with NNRTIs and PIs. Unlike Isentress, which requires two doses a day, elvitegravir is administered once daily, but requires boosting by a PK enhancer, such as AbbVie's ritonavir or Gilead's cobicistat, in order to delay the metabolism of elvitegravir by cytochrome P450 enzymes (Mathias et al., 2009). Elvitegravir has been approved as a component of Gilead's single-pill regimen, Stribild (elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine), which was approved by the FDA in 2012 and currently under review in the EU and Japan. Elvitegravir is also being developed as a standalone compound, for which an NDA was submitted to the FDA in June 2012 (Gilead Sciences, press release, June 27, 2012). GlobalData estimates that elvitegravir will be launched as a standalone drug in 2013.

Scope

- Overview of HIV, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Elvitegravir including product description, safety and efficacy profiles as well as a SWOT analysis.

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