Human Immunodeficiency Virus

Pharmacor -- June 2008

  Introduction:

HIV is a dynamic market that is continually changing as the result of one of the most active pipelines, significant investment in R&D, and continually evolving treatment practices. Since we last reported on HIV, several important events have occurred: two new ARV drug classes--CCR5 antagonists and integrase inhibitors--have entered the market; BMS/Gilead’s Atripla reached several European markets; Johnson & Johnson expanded its HIV franchise by launching its first NNRTI, etravirine (Intelence); and a number of updates to the U.S. and European HIV treatment guidelines have been issued, including the firm recommendation for ARV treatment initiation in asymptomatic HIV patients with CD4 count of 350 cells/mm³. Taken together, these events and the upcoming patent expiry of several key ARV agents are expected to greatly influence both clinical practice and market trends in the HIV space during our 2007-2017 forecast period.

  Questions Answered in This Report:

Maraviroc (Pfizer’s Selzentry), the first CCR5 antagonist, and raltegravir (Merck’s Isentress), the first integrase inhibitor, were introduced in the second half of 2007. Both agents are indicated only for treatment-experienced patients at the time of launch. How are physicians incorporating each of these novel ARV agents into their clinical practice? Is it likely maraviroc and raltegravir will be approved for treatment initiation, and will these agents move to earlier lines of therapy? What is the commercial outlook for maraviroc and raltegravir over the next ten years?

In 2007, revised versions of the U.S. and European treatment guidelines were published. Among the most important changes is the new CD4 count threshold for treatment initiation; the new guidelines firmly recommend ARV treatment intervention for all asymptomatic HIV patients with 350 CD4 cells/mm³. Will this change in the guidelines have an impact on the number of drug-treated patients across the U.S. and European markets that we cover? How receptive are physicians to early treatment initiation? What is the commercial impact of this revision?

Several follow-on agents to currently marketed products are in late stages of development, mainly rilpivirine (a NNRTI from Johnson & Johnson), vicriviroc (a CCR5 antagonist from Schering-Plough), and elvitegravir (an integrase inhibitor from Gilead). Barring any major delays in the pivotal trials, these drug candidates are expected to enter the HIV market over the next two to three years. What do experts interviewed perceive to be the clinical advantages, if any, of these emerging therapies over their predecessors? What is the commercial potential for these new therapies that will enter a highly mature and competitive market? Which patient segments are likely recipients of these follow-on class entries?

Survival after HIV/AIDS diagnosis continues to improve as treatment options advance. How will improved survival impact the number of prevalent cases over the next ten years?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

Primary research: 41 country-specific interviews with infectious disease physicians specializing in the treatment of HIV.

Epidemiology: Total HIV prevalence; diagnosed prevalence, drug-treated population, and newly diagnosed HIV cases.

Population segments in market forecast: HIV patients.

 Emerging therapies: Phase II: 15 drugs; Phase III: 5 drugs; registered: 33 drugs. Coverage of 26 select preclinical and Phase I products.

Market forecast features: We provide a ten-year forecast by individual agents in each of the seven markets. Uptake of emerging classes and their use in combination with current ARVs is based on assumptions from interviewed thought leaders and market analogues.