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2011 Pipeline Report shows that medical prospects for people with HIV, hepatitis C, and tuberculosis have never been better

FOR IMMEDIATE RELEASE 15 July 2011


CONTACT:
Polly Clayden, i-Base +44 77 64 950 296
Mark Harrington, TAG +1 347 515 3791

-- Analysis reveals a golden age of antiretroviral drug development, rapid uptake of innovator compounds, and rapid return on investment --

Rapid evolution of HIV and Hepatitis C Virus (HCV) therapies promises continuing progress, while a renaissance in TB drug, diagnostic, and vaccine development is underway

New York/London/Rome – 15 July 2011 – The new drug, diagnostic, and vaccine pipeline has never looked more promising for people with HIV, hepatitis C virus (HCV), and tuberculosis (TB), according to a report released today by Treatment Action Group (TAG) and HIV i-Base (click link to download).

As the writers of the report reveal, the prospects for dramatic—and in some cases revolutionary—changes in prevention and treatment for the three diseases in the next decade are extremely good.

For a second year now, TAG and i-Base have collaborated to produce the Pipeline Report. This year, Jonathan Berger from SECTION27 in South Africa contributed a new chapter on patent laws and antiretroviral licensing policies.

As the report makes clear, medically, the prospect for people with HIV, HCV, and TB to live long and healthy lives—and in the cases of HCV and TB, to be cured rapidly with safe, effective, oral combination therapy—has never been better.

A golden age of antiviral drug development

To assess the state of the HIV treatment development process, the authors went back over all the drugs TAG reported as entering phase II or beyond since 2003. “The past decade has indeed been a golden age of antiretroviral drug development,” commented Polly Clayden of i-Base and Mark Harrington of TAG. Of 29 new chemical entities approved by the U.S. Food and Drug Administration (FDA) to treat HIV infection since 1986, the report finds almost half (14/29) were approved in the years since 2003. Thirty-four drugs and fixed dose-combinations (FDCs) are FDA-approved for sale in the United States; a further 131 drugs and FDCs (including adult and pediatric formulations) are tentatively approved under the FDA’s generic registration program to facilitate global access through programs such as the President’s Emergency Program for AIDS Relief (PEPFAR).

The success rate for new antiretroviral drugs and FDCs that entered phase II or further trials since 2003 is a whopping 30.4% (14/46), according to the TAG/i-Base analysis. Expected approvals this year for the integrase inhibitor, elvitegravir, the pharmacokinetic booster cobicistat, and the two FDCs rilpivirine/FTC/TDF and elivitegravir/cobisistat/FTC/TDF (Quad)—would bring the success rate to 39.1% (18/46).

The success rate also demonstrates the rapidity in which new drugs and combinations are incorporated into the standard of HIV care in developed countries showing that investors will enjoy a substantial return on their investment—the HIV drug market is estimated at $13 billion a year currently, though only 19.4%—or 6.6 of 34 million—of the world's HIV positive persons are on treatment.

Globally, 34 million people are living with HIV infection, an estimated two billion with latent Mycobacterium TB infection, and up to 130 million with chronic HCV infection. At least 1.8 million people died from AIDS in 2009, one quarter of them from TB, which alone killed 1.7 million people. There is neither global nor national surveillance for HCV-related illness and death, but more than 300,000 people die from HCV complications each year, and HCV mortality will continue to increase in the coming decade.

HIV infection can be controlled with lifelong triple-combination antiretroviral therapy. Latent TB infection can be treated with six to nine months of isoniazid (INH) or 12 weeks of once-weekly rifapentine and INH. Active TB disease, if drug-susceptible, can be cured in 95% of cases with four drugs in six months, while drug-resistant forms of the disease can be cured up to 70% of the time if multidrug-resistant, or just 30% if extensively drug-resistant, with unpleasant combinations that can take up to two years to work, if they work at all. HCV is now curable in up to 75% of infected people with genotype 1 (predominant in major pharmaceutical markets) who have access to—and can tolerate—today’s standard of care: triple therapy with pegylated interferon, ribavirin, and an HCV protease inhibitor.

Decades of high-quality research, increased investment, and growing and targeted community-based activism have set the scene for the possibility—for the first time since HIV/AIDS emerged in 1981—to make dramatic reductions in new HIV infections worldwide, while saving the lives of as many of the 34 million currently infected who can access therapy. Treatment is continually improving, with modern combinations dramatically less toxic, more tolerable, and easier to take than the first generation ART combinations of the 1990s.

The authors warn that despite buoyant medical prospects, "the world’s activists and political leaders face a crisis in which the former must persuade the latter to redirect billions of dollars from unproductive wars into life-saving health research and access programs, at home and internationally.”

The report highlights the most pressing priorities for research, access and activism for HIV, HCV and TB, emphasizing opportunities for cross-cutting integration of efforts. And the authors stress, “Activists, scientists, implementers, and political leaders are obliged to exert their utmost efforts to accelerate scientific progress and save as many lives as possible in spite of the challenges we face.”

The report is released on the eve of the 6th International AIDS Conference on HIV pathogenesis, treatment and prevention in Rome, Italy, and is available on-line at:
www.treatmentactiongroup.org
www.i-base.info

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HIV i-BASE

HIV i-Base is a London based HIV treatment activist organization. HIV i-Base works in the UK and internationally to ensure that people living with HIV are actively engaged in their own treatment and medical care and are included in policy discussions about HIV treatment recommendations and access.

www.i-base.info

ABOUT TAG

Treatment Action Group (TAG) is an independent AIDS research and policy think tank fighting for better treatment, a vaccine, and a cure for AIDS. TAG works to ensure that all people with HIV receive lifesaving treatment, care, and information.

Treatment Action Group
261 Fifth Ave., Suite 2110
New York, NY 10016 USA
Tel +1 212 253 7922
Fax +1 212 253 7923

www.treatmentactiongroup.org