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Advancing Research, Securing Access

TAGline Spring 2013

By Mark Harrington

Now in its 20th year of publication, TAGline has long sought to inform its readers and TAG supporters of the myriad research and policy challenges we face as a community in the ongoing fight against HIV and two of its insidious comorbidities, viral hepatitis and tuberculosis. Many of these challenges are inextricably intertwined, as we highlight in this issue focusing on specific clinical research and treatment-access hurdles threatening progress for all three diseases.

We begin with Coco Jervis’s update on the Ryan White CARE Act, imperiled by political and budget paralysis in Washington, D.C., but widely considered a vital safety net for people with HIV, particularly in states with uneven implementation of the Affordable Care Act and its Medicaid-expansion provision.

In the expansive arena of hepatitis C drug development, we learn from Tracy Swan that pharmaceutical companies are jostling for what they hope is a billion-dollar market, merging and purging various combinations in an unseemly rush for FDA approval. Critical research and access issues remain, however.

When it comes to pediatric TB, drug companies couldn’t be less interested. As Polly Clayden notes, drug- and regimen development for pediatric TB progresses even more slowly than for adult TB, and public-sector alternatives are needed to fund essential clinical trials. Meanwhile, as Lindsay McKenna explains, adaptive clinical-trial designs may allow for the rapid evaluation of new preventive and curative regimens for both pediatric and adult TB. As Erica Lessem writes, however, the high price of drugs—notably Sanofi’s rifapentine—is preventing the full benefits of these scientific advances from being realized.

Over the past year, TAG has looked back to the epidemic’s early, dark years, when no effective HIV treatment strategies existed. In this issue, I cover the emergence of highly active antiretroviral therapy (HAART) in 1995–96, and the vital role activists, such as TAG’s Spencer Cox (1968–2012), played in demanding higher standards from clinical trials, sponsors, and regulators.

A number of highly effective antiretrovirals are coming off patent over the next five years, which could translate into billions of dollars saved for the U.S. health care system alone. But, as Tim Horn writes, we need to ensure that the best drugs and combinations are made available quickly.

Finally, HAART alone does not restore effective immunity in some 10% to 15% of people with HIV. Richard Jefferys explains that these individuals, known as immunologic nonresponders, may need additional, possibly immune-based, therapy to fully recover functional immune systems.

As it has done since 1992, TAG will continue its push for the evidence-based research required to address today’s HIV, viral hepatitis, and TB priorities, and importantly, to translate the results into clinical practice as quickly as possible.•