The road to ensuring access to affordable, effective HIV meds for 15 million in poor countries

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Just as we have reached the point where universal access is no longer an unattainable dream, there are market forces afoot that could make access to effective, affordable antiretroviral therapy (ART) more challenging than it has been for a number of years, said Chairman of the UNITAID Executive Board Phillippe Douste-Blazy at the opening of a United Nations (UN) High-Level Meeting side event in New York City Thursday afternoon.

Pharmaceutical companies are seeking more patents than ever before, including in places like India where the majority of generic HIV drugs are manufactured, Douste-Blazy said.  There is also a concern that some companies are withdrawing from the market—at least the market relevant to developing countries.

Co-hosted by UNAIDS and UNITAID, the event was highly relevant to the treatment goal reportedly embraced in the new UN declaration (15 million people on ART in low-income countries by 2015) expected to be adopted Friday, and addressed how to expand access to affordable effective HIV medications in these countries.

Panelists discussed a number of potential solutions to these challenges.  Paul DeLay from UNAIDS spoke about “Treatment 2.0,” an action plan to radically simplify approaches to HIV treatment to expand access and allow sustainability. He mentioned efforts to look at reducing drug dosages and frequency and the promise of longer-acting injectible ART.

In regard to the current market and demand for ART, the Clinton Foundations estimates that 97 percent of individuals receiving treatment in developing countries are on first-line therapy. The foundation projects a 15 percent increase in demand per year with a 20 percent increase projected for second-line therapy.  These projections are based on current World Health Organization treatment guidelines, which could well be modified in light of the dramatic research findings of HPTN 052 showing that HIV-infected persons on ART are more than 96 percent less like likely to sexually transmit the virus to an uninfected partner. 

There has been a shift away from D4T to tenofovir – which translates into an increase in the cost of a first -line regimen from $109 to $130 per patient per year.  The cost of a second-line ART drug regimen currently stands at $673 per patient, per year.   Notably, the cost of the medications represents the lion’s share of the cost of a second-line treatment intervention, while associated care delivery costs reflect the majority of the cost of first-line treatment.

UNITAID was described by its Coordinator of Market Dynamics, Brenda Waning, as a market catalyst, creator and fixer.  She described how the drug market has become more complicated by a variety of factors including the greater participation of middle-income national governments as drug purchasers, growing pharmaceutical company interest in the potential markets of middle-income countries, and the blending of innovator and generic drug company relationships.

Today, developing countries represent only 6 percent of the global antiretroviral drug market.   And there are urgent needs that are unique to developing countries—a fixed-dose combination pediatric regimen, and a potent ART regimen that works effectively with anti-tuberculosis medications to name two.

The Medicines Patent Pool recently launched by UNITAID is one mechanism aimed at facilitating production of affordable, generic medicines for use in resource-poor settings. Patent owners, private and public, are encouraged to participate.  So far the National Institutes of Health has licensed a drug patent to the Pool and negotiations are currently under way between the Pool and Gilead Sciences, Roche and Viiv HealthCare.  Pool Director Ellen ‘t Hoen sounded optimistic, but acknowledged that when combination medications have more than one patent holder, it is essential to get each of them on board.

Yet another daunting challenge on the road to universal access to HIV treatment, serious efforts to expand access to point-of-care diagnostic and monitoring technologies like CD4 and HIV viral load have barely begun.

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