PharmExec Blog

AIDS: ARV Optimism Tempered by Home Truths

The prospect that antiretroviral drugs could prevent HIV infection in high-risk populations was the big news emerging from last month’s International AIDS Conference in Washington, DC.

But the news raises the tricky ethical question of whether the US should spend $11,000 per patient to keep uninfected individuals healthy, when funds are lacking to provide life-saving treatment to millions of sick patients around the world.

Nearly half of HIV-infected people in low- and middle-income countries are not receiving needed drug therapy, noted Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. And the Centers for Disease Control and Prevention (CDC) reported that only one-third of Americans infected with AIDS get steady care, whites doing better than African-Americans, and young people faring the worst.

The high cost of AIDS therapies in the US remains a sore issue in the AIDS community, which seeks strategies for negotiating cheaper rates. An analysis by Rand for the AIDS Healthcare Foundation examines a range of possibilities, including adoption of reference pricing, changing drug coverage for dual eligible beneficiaries in Medicare, authorizing federal government purchase all AIDS drugs, increasing price transparency to support open negotiations, and ending requirements that formularies cover all AIDS treatments to give plans and purchases added negotiating power.

But treatment costs will decline in the US as key ARVs lamivudine and efavirenz lose patent protection. Development of one-pill and once-per-day combination therapies promise to improve adherence with prescribed regimens, further curbing transmission and disease progression.

The US and other nations and international organizations are spending some $17 billion a year on AIDS treatment programs in Africa and other regions. Another $22 billion, according to some estimates, is needed to provided appropriate care for all AIDS patients, an investment calculated to reduce the spread of infection sufficiently to bring the epidemic under control. Former president Bill Clinton put the cost of treating an AIDS patient in a poor nation at a record low of $200 a year, with less than half of that amount used to purchase drugs due to success in obtaining more low-cost generic therapies.

The big drop in outlays for medicines has been supported by FDA approval of generic versions of ARVs for use in poor nations through the President’s Emergency Plan for AIDS Relief (PEPFAR). FDA announced that it has tentatively approved more than 150 ARVS since 2003 to make patented drugs available to poor countries.

A “robust arsenal of antiviral drugs” and other interventions provide an opportunity for ending the HIV/AIDS pandemic, said Fauci, in a plenary address at the conference. (Just before the meeting, FDA approved Gilead Science’s two-ARV combination treatment Truvada as a pre-exposure prophylaxis, or PrEP.) “AIDS is on the run,” headlined The Economist, describing how the disease has shifted from a death sentence three decades ago to a manageable disease. Fauci and others raised the prospect of an AIDS vaccine. Talk of a “cure” was muted, but clearly in the minds of the 24,000 attendees of this international gathering, and there was optimism at the conference for the first time about bringing an end to the global AIDS pandemic.

Fauci and others urged donor nations and international organizations to recognize the value of spending more now to curb the spread of AIDS. Expanded treatment appears to reduce the rate of new infections, and conference officials released new guidelines calling for everyone infected with HIV to start ARV therapy immediately, instead of waiting until the disease progresses. This approach and other developments generated considerable optimism that a larger effort to control AIDS will pay very large dividends, and proposals for new taxes and other funding sources offer the prospect that needed funds will emerge.

Yet AIDS advocates raised concerns that over-reliance on drugs could do more harm than good. They and other experts urged continued promotion of condom use, voluntary male circumcision and prevention of mother-to-child transmission as more effective and affordable strategies for curbing the spread of infection.

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