In the absence of a cure or vaccine for HIV/AIDS, drug treatment has at least helped lower the pandemic's toll.
Since 2003, much of the treatment dispensed in hard-hit countries has come in the form of generic versions of previously expensive drugs. The President's Emergency Plan For AIDS Relief, or PEPFAR, has paid for quite a bit of the medicine.
While PEPFAR is credited with having saved 1.2 million lives, authors of a study published in the latest Health Affairs say its success was made possible, in no small part, by changes at the Food and Drug Administration.
Starting in 2004, the agency began expediting the tentative approval of generic drugs, allowing production of more than 140 generic versions of common antiretrovirals, or ARVs, to be offered through PEPFAR, according to the study.
A tentative FDA approval means the drug meets the agency's standards for safety, effectiveness and manufacturing quality. The approvals are tentative only because patents protect the brand-name drugs from generic drugs in the U.S. market.
The change at FDA brought PEFAR's share of the cost for drug treatment down from $1,100 per person annually in 2004 to $335 per person in 2012.
It's a drop, the study authors say, that allowed PEPFAR to offer the drugs to millions more people than would have otherwise been treated. In the 15 countries that PEPFAR targets, approximately 70 percent of those that receive ARV treatment get generic versions of the drugs, the study says.
But the future for generics is unclear, Kartik Venkatesh, the lead study author of the study, explains to Shots. While most generic drugs are manufactured in middle-income countries like India, restrictions imposed by the World Trade Organization on producing patented formulas has limited some development.
Changes over the past decade have slowed the advancement of generic second- and third-generation antiretroviral drugs, which health care workers use when patients develop resistance to the first-line regimens available.
In a presentation of the findings at a briefing on PEPFAR in Washington Tuesday, Venkatesh underscored the importance of access to new generic drugs. A commitment by President Obama in 2011 to provide ARVs to six million people worldwide by 2013, Venkatesh said, will depend on keeping drug prices down.
The stakes are high. "Making the drugs available earlier leads to a better clinical outcome for the individual and lowers the transmission risk for their partner," he said. "So it also gives us chance to potentially curb the epidemic."