The U.S health care system could save over $1 billion dollars a year if they replace current antiretroviral drugs for HIV infection with generic versions of the medications, a risky move that could seriously affect the efficacy of HIV treatment.
The implications of such a change was explored in a study published in the January 15 edition of Annals of Internal Medicine.
According to the lead author of the study, Rochelle Walensky, MD, MPH, of the MGH Medical Practice Evaluation Center:
"The switch from branded to generic antiretrovirals would place us in the uncomfortable position of trading some losses of both quality and quantity of life for a large potential dollar savings.
By estimating the likely magnitude of these offsetting effects now - before generic antiretrovirals actually hit the shelves - we can confront our willingness as clinicians, patients and as a society to make these difficult choices."
Antiretroviral drugs cost the country about $9 billion a year, most of which is funded by the government. The current drugs on the market include Atripla which contains three brand-name antiretrovirals: emtricitabine (Emtriva), efavirenz (Sustiva), and tenofovir (Viread). There is already a generic drug called lamivudine very similar to emtriciabine as well as a generic form of efavirenz expected in the near future.
By replacing two of the three brand name medications, patients will soon be able to take these much more inexpensive generic forms of the drugs along with the brand name drug tenofovir, potentially saving the country millions of dollars. However, this comes at a cost, as it is thought that because the treatment regime is more complicated - patients have to take three separate drugs, rather than just the one - there may be more patients missing doses, which makes it much more likely that the treatment is not effective.
In addition, scientists found that the effectiveness of lamivudine (a generic drug very similar to emtricitabine) is slightly inferior to the brand name version - it's less resistant to certain viral strains.
The researchers simulated the effects of taking the two generic drugs along with tenofovir using a complex mathematical model of HIV progression. They were able to examine the efficacy of the daily three-pill regime by including a worst case scenario in the simulation - to test their viral resistance.
If all HIV patients in the U.S were to take generic forms of medications it would cut the total cost of treating them by nearly $42,500 per person. This would amount to savings of around $1 billion for the country as a whole.
The study's senior author, Bruce Schackman, PhD, associate professor of Public Health at Weill Cornell Medical College, says:
"Diverting patients from the most effective, branded treatment alternative could be made more acceptable if the savings were directed to other HIV-related needs. For example, fewer than half the state-funded AIDS Drug Assistance Programs include the effective protease-inhibitor-based treatment for hepatitis C virus (HCV), which infects up to 25 percent of HIV-infected individuals. We calculated that, for every 15 patients switched to the generic-based regimen, one who is also infected with HCV could be treated and potentially cured of that infection."
Walensky, a professor of Medicine at Harvard Medical School believes that if people are consistent with their daily-three pill medication regime, regardless of how complex it may be, the effectiveness will be consistent with the standard form of treatment - of only taking the one pill. However, he also notes that if a patient has become used to to the simple nature of only having to take one pill, the risk of treatment failure will be higher.
"There's no getting around the fact that savings from generics will only be realized if we deliberately route patients away from the most effective, branded treatment alternative," she stresses. "This is a trade-off that many of us will find emotionally difficult, and perhaps even ethically impossible, to recommend. All of us - consumers, providers and advocates - would be far likelier to embrace such a policy change if we knew the savings would be redirected towards other aspects of HIV medicine."
The advantage of generic drugs is that they are significantly more cost effective than brand-name alternatives, they played a crucial role in the U.S. government's plan for AIDS relief in over 15 countries, helping to save millions.