Tuesday, September 18, 2012

The first HIV prevention pill is now on the market.

The Food and Drug Administration approved a new drug, Truvada, on July 16, 2012. While this antiretroviral drug is not a cure for HIV/AIDS, it is meant to help lower the risk of contracting HIV. The pill is for high risk individuals, including sex workers, IV - drug users, gay and bisexual men with multiple sexual partners, uninfected people in long-term relationships with partners who have HIV/AIDS, and heterosexuals who regularly engage in risky sexual behavior.

Truvada is not new. The drug was approved in 2004 and was taken in combination with other antiretroviral drugs for treatment with HIV. Truvada combines the anti-HIV drugs Emtricitabine and Tenofovir disoproxil fumarate into one pill. The drug blocks the action of a protein that HIV needs to replicate in a person's body. The cost is around $14.000 per year. The pill is to be taken once a day, and safe sex still has to be practiced. In order to qualify for Truvada, individuals must be HIV negative and must get tested every third month. This is to assure that you are still HIV negative, otherwise you might develop a resistance to the antiviral.

The Debate
The approval of Truvada has caused contentious debates. Some public health experts argue that Truvada will foster a false sense of security among users, leading people to believe they are immune to the virus and reducing their use of condoms. To prevent this, the FDA has worked with the manufacturer, Gilead Sciences, to develop a risk evaluation and mitigation strategy that includes educational programs for health professionals who prescribe the drug. Physicians are required to talk with their patients regularly about their sexual behavior and how to take the drug in order for it to work correctly. Other health professionals have raised concerns about the possible difficulty of people remembering to take their pill every day and ask how unrealistic it might be to prescribe a daily pill to a healthy, HIV negative person. Another concern is the high cost of Truvada. People who really need it may not be able to afford it. There is no guarantee that Medicaid, Medicare, or private insurance would cover the cost of Truvada. Many of those who are at high-risk are in lower socio-economic groups. Patent laws in the US will likely block the availability of cheaper generic versions of the pill.

Don't despair; there are solutions to these obstacles.
Saying the drug is too dangerous or that people will forget to take the pill every day is paternalistic, some argue. If the drug is prescribed to a patient, the physician must make sure the patient understands that Truvada is not a miracle pill to prevent HIV. There can be no confusion about how to use the drug. If people want to protect themselves, they should have the right to do so. Besides, women in theUS and other countries remember to take birth control pills to prevent pregnancy–demonstrating taking one pill every day can be worked into a person's routine.

Governments should pay for the drug. One might ask why he or she should be responsible for someone else's health, sexual behavior or personal choices. Here is why:

HIV and AIDS are everyone's problem. There are 50.000 new infections in the United States every year. Governments and their citizens have made great progress battling HIV and AIDS. We have launched safe sex campaigns and have educated people about the epidemic, but these efforts will only do so much. Everyone knows that most people will not stop having sex! While Truvada will not end the nation's HIV/AIDS epidemic, it will decrease the rate of new infections in the US over time (and perhaps in the rest of the world too if other countries approve this preventive drug.) The HIV/AIDS crisis is not contained at present; HIV and AIDS do not discriminate. We all need to combat the spread of HIV/AIDS in order to end this epidemic.

Read the FDA's statement here: http://www.cdc.gov/nchhstp/newsroom/FDA-ApprovesDrugStatement.html

Sanna Klemetti

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