I have some exciting news to share with you about an HIV prevention pill that is getting a step closer to becoming the first drug approved to prevent healthy people from becoming infected with Human Immunodeficiency Virus (HIV), the virus that causes Acquired Immune Deficiency Syndrome (AIDS). It’s important to note that approval has not yet been given, but last Tuesday the United States Food and Drug Administration (FDA) said that the drug Truvada manufactured by Gilead Sciences, Inc. appears to be safe and effective for HIV prevention.
The report concluded that taking the pill daily could spare patients “infection with a serious and life-threatening illness that requires lifelong treatment”. On Thursday a panel of FDA advisers will consider the review when it votes on whether Truvada should be approved as a preventative treatment for people who are at high risk of contracting HIV through sexual intercourse. The article states that the FDA is not required to follow the advice of its panels, but it usually does.
If Truvada receives approval, it will be a major breakthrough in the thirty year campaign against the virus. According to the article, there are no other drugs proven to prevent HIV and a vaccine is believed to be decades away. This news will not assist those who are already infected with the virus, but it’s good news for HIV-negative people who wish to remain negative. Hopefully research will continue towards a vaccine for HIV-positive people and a breakthrough will not be too far away.
Researchers first reported that Truvada could prevent people from contracting HIV in 2010. Truvada is a combination of two older HIV drugs, Emtriva and Viread. A three year study has found that daily doses of Truvada cut the risk of infection in healthy gay and bisexual men by 44%, when accompanied by condoms and counseling. The FDA reviewers said on Tuesday that patients must be diligent about taking the pill every day if using it as a preventative measure and the adherence plays an important part in the effectiveness of Truvada for HIV prevention.
Adherence to the medication was less than perfect in clinical trials and the reviewers are concerned that patients may forget to take their medication even more than those in the clinical studies. I guess this comes down to each person making sure they adhere to the daily dosage requirements. The effectiveness of Truvada has previously been shown that adherence is essential, so anyone considering using Truvada as a way of preventing HIV needs to ensure they are prepared to take the pills when required each day, otherwise taking Truvada will be considered to be less effective.
An issue that could be a major barrier to the usage of Truvada is the cost. It is believed that Truvada’s price tag is $900 a month, or just under $11,000 per year. If you are paying that sort of money, it may make you adhere to the daily dosage requirements, but some may try to save costs by using it sporadically and that is a concern. It will be interesting to see whether Truvada is subsidized if approval is given by the FDA. Apparently some researchers have said that the prevention pill is not the chemical equivalent of condoms and they have concerns about this being a condom replacement.
- First drug for HIV prevention gets FDA nod – The Herald Sun