The US Food and Drug Administration has approved the use of a drug designed to prevent HIV infection in advance. What are the disadvantages and advantages and what considerations must be taken into account if and when the use of the drug in Israel will be examined?
Rafael Shalhav Galileo
In May 2012, the Advisory Committee on Antiviral Medicines of the American Food and Drug Administration (FDA) recommended that the administration approve for the first time the use of a medicine designed to prevent infection with the HIV virus.
The drug, Truvada, is already being used today to slow down the spread of the HIV virus in infected people, to allow them a better quality of life. The new use would be the first time that drugs would be given to healthy people to prevent HIV infection only because of an increased risk and not because of actual infection. According to the studies that accompany the director's examination procedure, using the drug among healthy people reduces the risk of infection by about 75%.
Opinions among the experts are divided regarding the approval of the drug Troveda for prophylactic use. William McCall (McColl), the political director of the AIDS United organization, said that although the drug is not a panacea and does not provide a comprehensive answer, it is another factor that joins the complex of preventive solutions for AIDS and HIV - the virus that causes it. Dr. Robert Grant, the head of the panel that recommended the approval, was even more optimistic and was quoted as saying to the media that this is a significant milestone, in an era where for the first time we can see the end of the AIDS epidemic.
Talk about it in the forum
However, the recommendation was also met with resistance, mainly due to fears of excessive reliance on it. Some of the panel members expressed concern about the possibility that those who take the drug will reduce the use of condoms, which are the most successful preventive measure against infection with the HIV virus.
In the end, after a 12-hour discussion, the committee voted on three new indications for the use of the drug. The first indication includes approval for use among men who have sex with men, and it passed with a majority of 19 supporters against 3 opponents. The second recommendation is for the approval of the use among healthy spouses of HIV carriers, and it passed with a majority of 19 supporters against 2 opponents and one who abstained. The third recommendation is for the approval of the use among others who are at risk of infection through sexual activity, and it passed with a majority of 12 supporters against 8 opponents and 2 abstentions.
Preventive use - his reward for his loss?
In many cases prophylactic use of drugs may increase people's participation in dangerous activities, without fully protecting their safety. In some studies, for example, a correlation has been found between the use of sunscreen against the sun's radiation and melanoma, and one of the explanations offered for this is that people who use sunscreen feel safer to be exposed to the sun for long periods of time, even though the protection of their skin is not complete and even fades completely after a while .
Monitoring the behavior of sunscreen users revealed that many people tend not to use the cream according to the manufacturer's instructions, and that there is a tendency not to understand the type of protection that the cream provides. These two facts lead to a mismatch between the users' expectations and the product's features, and to the fact that the protection provided by the sunscreen is actually lower than what is indicated on the product itself.
As mentioned, one of the concerns raised in the deliberations of the committee that discussed the approval of the prophylactic use of Troveda is that a similar phenomenon will occur when taking the drug, and that the use will lead to the existence of unprotected sex.
This is not just a medical matter. Illustration: shutterstock
How exactly will the medicine be received in Israel?
An examination of the three indications for use that the committee recommended also raises some questions. Since the outbreak of the AIDS epidemic in the eighties of the 20th century, infection with the virus was associated in the eyes of many with a moral defect. While homosexuality was socially and legally unacceptable, the outbreak of the AIDS epidemic among the homosexual community in the United States led to the formation of a public stigma, which linked infection with the virus to inappropriate behavior. Even today, after social struggles, many of those who have been infected with the virus are afraid to be exposed for fear of judgment or the distancing of friends and family.
The US Centers for Disease Control (CDC) reports that the three main causes of HIV infection are sex between men, heterosexual sex, and injecting drugs. Another group known to have a high risk of infection are women and men engaged in prostitution. However, the advisory committee's recommendations do not include the indication for the use of the drug among drug users or those engaged in prostitution, and one can only wonder if one of the reasons for this is the fear that an official indication will be perceived in society as providing governmental and medical protection for illegal or unacceptable activities.
In addition to this, the questions of origin and race also have significance in terms of the percentage of infection with the virus, and in the United States the percentage of infection among African Americans is higher than that of whites. The indication for the use of the drug did not include a specific reference to this issue, leaving only a vague indication for use among users at increased risk due to sexual activity.
These questions will also arise in Israel, if and when the Ministry of Health examines the approval of the drug for use. Will the drug be approved for use among people who inject drugs to protect them from infection? Will the labeling explicitly mention population groups with a higher risk of infection? It is not known how exactly the medicine will be accepted in Israel, but it can be assumed that the American labels will serve as a guideline for any label that will be accepted in Israel.
At every stage, the committee will have to remember one significant point: the price of the medicine today, without medical insurance, is about 1,100 dollars, while its price under insurance in the United States is only about ten dollars. In Israel, where the health services basket determines which medicines will be given to the insured at a discount, a patient who requests a discount on the purchase of a medicine will only be entitled to it if the prescription is according to the label included in the basket. Thus, the difference between the registered label and the off-label use may be expensive in such a way that it will not allow certain populations to benefit from the protection that the drug provides.
AIDS prevention - a global view
The indications for the use of Troveda to prevent infection also raise questions about how the drug is used globally. The patterns of AIDS infection in third world countries are completely different from the patterns of infection in developed countries. UNAIDS, the United Nations program to fight the epidemic, states that most of those infected with the HIV virus in the world are in third world countries, and that most of them are women who have heterosexual sex, mainly due to the tendency of men to have unprotected sex with more than one partner. .
Another alarming phenomenon is the infection of children through their mothers. Most of the men infected with the virus are not aware that they have been infected, or the practical consequences of this on their health, therefore many of them do not receive treatment as carriers. The American Drug Administration's advisory committee, which directs its recommendations to the American public, recommended labels that are not beneficial to women at risk in many countries around the world, due to the different infection patterns.
Although the US labels do not have a direct impact on the use of the drug in other countries, it may have an impact on the ability of international aid organizations to use the drugs they buy with donation funds. In the absence of a label for the use of the drug in a manner that corresponds to the infection patterns in developing countries, the purchase of the drug for use outside of the label may encounter difficulties, since it is a use that has not been tested and approved.
The way drugs affect the human body is a scientific matter, but the way drugs are marketed and approved for use also includes many social and cultural elements. This is especially true when it comes to diseases whose mode of transmission is related to behavior patterns that change from place to place, and which leads to moral judgment in certain societies. If and when the use of the drug in Israel will be examined, the relevant authorities will have to consider these questions seriously, and make sure that the nature of the indication does not impair the ability to use the drug in the most beneficial way.
The full article was published in Galileo magazine, July 2012
