Controversial HIV drug approved

Controversial drug to prevent HIV

07/19/2012

Even after the approval of the HIV-preventive Truvada in the US, the drug remains controversial. While advocates like Margaret Hamburg of the US Food and Drug Administration (FDA) of one „Milestone in the fight against HIV“ speak, the critics point to the weaknesses of this preventive therapy. Users would be in false security, the viruses could develop resistance and the costs were clearly too high.

The newly-approved Truvada HIV drug from the US pharmaceutical company Gilead Sciences aims to significantly reduce the risk of HIV infection during sexual intercourse with HIV-positive persons. Healthy people living in partnership with people living with HIV are therefore advised to take preventive use of Truvada in the US in the future. However, the preventive medicine is by no means a substitute for condoms, but merely improves the protection against infection when used concurrently, according to the announcement by the US authorities on the occasion of the official approval of Truvada. Since the study data on the benefits and risks of the HIV-preventive medicine are not yet complete, the costs are relatively high and the development of resistances in the HIV virus is feared, however, there are many criticisms of the approval of the controversial drug.

In case of high risk of infection, take HIV-preventive medicine?
In future, people with a high risk of infection will be able to take Truvada once a day in the US and thus build preventive protection against HIV - that's the theory, at least. The US Food and Drug Administration (FDA) substantiated its approval of the drug with two studies that concluded that Truvada significantly reduces the risk of HIV infection for both heterosexual and homosexual people. In heterosexual couples in which one partner was HIV-positive, one clinical trial showed a 75 percent reduction in the risk of infection for healthy partners. In the other study, the risk of infection of homosexuals decreased by 73 percent after taking Truvada. Reason enough for the FDA expert Margaret Hamburg to accept the approval of Truvada „Milestone in the fight against HIV“ to call. Previously, Truvada was already prescribed to people with a positive HIV diagnosis as part of a combination therapy, but the now approved in the US preventive use is a novelty.

Risks with the HIV prevention drug Truvada
However, many questions remain open on HIV prevention and the results of further studies are expected in a few months. According to the critics, the previous study data are not sufficient to conclusively assess the mode of action of the pill - especially in the female organism. In addition, there is a risk that users could be weighed down by taking such medicines in false security. Also, some doctors have already expressed concern that the HI virus could develop resistance to Truvada. Furthermore, the previous efforts of the international community in the fight against AIDS in recent years, even without such preparations quite effective. UN Secretary-General Ban Ki Moon said in the foreword to the latest report of the United Nations HIV / AIDS Program (UNAIDS), „There is a real chance of eradicating new infections of children in the next three years.“ The number of HIV new infections as a whole, which had already fallen by 20 percent in the past ten years, is expected to fall further in the UNAIDS report.

Superfluous or useful HIV drug?
This raises the question of whether preventive use of Truvada is actually needed to contain HIV. Especially since contravene with condoms anyway no way over and Truvada can only be used in addition. Even the long-term drug supply of healthy people may indeed be a lucrative business for the manufacturer of the drug, but is criticized by critics sharp. Not only because under certain circumstances may threaten significant side effects, but also because at Truvada with approximately 1,000 euros per month incurred relatively high costs. For example, the announced approval of Truvada as an HIV-preventive drug will certainly be among the expected approximately 25,000 participants at the 19th International AIDS Conference in Washington. (Fp)

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Picture: segovax