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An independent panel of experts recommended the US Food and Drug Administration (FDA) last Thursday to grant marketing authorization for the preventive anti-AIDS drug “Truvada” to protect against HIV infection. Except for the last resort, FDA approval, the anti-AIDS pill has passed all hurdles in the US sector. However, many doctors are skeptical and criticize the high expectations that are probably associated with medication. In addition, the agent sometimes has significant side effects.
Protective agent against AIDS
Many international pharmaceutical subgroups have been working on a drug that protects against AIDS for a long time. In the USA, a pharmaceutical subcontractor has now climbed almost all hurdles for the first time in order to achieve a preventive measure against the spread of HIV infections. "A pill against AIDS?", By no means say many experts. Because the drug could lead many people to underestimate the risk of fatal infectious disease. In addition, the drug must be taken exactly in accordance with the instructions in order to fully develop its effectiveness.
Committee of Experts Approves Market Access
After an eleven-hour session and numerous other hearings, almost all of the 22 independent experts approved the marketing authorization for the drug "Truvada" developed by the pharmaceutical manufacturer Gilead Sciences. In most cases, the commercialization of medicinal products is open because the FDA authority adheres to the recommendations of the Commission without exception, although there is an obligation to do so. A final decision is expected by mid-June 2012. The decision is the approval of a preventive agent. Truvada is already being used successfully in combination with other medications to treat HIV and AIDS patients.
In the course of a clinical study, the risk of infection in heterosexual life partners, one of whom was "sero-positive", was reduced by a maximum of 75 percent. Another study concluded that the risk of HIV infection among homosexual non-infected people could be reduced by up to 73 percent.
Preventive anti-AIDS pill not a miracle cure
Many experts are at least skeptical about the market growth due to numerous criticisms. For one, drug therapy causes up to $ 14,000 a year. On the other hand, Truvada is "not a miracle cure", as the AVAC anti-AIDS group chairman Mitchell Warren said after the committee's consultation. However, Warren also sees the drug as an "important contribution to the fight against AIDS." Many millions of women and men who are at risk of HIV offer "every new possibility of HIV prevention offers additional hope." Spouse or life partner of people infected with HIV.
Doctors and nursing staff, who treat and care for HIV-infected and AIDS patients every day in clinics, expressed skepticism. Dr. med. Roxanne Cox-Iyamu of the Elizabeth Taylor Medical Center in Washington warned that the viral pathogen could develop resistance to "Truvada". Furthermore, in view of the data, it can be seen that the mode of action in women is inadequate. According to the doctor, the data collection showed that the active ingredient had fewer effects in the female organism. Her colleague and nurse Karen Haughey warned that the anti-HIV pills are not entirely safe. Eventually, undesirable and severe side effects such as "liver failure and severe diarrhea" can occur, said Haughey. In addition, the drug must be taken regularly and exactly according to the regulation. That "demands a high degree of self-discipline from the patients," she said. Otherwise, modes of action are not as desired.
Large-scale study showed protective effects
The study data of the drug originate from the "iPrEx HIV Prevention Study", which was published in 2010 in the medical journal "New England Journal of Medicine". Scientists tested the anti-AIDS pill on almost 2500 gay-oriented men in Brazil, Ecuador, Peru, Thailand, South Africa and the USA from 2007 to the end of 2009. All participants were not infected with HIV at the start of the research work and were also continuously examined. Before the study began, all subjects were randomly divided into two equal groups. One group received the new agent and another part a pill without active ingredient (placebo). The study participants were made aware of the transmission risks and did not know which preparations they were taking in the long term. In the end, it turned out that up to 73 percent fewer HIV infections with the active ingredient medication occurred if the pills were taken regularly.
Those who did not take the regulations quite as strictly and only ingested Truvada irregularly showed a significantly lower protective effect as a result. Here the rate was 44 percent fewer infections compared to placebo. The results of that time were considered "a breakthrough" in the prevention of AIDS by experts.
The study was heavily criticized even then. The AIDS scientist from the University Hospital Essen, Dr. Stefan Esser, the study is "ethically questionable" because it treats healthy people instead of infected people. It is better to treat people with AIDS. This also minimizes the risk of infection and at the same time helps the patient, says Esser. (sb)
AIDS: drug is said to protect against HIV infection
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