HIV protection anti-AIDS pill no miracle cure

Truvada: doctors criticize HIV drug

05/14/2012

An independent panel of experts recommended to the US Food and Drug Administration (FDA) last Thursday the preventive anti-AIDS medicine „Truvada“ To protect against HIV infection, to grant a marketing authorization. Except for the last resort, the FDA's approval, the anti-AIDS pill in the US Sector has overcome all hurdles. But many physicians are skeptical and criticize the high expectations that are probably connected with drug. In addition, the remedy partly has significant side effects.

Protective agent before AIDS
Many international pharmaceutical companies have been working on a means to protect against AIDS for a long time. For the first time in the US, a pharmaceutical company has climbed nearly all the hurdles to reach a preventive remedy for the spread of HIV infection. „A pill against AIDS?“, By no means say many experts. For the remedy could lead many people to underestimate the risk of the deadly infectious disease. In addition, the remedy must be taken exactly according to the prescription instructions in order to fully develop its effectiveness.

Expert Committee approves market delivery
After an eleven-hour session and numerous other hearings, almost all of the twenty-two independent experts have received marketing approval for the drug developed by the pharmaceutical company Gilead Sciences „Truvada“ agreed. In most cases, commercialization of pharmaceuticals is therefore open-ended, as the FDA authority invariably adheres to the recommendations of the Commission, although it has a duty to do so. A final decision is expected by mid-June 2012. The decision is to authorize a preventive medicine. Truvada is already being successfully used in combination with other medicines to treat HIV and AIDS patients.

In the course of a clinical study, the risk of infection among heterosexual partners, one of whom was a partner „sero-positive“ was to be lowered by a maximum of 75 percent. Another study found that the risk of HIV infection among homosexual non-infected persons could be reduced by as much as 73 percent.

Preventive anti-AIDS pill no miracle cure
Many experts consider the market availability due to numerous criticisms at least skeptical. On the one hand, drug therapy causes up to $ 14,000 (around € 10,800) a year. Second, Truvada „not a miracle cure“, As the chairman of the anti-AIDS group AVAC, Mitchell Warren said after the committee consultation. However, Warren also sees one in the remedy „important contribution to the fight against AIDS.“ Many millions of women and men who have a potential HIV risk offer „every new possibility of HIV prevention gives extra hope.“ This refers above all to spouses or life partners of HIV-infected persons.

Physicians and nursing staff who treat and care for HIV-infected and AIDS-ill patients in clinics on a daily basis expressed skepticism. Dr. med. Roxanne Cox-Iyamu of the Elizabeth Taylor Medical Center in Washington warned that the viral pathogen might develop resistance to "Truvada". Furthermore, in the light of the data, it is clear that the effects on women are inadequate. According to the physician, the data collection revealed that the active substance in the female organism shows fewer effects overall. Her colleague and nurse Karen Haughey warned that the anti-HIV pills are not completely safe. Finally, unwanted and serious side effects like „Liver failure and severe diarrhea“ occur, said Haughey. In addition, the remedy must be taken regularly and exactly according to prescription. The „demand from the patients a high self-discipline“, she said. Otherwise, modes of action are not as desired.

Large-scale study showed protective effects
The study data of the remedy originate from the „iPrEx HIV prevention study“, in 2010 in the medical journal „New England Journal of Medicine“ has been published. Scientists tested the anti-AIDS pill between 2007 and the end of 2009 on nearly 2,500 gay-oriented men in Brazil, Ecuador, Peru, Thailand, South Africa and the USA. All participants were not infected with HIV at the beginning of the research work and were continuously examined. Before the start of the study, all subjects were randomly divided into two equal groups. One group was given the new drug and another part a pill without an active ingredient (placebo). The study participants were informed about the transmission risks and did not know themselves, which preparation they took in the long run. In the end, it was found that up to 73 percent fewer HIV infections in the drug drugs were made when the pills were taken regularly.

Those who did not take the regulations quite precisely and took Truvada only infrequently, showed in the result a significantly low protective effect. Here the rate was 44 percent fewer infections compared to placebo. The results of that time were in the professional world „as a breakthrough“ considered in the prevention of AIDS.

The study was already heavily criticized at that time. The Aids scientist from the University Hospital Essen, Dr. Stefan Esser, the study was "ethically questionable" because healthy people would be treated instead of infected people. Aids patients should be treated better. This also minimizes the risk of infection and at the same time help the patient, so Esser. (Sb)

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AIDS: drug to protect against HIV infection

Picture: segovax