Posted on Nov 25, 2010 by Sergio Ulloa
A study organized by the government of the USA and recently published in the New England Journal of Medicine, dubbed iPrEx (Phase III Chemoprophylaxis for HIV Prevention in Men), has shown that a once-a-day pill could be used to treat HIV positive patients in combating the virus. Recent trials of the combination drug Truvada have been completed with nearly 2,500 men participating in the research; it showed signs that the new drug could lower the chance of male-to-male HIV infection.
Gilead Sciences Incorporated - the California based drug manufacture of Truvada - has submitted an application to the FDA (Food and Drug Administration) for permission to market a single combination drug of Truvada (emtricitabine and tenofovir disoproxil fumarate) in addition with Tibotec Pharmaceuticals Ltd.'s TMC278 (rilpivirine hydrochloride) for treating adults infected with HIV. The two companies have been collaborating since June 2009, and the new combination drug is supposed to be a safer follow up to one of Gilead Science's previous combination drugs Atripla, which combined Truvada and Bristol-Myers Squibb Co.'s Sustiva (efavirenz).
The National Institute of Allergy and Infectious Diseases (NIAID) sponsored the recent study - known as iPrEx - through the non-profit independent research organization J. David Gladstone Institute, which is associated with the San Francisco based University of California. The drugs were donated by Gilead Sciences, with the Bill & Melinda Gates Foundation also providing additional funding.
Research has shown that if Truvada is taken by HIV sufferers, it could reduce the risk of infection by 44 percent - with a higher avoidance of contraction if the drug is taken on a regular basis. Almost 2,500 gay or bisexual men from the United States, Thailand, Peru, Brazil, Ecuador and South Africa were randomly selected to take-part in the trial, with half of the test group given a placebo.
Anthony S. Fauci, M.D., director of NIAID said "We now have strong evidence that pre-exposure prophylaxis with an antiretroviral drug, a strategy widely referred to as PrEP, can reduce the risk of HIV acquisition among men who have sex with men, a segment of the population disproportionately affected by HIV/AIDS,"
Participants from the six countries who took part in the study all received an intensive package of preventive measures to reduce the risk of HIV infection during the trial. The patients in the trial were given HIV testing, counseling on safe sex, condoms and medical treatment for sexually transmitted infections. Half of the test group were given Truvada, which was provided by Gilead Sciences for the study.
The tests were conducted over a 12 month period and found that if Truvada was taken it appeared to cut to the transmission of HIV by 44 percent, when compared with the group taking placebo tablets. The results from the initial studies - confirmed by blood tests - indicated that the pill could reduce transmission levels by up to 73% if taken on a regular and consistent basis.
If Truvada proves to be successful in the fight against HIV, it could be a major breakthrough in combating the spread of AIDS worldwide. A decision on how Truvada can be best used to possibly prevent AIDS occurring is still to be taken.
Further research is planned to be carried out among other groups, including women and intravenous drug users, to see if the drug can be used to control the virus. So far the research into Truvada has proven to be encouraging in controlling the global epidemic, with further studies planned for the future to see if any advances can be made.
There still areas of concern at this early stage, including the long term effect of taking the drug for an extensive period of time; concerns also cover the issues of how often the pill should be taken and the overall cost of the medication. In the USA, the cost of medication could be in the region of US$1,000 per month, while in low-income countries generic versions of the drug could cost a person around US$15 per month. The affordability of the drug is believed to be out of reach for many people who need it.
The key goal behind Truvada is to help stop HIV from reproducing. The anti-HIV drug is designed to combat the virus which attacks the immune system - made up of millions of cells - by helping in the fight against the infection. The recent study into the use of Truvada does not show the affect the drug may cause if taken regularly for a three year period.
The study into the use of Truvada is seen as a major advancement in the fight against HIV. UNAID reports that there is an estimated 33.3 million people HIV positive worldwide - although it is thought the epidemic peaked in 1999, with the number of new infections declining by 19 percent since; the UN now estimates that there are 15 million people living in low and middle income countries who require treatment for AIDS.
Although the virus has declined over the last decade, if the study on the benefits of Truvada evolves and proves to be successful, it is possible that it could cut the
transmission of HIV significantly and be a major step forward in global health. However, it is recognized that Truvada is not a preventive cure for HIV, but early findings show Truvada lowers the risk of the new infections among healthy gay men - emphasis being placed on the consistent application of correct safe sex methods as still the best form of protection against HIV infection.
Anthony S. Fauci, M.D., director of the NIAID further said: "Additional research is needed, but certainly this is an important finding that provides the basis for further investigating, developing and employing this prevention strategy, which has the potential to make a significant impact in the fight against HIV/AIDS."
The initial results of trials may prove to be significant in the battle against HIV/AIDS. The positive effects on the use of Truvada need to be expanded in order to develop new measures to prevent the transmission of HIV globally. It is vital additional research is completed in the development of medication to fight HIV, with the issues relating to costs, drug-resistant strains of HIV and the long team treatment process fully addressed.