MARKING A MILESTONE TO ENDING THE HIV/AIDS VIRUS

Scientist and researchers strongly believe to this day that the chimpanzee version of the immunodeficiency virus in which is called “Simian immunodeficiency virus or SIV” most likely was transmitted amongst humans and mutated into HIV when humans use to hunt chimpanzees for meat and came into contact with their infected blood. However over decades, the virus slowly spread across Africa and later into other parts of the world;

The first discovery of a human becoming infected with the HIV-1 virus was first detected in the Kinshasa section of the Democratic Republic of the Congo (DRC), A blood sample in which was collected from a man in the Kinshasa section of the DRC came back that he had been infected with the HIV-1 virus during that time and up until now how this man’s immune system became compromised with the HIV-1 virus was and still remains unclear to scientist and researchers.

Since the discovery of this virus was detected scientist and researchers have devoted enormous amounts of time, man power and financial investments into further understanding the emergence of this new virus that has broken out into an epidemic.

Over the decades scientist and researchers have not let this virus slip out of control, they first took a grasp on it between the late 1950’s and the early 1970’s during the time period in which antibiotics was first introduced, with a major outbreak over in the African Nation scientist and doctors started a massive antibiotic injection campaign in which had been designed to combat this new strain of virus in the human immune system.

In the advancements of our decades the science and pharmaceutical industries also advanced in science and medicine, by 1987 a new pharmaceutical company emerged by the name of “Gilead Sciences” since this Pharmaceutical companies emergence the company has been devoted to the advancement in medicine and have been primarily concentrated on the advancement of antiviral drugs which are used in the treatment of viruses such as the HIV, hepatitis B, hepatitis C, and influenza viruses.

It was not until decades later that Gilead Sciences took a strong hold on the human virus by researching and producing a HIV-1 preventative medicine called Truvada (AKA PReP)which is a combination of both antiviral medicines tenofovir and entricitabine, after endless amounts of time and resources spent into the research and discovery of this new HIV-1 preventative medicine the pharmaceutical company attempted to get it approved by the United States Food and Drug Administration.

On July 16, 2012 The U.S. Food and Drug Administration (FDA) approved Truvada (tenofovir plus emtricitabine) for release to the public and deemed it to be effective in the combat to gain a much stronger hold over such an epidemic, Both medical professionals and all those involved in the fight to put an end to this epidemic strongly feel that we as entire world have became very knowledgeable and understanding of this outbreak and feel that Truvada has taken us one step closer to finding a much needed cure to the battle of this virus.

In a FDA press release professionals stat the “The approval of Truvada marks an important milestone in our fight against HIV," said FDA Commissioner Margaret A. Hamburg, M.D. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

As a part of this action, the FDA is strengthening Truvada’s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status. The FDA strongly recommends against such use.

"The REMS for Truvada for the PrEP indication is aimed at educating health care professionals and uninfected individuals to help ensure its safe use for this indication without placing an unnecessary burden on health care professionals and patients," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The release in which was released by the FDA continued to states; “Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection, such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status, a high number of sex partners, and exchange of sex for commodities. Results showed Truvada was effective in reducing the risk of HIV infection by 42 percent compared with placebo in this population. Efficacy was strongly correlated with drug adherence in this trial.

The Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not (serodiscordant couples). The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75 percent compared with placebo.

No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.

As a condition of approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of seroconversion, and resistance development in seroconverters. Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada for a PrEP indication and to develop an adherence questionnaire that will assist prescribers in identifying individuals at risk for low compliance”

Ever since this milestone has been marked this has taken our science and pharmaceutical industries one step closer in the advancement of finding the cure to end this epidemic, researchers state that even though we are one step closer we still have many strides to take in order to put a complete end to the HIV/AIDS epidemic.

Over 50 years ago today scientist, researchers or medical professionals had no knowledge or understanding of this virus and had no way of treating however its due to the endless amounts of time and resources that are continuously devoted along with the advancements in technology in which gave all medical and science professionals in-depth details and understanding into the HIV/AIDS virus.

Truvada is not intended for everyone, anyone interested in starting Truvada is encouraged to talk to your health care professional before starting Truvada.

For Additional Information You Can Visit TRUVADA Online

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