Good news-FDA Approves First Drug to Reduce Risk of HIV Infection

What Is AIDS? What Is HIV?

AIDS (Acquired immune deficiency syndrome or acquired immunodeficiency syndrome) is a disease caused by a virus called HIV (Human

Immunodeficiency Virus). The illness alters the immune system, making people much more vulnerable to infections and diseases. This susceptibility worsens as the disease progresses.

HIV is found in the body fluids of an infected person (semen and vaginal fluids, blood and breast milk). The virus is passed from one person to another through blood-to-blood and sexual contact. In addition, infected pregnant

women can pass HIV to their babies during pregnancy, delivering the baby during childbirth, and through breast feeding. HIV can be transmitted in many ways, such as vaginal, oral sex, anal sex, blood transfusion, and contaminated hypodermic needles. Both the virus and the disease are often referred to together as HIV/AIDS. People with HIV have what is called HIV infection. As a result, some will then develop AIDS. The development of numerous opportunistic infections in an AIDS patient can ultimately lead to death.

According to research, the origins of HIV date back to the late nineteenth or early twentieth century in west-central Africa. AIDS and its cause, HIV, were first identified and recognized in the early 1980s. There is currently no cure for HIV/AIDS. Treatments can slow the course of the disease - some infected people can live a long and relatively healthy life.

New research- FDA Approves First Drug to Reduce Risk of HIV Infection

 

Important point of research….

The drug is not a substitute for safer sex practices

Patient Must Be HIV-Negative

To get this information you can use HIV Home Test Kit

The US Food and Drug Administration (FDA) announced on Tuesday that is has approved the first over the counter HIV test kit that allows Americans to test, in the privacy of their own homes, whether they are infected with the virus that causes AIDS.

 

The OraQuick In-Home HIV Test detects the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). It is the first rapid diagnostic test for any infectious disease that the FDA has approved for sale over the counter.The kit, from OraSure Technologies of Bethlehem, Pennsylvania, is an over the counter version of a test used by trained technicians in clinical settings that the FDA approved in 2004.The user takes an oral swab, and places it in a specially prepared vial that comes with the kit. The result is ready in 20 to 40 minutes. The kit is not as reliable as getting tested by a trained clinician.

A positive result does not necessarily mean that the user is definitely infected with HIV, but that they should then go and get themselves tested in a medical setting to confirm the result. Similarly, a negative result does not necessarily mean the user is definitely not infected: particularly if they may have picked up the virus in the previous three months. Based on clinical studies, the kit is expected to show one false positive out of every 50,000 results and one false negative out of every 12 results. The idea is not for the home test kit to replace medical testing, but to provide another route for people to find out their HIV status. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, told the press, knowing your status is an important factor in the effort to prevent the spread of HIV.

The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate," she added.

The US Food and Drug Administration (FDA), announced on Monday that it has approved a existing drug, Truvada for reducing risk of infection by sexually transmitted HIV-1 in adults. This is the first drug the FDA has indicated for uninfected adults at high risk of acquiring HIV through sex. HIV-1 is the most common form of the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). Agency experts say Truvada, produced by Gilead Sciences Inc, should be used in combination with safe sex practices. The once-daily oral medication is a combination of two antiretroviral drugs used to treat HIV: tenofovir disoproxil fumarate and emtricitabine.

Clinical Trials

The data supporting the approval of Truvada for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP), comes primarily from two large placebo-controlled trials that showed taken once daily, the drug significantly reduced the risk of HIV infection in uninfected adults at high risk of acquiring the virus through sex.

One trial, called Pre-Exposure Prophylaxis Initiative (iPrEx), involving about 2,500 HIV-negative gay and bisexual men and transgender women, showed the drug reduced risk of HIV infection by 42%. That trial was sponsored by the US National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation.

The other trial, called Partners PrEP, involving about 4,800 heterosexual couples where one partner was HIV positive and the other was not, found the drug reduced risk of infection by 75%. That trial was sponsored by the University of Washington and funded by the Bill and Melinda Gates Foundation. Connie Celum, Professor of Global Health and Medicine at the University of Washington and lead investigator of the Partners PrEP trial, said,The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure.

Several other studies also support the use of Truvada for HIV risk reduction.

In all trials of Truvada for PrEP, the most commonly reported adverse events were headache, stomach upset and weight loss. The frequency and types of side effects are similar to use of the drug for HIV treatment, which now has a history of four million years of patient use.

Altogether, treatments containing tenofovir, add up to nine million patient years of experience.

New Use of An Existing Drug

Truvada, currently the most-prescribed antiretroviral in the US, was approved in 2004 in combination with other antiretrovirals, to treat HIV-infected adults and children over 12 years old. The drug works by stopping HIV from establishing itself and multiplying in the body.

Debra Birnkrant is director of FDA's Division of Antiviral Products. She told the press thanks to medical advances, and the availability of nearly 30 approved individual HIV drugs, we can now treat the infection as a chronic disease most of the time, instead of the life-threatening disease we used to view it as in the 80s and 90s. "But it is still better to prevent HIV than to treat a life-long infection of HIV," she said. Safe use of Truvada for HIV Prevention

Gilead and the FDA have produced a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of Truvada for PrEP. The REMS materials aims to educate and inform uninfected patients and their doctors about how to use Truvada for HIV prevention.

They point out Truvada for PrEP should only be used by HIV-negative patients, and emphasize the importance of sticking strictly to the dosing regimen and of understanding the drug should only form one part of a comprehensive strategy to prevent HIV-1 infection. They also note that treatment should not be initiated when clinical signs or symptoms consistent with acute HIV-1 infection are present.

The comprehensive strategy includes consistently using condoms correctly, receiving counseling for risk reduction, regular HIV tests every three months, and being treated for other sexually transmitted diseases.

The drug is not a substitute for safer sex practices, said Birnkrant.

In a press statement, Gilead has announced the company will issue vouchers for free HIV tests and condoms, and provide an opt-in service that sends regular reminders about HIV testing. It will also subsidize HIV resistance testing for anyone who becomes HIV-positive while taking Truvada for PrEP. The company also announced that, based on the iPrEx trial results, in January 2011, the US Centers for Disease Control and Prevention (CDC), issued interim guidelines on how to use Truvada as PrEP among high risk men who have sex with men.

The CDC is in the throes of developing formal guidelines for use of the HIV prevention drug with men and women. These will include procedures for HIV testing and health screening prior to treatment, as well as ongoing surveillance of cases of infection that may arise despite use of the drug, monitoring of any drug resistance among those who become infected, as well as side effects and clinical toxicities.

Patient Must Be HIV-Negative

In their press announcement, the FDA emphasize the importance of ensuring Truvada as PrEP is only given to patients who are HIV-negative. This is because when the drug is used to prevent HIV, the patient must also take a third drug, so the treatment is not the same as for a patient who is already infected.

Which of the other approved HIV drugs is taken with Truvada depends on the patient, said Birnkrant. Also, before prescribing Truvada as PrEP, doctors must consider with their patients a number of factors in order to weigh the risks against the benefits, said Birnkrant. These include:

The patient must undergo an HIV test to ensure he or she is HIV-negative.

The patient must not have flu-like symptoms: these are a "red flag" because they could be early signs of acute HIV infection, even if the test is negative. It takes time for the antibodies that indicate HIV infection to appear in the blood and in the meantime they won't be picked up in a test.The safety concerns about Truvada are linked to effects on bone and kidneys. Although evidence from trials suggest these are mild and reversible once medication ceases, people with a history of bone or kidney problems should have regular monitoring if they take the drug.

Patients should also undergo tests for hepatitis B, because these infections can worsen in patients who are co-infected with HIV-1 and hepatitis B when medication with Truvada ceases.