Truvada is a once-daily pill that has the power to protect against the transmission of HIV. It proved to be 100 percent successful in a recent study.

A blue pill could be the key to preventing the spread of HIV, according to a new study.

Researchers found that Truvada, a once-daily pre-exposure pill, was 100 percent successful in keeping high-risk individuals from becoming infected with HIV.

Experts are notoriously skeptical about HIV-prevention drugs, but the recent results have brought renewed hope to the medial community.

The Study

Truvada is a fixed-dose combination of two antiretroviral drugs (Tenofovir, Emtricitabine) that is manufactured by Gilead Sciences.
Image:Instinct Magazine

Researchers at Kaiser Permanente in San Francisco conducted a study on Truvada to test it as a pre-exposure prophylaxis (PrEP). The observational study took two and half years and included 600 participants with a high risk of developing HIV.

The majority of participants were homosexual men who frequently engaged in sex with other men. All participants were healthy at the beginning of the study. Each individual was prescribed a daily regimen of the Truvada pill.

Previous PrEP treatments have reduced the risk of becoming infected with HIV by up to 92 percent when taken every day. A British study of homosexual men, called PROUD  showed that their risk was reduced by 86 percent.

In the most recent study, published in the Clinical Infectious Diseases, 100 percent of participants did not become infected with HIV.

The study is considered to be “the first to extend the understanding of the use of PrEP in a real-world setting and suggests that the treatment may prevent new HIV infections even in a high-risk setting,” according to lead author Jonathan Volk, a physician and epidemiologist at Kaiser Permanente San Francisco Medical Center.

The Future of PrEP

PReP treatments are gaining a lot of support, but questions about effects of the treatment and how it will change sexual practices have yet to be seen.
Image: Bent Con

In 2012, the Food and Drug Administration approved Truvada as a preventive HIV treatment.

Dubbed a “party drug” by the AIDS Healthcare Foundation, the opposition thought high-risk individuals would use it as a replacement for condoms, which could further spread other sexually transmitted diseases. The popularity of the hashtag #Truvadawhore illustrates how quickly the drug developed a bad reputation.

The study results are promising, encouraging many critics to change their minds. But a number of questions remain unanswered.

Researchers are studying factors that could influence the consistent use of the pill, its effectiveness if not taken before and after sex, and how to implement education programs in a standard medical atmosphere.

Truvada is being tested in clinical trials in different populations throughout the world. The National Institutes of Health in South Africa is testing the drug in heterosexual adolescent men and women ages 15 to 19. In Australia, the drug is being tested for people infected with HIV who are in relationships with HIV-negative partners.

When Truvada is released, it will need to be used in conjunction with additional protections like condoms. It will be interesting to see how the drug is priced and if  lower economic classes will be able to access it.

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Alexis Benter

A team at the Scripps Research Institute in California has discovered a new means to fight HIV, which could forever change the way the virus is treated and prevented. A different means of approaching vaccination, the treatment has started to show promise in primates.

The team believes this new treatment could revolutionize HIV and the way it is handled in treatment. The procedure involves changing the monkey’s DNA in already functioning blood cells with a complex gene therapy process. The change in the DNA alters the way in which the monkey produces blood.

After the procedure, the monkeys begin to produce all of the tools needed to fight and inhibit HIV. This treatment has the potential to be used in humans, and the team at Scripps is excited to start human trials as soon as possible.

“This innovative research holds promise for moving us towards two important goals: achieving long-term protection from HIV infection, and putting HIV into sustained remission in chronically infected people,” said Dr. Anthony Fauci of the US National Institutes of Health in an article with BBC.

One of the troubles with HIV vaccines in the past is that they’ve struggled to keep up with the rapid manner in which HIV multiplies and changes in the body. The vaccines produced cannot keep up with the virus, and thus prove ineffective. This new approach is stronger than any antibody in fighting the disease.

This treatment holds the potential to eradicate HIV across the globe. Its effectiveness in treating monkeys and its strength in fighting the virus make it a treatment and prevention option worth paying attention to. Moreover, regular STI testing is crucial for maintaining sexual health. Ensuring that individuals get tested for STIs on a regular basis is essential, and you can find more information about STI testing and its importance linked here.

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Playing Devil’s Advocate: The FDA

Enacted at the height of the AIDS epidemic in the 1980s, the original ban was put in place when the virus was not yet understood. Although a lot has changed since then, the FDA still depends on a wide margin of error for all blood donations, claiming that the policy change is consistent with existing limitations placed on other individuals.

For example, the current policy indicates that a one-year deferral period is necessary for people who are at risk from exposure to malaria or from engaging in sex with prostitutes or intravenous drug users, according to The New York Times.

Via: Imgarcade

The medical reason for not lifting the ban entirely is the “window period” between infection and a positive test result. But thanks to the quickness and accuracy of modern HIV-testing, some scientists argue that it is unlikely for infected blood to be introduced into the system. The FDA, guided by an advisory committee to the U.S. Department of Health and Human Services, disagrees.

“At this time we simply do not have the scientific evidence to show that you can go to a shorter period,” said Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research.

Playing Devil’s Advocate: LGBT Activists

While it is the FDA’s responsibility to be cautious, rights groups believe that the ban is unsupported by scientific claims, and that it continues to play on outdated stereotypes. Lambda Legal calls for a shorter deferral period of two months or less, claiming “within 45 days of exposure, currently required blood donation testing detects all known serious blood-borne pathogens, including HIV,” according to an article from The Wall Street Journal.

Activists believe that these regulations hold gay men to a different standard, asserting that many men who have sex with other men are in monogamous relationships and consistently use protection during sexual encounters. According to the Huffington Post, the American Medical Association supports conducting individual risk assessments, which focus on behavior instead of sexual orientation.

Via: Ars Technica

The Numbers

“The Williams Institute on Sexual Orientation and Gender Identity Law at the University of California, Los Angeles said in September in a study that eliminating the ban would bring in 615,300 pints of blood annually. Instituting a one-year deferral period would bring in 317,000 pints, the study found,” according to Reuters.

While some are satisfied with taking incremental steps, others claim that if the ban were removed entirely, the expected supply could potentially double. Although the nation’s reserve is reported to be relatively stable, the American Red Cross asserts that there is always a need for more blood.

The indicated policy change will increase the supply by hundreds of thousands of pints per year, but it will not go into effect right away. The FDA is expected to publish a draft guidance that will be followed by a comment period in early 2015, which will decide whether or not the policy change will become final.

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   Big Pharma should not be trusted blindly. Pharmaceutical companies have shown they are willing to put profits before people: lying about side effects, faking clinical trials to get drugs approved and even selling contaminated medicines. One such case of Big Pharma’s greed began in the early 1980s, and involved an emerging disease known as AIDS. Cutter Biological, a division of Bayer Corporation—that’s right, the company that makes your aspirin—discovered in 1983 that some of the blood plasma it was selling to hemophiliacs contained the AIDS virus. Baxter International, the second-largest manufacturer of blood products, discovered the same year that its blood plasma was also infected.

   The contaminated product was Factor 8, a blood-clotting protein. Hemophiliacs are unable to produce Factor 8 on their own, which leads to excessive and unstoppable bleeding. Hemophiliacs need regular infusions of blood plasma to supplement Factor 8, or a minor cut can cause them to bleed to death. Baxter International and Bayer Corporation were the two largest manufacturers of Factor 8, and hemophiliacs in the US had no where else to turn to get this medicine.

   The Center for Disease Control warned in 1983 that blood products like Factor 8 were infecting hemophiliacs with AIDS. An outbreak of AIDS among hemophiliac children in the US was traced straight back to Bayer’s Factor 8 product. Ryan White was diagnosed in 1984, at the age of 13, with HIV. Ryan was a hemophiliac who had taken contaminated Factor 8. He was one of 10,000 Americans, mostly children, who contracted HIV/AIDS after taking contaminated Factor 8 made by Bayer and Baxter.

Profits Before People

   Documents later revealed that Bayer and Baxter made a practice of getting blood serum from high-risk groups of people. They put profits before people, taking blood from groups at a high-risk of having infectious diseases in order to save money. On top of this, Bayer and Baxter violated federal law by not testing the blood for diseases.

Taking Lives For Money

   At the same time, Bayer and Baxter made a “voluntary agreement” with the FDA to stop selling the contaminated serum. Despite this, Bayer and Baxter continued to sell their remaining stocks of the contaminated Factor 8 to Asian and Latin American countries. When FDA regulators found out that Bayer and Baxter were still selling the AIDS-infected products, instead of filing criminal charges, they offered to help hush it up. In a meeting with Bayer and Baxter executives, Harry Meyer, the FDA’s chief regulator in charge of blood products, said he wanted to resolve the issue “quietly … without alerting Congress, the medical community and the public.”

   Executives at Bayer and Baxter knew the blood plasma was contaminated yet they continued selling it across the world. The FDA, supposed to protect consumers from dangerous medicines, conspired with Bayer and Baxter to keep the public and Congress in the dark about the contaminated blood plasma. In a meeting with Bayer and Baxter executives, Harry Meyer, the FDA’s chief regulator in charge of blood products, said he wanted the crisis to be resolved “quietly … without alerting Congress, the medical community and the public.” Bayer and Baxter kept selling contaminated blood plasma and the FDA helped them cover up the facts. Harry Meyer, the man in charge of defending the public, told Big Pharma executives he wanted the matter dealt with “quickly and quietly.”

No Justice

   Nobody knows exactly how many people outside the US were infected by Bayer and Baxter’s contaminated blood plasma, but there was hell to pay. The leaders of health departments and drug company executives in Argentina, Indonesia, Japan, Malaysia, Portugal and Singapore were sent to jail for negligence, while the real criminals—the FDA and Bayer and Baxter’s top executives—walked away. Despite the tens of thousands of people whose lives were cut short by this conspiracy, no criminal charges have been filed against Bayer, Baxter, the FDA or anyone else in the United States.

   American hemophiliacs have been left on their own, forced to sue Bayer and Baxter in civil courts. The saddest part is that many hemophiliacs must still buy Factor 8 from the same companies—Bayer and Baxter—that infected and killed thousands of their fellow sufferers throughout the 80s and early 90s. They have no alternative, and can only hope the medicine they need to survive isn’t tainted or contaminated by Big Pharma, with the FDA turning a blind eye.

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