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The U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.
The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.
As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.
"Today’s approval 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.
Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of development of resistant HIV-1 variants. The central component of this REMS is a training and education program to assist prescribers in counseling individuals who are taking or considering Truvada for PrEP. The training and education program will not restrict distribution of Truvada but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for the PrEP indication.
"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.
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.
Gilead Sciences, Inc. is based in Foster City, Calif.
For more information:
- FDA: Consumer Update - FDA Approves First Medication to Reduce HIV Risk1
- FDA: HIV and AIDS Activities2
- CDC: Pre-Exposure Prophylaxis (PrEP)3
- NIH: AIDS Information4
- HHS: AIDS News and Resources5
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
This article has been republished from Out & About Nashville, and was part of a series of first-person pieces written by the late Bobbi Williams.
When I was 14 years old, I surreptitiously made my way through the stacks in the local library until I came to the Psychology section. One after one, I took down the books whose titles I thought would provide an answer, went to the table of contents and, if there were any, I flipped to the pictures.
Eventually, I landed on one with a word I had never seen or heard: Transvestite. And on the next page there was a black and white photo of a man wearing a dress, looking like he had just crawled out from under a rock. I can still see the expression of guilt on his face.
Not long after that, the newspapers and TV broke the story of Christine Jorgensen, a former member of the U.S. Army who had gone to Denmark to have Sexual Reassignment Surgery (SRS). Of course, the majority of the reports were always accompanied by some sort of joke, such as “Christine Jorgensen went abroad and came back a broad!”
America's First Trans Celebrity: Christine Jorgensen youtu.be
But those two events rescued me. I learned that I was not the only person in the world with this “affliction,” this sense that something wasn’t right. And I got a word I could apply to it and maybe even hope for a cure. But it was too early. I knew that to say out loud, even maybe, that I should have been born a girl, would mean being ostracized, becoming part of the joke, so I chose the path followed by most transgender people of my generation. I put all of my energy into making sure that no one knew.
And that wasn’t easy. For no matter what I did, I couldn’t match the image of the all-American boy, so I became the class clown. If I wasn’t the John Wayne male, at least I could be Lenny Bruce. It was my way of deflecting the mismatch, and, to some extent, it worked.
Others like me took varying escape routes, becoming athletes, businessmen, or whatever role they could slip into and hide behind. Most married, had kids, and did whatever was necessary to survive, with varying results, but never with happy endings.
Segue to the present. The scenario I described above is, to a great extent, still being played out, but now there are exceptions. Transgender kids today can find some consolation on the Internet. They can learn early on that they aren’t “afflicted.” They can make contact with others like themselves. And they can read about transgender people who are proud of themselves and what they have accomplished as well as hearing about transgender children whose parents accept them and allow them to be who they are.
But the information highway is not all smooth driving. And naïve youth can get lost on detours and take wrong turns, winding up as prey to the trolls, predators, and religious zealots—as well as various other kinds of bullies—who inhabit the virtual world.
So is it any better today for our transgender youth? Most still have parents who reject them and peers who bully them. Nearly half of transgender teens have seriously thought about taking their lives, and one quarter report having attempted suicide  compared to a rate of 1.6 percent for the general population.
It’s far from a perfect world. But I believe it is definitely better than the one I grew up in, because it’s a world where the President of the United States has condemned “the persecution of women, or religious minorities, or people who are lesbian, gay, bisexual, or transgender”; it’s a world where the parents of transgender children have publicly supported their sons or daughters and stood up to schools that would try to discriminate against them; it’s a world where the medical and psychiatric professions have come to recognize that being transgender isn’t a disease. All these things were inconceivable possibilities on the day I sneaked into the library.
Nina Simone To Be Young Gifted And Black youtu.be
When I was a teenager, Nina Simone had a hit record titled “To Be Young, Gifted, and Black” that has since been covered by artists as diverse as Elton John, Rah Digga, and Faith Evans. A portion of the lyrics say, “We must begin to tell our young / There’s a world waiting for you / This is a quest that’s just begun.” That same message applies today.
To be transgender is not a curse; it’s a gift. As Derrick Moeller, a graduate student in Education at Iowa State University and a transman explains, “Having to contemplate what your gender identity and gender expression looks like is a privilege that most folks don’t have to go through” . Rather than being rejected they will know that they have been blessed, so that their plea “Why was I made like this?” will be replaced by a prayer of gratitude: “Thank you for making me like this.”
 Grossman, A.H. & D’Augelli, A.R. (2007). Transgender Youth and Life-Threatening Behaviors. *Suicide and Life-Threatening Behaviors* 37 (5), 527-37.
 Tiffany Herring, January 28 2015 Iowa State Daily [goo.gl/YSL3SC].
Many of us have made resolutions and pledged ourselves to transforming some aspect, or aspects, of our lives. For some, these resolutions will involve career, budget, home ownership, etc., but for a LOT of us, they will involve various health, exercise and fitness goals.
Often, these resolutions are vague, like “lose weight” or “exercise more”, and way too often they begin with a gym contract and end with Netflix and a bag of takeout. Getting specific can help in holding yourself accountable for these commitments, though. So we thought it might be interesting to talk with a local gay trainer, James Mai, about his fitness journey, his work as a trainer and how he keeps himself motivated, and get some of his suggestions for carrying through on this year’s fitness resolutions!
Mai said he hasn’t always been athletic, though he was thin. “I have not always been athletic. I danced a bit in college but never lifted a weight. I was what you call ‘skinny fat’ and I didn't know any different. I only started truly working out three years ago, when I started in the entertainment industry.”
The motivation to get into better shape was work. “Fitness was a byproduct of having to keep up my looks for castings,” he explained. “I found a love for training because everyone is on a different path, but I knew that I enjoyed being on that journey to help others get to be their more confident selves.”
Training, of course, keeps Mai in the gym, and helping others reach their goals keeps him motivated. He trains at Barry’s Bootcamp in Nashville, and he’s clearly passionate about his workplace.
“Barry's Bootcamp has been my family for the past 3 years!” Mai said. “There is a community of people that come together and actually encompasses what a fit family truly is.”
Barry’s describes its gym as “the room where everything becomes possible. Where you push through the ‘I can’t’s’ and ‘If Only’s.’ Where you run faster, lift more, lean out, quiet down. This is what transformation looks like. Where you become the best version of yourself.”
“The workout itself is designed for efficiency. The intervals and strength training combinations are proven to lean and tone your body. This isn’t a fitness trend. It’s just science. And it works,” the company says. “Then there’s the ‘thing’ that happens when the doors close, lights dim, and music turns up. There’s a palpable energy in the room that pushes you one step further. It’s the soul, body, brain revolution that’s uniquely Barry’s.”
Mai’s commitment to health continues outside the gym, though. “Outside the gym, I love dancing, and you can see me taking classes at DancEast to brush up on my technique or out and about just jamming to music. Dance is a great way to move your body and a cardio workout, if you are really get into it.”
It’s not all about what you do with your body: what you put into it matters as well. “Diet is a huge part of getting results that you want, in addition to time at the gym,” Mai explained. “I meal prep every week, so that I know what goes into my body and I can monitor the macros that I am consuming each day. There are plenty recipes and information about meal prep options to help you reach yours goals. Check it out, test it out, and choose what you like and don't like.”
Mai also doesn’t do something that might be a hard habit to break for some of us: “I also don't drink, so that helps keep off those unwanted calories that I don't need!”
Asked for some strategies he’d suggest for people looking to get healthier and keep those New Years resolutions, especially those of us out of practice or new to trying to get in shape, Mai offered the following:
Try to exercise every day.Be active, whether it's a simple walk or run, bike ride, dance class, yoga, or swim. Daily exercise builds adrenaline, endorphins, pheromones, and testosterone—which are ingredients for the perfect healthy addiction. Once exercise becomes a daily habit, you will miss it if something gets in the way.
Get a workout buddy.Friends don't let friends down. With a friend, you can hold each other accountable and keep that motivation intact. Try a new studio together, take a class together, and laugh and share the joy of your journey together.
Vary your diet.Most people will eat the same thing every time, given the option. Think about how what you eat powers you through your activities. There are many types of diets out there. From keto or whole 30, paleo to low carb, research and try out what works for you. Even gradually incorporating aspects of these diets can help you towards your goals.
Get more sleep.Take naps, go to bed earlier, and give yourself more time to rest. Sleep volume is directly correlated to physical and mental health.
Focus on yourself and your feelings.Often, people strive to lose weight or make muscle gains and focus on the scale to see their progress. Making change takes time and is not immediate. Instead of focusing on the numbers right away, focus on how you feel after a workout: strong after a lifting exercise, energized after cardio, or relaxed and connected after a yoga session. By focusing on how you feel rather than the scale, you are more inclined to stay motivated on your fitness journey.
Mai also had some suggestions for incorporating health goals into daily life. “Being healthy is comprised of many parts: Mentally, physically, and emotionally. Filling these capacities takes time and needs attention and care. At the end of the day, you are working on living your best life, and, by living a healthy life, you impact not only how you feel but also how others feel around you.
“Mentally,” he explained, means “Keep learning. Feed your mind and continue to grow. Workout your mind and allow it to keep you informed and motivated. Eat well. Drink sensibly. Take a break from social media, because the perceptions versus the realities of posts on social media can mess with your emotions and how you think. Allow yourself to connect mind, body and soul.”
“Physically, working out and exercising allows you to get to your best self. Like Elle Woods says in Legally Blonde, ‘Exercise gives you endorphins. Endorphins make you happy. Happy people just don't shoot their husbands, they just don't.”
“And emotionally, how you feel about yourself feeds into how you perform. If you look in the mirror and you don't like how you look, you are less likely to want to go out and have a good time,” he added. “By emotionally feeding yourself positivity, you are creating a more well-rounded version of yourself. Every time you look in the mirror, tell yourself ‘I'm beautiful and worthy.’ These words of affirmation to yourself may seem silly, but are crucial to your health. Start believing that you are beautiful and worthy and that positivity will take strives in your life.”
For more information on Mai’s gym, visit barrysbootcamp.com.
Rarely are the words, “I’m bi,” heard. Whether on TV, film or even from friends and family, it’s almost nonexistent. Coming out as gay is thought to be brave; a pivotal moment in someone’s life. Coming out as bi, however, is often met with rolled eyes, being viewed as a sexual object, and even with the chant, “Bi now, gay later.” Being bisexual isn’t heralded as brave: it is often treated as if it isn’t even a real thing!
Many well-known blogs have used the purple analogy to explain bisexuality. Purple is known as its own color and not half red, half blue. There are even several shades of purple, some with more red or some with more blue. The same exists in bisexuality, where attraction can be fluid. Some can be hetero- or homo-romantic (meaning that when it comes to establishing romantic relationships they are primarily attracted to members of the opposite sex, or same-sex, respectively) but do enjoy physical, sexual contact with someone of different sex than their partner. Some can be polyamorous and even cohabitate with both sexes. And others decide on their romantic and sexual partners freely, a person to person decision based on what about the individual might tickles their fancy.
Understanding bisexualityPhoto by Isi Parente on Unsplash
While bisexuality, on the surface, should be welcomed as yet another beautiful way of living—loving hearts and not parts, if you will—bisexuality is often viewed in a not so great light or simply swept under the rug by both the straight and broader lesbian and gay communities.
I asked men and women who identify as bisexual to help us take a look at what it means to be a shade of purple in the big world of pink and blue. It should be noted, and of some concern, that most did not want to be identified by full name, or to use a photograph, in order to avoid judgment from one community, the other, or both, or even because of the risk of losing their jobs and family.
Sorting through the responses to our questions on bisexuality, early feelings of attraction for both sexes was a common theme. Most relate it to the same feelings as straight or gay people face. “I’ve known I was bisexual since I was very little,” Emma Frye stated. “I realized I was not attracted solely to one sex as early as I understood attraction. Most people know they’re straight or gay early in life; I was the same with bisexuality”
Some state that they did not recognize their feelings as bisexual, or perhaps did not know there was a name for it, like Lish Rodriquez: “I didn’t know about bisexuality—I just knew that I liked those people. As I grew older and the media picked up more stories about homosexuality and the AIDS/HIV epidemic, it gave me the word ‘bisexual’ to identify with.”
What comes up also, is the difference in fluidity. The majority of respondents were in an opposite-sex marriage and thus present outwardly to the wider world as heterosexual. Out of those people, many refer to themselves as “swingers.” This is a way for them to explore their bisexuality, with or without their spouses’ involvement, while keeping their marriage and families intact.
Taking the “B” out of “LGBT”
Despite its banner of open acceptance, there is a great deal of questioning in the wider lesbian and gay community about the status of the “B,” and just as some have called for the expulsion of the transgender community from LGBT, others are calling for the removal of the “B”.
One Tumblr blog, “Unpopular Opinions,” states, “I think we should take the B out of LGBT. Bisexuals have it way better than most of us in the queer community. They have straight privilege and ride on the coattails of the gay community.”
Turns out, that just as in the transgender community some agree for very different reasons, some bisexuals likewise argue that this just might be a good idea. Recently a YouTuber known as BisexualRealTalk called for the “B” to be taken out of “LGBT.” He concluded that a bisexual looking for support in the LGBT community was ultimately going to have more questions, be left with a greater sense of uncertainty, and come away with a deeper sense of being alone. “Expectation kills,” he says. “The LGBT community is not our friend”
In fact, a major Canadian study published by the San Francisco Human Rights Commission in 2010 called “Bisexual Invisibility: Impacts and Recommendations,” found bisexual men are 6.3 times more likely, and bisexual women 5.9 times more likely, to report having been suicidal than heterosexual people. Bisexuals are also 3-5 times more likely to feel suicidal than gay men and lesbians.
The majority of those we surveyed also felt discrimination from the LGBT community. Rae Schomburg-Hall states, “I receive scorn from most lesbians as they feel I should ‘pick a side’ and I must just need to ‘make up my mind.’” She feels she is seen as “a confused individual. An oversexed person, just looking for fulfillment. Not to be trusted. An interloper. This, coming from a community that heralds inclusion and acceptance is just…just…wrong.”
Views and Perceptions About Bisexuals
Reading through blogs and articles mentioning bisexuality, it doesn’t take long to find the words "greedy," “whore,” or “slut” being heaped upon bisexuals individually or as a group. The belief that bisexuals, regardless of the evidence, aren’t actually, or can’t be, monogamous is another common attitude.
“There are definitely people who think being bisexual means the exact opposite of monogamous, which is kind of hilarious” answers one of our participants. “I think people's sexuality is so personal, and it varies from person to person. Not all of us sleep with everyone, just because we can, although I have had close friends say that I was a whore or a slut because I dated both ‘sides’ from my pool of friends as a young adult.”
R.J. Aquiar, YouTube’s “NotAdam,” has a series he calls “Ask a Bi Guy,” where he addresses many of the perceptions and attempts to use his personal experience to change the attitudes on bisexuality. In response to our questions, he wrote, “There are still so many people out there who can't accept our identity as valid. They're so adamant about sticking to their existing world view, so they'll look for any reason to dismiss us rather than accept this new information that might require them to change their world view. That doesn't necessarily make them bad people, since it's human nature to do that. And it's even more understandable when you look at how much society enforces that gay/straight binary. Most people would, for instance, refer to a male/male or female/female couple as a ‘gay couple’ rather than a ‘same-sex couple’ while a male/female couple is most often referred to as a ‘straight couple’. If you know what to look for, there's bi-erasure all over the place. This can make it really difficult for a bi person to consider coming out since it means having to face all of that adversity head on.”
Men vs Women
Attitudes men versus women concerning bisexuality certainly differ. It is often said that women have it “easier” being bi. The acceptance of a bisexual woman actually involves oversexualizing her. When a woman says she is bi, many men would jump at what they think is a sure-fire way into a threesome. Very rarely is she viewed as a potential monogamous partner.
And if she comes out to a potential same-sex partner? She is often not taken seriously. There is a fear she will want to return to a heterosexual fantasy of husbands, children, and white picket fences in the suburbs. After all, bisexuals are always viewed as having the potential for passing in straight society as an option. One lesbian told us “I’m scared I’ll be hurt by bisexual women, so I won’t mess with them at all”.
Bisexual men do face a different demon, and because of it, very few men will ever come out as bi. Cooper S Beckett—author of “My Life on the Swingset” and “A Life Less Monogamous”—offers personal insight on this. There is “the immediate assumption that I was gay and kidding myself. I've been told it was a phase as well. Straight men don't like bi men, because they're afraid of another man coming along and treating them the way they've traditionally treated women, as someone you could cajole into doing something. They're worried about being cajoled into ‘gay sex.’ I've been told to my face by a gay man that I'm not bi, I'm just on the road to gay town. It's shocking and sad. But I think acceptance is growing.”
Finding a Tribe
There are plenty of online communities to join. Binetusa.org and shybi.com are places to discuss the unique challenges and obstacles bisexuals face. Bisexual.org has a fantastic library of articles, and discussions, and even lists famous people you might not have known were bi. In your local community, look at meetup.org to find bisexual or bisexual friendly meet-ups.
It is much easier to research within the bisexual community than to look in the LGBT community. It is most important to fight for your rights and support others who are questioning or longing for understanding.
“A lot of LGBT experts call bi people ‘the silent majority', since there are likely a lot more bi people out there who would rather hide than come out and deal with all the stigma,” Aguair writes. “Unfortunately, the only way we can change that is for more bi people to live their lives openly, and demonstrate firsthand how much it doesn't have to be that big a deal. It also illustrates how important it is for bi, pan, and other sexually fluid people to come together and form a community to support one another”
Pam Simmons, who has struggled with her bisexual identity for many years, wrote, "The best advice I could give is to find someone you trust and share what you are feeling, how it is affecting you, your fears & doubts. The journey to identifying as bisexual may be a lifelong process. But that’s ok. You define you…. Nobody else. Be true to yourself. And most of all, love yourself.”