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Drug reducing risk of sexually acquired HIV infection approved

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.

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FDA approves first drug for reducing the risk of sexually acquired HIV infection; evidence-based approach said to enhance existing prevention strategies

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.

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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.

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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.

In a statement, the MSMGF has applauded this “important milestone in the fight against HIV”.

“The FDA’s announcement notes that Truvada, when taken as PrEP, should be used as part of a comprehensive approach to HIV prevention. Combination approaches to prevention should include access to condoms and lubricants, risk reduction counseling, regular HIV testing, mental health services, and community mobilization, as well as PrEP,” stated MSMGF. “It is essential that each of these prevention strategies be closely connected to accessible treatment and care for gay men and other men who have sex with men (MSM) already living with HIV. They must be guided by a human rights approach, aiming to eliminate barriers for all those who seek services, while protecting confidentiality, privacy, and dignity.”

MSMGF, nonetheless, added that while PrEP is an important new addition to the HIV prevention toolkit, “we must remember that considerable work remains to be done regarding the rollout of comprehensive prevention in places where treatment and care for gay men and other MSM are severely compromised. Comprehensive HIV prevention, treatment, care, and support services continue to be out of reach for the majority of MSM worldwide.”

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“As advocates, it is our role to continue to push for Universal Access to HIV prevention and treatment, and we must reinvigorate our efforts to challenge the homophobia that continues to undermine public health approaches for our communities around the world,” MSMGF added.

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.

Health & Wellness

Long-term mental health benefits of gender-affirming surgery for transgender individuals

A study found that among transgender individuals with gender incongruence, undergoing gender-affirming surgery was significantly associated with a decrease in mental health treatment over time.

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For transgender individuals, gender-affirming surgery can lead to long-term mental health benefits, according to new research published in the American Journal of Psychiatry. The study found that among transgender individuals with gender incongruence, undergoing gender-affirming surgery was significantly associated with a decrease in mental health treatment over time.

Researchers Richard Branstrom, Ph.D., and John E. Pachankis, Ph.D., with the Yale School of Public Health, New Haven, Connecticut, used the Swedish Total Population Register to identify more than 2.500 individuals who received a diagnosis of gender incongruence (i.e., transsexualism or gender identity disorder) between 2005 and 2015. Among individuals with gender incongruence, just more than 70% had received hormone treatment and nearly half (48%) had undergone gender-affirming surgical treatment during the 10-year follow-up period. Nearly all (97%) of those who had undergone surgery also received hormone treatment. Less than one-third had received neither treatment.

They analyzed mental health treatment in 2015 in relation to the length of time since gender-affirming hormone and surgical treatment, including distinguishing the potentially interrelated effects of the two treatments. The mental health measures included health care visits for mood and anxiety disorder, antidepressant and anti-anxiety prescriptions, and hospitalization after a suicide attempt.

Increased time since last gender-affirming surgery was associated with reduced likelihood of use of mental health treatment. The study found the odds of receiving mental health treatment were reduced by 8% for every year since receiving gender-affirming surgery over the 10-year follow-up period. They did not find the same association for hormone treatment.

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The study also found that compared with the general population, transgender individuals with a gender incongruence were

  • about six times as likely to have had a mood or anxiety disorder health care visit;
  • more than three times as likely to have received prescriptions for antidepressants and anti-anxiety medication; and
  • more than six times as likely to have been hospitalized after a suicide attempt.

Despite the reduced mental health treatment use after gender-affirming surgery, treatment use among transgender individuals continued to exceed that of the general population.

The authors conclude that “in this first total population study of transgender individuals with a gender incongruence diagnosis, the longitudinal association between gender-affirming surgery and reduced likelihood of mental health treatment lends support to the decision to provide gender-affirming surgeries to transgender individuals who seek them.”

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Polyamorous families face stigma during pregnancy and birth

Polyamorous families experience marginalization during pregnancy and birth, but with open, nonjudgmental attitudes from health care providers and changes to hospital policies, this can be reduced.

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Polyamorous families experience marginalization during pregnancy and birth, but with open, nonjudgmental attitudes from health care providers and changes to hospital policies, this can be reduced. This is according to new research – “The Polyamorous Childbearing and Birth Experiences Study (POLYBABES): a qualitative study of the health care experiences of polyamorous families during pregnancy and birth” – published in CMAJ (Canadian Medical Association Journal).

As it is, in the US alone, an estimated one in five single Americans have engaged in consensual polyamory, or consensual nonmonogamy, and interest in these types of relationships seems to be increasing. People who identify as gay, lesbian or bisexual are more likely to be in consensual nonmonogamous relationships.

Few studies exist on the experiences of polyamorous families in health care, and it appears there are none on experiences during pregnancy and birth.

“[G]iven the high proportion of polyamorous individuals who are of child-bearing age and the substantial potential for stigma, it is important to investigate polyamorous individuals’ experiences with reproductive care providers to better inform practice,” writes Dr. Elizabeth Darling, a study author and assistant dean, midwifery, and an associate professor, Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, with coauthors.

Several themes emerged in this qualitative study of 24 participants, including 11 women who gave birth within the last five years and 13 partners.

Key points:

  • Participants deliberately planned families, choosing health care providers who they thought would be less discriminatory because of relationship status.
  • More partners means more support, although some partners were not able to fully share this support because of discomfort in disclosing polyamorous relationships.
  • People in polyamorous relationships often chose to disclose their status when it was medically relevant, and they received both positive and negative reactions from health care providers.
  • Navigating the health system presented challenges, including administrative barriers, in which forms did not have enough space for additional partners, or newborn identification bracelets that could be issued for only two parents
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To improve health care experiences for polyamorous families, the study participants suggested health care providers should acknowledge the partners’ presence and roles, be open and nonjudgmental, adapt administrative forms and procedures, and advocate for patients and their families.

“Our findings align with recent reports that individuals engaging in consensual nonmonogamy face stigma with respect to accessing health care,” write the authors. “Our results also suggest that polyamorous individuals face concerns similar to those of other gender and sexual minorities regarding administrative barriers and challenges with disclosure to health care providers.”

The authors state that substantial work needs to be done to remove marginalization experienced by these families in the health care system.

“[R]educing providers’ implicit biases toward sexual minority groups, and patients in consensually nonmonogamous relationships in particular, is vital to addressing health disparities,” writes Dr. Sharon Flicker, Department of Psychology, California State University, Sacramento, California, in a related commentary.

“Health care providers have an opportunity to mitigate this stress by providing inclusive environments and sensitive health care.”

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Political divisiveness can cause an increase in homophobic bullying

Divisive partisan climates can cause an increase in homophobic bullying. But one school initiative was found to prevent and combat homophobic bullying – i.e. the formation of gay-straight alliance clubs.

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Divisive partisan climates can cause an increase in homophobic bullying. This is according research Dr. Yishan Shen, an assistant professor in the School of Family and Consumer Sciences at Texas State University at Austin.

According to Shen – whose research group was headed by Stephen Russell, chair of the Department of Human Development and Family Sciences at the University of Texas – being a teenager is hard enough, but Dr. Yishan Shen, an assistant professor in the School of Family and Consumer Sciences at Texas State University, has uncovered additional challenges for youths between 10 and 19 who are targets of bullying during contentious political campaigns.

While examining data from the California Healthy Kids Survey gathered before a 2008 referendum known as Proposition 8, Shen found what she described as an “odd peak of homophobic bullying in 2008.”

Shen reported the trend to Russell, whose laboratory she joined as a graduate student at UT in 2015 to expand her scholarship to other minority and marginalized groups. Russell dubbed Shen’s finding as “The Prop 8 Effect”, in a reference to attitudes about a California ballot initiative intended to eliminate the right of same-sex couples to marry. They continued studying the topic, with their findings published as Proposition 8 and Homophobic Bullying in California in the journal Pediatrics.

The researchers determined that secondary school students reported “significantly more” homophobic bullying as the Prop 8 vote was approaching, but less after the Prop 8 vote. 

The researchers tried running different statistical analyses to see if there are other possible explanations, like the economic or ethnic makeup of the schools, but after controlling for each of these variables, the same pattern was observed, thereby leading them to conclude that the increase in rates of bullying was associated with Prop 8.

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 One school initiative was found to prevent and combat homophobic bullying in their study – the formation of gay-straight alliance (GSA) clubs. 

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SM Supermalls to install gender-neutral restrooms starting this November

SM Supermalls will begin installing all-gender restrooms in its malls starting this November. The move will be first done in malls in Metro Manila, including SM Mall of Asia, SM City North EDSA, SM Megamall, SM Aura Premier and The Podium; as well as at SM Seaside City Cebu.

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Real move for inclusion; or mall-versus-mall PR effort targeting the pink peso?

Months after Araneta Center’s Farmers Plaza in Cubao, Quezon City figured in a much-hyped controversy for refusing to allow a transgender woman to use a toilet befitting her gender identity, SM Supermalls announced that it will begin to install all-gender restrooms in its malls starting this November.

The move will be first done in malls in Metro Manila, including SM Mall of Asia, SM City North EDSA, SM Megamall, SM Aura Premier and The Podium; as well as at SM Seaside City Cebu.

The move, according to a statement released by the giant company, is a “leap towards a more gender-inclusive community”, as SM Supermalls aims to “continue to provide a safe community space that advocates inclusivity, equality, and respect for all regardless of gender expression, identity, or sexual orientation.”

“With inclusivity and innovation at the core of everything we do, we endeavor to create spaces where all shoppers are welcome,” SM Supermalls COO Steven Tan was quoted as saying.

The all-gender restroom will be a new facility in addition to the male, female, and PWD restrooms in these malls.

The effort may be commendable, but SM Supermalls is not always on the side of what’s right. In 2015, for instance, its establishment in Baguio City, SM Baguio, cut 60 trees surrounding the mall for its expansion, including to build additional parking.

SM Supermalls is also infamous for practicing contractualization – i.e. not regularizing its employees, thus failing to give many security of tenure and benefits.

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Positive family relationships linked with lower levels of depressive symptoms

Positive family relationships during adolescence appeared to be associated with lower levels of depressive symptoms from adolescence to midlife in this observational study of about 18,000 adolescents followed up until they were 32 to 42 years old.

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How are adolescent family relationships associated with trajectories of depressive symptoms from adolescence into midlife for women and men?

This was the question asked by a study – “Association of Positive Family Relationships With Mental Health Trajectories From Adolescence To Midlife” by Ping Chen, PhD and Kathleen Mullan Harris, PhD – published by JAMA Pediatrics, with the findings suggesting an association of early intervention in family relationships during adolescence with better mental health into adulthood and midlife.

The study analyzed data from the National Longitudinal Study of Adolescent to Adult Health, which used a multistage, stratified school-based design to select a prospective cohort of 20 745 adolescents in grades 7 to 12 from January 3, 1994, to December 26, 1995 (wave 1). These respondents were followed up during four additional waves from April 14 to September 9, 1996 (wave 2); April 2, 2001, to May 9, 2002 (wave 3); April 3, 2007, to February 1, 2009 (wave 4); and March 3, 2016, to May 8, 2017 (sample 1, wave 5), when the cohort was aged 32 to 42 years.

The study sample of 8,952 male adolescents and 9,233 female adolescents that were analyzed was a US national representation of all population subgroups by sex, race/ethnicity, socioeconomic status, and geography.

Levels of depressive symptoms (Center for Epidemiologic Studies–Depression Scale [CES-D]) from ages 12 to 42 years were then used to estimate propensity score–weighted growth curve models to assess sex differences in trajectories of depression by levels of positive adolescent family relationships.

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A total of 18,185 individuals (mean [SD] age at wave 1, 15.42 [0.12] years; 9233 [50.8%] female) participated in the study.

The study found that females and males who experienced positive adolescent family relationships had “significantly lower levels of depressive symptoms from early adolescence to midlife than did those who experienced less positive adolescent family relationships.”

For example, depressive symptoms were lower among those with high levels of family cohesion compared with those with low cohesion between 12 (1.26 lower CES-D score; 95% CI, 1.10-1.42) and 40 (0.78 lower CES-D score; 95% CI, 0.50-1.06) years of age among females and between 12 (0.72 lower CES-D score; 95% CI, 0.57-0.86) and 37 (0.21 lower CES-D score; 95% CI, 0.00-0.41) years of age among males.

The study also found that the reduction in depressive symptoms associated with positive adolescent family relationships was greater for females than males during the adolescent and early adulthood years (ie, early 20s) (eg, low-high cohesion difference in mean CES-D score, −1.26 [95% CI, −1.42 to −1.10] for females and −0.72 [95% CI, −0.86 to −0.57] for males at 12 years of age; low-high cohesion difference in mean CES-D score, −0.61 [95% CI, −0.69 to −0.53] for females and −0.40 [95% CI, −0.48 to −0.31] for males at 20 years of age), after which females and males benefited equally from positive adolescent relationships throughout young adulthood to midlife.

As per the authors, “The findings suggest that positive adolescent family relationships are associated with better mental health among females and males from early adolescence to midlife. Interventions in early family life to foster healthy mental development throughout the life course appear to be important.”

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This is noteworthy for the LGBTQIA community because other studies highlight the relevance of family support to LGBTQIA people. An earlier study released in July, for instance, showed “that derisive parenting fosters dysregulated anger in adolescent children. Dysregulated anger is indicative of difficulties regulating emotion, which typically result in negative emotions, verbal and physical aggression, and hostility. Increases in dysregulated anger, in turn, place adolescents at greater risk for bullying and victimization, and for becoming bully-victims (bullies who also are victimized by other bullies).”

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Divided US Supreme Court to decide whether Civil Rights Act should also protect LGBT workers

Outrage Magazine is at the US Supreme Court, where oral arguments were heard on a major civil rights question: Are gay and transgender people covered by the law barring employment discrimination on the basis of sex?

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WASHINGTON, DC – The US Supreme Court heard oral arguments on a major civil rights question: Are gay and transgender people covered by the law barring employment discrimination on the basis of sex?

As FYI: Legal developments in many countries – including the Philippines – are affected by those in the US. For instance, when the Philippines’ Supreme Court heard oral arguments on marriage equality in the country, the civil rights movement in the US was mentioned, along with other international laws/statutes pushing for LGBTQIA human rights.

At the SCOTUS, three cases are being heard.

Two of those cases, Altitude Express Inc. v. Zarda and Bostock v. Clayton County, ask whether a worker can be fired for their sexual orientation. The third, R.G. & G.R. Harris Funeral Homes v. EEOC, asks whether a worker can be fired because of their gender identity.

US currently has a federal civil rights law that somewhat touches on this – Title VII of the Civil Rights Act of 1964, which forbids employers from discriminating against employees on the basis of sex as well as gender, race, color, national origin and religion.

However, the text of the law bans only “sex” discrimination, not specifically stating discrimination based on a worker’s “sexual orientation” or “gender identity”.

It is worth noting, therefore, that in the US, 29 states still do not have a law protecting the rights of LGBTQIA workers from being fired solely because of their SOGIE.

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The cases now at SCOTUS, therefore, ask whether concepts like sexual orientation and gender identity – both tightly bound to the concept of sex (meaning gender, not sexual intercourse) – should also be included under its grasp.

Thus far, the members of SCOTUS are divided.

The top court’s liberal members are expected to vote with the plaintiffs and the argument that LGBTQIA workers should be covered by Title VII of the Civil Rights Act.

Associate Justice Sonia Sotomayor was among those who already noted that firing LGBTQIA people not because they under-performed but because of who they are may fall under the statutory ban on sex discrimination. “We can’t deny that homosexuals are being fired merely for being who they are and not because of religious reasons, not because they are performing their jobs poorly,” Sotomayor said, calling it “invidious behavior.”

For Associate Justice Elena Kagan, Title VII prohibits employment discrimination that occurs “because of (an employee’s) race, color, religion, sex, or national origin.” The language used here is broad and it suggests that a simple test should apply in sex discrimination cases. A plaintiff in such a case should prevail unless they would have experienced the exact same treatment if they “were a different sex.”

For Associate Justice Ruth Bader Ginsburg, interpretations of Title Vii had changed in the past. Since this law was enacted, the SCOTUS has held that it applied to discrimination based on sex stereotypes, as well as same-sex harassment. And though these areas were presumably not on the minds of the legislators who voted for it, “no one ever thought sexual harassment was encompassed by discrimination on the basis of sex back in 1964. It wasn’t until a book was written in the middle 1970s bringing that out,” Ginsburg said. “And now we say, ’Of course, harassing someone, subjecting her to terms and conditions of employment she would not encounter if she were a male, that is sex discrimination. But it wasn’t recognized.”

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But conservative justices – including those appointed by US Pres. Donald Trump, who may continuously claim to be pro-LGBTQIA but has been attacking LGBTQIA human rights in the country by implementing policies not beneficial to the LGBTQIA community (such as banning transgender people from serving in the military) – are concerned of “massive social upheaval” if the court will rule in favor of LGBTQIA workers, instead of allowing Congress to legislate on the subject.

Decisions from the nine justices of America’s highest court are due by next June. – WITH SUZETTE MAGALLANES-PADOR

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