Homosexual men are being tortured with electric shocks and beaten to death in concentration camps in Chechnya. This is the first concentration camp for homosexuals since Hitler’s camps in 1930s.
Reports have emerged that 100 gay men were detained and three killed in these camps last week. Novaya Gazeta, a Russian newspaper known for its critical and investigative coverage of Russian politics and social affairs, said that several camps have been set up in Chechnya where gay men have been forced to promise to leave the republic.
The report in Novaya Gazeta said that those arrested include well-known local television personalities and religious figures.
President Ramzan Kadyrov, a key ally of Russian President Vladimir Putin, allegedly ordered the clampdown and is known to have previously encouraged extrajudicial killings of homosexual men as an alternative to law enforcement. Kadyrov claims that there are no gay men in the republic and denies the arrests ever took place. He described the allegations as ‘absolute lies and disinformation’. He, instead, claims that such people would be killed by their own families. In some cases, gay men in prison have been released early specifically to enable their murder by relatives.
In October 2017, the BBC had reported about a young Chechen man, Maxim Lapunov, who had escaped illegal detention and torture in Chechnya. He had described being held for 12 days in a blood-soaked cell, beaten with sticks, threatened and humiliated by the police. He was released only after his family members and friends started putting up missing posters around the Chechen capital and his family reported his disappearance.
MailOnline talked to Svetlana Zakharova, from the Russian LGBT Network, who said: “Gay people have been detained and rounded up and we are working to evacuate people from the camps and some have now left the region.”
“Those who have escaped said they are detained in the same room and people are kept together—around 30 or 40. They are tortured with electric currents and heavily beaten, sometimes to death.”
A prisoner who escaped told Novaya Gazeta that prisoners were beaten to force them to reveal other members of the gay community. Another said that before being incarcerated in one of the camps, he survived by bribing Chechen police thousands of rubles every month in order to survive. By creating these camps, the survivor said, the regime had taken another step against gays.
Alexander Artemyev, from Amnesty International in Russia, told MailOnline: “We can only call on the Russian authorities to investigate the allegations. Homosexuals in Chechnya are treated very harshly and prosecuted daily, and they are afraid to talk about it.”
Artemyev said homosexuals are forced to hide or leave the country. He said they were keeping in touch with the LGBT network that helps people in Russia find shelter. People there cannot talk to anyone about it as it puts them and those they speak to in danger.
Ekaterina Sokirianskaia, Russia project director for the International Crisis Group, told MailOnline: “The story is very much developing…victims are escaping.”
A brutal campaign against LGBT people has been sweeping through Chechnya, said Tanya Lokshina from Human Rights Watch in Moscow. The climate of fear is so overwhelming that people do not dare to speak to human rights monitors or journalists even anonymously, she said. “Filing an official complaint against local security officials is extremely dangerous, as retaliation by local authorities is practically inevitable,” she said.
“It is difficult to overstate just how vulnerable LGBT people are in Chechnya, where homophobia is intense and rampant. LGBT people are in danger not only of persecution by the authorities but also of falling victim to “honour killings” by their own relatives for tarnishing family honour,” she said.
Campaigners have expressed concern with the findings of the first round of public consultation on what schools should be teaching in the Relationships Education and Relationship and Sex Education (RSE) curricula.
The consultation, which runs until November 7, 2018, was called following government plans to introduce the mandatory subjects in schools across the country by September 2020.
Then-Education Secretary Justine Greening promised the revised curricula would be inclusive of LGBT issues, although the draft guidance published under her successor Damian Hinds in July leaves schools “free to determine how they address LGBT specific content,” even if the ministry’s recommendation is that the teaching “is integral throughout the programmes of study.”
Campaigning group Level Up believes this position risks excluding LGBT+ students “from the information they need to have happy, healthy relationships,” particularly following the review of the open consultation’s responses so far, which the group obtained following a Freedom of Information request.
The findings from the Ipsos MORI executive summary show that the vast majority of respondents to the consultation are adults (15,528 of the total 17,852) and only 13 percent came from young people—a majority of these were cast by people aged 15-18 years old.
The report also indicates that “opinions were split regarding when children should be taught about LGBT relationships,” with several respondents believing that it wasn’t appropriate to teach about these issues at primary school.
This is despite “relationships with family” emerging as the most popular topic of discussion for pupils taught about Relationships Education, which is meant to encompass an understanding of different kinds of family compositions.
In secondary education, the report noted “teaching about gender and sexual identity was seen as important. Other themes that emerged were marriage, sexual health, contraception, safe online relationships, mental health and physical health.”
But as Level Up campaigners noted, there is a big discrepancy in responses with regards to the importance of marriage as part of the RSE teachings—only 3 percent of young people who responded to the survey wanted information on marriage, compared to 39 percent (5,746) of adult respondents who stated that commitment is the most important subject area, with an emphasis on traditional marriage.
In comparison, 31 percent of young people who answered the consultation stated that teaching about gender and sexual identity in SRE would contribute to “raising awareness and acceptance” of LGBT+ youth.
“We would encourage schools to ensure RSE truly represents LGBT identities and communities because that’s the only way it will be relevant, effective and truly inclusive of all students,” said Lisa Hallgarten, Head of Policy and Public Affairs at Brook, a charity working to provide wellbeing and mental health support for young people.
“I grew up in a violently homophobic home, I would do anything to turn by the clocks and get a decent sex education at school for me and my brothers and sisters. And now’s our chance,” she said. “Providing young LGBTQ+ people with the information they need to have happy healthy relationships is essential, not optional.”
The American Academy of Family Physicians (AAFP) in the United States has taken a stance against performing unnecessary surgery on intersex children.
The organization, which was founded in 1947, issued the new guidelines earlier this year.
Intersex people are those born with variations in their sex characteristics. This can include chromosomes, gonads, sex hormones, or genitals.
Most of the time, these variations are benign and non-threatening, meaning intersex surgery is largely cosmetic. Doctors regularly began performing surgery on intersex infants and children in the 1960s.
Rationale for this action stemmed from surgery prior to adult memory would be less traumatic, as well as a single gender identity being preferable (especially with ‘clear’ genitalia). Parents also sometimes wanted to ‘fix’ their children.
Vocal criticism gained steam in the 1990s, especially with the founding of the Intersex Society of North America in 1993.
Some studies have found negative consequences of these invasive surgeries, including scarring, incontinence, sterilization, and psychological trauma.
Unnecessary and harmful
‘Many intersex children are subjected to genitalia-altering surgeries in infancy and early childhood without their consent or assent,’ the AAFP wrote in their statement.
‘The surgery can lead to decreased sexual function and increased substance use disorders and suicide. Scientific evidence does not support the notion that variant genitalia confer a greater risk of psychosocial problems.’
Several other medical and non-medical organizations have also condemned the practice.
They include the World Health Organization, three former US surgeons-general, Physicians for Human Rights, Amnesty International, Lambda Legal, the ACLU, and more.
Eminem used the word ‘faggot’ and absolutely no one was shocked.
A couple of weeks ago Eminem dropped his surprise album, Kamikaze, featuring one of the diss tracks he’s built his entire career perfecting. But you’d think that someone so known for weaving together insulting tracks could steer away from such lazy expressions like the f-word.
I, a weaker writer than this supposed legend, don’t have to resort to slurs. I can just call him a has-been who’s built his relic of a career on the backs of insulting minority groups and such a deep hatred of women I’m surprised he’s not currently in police custody. But here we are.
Yet now he’s sort-of, kinda apologized for using the word. Again. We need to reject this apology.
The word appears on the track Fall, where he slams Tyler the Creator – who has opened up about his sexuality on past albums – with the lyrics: ‘Tyler create nothing, I see why you called yourself a faggot, bitch / It’s not just ‘cause you lack attention / It’s cause you worship D12’s balls, you’re sacrilegious.’
Not just one but two bits of homophobia. All because he said that one of his albums wasn’t very good.
People against the rapper
The backlash was inevitable. People called him out on social media. LGBTI ally and creator of ‘that song you swear you remember from somewhere’ Dan Reynolds from Imagine Dragons dragged him. Justin Vernon, who appeared on the track, distanced himself from its ‘tired’ message’. And now Eminem has sadly addressed the whole matter in an interview with Sway.
You can read the full ‘expression of regret’ here, but the non-apology ends with ‘I wasn’t in the right mind frame. I was angry.’
He ‘[realizes] that I was hurting a lot of other people by saying it,’ but it doesn’t matter, because he was angry. Mr Mathers, you are a grown man. You are responsible for your own emotions. Your anger doesn’t justify using a homophobic slur and perpetuating a negative attitude towards homosexuality. I don’t know why I need to explain this to an adult. I would explain this to a three-year-old.
Tyler the Creator isn’t free from this. Sure, he’s now hinted towards his sexuality, but it doesn’t automatically do away with the fact he used the f-word negatively 9 times on Gobblin. Yet whataboutisms aren’t helpful. Eminem’s use is insulting and his non-apology is even more so.
Because Eminem doesn’t actually care. The Marshall Mathers LP, one of his most popular albums, is basically built on that word from the ground up. He probably doesn’t even hold any homophobic beliefs; he just likes the reaction. But Eminem is slightly worried that this negative tide against homophobia might one day affect his album sales, though right now he doesn’t have to worry. Loads of fans bought it.
People don’t care about homophobia if the music is good
People are performatively woke but once that album drops, suddenly calling people out on social media takes a backseat to Slim Shady’s bars. And Eminem has been weaponizing homophobia since the beginning. Even if he justifies it, like in this Rolling Stone interview where he says: ‘Those kinds of words, when I came up battle-rappin’ or whatever, I never equated those words [with being gay].’
Eminem doesn’t and might never care what he is doing. But you know who should care? Fans of Eminem. The ones who are out there buying his stuff. Streaming the album. Spending $100 on a concert ticket. He shouldn’t be censored by anyone but the reaction of his fans.
Because they are propagating a culture that allows people to profit from using slurs as insults, that continues to equate being gay with something negative. Homophobia in society builds around this. If you think it’s ‘just a word’, that people are ‘easily offended’, and that Eminem is ‘just an artist’, then, my friend, you definitely haven’t been paying attention.
It’s a slippery slope, and the more people like Eminem equate the word ‘gay’ or ‘f**got’ with a negative attribute and get away with it, the more we create a culture that views people of that sexuality as bad.
A Christian College has stopped a man from returning to finish his degree because he’s gay.
Gary Campbell hoped to resume his classes at Clarks Summit University in order to receive the final six credits for a Bachelor’s degree. Afterwards, he planned to start a job working with recovering addicts.
However, Gary says the school dismissed him because he’s gay.
The college, in Pennsylvania, prohibits students from engaging in same-sex relationships and ‘reserves the right to dismiss or deny the enrollment of those whose behavior or influence upon our community should prove to be contrary to the best interests of our students, the Clarks Summity University Community Commitment and to our Lord Jesus Christ,’ according to the school handbook.
No public affection
They originally accepted him into the college. But once informed of his sexuality they repealed the offer.
The prospective student wrote to the college: ‘One of my top goals being in recovery was to finish my bachelor’s degree. Having a degree is much more to me than a certificate, it’s a culmination of hard work, sweat and tears, and I owe it to myself and to my recovery to accomplish this goal.
‘I ask that you not view me only as a homosexual, but as a determined, compassionate, hard-working man who is of good moral character. My goal again is to assist my community and help those who are struggling in the grip of addiction.’
Originally, Campbell earned 109 college credits from 2001 to 2003, before dropping out. He planned to finish at community college. Instead, he enlisted in the Navy.
He struggled with alcoholism throughout and was discharged after driving drunk on base.
Gary is now 19 months sober and wants to use his degree to help other people. He even crowdfunded the $795 (£612/686.65EU) to finish it.
According to the handbook, students must attend chapel, cannot display physical affection (including holding hands) and cannot spend time alone with members of the opposite sex. They also can’t smoke, drink, or watch R rated movies, even if over 21-years-old.
A gay student is suing his school after teachers ignored him as he was being attacked by bullies.
Guadalupe Paredes, 19, has said the school were ‘deliberately indifferent’ to his daily torment.
One official even allegedly told his mother Parades brought it on himself by ‘acting gay and telling other students he was gay’.
The 19-year-old has named the Kenosha Unified School District, and five administrators as defendants.
In fifth grade, when he was around 10 years old, he was hospitalized for psychiatric treatment over the abuse he suffered at school.
The lawsuit says the assistant principal at Edward Bain School of Language and Art changed when Parades came out in fourth grade.
He says the principal told him to bring concerns to him because the assistant principal, Ron Sandoval, ‘did not feel comfortable with [Parades’] kind’.
The anxiety of returning to school each day got worse, vomiting on Sunday nights.
When his mother spoke to administrators, they suggested Parades just ‘avoid’ the harassers.
He then started hiding from and sometimes missing classes to avoid contact.
In sixth grade, he moved to a different school. Many of his harassers followed.
One told him in a restroom he should kill himself.
Despite his mother complaining to school officials, there is no written record of any investigation.
And that was when a school official told Parades that he brought the trouble onto himself by ‘acting gay and telling other students he was gay’.
Harborside school officials at one point decided the teen and his main bully should work together on a poster project or face a three-day suspension.
Parades couldn’t face spending time alone with the other student and chose to be suspended.
When he began Reuther Central High, he no longer reported bullying ‘because he believed it was hopeless’.
His grades declined. Later, he was hospitalized.
The lawsuit brings claims under Title IX which bans discrimination based on sex in schools that receive federal funding.
The suit claims the harassment prevented Parades from receiving the educational opportunities offered by the district.
A Kenosha Unified School District official has declined to comment.
Britain’s High Court today ruled to overturn pharmaceutical company Gilead Science’s patent extension on Truvada. The HIV medication is also used for PrEP (Pre-Exposure Prophylaxis). When taken as advised, this stops HIV negative people acquiring HIV.
PrEP is not yet available on the NHS in England and Wales. The NHS is currently conducting a trial to test its cost efficiency. It is still in the process of recruiting around 10,000 high-risk participants for the ongoing trial.
Opponents of the NHS supplying Truvda say the medication is expensive. They point to the fact branded Truvada could cost the NHS up to £350 per month per person.
Supporters of PrEP say this is a price worth paying given its effectiveness. They argue the NHS has to pay more to provide a lifetime of HIV treatment to someone with HIV.
Currently, the NHS is only allowed to supply branded Truvada from Gilead.
Truvada was due to come off patent in July 2017, but Gilead extended its exclusivity until 2020 by a supplementary protection certificate (SPC). This prohibited smaller pharma companies from selling generic versions of the drug in the UK.
Generic versions could cost from around 80-90% cheaper, depending on the manufacturer. The NHS is often able to negotiate cheap deals because it buys in bulk.
The High Court today ruled against Gilead Sciences. The court’s decision follows a similar ruling in Ireland last year. There, those with HIV and or seeking Post-Exposure Prophylaxis treatment can use Truvada. Ireland does not yet offer Pre-Exposure Prophylaxis.
‘This represents a huge cost saving’
Many HIV and sexual health advocates welcomed today’s decision.
Deborah Gold, chief executive of NAT (National AIDS Trust) said: ‘We welcome this court decision, which overturns the patent extension for Truvada.
‘The decision will mean that unbranded versions of the drug can be legally prescribed. This represents a huge cost saving to buying a drug that would save public money, even at full price.
‘We continue to urge the NHS in England to commission PrEP by April 2019, as the current trial is not reaching everyone at risk. Indeed some have acquired HIV after being turned away from clinics whose trial places are full.
‘With the generic, unbranded version of the drug available at a fraction of the cost, the pressure increases on NHS England to begin routine commissioning, and make PrEP available to all who need it, urgently.’
‘I would urge NHS England to seize this moment’
Matthew Hodson, Chief Executive of HIV information organization NAM, also welcomed the judgement.
‘PrEP was already cost effective for people at high risk of HIV at Gilead’s price. This ruling should mean that much cheaper generic versions can be purchased by the NHS, ultimately saving even more money.
‘I would urge NHS England to seize this moment and swiftly rollout PrEP to all those who need it. This can be done in parallel to the existing trial.
‘PrEP has contributed to the significant declines that we have recently seen in HIV diagnoses among gay and bisexual men.’
Dating app Grindr today launched its new ‘Kindr’ initiative. The project arrives in response to complaints from some users after experiencing racist, body-shaming or stigmatizing language.
Grindr announced Kindr a few weeks ago, but provided scant details as to what the project would entail.
Today, it released the first of a series of videos in which it addresses the debate around online behaviour. It also unveiled new user community guidelines. These state profiles face moderation if they list what they disliked based on racial group or gender expression
The first video features app users explaining why stating what you’re not looking for – in relation to racial groups – is problematic.
It starts by stating some blatantly racist language users have heard online (‘Go back to Mexico’, ‘People like you are the reason Ebola exist’), before moving on to the ‘covert racism’ of profile preferences.
One man explains how reading exclusionary messages online feels like walking down a street and seeing shop signs welcoming only one kind of customer.
‘Racism is you thinking I’m not going to be smarter than you when you first meet me,’ says one black contributor, Rakeem Cunningham.
Rakeem Cunningham (Photo: Grindr)
‘Or when black people are articulate and other people go, “Oh, you’re so well spoken!” Like, that’s the stuff that bothers me, and that’s the stuff I think needs to be addressed. I think the racism that’s not overt but that’s covert is the main problem.’
An Asian contributor, Joel Kim Booster, says that he began to wonder if there was something wrong with him, or if there was something he should be ashamed about when interacting with guys online. ‘It opened my eyes to a hierarchy that I wasn’t participating in before.’
Why not just stay quiet instead of needlessly offending someone?
‘If you don’t put “No Asians” in your profile, that doesn’t mean you have to fuck Asians now. It just means I don’t have to see it,’ he says.
‘It is not racist to not be attracted to me personally,’ he adds. ‘But for you to say “I know what every Asian guy looks like and I know for a fact that I would not be attracted to any of them…” Like that comes from a racist place because you don’t know what we all look like. That’s ugly.
‘We have only so much in our profiles to get across whatever the fuck we want to get across to all the other guys on this app, and you’re going to take space to narrow it by what you don’t want. Just tell me what you do like. If you tell me you like the fucking Jonas Brothers, I know I’m not for you.’
Former Queer Eye alum Jai Rodriguez also takes part. He points out, ‘You don’t know what the person on the other side of the phone is going through. You have no idea what they’re experience is or what else they have going on. Or what that comment might do to them.’
Many talk about the impact of language.
‘No matter what battle you’re going through, you don’t have to break other people in order to feel good,’ says contributor Jasmine Aksornkij. ‘You don’t have to hurt other people in order to make you feel uplifted.
The video ends with the campaign’s tagline: ‘It’s time to play nice.’
‘Responsibility to not only protect our users, but also to set the standard’
‘Sexual racism, transphobia, fat and femme shaming and further forms of othering such as stigmatization of HIV positive individuals are pervasive problems in the LGBTQ community,’ said Landen Zumwalt, head of communications at Grindr, in a press statement.
‘These community issues get brought onto our platform, and as a leader in the gay dating space, Grindr has a responsibility to not only protect our users, but also to set the standard for the broader community that we serve.
‘Online discrimination has reached epidemic proportions affecting not only Grindr but other social networks. Our ‘Kindr’ initiative is a rallying call for Grindr and our community to take a stand against sexual racism and all forms of othering.
‘Together, we will work to maintain a welcoming and inclusive environment and end the need for people to include exclusionary statements on profiles.’
New community guidelines and moderation
Grindr says it will be rolling out more videos over the next five weeks. It has also updated its community guidelines. In these, it says that moderators will act if they see people making statements such as ‘No Asians’ in their profile descriptions.
‘We have a zero-tolerance policy for discrimination, harassment, and abusive behavior. We want you to be yourself, but not at the expense of someone else. Anyone found bullying, threatening, or defaming another user will be banned.
‘We will also remove any discriminatory statements displayed on profiles. You’re free to express your preferences, but we’d rather hear about what you’re into, not what you aren’t.
‘Profile language that is used to openly discriminate against other users’ traits and characteristics (“No fats, no fems, no Asians”) will no longer be tolerated and will be subject to review by our moderation team.’
Other apps take action
Grindr is not the only dating app acting to moderate racist language and stigmatizing behavior. Last week, Chappy launched its own ‘zero tolerance for abuse’ campaign. Scruff also announced earlier this month that it would make its ‘ethnicity’ field optional.
Grindr was launched in 2009 and now claims to have 3.8million daily active users. It was sold in its entirety to Chinese gaming company Beijing Kunlun Tech last year. Grindr remains headquartered in Hollywood, California, but The company is considering an initial public offering.
Hong Kong has made spousal visas available to same-sex couples for the first time in the wake of a court ruling—but the government has firmly ruled out permitting same-sex marriage.
Hong Kong only recognises marriage as between a man and a woman, but the international business hub has come under pressure from employers and LGBT+ activists to respect the rights of same-sex couples.
A security guard stands at an entrance to the Court of Final Appeal in Hong Kong on July 4, 2018. (VIVEK PRAKASH/AFP/Getty)
In the wake of the ruling, the government has announced a revised policy that goes into effect this week. The new policy allows the recognition of same-sex unions for visa applications, but no other element of law.
The Hong Kong government confirmed: “From September 19, 2018, a person who has entered into a same-sex civil partnership, same-sex civil union, ‘same-sex marriage’, opposite-sex civil partnership or opposite-sex civil union outside Hong Kong with an eligible sponsor in accordance with the local law in force of the place of celebration and with such status being legally and officially recognised by the local authorities of the place of celebration will become eligible to apply for a dependant visa/entry permit for entry into Hong Kong.”
LGBT activists in Hong Kong (Isaac Lawrence/AFP/Getty)A spokesman added: “As the [court] recognised in its judgment, a valid marriage under Hong Kong law is heterosexual and monogamous and is not a status open to couples of the same sex.
“The revision has nothing to do with legal recognition of same-sex civil partnership, same-sex civil union, ‘same-sex marriage’, opposite-sex civil partnership or opposite-sex civil union in Hong Kong. Nor should there be any expectation of such plan by the Government.
“The revision does not compromise the Government’s position in any legal proceedings.”
The government stressed: “The revision concerns the immigration policy on applications for entry of non-local dependants only and it does not affect the meaning of ‘spouse’ under this Policy. It does not affect any other policies of the Government or any other rights under the existing law in Hong Kong.”
Integrase inhibitors—potent antiretrovirals that quickly and powerfully suppress HIV—have allowed HIV researchers and clinicians to explore dosing regimens that involve fewer than three or four drugs. Proponents of dual therapy say that effective regimens involving fewer drugs will lower costs, decrease pill burden and reduce the potential for drug-drug interactions and side effects. But is it that simple?
Monica Gandhi, MD, MPH
“Two-drug regimens are exciting,” said Monica Gandhi, MD, MPH, medical director of the Ward 86 HIV clinic at San Francisco General Hospital and associate division chief of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF. “But there are many clinicians who have been treating HIV for a long time that are a little bit alarmed over the two-drug fanfare. We’re not quite ready to jump on board with two-drug regimens for everybody.”
“On principal, fewer drugs is better,” said Keith Henry, MD, from Hennepin County Medical Center. “I like the philosophy of using fewer drugs, but I’m still not convinced that it’s going to be hugely beneficial. There may be only nuanced or subtle clinical advantages of a two- versus three-drug strategy evident over time—that we haven’t fully studied—especially if the drug you’re jettisoning is relatively non-toxic. In the U.S., most people that are on standard three-drug regimens are increasingly on one of the simplest, safest regimens currently available.”
Currently, there is only one recommended two-drug regimen option for people living with HIV, but the future may well bring more. Here’s a summary of challenges with the current option, and an overview of two other combinations currently being tested.
Dolutegravir plus rilpivirine
Juluca tablet (Photo: ViiV Healthcare)
Dolutegravir (integrase inhibitor) plus rilpivirine (NNRTI) is the only two-drug regimen currently recommended by the U.S. Department of Health and Human Services (DHHS). These medications can be purchased separately (no generic versions are available in the U.S.), so some people on this regimen take two pills once per day. This combination is also formulated as a single-tablet under the brand name Juluca, which is one tablet taken once per day.
This two-drug combination is not recommended for people just beginning antiretroviral therapy—it’s only a switch option for people who have been virally suppressed for at least six months.
Gandhi said that at Ward 86, the HIV clinic at San Francisco General Hospital, very few people are taking Juluca or dolutegravir and rilpivirine. The combination has been studied only in patients without a history of virologic failure, which is not common among people treated for HIV at Ward 86. Moreover, the risk of drug resistance, and need for food security, makes this regimen only a good choice for people who are highly adherent to their medications—and Ward 86 sees many patients who are unstably housed, struggling economically or otherwise experiencing life challenges that can stand in the way of perfect adherence.
“The concern about a two-drug regimen and starting patients on this regimen is that if you lose something like dolutegravir [to drug resistance], that would make it really difficult in the future in terms of treatment options,” said Gandhi. “I think Juluca is very exciting, but it may be more so for people who haven’t had any failure to previous regimens and who are highly adherent. It’s not for everybody,” she said.
Another issue is that Juluca—a new drug approved in November 2017—is expensive, and the ease of a complete one-tablet regimen may be offset by its high price tag. Henry from Hennepin County Medical Center said that at his hospital’s pharmacy, Juluca can cost more than $38,000 for one person’s year-long supply. (The wholesale acquisition cost is nearly $31,000/year.)
“If we purchase the tablets separately, it’s hundreds of dollars per month cheaper than that. If you look at what’s happening in society in healthcare in general, we still have to be good stewards of resources,” he said. “If you have individual small pills that are well-tolerated, I am not convinced that you always have to go with the single-tablet.”
Dolutegravir plus lamivudine
Dolutegravir plus lamivudine (3TC) is a promising two-drug regimen that is currently being studied. (It is not yet approved or recommended for use by the U.S. DHHS.) A generic version of lamivudine is available in the U.S.
At the AIDS 2018 conference in July, Pedro Cahn, MD presented results from the GEMINI-1 and GEMINI-2 studies comparing dolutegravir/lamivudine to a standard three-drug regimen of dolutegravir/tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). The study enrolled treatment naïve people who had not yet started antiretrovirals, with no evidence of drug resistance.
The researchers compared the percent of people who achieved viral suppression after 48 weeks between the two treatment groups, in addition to differences in CD4 count gains, adverse events and other safety and tolerability data.
Overall, the studies demonstrated that the two-drug regimen was non-inferior to the three-drug regimen: 93% of participants in the two-drug regimen and 94% of participants in the three-drug regimen achieved virological suppression at 48 weeks.
There were fewer drug-related adverse events with the two-drug regimen, and the two-drug regimen was also associated with better kidney and bone outcomes.
“As you well know, today ART means lifelong treatment,” said Cahn. “So as much as we can do to reduce drug burden for our patients is very welcome in terms of less long-term drug toxicity.”
Henry said that it will be interesting to see, as more efficacy data becomes available, what the differences might be between dolutegravir paired with lamivudine versus rilpivirine. He also plans to keep an eye on cost, and says this will continue to be a concern for patients and providers.
“This is part of the confusion of our health care system right now—and we’ll continue to have more of these dilemmas as time goes on and as we have more two-drug options and more generic drugs available. What is the real benefit of a single-tablet integrase regimen versus two or three small pills that are generic and much cheaper? If the single-tablet is 5% or 10% better tolerated or effective, but 45% to 50% more expensive, would a cost analysis support the use of the branded drug? We haven’t gotten into this as much as we should, but the overall state of healthcare financing means that we need to be more cost-benefit conscious.”
Cabotegravir plus rilpivirine
Cabotegravir LA vial and syringe (Photo courtesy of David Margolis)
Perhaps the most exciting two-drug regimen currently being tested is the long-acting formulation of rilpivirine and cabotegravir (which is an experimental integrase inhibitor). The dosing regimen now being tested frees people from taking oral antiretrovirals every day. Instead, people receive a long-acting injection once every four weeks or once every eight weeks.
So far, results of the LATTE-2 study, which is testing this formulation, are very promising. The injected cabotegravir and rilpivirine medications kept viral loads suppressed in 94% of people receiving injections every eight weeks and in 87% of people receiving injections every four weeks, when measured at the 96-week time point. People receiving the injections report high levels of satisfaction and convenience with the regimen, and also express willingness and desire to continue with this drug regimen.
If the long-acting injectable comes to market, Gandhi said she believes it could benefit people who struggle to take medication every day—in addition to people who are highly adherent (a bimodal population).
“We have many patients at Ward 86 who simply cannot fit taking a medication every day into their lifestyle, but, who actually show up to the clinic fairly often. People who are homeless may not come in for their primary care visits, but they show up for acute care visits. They’re engaging with the clinic a lot, which gives us hope that this will be an opportunity for treatment.”