Merck Gets FDA Approval On 2 New HIV Meds

Pharmaceutical drug giant Merck has obtained approval from the Food and Drug Administration (FDA) for two new medications to address HIV.

Pifeltro (doravirine) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI). That medication is paired in a three-drug single tablet dose to be marketed as Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).

Both are indicated for treating HIV-1 in adults with no prior anti-retroviral treatment.

The approval for the once-a-day pills come after two double-blind, active-controlled phase 3 trials showed positive results.

In a trial called “Drive-Ahead,” 728 patients were treated with either Delstrigo or Gilead’s Atripla for 48 weeks.

At the end of the study, viral suppression rates were similar with Delstrigo reaching 84% and Atripla achieving 81% suppression.

In addition to edging Atripla on viral suppression, Delstrigo patients saw better results regarding LDL cholesterol and non-HDL cholesterol.

The Delstrigo group also experienced lower incidence of neuropsychiatric adverse issues like sleep problems, dizziness and being able to concentrate more clearly.

While there is currently no cure for HIV/AIDS, the Centers for Disease Control have previously announced that when HIV+ folks stay on their prescribed medications on a daily basis, not only are viral loads lowered to ‘undetectable,’ but ‘undetectable’ means the virus is untransmittable.

(h/t PharmaPhorum)

New Study: HIV+ Men On Effective Treatment Don’t Transmit Virus To Partners

The results of a new medical research study presented at the International AIDS Conference in Amsterdam shows men who are HIV+ currently undergoing treatment do not pass the virus to negative partners.

The results of a new medical research study presented at the International AIDS Conference in Amsterdam shows men who are HIV+ currently undergoing treatment do not pass the virus to negative partners.

According to the PARTNER 2 study, when HIV+ men are on effective HIV treatment bringing their viral load to ‘undetectable,’ not one incidence of transmission was noted even in cases of condomless sex.

While the original PARTNER study focused on sero-discorant couples (one positive, one negative), that study looked primarily at opposite-sex couples, although there were 635 same-sex couples included.

PARTNER 2 involved data from those 635 couples plus another 337 same-sex couples added to the mix. Overall, couples from 14 countries took part in the study.

Looking at over 77,000 condomless sex acts between the partners, not one incident of transmission occurred when the HIV+ partner had a viral load under 200 copies/ml.

This seems to validate a previous study, Opposites Attract, which came to the same conclusion.

When you combine the participants of the two studies, medical experts couldn’t find one case of HIV transmission in examining 126,000 incidents of anal sex without a condom.

Researcher Alison Rodger told aidsmap.com, “We looked so hard for transmissions. And we didn’t find any.”

“This is the moment when science trumps stigma,” said Executive Director of NAM, Matthew Hodson, a leading HIV/AIDS organization in the United Kingdom. “This is the moment when facts must conquer fear.”

“The knowledge that when we are undetectable we can’t pass the virus on to our sexual partners has the power to encourage people to test and to remain adherent to their treatment,” added Hodson. “Just as importantly it can have an impact on the way that people with HIV think about themselves, removing some of the stress and fear that many in our communities experience.”

All of this helps to underscore the message “Undetectable = Untransmittable,” which countless sexual health organizations have been supporting in an effort to reduce the stigma of being HIV positive.

“This should be reassuring to every gay and bisexual man who is HIV-undetectable that you are not a danger to anyone and no person should use your status as a way to reject you,” said Ian Howley, Chief Executive of HERO – Health Equality and Rights Organization.

News Round-Up: July 11, 2018

Imagine your doctor looks like this…? #woof

A few news items you might have missed:

• So, he has lots of clothes on – I know, I know – but this InstaHunk (above), med student Marco, makes my days with pics like this. That face, those arms… #dang

• Israel’s Parliament has voted down a proposed amendment that would have allowed same-sex couples the right to have children via a surrogate. #Boo

• According to a new poll by Pew Research, when asked “What president has done the best job in your lifetime?” more than four-in-ten (44%) say Obama is the best or second best president of their lifetimes, 33% say Bill Clinton and 32% say Ronald Reagan. The Donald was only considered “best” by 19% of respondents.

• A recent study shows condoms are 91% effective in preventing HIV transmission. Previous estimates put the efficacy of condoms at about 70%.

• If a picture is worth a thousand words…

Trump Administration Siphons HIV/AIDS Funds For More Child Detention Centers

As the public battle about family separations at the U.S. southern border rages on, reports show the Trump administration is taking money from HIV/AIDS programs to fund further separations.
Donald Trump

As the public battle about family separations at the U.S. southern border rages on, reports show the Trump administration is taking money from HIV/AIDS programs to fund further separations.

The Office of Refugee Resettlement is looking ahead at the possibility that 25,450 more beds for immigrant children could be needed by year’s end.

The office, part of the Department of Health and Human Services, was apparently surprised when U.S. Attorney General Jeff Sessions announced the new “zero tolerance” policy that families would be separated if caught crossing the border without authorization.

Under the policy, parents are imprisoned and children have been placed in cages that Sen. Jeff Merkley, who visited a facility, described as resembling “dog kennels.”

Now, in preparation for a new surge of family separations, the HHS is not only asking for supplemental funds, but according to news website Slate is also planning to reallocate money from the Ryan White HIV/AIDS Program.

The Ryan White CARE Act was introduced in 1990 by Sen. Ted Kennedy weeks after the death of its namesake Ohio teen, who had been infected with HIV via a blood transfusion to treat his hemophilia. The bill was signed into law by President George H.W. Bush.

According to the program’s website, the Ryan White HIV/AIDS program “provides a comprehensive system of care that includes primary medical care and essential support services for people living with HIV who are uninsured or underinsured.”

Slate’s reporting indicates the process of transferring those HIV/AIDS funds has already begun.

This is just one more example of the Trump/Pence administration’s bias against the LGBTQ community which is massively impacted by the HIV/AIDS epidemic.

Vice President MikePence famously pledged to siphon funding from the program in order to fund state-sponsored ‘gay cure’ therapy.

On his 2000 Congressional campaign website, Pence posted:

“Congress should support the reauthorization of the Ryan White Care Act only after completion of an audit to ensure that federal dollars were no longer being given to organisations that celebrate and encourage the types of behaviours that facilitate the spreading of the HIV virus.

“Resources should be directed toward those institutions which provide assistance to those seeking to change their sexual behavior.”

Additionally, HHS is moving $79 million from refugee resettlement programs. The loss of those funds will undercut medical assistance and social services for refugees in the United States.

(h/t Slate)

Survey: 43% Of Gay People Would Be “Uncomfortable” Kissing Someone HIV+

A new survey shows 3 in 10 lesbian, gay or bisexual people (LGB) would ‘swipe left’ on a dating app to reject someone who is HIV positive even if those people are on effective treatment.

The research, conducted by YouGov for the UK-based Terrence Higgins Trust, showed 35% of respondents would reject someone who was openly HIV positive on dating apps like Tinder and Grindr.

Additionally, 31% admitted they didn’t know how they would react.

The deep dive into attitudes towards sex, relationships and HIV, reveals a disheartening level of bias caused in great part by a lack of understanding of HIV transmission.

Also from the survey:

• 43% said they would be uncomfortable kissing someone with HIV in spite of the fact that science has shown for decades HIV can’t be passed on through kissing

• 77% indicated they wouldn’t be comfortable having comdomless sex with someone HIV positive

• 55% said they don’t believe HIV positive people with undetectable viral loads can’t infect another person

The PARTNER study examined 58,000 instances of sex between an HIV positive person on effective treatment and a partner without HIV, and there were zero cases of HIV transmission.

Ian Green, chief executive at Terrence Higgins Trust, speaking to Pink News, said, “It’s truly devastating to hear that so many wouldn’t swipe right for or even kiss someone living with HIV who’s on effective treatment.

“We’ve known for three decades that HIV can’t be passed on through day-to-day contact and that includes kissing.”

Terrence Higgins Trust has launched their Can’t Pass It On campaign to promote the truth and science about HIV transmission and combat the stigma of HIV. The campaign gives people living with HIV a very easy way to inform and educate without having to get into specifics.

From the website: “By helping to spread the word and ensure that people know the facts about HIV and effective treatment, we hope to tackle stigma and remove the fear that often surrounds the virus.”

Here in the U.S., the Centers for Disease Control and Prevention also agrees that undetectable = untransmittable.

Find out more about HIV transmission at www.tht.org.uk/cantpassiton

Donald Trump Ignores LGBTQ People On National HIV Testing Day

Even when it comes to observing National HIV Testing Day, Donald Trump’s White House continues to ignore the LGBTQ community.

The annual observance, founded in 1995, encourages Americans to get tested and know their HIV status.

While the Trump White House did issue a statement yesterday, it was completely void of any mention of LGBTQ people.

On National HIV Testing Day, we recognize the great progress we have made in the fight against Human Immunodeficiency Virus (HIV), including our Nation’s efforts to spread awareness about the importance of getting tested. Early detection of HIV—using a simple and routine test—is instrumental in helping contain the advancement of the virus to Acquired Immunodeficiency Syndrome (AIDS).

Today, medical advances are helping more than one million Americans affected by HIV live longer and healthier lives. Further, in June 2017, the Food and Drug Administration approved generic medications that dramatically reduce the risk of infection in the first place.

Despite this progress, in 2016, nearly 40,000 people were diagnosed with HIV in the United States. People between the ages of 20 and 29 received more than a third of those diagnoses. Even more troubling, 44 percent of people living with HIV between the ages of 13 and 24 were unaware that they were carrying the virus. National HIV Testing Day is an important reminder that those who are unaware they are carrying the disease are the most at risk for inadvertently infecting others and missing out on potentially life-saving treatments.

As we observe National HIV Testing Day, we celebrate the advancements we have made in medical science, and I encourage all Americans to invest in their health and be aware of their HIV status. Through greater awareness and education, we can all do our part to lead healthier and longer lives.

So, while acknowledging the disease and a few statistics based on age, what the statement clearly omits is any mention of the fact that the risk for HIV disproportionately affects LGBTQ people and people of color.

According to the Centers for Disease Control, gay and bisexual men are affected by HIV more than any other group in the United States. When you factor in race, the numbers skew even further.

Since taking office, Donald Trump and his administration have continually ignored and shown disrespect for the LGBTQ community.

Last December 1, Trump’s first World AIDS Day as president, the White House issued a proclamation that completely ignored LGBTQ folks.

Shortly after that, Trump fired the entire Presidential Advisory Council on HIV/AIDS without reason.

Both last year and this year, Trump took the time to observe June as National Ocean Month, National Caribbean-American Month and National Homeownership Month.

But complete silence about Pride Month.

Remember when Trump campaigned saying he would be ‘better for the gays’ than Hillary?

Yeah, not so much.

Podcast: Jury Awards $18.4 Million Over Cancelled HIV Test; Web Series Imagines A World Where AIDS Never Happened

In this week’s podcast:

• A gay man is awarded $18.4 million over a cancelled HIV test

• New web series Fathers wonders “Who would we be if AIDS hadn’t happened?”

• Tan France, fashion guru for Queer Eye, says his family thought the ‘make better’ series converted straight men to gay

• There’s new music from out indie recording artist Aiden James “Colorblind”

All that and more in this episode of The Randy Report

News Round-Up: June 22, 2018

InstaHunk Obaid Habibi

Some news items you might have missed:

• I’d love to lie and tell you this is my new assistant, but alas, no. It’s InstaHunk Obaid Habibi hanging out at his laptop 🙂

• A Kansas man was arrested trying to have sex with a parked car. I kid you not.

• A promising HIV vaccine demonstrated its power by neutralizing HIV strains in animals and is almost ready for human testing.

• A cop, charged with rape and indecent assault and battery performed in a broom closet, says the sex was consensual. At the time of the encounter, the officer was married to a woman who happened to be the chief of police.

• S-Curve Records has signed this year’s Eurovision Song Contest champ Netta. The Israeli pop maverick’s viral smash “Toy” has been viewed over 76 million times since the competition.

• 60% of LGBTQ+ student loan borrowers say they regret taking out student loans. On average, LGBTQ borrowers have $112,607 in student loan debt — $16,000 more than the general population average of $96,211.

• The U.S. Supreme Court has ruled that law enforcement authorities need a warrant before tracking a cell phone’s location data. In the ruling, SCOTUS likened cell phones to GPS ankle monitors.

• Barbra shared this short clip via Instagram and I had to watch five times. From “Barbra The Concert,” its currently available on Netflix.

Jury Awards Gay Man $18.4 Million In Cancelled HIV Test Lawsuit

After doctors canceled an HIV test during his treatment, a gay man was awarded $18.4 million by a jury

In 2007, Sean Stentiford consented to an HIV test while being treated for facial paralysis at Lahey Hospital & Medical Center in Burlington, Massachusetts.

According to The Boston Globe, he agreed to the testing after a resident at the hospital told him his symptoms were ‘highly suggestive’ of HIV infection.

His neurologist, Dr. Kinan K. Hreib, disagreed and cancelled the test writing in Stentiford’s file that there was “no risk of HIV,” despite the fact that he was gay and had worked as a paramedic earlier in his life.

The Centers for Disease Control recommend sexually active gay men be tested for HIV at least once a year. Going back to 2006, Stentiford’s medical records reflected that he was a gay man.

Although blood tests were performed, the HIV test was removed from the list without telling Stentiford.

Stentiford visited his primary care doctor, Dr. Stephen E. Southard, in June of 2007 where he was told his tests “looked good.”

At that point in time, having signed a release form for the test (in the presence of his sister), Stentiford believed the HIV test had been performed.

Three years later, his condition had worsened. It was at that time he learned the HIV blood test hadn’t been performed and that he was, indeed, HIV positive.

By that time, the disease had advanced to full-blown AIDS as he battled brain damage and cognitive impairment.

After an 8-day trial in U.S. District Court, a jury found both Dr. Hreib and Dr. Stephen Southard guilty of negligence which caused Stentiford harm.

A third physician was also found to be negligent but hadn’t caused him harm.

On Monday, the jury awarded Stentiford, now 48 years-old, $18.4 million in damages.

Now living in the Bronx, Stentiford no longer suffers from HIV/AIDS-related symptoms due to modern medications and treatment.

News Round-Up: June 4, 2018

(image via Instagram)

Some news stories you might have missed:

• Loving this new InstaHunk account find – Muscle_Woof (above). #WoofWoof

• A local veteran in a small Maine town has a big problem with a rainbow flag flying during Pride Month calling the show of LGBT support a “travesty.”

• Researchers in Australia have found a direct correlation between low cognitive ability and folks who hate gays.

• Promising news from the National Institutes of Health – a new experimental HIV vaccine has been shown to neutralize dozens of HIV strains from around the world.

• Environmental Protection Agency Administrator Scott Pruitt asked a top aide to purchase a “used mattress” from the Trump International Hotel for him…?

• UK trio Clean Bandit dropped their new self-directed music video for their single “Solo” featuring Demi Lovato released earlier this month which garnered over 20 million streams during its first week.

The song is a paean to “self-love” (solo, get it?) and even better, the story resolves with a rainbow-furred dog. What’s not to like? Hit the play button below 🙂