Should PrEP Be Available As An Over-The-Counter Medication?

Yesterday I reported on a push by California lawmakers to make PrEP (pre-exposure prophylaxis) and PEP (post-exposure prophylaxis) available to the public as over-the-counter medications to be dispensed by a pharmacist.

The legislation, Senate Bill 159, has passed in the state Senate and is working its way through the Assembly.

The bill has strong support from the San Francisco AIDS Foundation, APLA Health, the Los Angeles LGBT Center, and the California Pharmacists Association.

According to the Centers for Disease Control(CDC), studies have shown that PrEP reduces the risk of getting HIV from sex by about 99% when taken daily. So making the medications more accessible definitely sounds like a good idea.

But there are those who have reservations about the bill.

The California Medical Association (CMA) wants to see changes made before the bill becomes law. The CMA points to possible drug interactions as well as complications with liver or kidney functions that might occur if the patient isn’t being monitored on a regular basis by a physician.

There are other concerns as well.

For instance, Gilead Sciences, which manufactures the drug Truvada (tenofovir) used in PrEP, was sued in April by eight patients who took the medication for years.

They say Gilead “deliberately withheld a much safer version of these drugs from the market for more than a decade” in an attempt to maximize profits from Truvada, according to Biospace.com.

The plaintiffs say Gilead was slow in sharing adverse event reports which indicated HIV drugs using a formulation known as tenofovir disoproxil fumarate (TDF) caused far more serious complications than previously reported.

Medications that utilized this formulation were marketed up to 2015 as Truvada, Viread, Atripla, Complera and Stribild.

Gilead Sciences had developed a safer, more effective anti-viral HIV treatment formulation, tenofovir alafenamide fumarate (TAF), which was patented in 2015.

While the lawsuit is slowly working its way through the courts, some critics of SB 159 say the general public may not know which medications may or may not work for them. Plus, would the average pharmacist have an extensive background on the different medications used for PrEP?

Additionally, Gilead is on the verge of having a new HIV drug, Descovy, approved for use in PrEP. Descovy has already undergone phase II trials and is awaiting final approval which could come as soon as September or October.

While Truvada continues to be effective, according to Biospace.com, Gilead says Descovy is “safer than Truvada for PrEP and ‘offers more efficient delivery’ of the antiviral components, which results in a higher concentration of the drug in the cells where HIV can occur.”

Gilead has stated an approved version of Descovy would cost about the same as Truvada, about $21,000 a year.

While that FDA approval is expected shortly, an Israel-based company, Teva Pharmaceutical, is expected to make a generic version of Truvada available possibly as soon as 2020.

Since 2004, Truvada has definitely helped save lives as part of a daily HIV treatment and, since 2012, as the only drug approved for use as PrEP.

I personally support making safe, life-saving drugs as available as possible.

But here's a question - if you knew there was a less-toxic but more expensive drug on the market versus an older, generic medication, what would you do?

(source: Biospace.com)

Podcast: Cuba Marches, Gilead Donates, Indya Moore Covers ELLE, Matt Bomer Stars In 'Papi Chulo'

In this week's podcast:

• Pharma giant Gilead will donate up PrEP medications for up to 200,000 American individuals in the effort to stop HIV

• Cuban gays stage an impromptu Pride march after the government cancels the annual parade

• A school in Indiana planned to deadname a transgender student at graduation

• Indya Moore becomes the first transgender woman to cover Elle Magazine

• And Matt Bomer plays a gay weatherman in the upcoming movie, 'Papi Chulo'

All that and more in this episode of The Randy Report

Hit the play button below.

If you enjoy catching up on LGBTQ news in a quick podcast, I’d appreciate it if you would share The Randy Report with your friends.

I like to think of this podcast as the 60 Minutes of gay news —— only shorter ;)

Gilead Will Donate PrEP For 200K People

The Department of Health and Human Services has announced that pharmaceutical company Gilead Sciences, Inc. has agreed to donate pre-exposure prophylaxis (PrEP) medication for up to 200,000 individuals each year for up to 11 years.

PrEP is used to reduce the risk of HIV infection in individuals who are at higher risk for HIV. It has been shown to reduce the risk of new infection by up to 97 percent when taken consistently.

The agreement between the U.S. Department of Health and Human Services and Gilead will last until at least December 31, 2025 and possibly through December 31, 2030, and will provide medication to treat individuals who are at risk for HIV and who are uninsured.

This donation will deliver Gilead’s PrEP medication Truvada, which currently carries a list price of more than $20,000 per patient per year, to up to 200,000 people per year, including in the states and counties identified as priority areas in the Trump Administration plan - PDF to end the HIV epidemic in America.

Gilead will donate Truvada until its second-generation HIV preventative medication, Descovy, becomes available. At that time, Gilead will donate Descovy. The agreement would end after 11 years, or when a generic version of Descovy becomes commercially available, whichever comes first. The government has agreed to cover costs associated with distributing the drugs.

I’m pleased to announce that as a result of discussions between the Trump Administration and Gilead Sciences, Inc., Gilead has agreed to make a historic donation of #HIV prevention medication for up to 200,000 individuals each year for up to 11 years.

— Secretary Alex Azar (@SecAzar) May 9, 2019

The agreement will provide pre-exposure prophylaxis (PrEP) to treat individuals who are at risk for HIV and who are uninsured, including in the states and counties identified as priority areas in @POTUS’s plan to #EndHIVEpidemic in America.

— Secretary Alex Azar (@SecAzar) May 9, 2019

But some folks point out this isn't a simple case of the Gilead folks being generous.

The U.S. government spent years, as well as tens of millions of dollars, developing the treatment. The federal government patented the treatment in 2015, but doesn't make a penny from it while Gilead, which has a U.S. monopoly on the drug, has cleaned up.

A month's supply of Truvada can cost $2,000, but costs a small fraction of that to produce.

This isn’t a donation. We, the American public, own the patent for this therapy. Gilead basically stole it and is now kindly giving some back. https://t.co/F3zUUEJEUm https://t.co/2lQMcGYKR5

— Adam W Gaffney (@awgaffney) May 9, 2019

(via press release)

News Round-Up: February 20, 2019

(image via Instagram)

Some news items you might have missed:

• I might be a little obsessed with this handsome face. InstaHunk Steve_In_LA is pretty easy on the eyes as well ;)

• New York City Council Speaker Corey Johnson has called for feds to 'break the patent' on Truvada, which is commonly prescribed as PrEP. Since the federal government helped fund the research for the drug, it has the right to break the patent and allow other companies to produce a generic version. PrEP has been shown to be 99% effective in protecting against HIV infection when used on a daily basis.

• The Republican-controlled Indiana Senate has voted to scrap all protected characteristics, including gender identity, race and sexual orientation, from a proposed hate crime bill. Indiana is one of only five states with no hate crime law in place.

• A lesbian couple in Indiana were refused service by their tax preparer, Nancy Fivecoate, because they were married. Fivecoate says she has gay clients, but she can't work for gay married clients. What do taxes have to do with religious beliefs?

• 18-time Grand Slam winner Martina Navratilova has been removed from the advisory board of pro-LGBTQ sports organization Athlete Ally for her recent anti-transgender remarks. The tennis champ says its 'cheating' to let trans women compete in women's sports.

• As he was recovering from a life-shaking breakup, out singer/songwriter Kisos penned (in real time) his upcoming EP, sweet nothings, featuring one track for each of the 5 stages of grief.

The lead single, "Happily Ever After," is a bouncy electro-pop bop with the handsome artist deep in denial, using delusion as poisoned motivation to better himself and survive the pain of seeing his ex with someone new.

Hit the play button below and enjoy! "Happily Ever After" is available now - click here.

News Round-Up: September 18, 2018

Some news items you might have missed:

• Just to prove folks can be oh-so-sexy fully clothed, check out all of what med student Marco has going on underneath. Oh, yeah, and there's that easy-on-the-eyes face. #woof

• The security guards who ejected fans waving rainbow flags at a concert by pop phenom Dua Lipa concert last week have been arrested for their actions.

• Out Olympic figure skater Adam Rippon is donating a pair of skates and the competition outfit he wore when he helped Team USA win a bronze medal at the 2018 games to the Smithsonian’s National Museum of American History.

• Britain’s High Court has overturned pharmaceutical company Gilead Science’s patent extension on Truvada. This ruling could mean affordable, generic versions of the drug could be available in the UK by April 2019.

• Roseanne Barr says the upcoming Roseanne spinoff, The Connors, will kill off her character by having her die of opioid overdose as a 'screw you' to Trump supporters. However, in the recent season of the rebooted Roseanne, writers had laid the groundwork for her character to struggle with prescription pain killer addiction.

• Digital series After Forever won "Best Short Film Ensemble" at the L.A. Indie Film Festival this weekend.

• A Sesame Street writer admits he always considered and wrote the longtime characters Bert & Ernie as a "loving couple."

The folks at Sesame Street did respond to the recent revelation by tweeting a statement about the "best friends" which read, in part, "Even though they are identified as male characters and possess many human traits and characteristics (as most Sesame Street Muppets do), they remain puppets, and do not have a sexual orientation."

Please see our statement below regarding Bert and Ernie. pic.twitter.com/6r2j0XrKYu

— Sesame Workshop (@SesameWorkshop) September 18, 2018

Report: Another Man Diagnosed With HIV While Taking PrEP

Health officials in Washington State report a local man has been diagnosed with HIV while taking PrEP (pre-exposure prophylaxis).

The Seattle & King County’s Public Health Department reports the unnamed man was infected with a rare strain of HIV resistant to the medications in Truvada, the drug’s commercial name.

No details are available on whether he took the medication regularly.

If taken correctly, PrEP has been shown to reduce the risk of HIV by up to 99%.

From OutBreakNewsToday:

Truvada as HIV PrEP is very effective if taken consistently. It reduces the risk of acquiring HIV through sex by over 90%, and perhaps by over 95%. It is also more than 70% effective in preventing HIV infections transmitted through sharing injection equipment. So while it is very effective, like many drugs, it is not 100% effective.

There have been very few reports of HIV infections while taking PrEP.

An Australian man participating in a PrEP clinical trial became infected in 2017 with a drug-resistant strain of HIV.

Also last year, a Dutch man was diagnosed with HIV but doctors there speculate that his “remarkably high” number of sex partners might have been a factor in his infection.

The Centers for Disease Control recommended in 2015 that sexually active gay and bisexual men, or about one in four, be on PrEP.

New York City: HIV Diagnoses Drop To Historic Low

The New York City Department of Health has released a new study that shows new HIV diagnoses have dropped to the lowest rate in the city's history.

The report shows that 2,279 people were diagnosed with the virus in 2016, down 8.6% from 2015.

The department first began tracking HIV statistics in 2001 which saw 5,906 new infections.

Researchers credit the decline in great part to the spread of preventative drug PrEP. The drug is available for low or no cost at the city's eight health clinics.

At the beginning of 2016 only 5% of men having sex with men were using the drug. But by the end of the year, that figure jumped to 30%.

“The technology has landed, and implementation is moving quickly,” Dr. Demetre Daskalakis, the Health Department’s Deputy Commissioner for Disease Control, told Jezebel. “Finally we’re seeing that the curve of decline is statistically significant. I think this is a harbinger of really good things to come.”

It's not all good news though. The report also showed a slight increase in new diagnoses for women, particularly black and Latina women.

Daskalakis told Jezebel, “We’re going to really energize our next campaign to be very, very women focused. We need to better with women, and so we will.”

Podcast: Texas' Bathroom Bill, FDA Approves Generic Truvada, Tony Award Predictions & More

On this week's The Randy Report podcast, I look at these LGBT headlines:

• Texas Gov. Greg Abbott is calling a special session of the Texas legislature to try an pass an anti-transgender “bathroom bill”

• The FDA has approved a generic version of Truvada

• Transgender leaker Chelsea Manning gave her first interview since being released from prison

• "Guardians of the Galaxy" star Dave Bautista has a message for homophobes

• Just a few predictions of who might win at this year's Tony Awards

All that and more in this episode of The Randy Report.

You can subscribe to The Randy Report podcast (for free!) on iTunes here.

Assurant Health Will End PrEP Coverage

Although Truvada is approved by the FDA and endorsed by the CDC, one health insurer says they will no longer cover the prescription drug.

Assurant Health, a national company specializing in health insurance coverage for individuals and small businesses, will no longer cover the med Truvada as pre-exposure prophylaxis (PrEP) to prevent contracting HIV.

Several Assurant customers who had been taking Truvada (comprising the antiretrovirals tenofovir and emtricitabine) as PrEP were recently notified that the insurer would end coverage of the med in July. “Prophylactic treatment is not a covered benefit as listed in the Exclusion Section of your member contract,” read one customer’s notice (see below).

“As a courtesy we will allow two additional months of prescription coverage for your Truvada prescription. This means you will continue to receive prescription drug card benefits for Truvada at CVSC Specialty Pharmacy until July 1, 2015.”

New French Study Indicates Taking PrEP Just Before Sex Could Reduce HIV Infection By 80%

For months now, medical research studies have indicated that taking Truvada, an anti-HIV medication, on a regular basis could effectively deter infection of HIV by over 90%.

Those studies showed that taking the drup at least four days a week on a regular basis could provide effective protection.

Now a new study in France indicates that taking two pills of Truvada just two hours before sex and two single doses within the following 24 hours could reduce the rate of being infected by 80%.

Researchers closed the study early due to the high effectiveness of the drug.

Via AIDS Map:

In an extraordinary development, a second European scientific trial of pre-exposure prophylaxis (PrEP) has had its randomised phase closed early due to high effectiveness, just two weeks after the UK PROUD trial did exactly the same thing. The investigators of the IPERGAY trial, which has six sites in France and one in Canada, announced today a “Significant breakthrough in the fight against HIV and AIDS” because IPERGAY had successfully demonstrated the effectiveness of its PrEP regimen.

IPERGAY’s early closure is significant not only because it adds confirmation that PrEP can be highly effective, but because it was testing an innovative, intermittent (“on-demand”) PrEP regimen. In this study, participants did not take PrEP daily, but only when they anticipated having sex. The regimen involved taking two pills of Truvada (tenofovir + emtricitabine) twelve hours before anticipated sex and then, if sex happened, two separate one-pill doses the following day. This extends the versatility of PrEP and provides an alternative regimen to daily dosing.

As this is still in research, folks on Truvada daily doses should NOT change their regimen without discussing with their doctors.

New study indicates PrEP could offer 100% protection

At the International AIDS Conference, currently taking place in Melbourne, Australia, the results of a study showing the efficacy of Truvada to prevent new infections of HIV were released.

The news appears to be very good.  Apparently, a dosage of at least 4 times a week can offer 100% protection against new infections.

Tested on more than 1 600 HIV-negative men, including gay men, bisexuals, transgender women and men-sleeping-with men (MSM) at 11 research sites on four different continents, the latest study found that PrEP provided 100 percent protection among participants who took the pill four times or more every week. Those who took the pill two or three times a week registered a protection rate of about 84 percent. Those who took fewer than two tablets in the same period had no protection at all.

Carried out by the US-based National Institute of Health over an 18-month period in Chicago, San Fransisco, Boston, Thailand, Rio de Janeiro and Cape Town, among other sites, researchers are convinced that using pre-exposure prophylaxis could save lives of high-risk populations. ay men are regarded as the key population or at highest risk of HIV infection and transmission. At the conference it also emerged that while the HIV/Aids burden was declining in parts of the world, HIV infection among gay men was increasing.

Taking Truvada on a daily basis as a preventative against HIV infection (a practice known as PrEP) has been around since 2010. But there have been questions about long-term side-effects from taking the drug.

New York State Dept of Health endorses Truvada to prevent new infections

The New York State Department of Health has approved use of the HIV medication Truvada to try to prevent new HIV infections.

From DNAinfo:

After months of anticipation, the Health Department's AIDS Institute released thorough clinical guidelines for pre-exposure prophylaxis, commonly known as PrEP, which is a daily dose of HIV medication that people who are HIV-negative but at-risk of contracting the virus can take to drastically reduce their chance of infection.

The drug, known by its prescription name Truvada, can reduce the chance of infection by as much as 73 percent, according to studies funded by the Bill and Melinda Gates Foundation.

However, the AIDS Institute stressed that PrEP alone was not enough to prevent new infections.

"PrEP should not be offered as a sole intervention for HIV prevention. PrEP should only be prescribed as part of a comprehensive prevention plan," the report says.

The state report recommends that doctors work with community AIDS organizations to identify high-risk individuals who could benefit from PrEP, then after discussing it with them, begin a 30-day trial before figuring out a longer-term plan.

While certainly anything that can slow down or prevent new infections is a good thing, my only concern reading this is people may take the drug thinking they are impervious to infection and possibly take part in unsafe sex practices.

Also, the drug Truvada costs between $8,000-14,000 a year. That's quite the heavy hit on someone's budget when condoms are much cheaper and have a better history of preventing infection.

I applaud the expansion of protections and admit I'm not smart enough to have all the answers. I'm just a little wary for folks who may think they have it covered by taking this pill.

Just my .02

FDA approves pre-exposure medication for HIV

The FDA has just given the green light to Truvada, the first drug approved to reduce the risk of HIV infection in uninfected individuals.

Taken daily, the drug is being touted as part of a pre-exposure prophylaxis (PrEP) strategy, in combination with safer sex practices, to reduce the risk of HIV infection in high-risk adults, including those with HIV-infected partners. The FDA previously allowed Gilead Sciences to manufacture Truvada (emtricitabine/tenofovir disoproxil fumarate) for use in conjunction with other antiretroviral agents for HIV-positive people.

“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Dr. Margaret A. Hamburg. “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.”

The medication shouldn’t be perceived as a cure or vaccine: Truvada for PrEP is only prescribed fpr individuals who are confirmed to be HIV-negative prior to using the drug. In double-blind studies of 2,499 HIV-negative men and women in high-risk categories, Truveda was effective in reducing the risk of HIV infection by 42% compared with the placebo. There are also potential side-effects including changes in fat distribution in the body and blood, kidney and liver dysfunction and weakening of the bones.


Via Queerty