Study Shows Injectable PrEP Taken Every Two Months As Effective As Truvada

(image via Depositphotos)

Could this be PrEP 2.0?

A large-scale clinical trial found that the injectable antiretroviral drug cabotegravir administered once every 8 weeks resulted in fewer new cases of HIV than daily doses of Truvada taken as pre-exposure prophylaxis (PrEP).

Begun in December 2016, the study involved more than 4,500 participants around the world.

All were deemed to be at risk of contracting HIV and randomly assigned to receive either a daily dose of Truvada or an injection every eight weeks. Those in the injectable group also were given a placebo pill, and those given Truvada received placebo injections.

After conducting an interim review of the trial, the study’s results clearly showed cabotegravir actually reduced HIV infection rates more than daily oral doses of Truvada.

According to Science Magazine, 12 infections occurred in the cabotegravir group versus 38 in the group that received Truvada. Both control groups were of the same size.

Statistically, that represents a 0.38% incidence in the cabotegravir group versus 1.21% in the Truvada one, a 69% difference in new infection rates.

The results were deemed so impressive that all participants, including those receiving placebos, will be offered the injections beginning this week.

Science Magazine reports the apparent success (the results of the study haven’t been published in a peer-reviewed journal yet) could be a more attractive alternative than a daily regimen of pills which has proved difficult for many people.

One drawback to the daily oral dose of Truvada has been the difficulty for some people to stay on schedule. A missed dose here or there can reduce the regimen’s effectiveness. On the flip-side of that equation, though, those who choose to use the long-acting injectable medication might miss a scheduled clinic visit which could reduce its effectiveness.

(source: ScienceMag.org)

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'

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.

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.

(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

Medical student Marco proves that you can be very sexy even fully clothed.

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.”

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.”