First Self-Injectable HIV Treatment – PRO 140 – With 98% Success Rate Could Be Available By 2017

First self-injectable HIV treatment has 98% success rate - could be available by 2017

The first self-injectable antibody, PRO 140, has documented an impressive 98% success rate in a Phase 2b clinical trial for patients with HIV.

In a monotherapy study, some HIV patients using PRO 140 are experiencing a completely suppressed viral load for 11 months.

PRO 140 could be commercial in 2017 if it has positive results from the upcoming Phase 3 trial.

PRO 140 blocks the HIV co-receptor CCR5 on T-cells, preventing viral entry. PRO 140 effectively reduces viral loads by as much as 1.8log with one dose per week.

If the HIV patient’s viral load is completely suppressed, the transmission rate becomes almost zero.

For now, the path to first approval for PRO 140 is in the treatment experience population.

Dr. Nader Pourhassan, CytoDyn Inc. President/CEO states,

“Results from six Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral load in people infected with HIV.

“Our Phase 3 protocol provides for an upcoming 25-week study with 300 HIV-positive patients. Selection of clinical sites, IRB approvals, patient screening, and other administrative matters are underway and expected to be completed in time for the first patient to be dosed in the third quarter of this year. Although CytoDyn has a green light to start its Phase 3 clinical trial of PRO 140, the Company may apply for a ‘breakthrough’ designation with PRO 140 as the first self-injectable antibody for HIV therapy.”

Phase 3 trials are expected to be conducted at over 30 sites in the U.S. The Company plans to submit its NDA (New Drug Application) for final approval of PRO 140 in November of 2016.

(via press release)

Reliably Taking HIV Cocktail Can Make Transmission Virtually Zero

Ground-breaking research findings were announced yesterday at the eighth International AIDS Society Conference in Vancouver, Canada, which show reliable adherence to HIV cocktails can disable the HIV virus to the point of no transmission during sexual activity.

The landmark study, financed with more than $100 million in federal research grants, confirmed initial results reported in 2011 and demonstrated that AIDS medications known as antiretroviral therapy, or ART, can suppress the virus for years. The virus can reemerge if the patient stops taking the medicine, but as long as it’s suppressed, the virus essentially is harmless and most patients can lead normal, healthy lives.

“If people are taking their pills reliably and they’re taking them for some period of time, the probability of transmission in this study is actually zero,” Cohen said by phone from Vancouver. “Let me say it another way: We never saw a case of HIV transmission in a person who is stably suppressed on ART.”

Technically speaking, if everyone with HIV could be on ART, there would be the possibility to eradicate the disease.

Researchers made it clear, however, that they continue to endorse the use of condoms. Most of those infected with HIV in the United States (estimated at 1.2 million) are not on medication addressing the virus. Only about 37% of folks with HIV are currently on antiretroviral therapy.

What Happens When An HIV+ Man Asks Strangers To Touch Him

Standing in a public park in Helsinki, Finland, a man named Janne stood next to a sign which read “I’m HIV-positive, touch me,” to see if the negative stigma attached with HIV/AIDS still exists.

Before you watch: what do you think happened? I’d love to know what you thought before and after.

(source)

Documentary: “Desert Migration”

The new documentary Desert Migration screens this Summer at Frameline Festival in San Francisco and Outfest in Los Angeles.

Clip Description:

When HIV treatments improved and people stopped dying by the thousands, many gay men took stock and said, “So…now what?” Their peer group was decimated and they themselves had only escaped death by a narrow margin.

Retiring to California’s Palm Springs seemed like a viable decision. Health services were great, housing was affordable, there was a large gay population and it was always sunny. The roads they took to get there were varied, but all promised a veritable Lost Horizon, where age, illness and sin were a thing of the past.

However, being left to your own devices in a town where the sun always shines has a way of exposing who a person really is. With no friends, no job, and traumatized by recent memories, the burden is entirely on the individual to make something meaningful grow in the dry, harsh desert.

Desert Migration examines the lives of these men; their history, their present, and their possible futures as they struggle to come to terms with the second chance they have been given. Faced with their own mortality and the inevitable wear and tear on their bodies from both the virus and the medications designed to save them, how do they strive to create a life of value? Their stories illuminate how people across the US and the world are struggling as they age with the virus and the damage it has caused.

Meet The Characters of BROADWAY BARES 25

Inspired by the golden age of Broadway, annual fundraiser BROADWAY BARES is back for it’s 25th installment – Broadway Bares: Top Bottoms of Burlesque – along with Tony Award winner and Broadway Bares creator Jerry Mitchell at the helm.

Clip description:

In a lavish and thrilling extravaganza, Broadway Bares: Top Bottoms of Burlesque will feature a cast of colorful characters for every desire and fantasy.

Broadway’s iconic personalities – from devilish divas to charismatic casting directors, luscious lyricists to studly stagehands – will combine the naughtiness of burlesque with the razzle-dazzle of Broadway.

The 2015 edition will fill NYC’s Hammerstein Ballroom on Sunday, June 21.

This always sold-out annual event combines the naughtiness of burlesque and the razzle-dazzle of Broadway. More than 150 of the hottest male and female dancers in New York City take to the stage for two sensational shows at 9:30 pm and midnight.

Broadway Cares/Equity Fights AIDS is one of the nation’s leading industry-based, nonprofit AIDS fundraising and grant-making organizations. By drawing upon the talents, resources and generosity of the American theatre community, since 1988 BC/EFA has raised more than $250 million for essential services for people with AIDS and other critical illnesses across the United States.

For more information and tickets head over to broadwaybares.com.

Scientists Develop Sub-Dermal Implant To Deliver 40 Days Of HIV Meds

Scientists from the Oak Crest Institute of Science, in Pasadena, CA, report that they have developed a matchstick size implant, similar to a contraceptive implant, that successfully delivers a controlled, sustained release of ARV drugs for up to 40 days in dogs with no adverse side effects.

“To our knowledge this is the first implant to be used for this purpose,” says Dr. Marc Baum, president and founder of Oak Crest.

Medical practitioners and scientists acknowledge that one of the main drawbacks in current medical treatments is the problem of adherence. “It’s unfortunate, but patients do not always follow the dosing instructions as prescribed,” says Dr. Baum.

“In clinical trials erratic administration of drugs has led to highly variable efficacy outcomes. That’s what peaked our interest in the possible use of a subdermal implant for the prevention of HIV,” suggests Dr. Baum.

“We are very pleased with the results of our preliminary studies and are working diligently to develop a subdermal implant for HIV prevention that will remain effective for a full 12 months.”

(from Science Daily)

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.”

David Barton Continues To Assert God Won’t Allow AIDS Vaccine Because Gays Must Be Punished

David Barton continues to assert that God will never allow an AIDS vaccine to be discovered because that would remove the “penalty” for homosexuality.

I don’t know how he factors in all the children born in Africa with the virus…

Note that in this video, Barton points to two different headlines that he claims came out six weeks apart.

Trouble is – they actually came out four years apart.

And were about two different studies.

Someone tell Barton that God hates liars.

Science: New Anti-HIV Drug Could Work As Unconventional Vaccine

Exciting news today from Science Daily – a new anti-HIV drug candidate appears so potent it could work as an unconventional vaccine against the disease:

The study shows that the new drug candidate blocks every strain of HIV-1, HIV-2 and SIV (simian immunodeficiency virus) that has been isolated from humans or rhesus macaques, including the hardest-to-stop variants. It also protects against much-higher doses of virus than occur in most human transmission and does so for at least eight months after injection.

“Our compound is the broadest and most potent entry inhibitor described so far,” said Michael Farzan, a TSRI professor who led the effort. “Unlike antibodies, which fail to neutralize a large fraction of HIV-1 strains, our protein has been effective against all strains tested, raising the possibility it could offer an effective HIV vaccine alternative.”

Read more at Science Daily.

FDA Recommends Allowing Gay Men To Donate Blood

According to a press release from the FDA, the FDA will recommend ending a discriminatory and decades-old ban on donations of blood from men who have sex with men. The ban, currently in place, prohibits and man who has ever had sex with another man from donating blood.

The new FDA guidance (still discriminatory but a step in the right direction) will be that men who have been not had sex with another man for at least a year may donate blood.

“Over the past several years, in collaboration with other government agencies, the FDA has carefully examined and considered the available scientific evidence relevant to its blood donor deferral policy for men who have sex with men, including the results of several recently completed scientific studies and recent epidemiologic data,” the FDA said in a press release.

“Following this review, and taking into account the recommendations of advisory committees to the U.S.Department of Health and Human Services (HHS) and the FDA, the agency will take the necessary steps to recommend a change to the blood donor deferral period for men who have sex with men from indefinite deferral to one year since the last sexual contact.”

The ban was originally put in place during the height of the AIDS hysteria in the 1980s. All blood is currently tested before used for any medical procedure or transfusion.