PrEP has first failure
February 25th, 2016
There has always been the assumption that a person on pre-exposure prophylaxis could become infected with HIV if they had sexual contact with a person who had a large viral-load of a strain of HIV which was resistant to each of the drugs in Truvada. Now there is a documented case. (Poz)
Researchers have for the first time documented a case of an individual contracting HIV, a multi-drug resistant strain, while apparently adhering well to the daily regimen of Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis (PrEP). The scientists concluded that it is indeed possible for individuals who are adherent to PrEP to contract HIV when they are exposed to a virus that is resistant to both drugs included in Truvada.
While this case is concerning, experts in the PrEP field suggest that such failures of PrEP will likely remain rare.
There have been strains of HIV identified which are resistant to tenofovir and strains resistant to emtricitabine, but random sample testing has not, until now, identified any strain which was resistant to both. Such virus is very rare.
An HIV strain may become resistant to a medication if the person infected uses medication in a sporadic manner allowing the virus to combat low levels of the medication until mutations occur. This person had a virus which was resistant to several medications.
While this is only one case out of tens of thousands of PrEP users (each of whom is tested quarterly) highlights the importance of using PrEP as an added layer of protection, not as a magic bullet.
Israel joins the PrEP revolution
February 23rd, 2016
The Israeli Health Ministry has for the first time approved pre-exposure prophylaxis that will help prevent HIV infection. The PrEP process, as it is called for short, involves taking drugs that substantially reduce the chances of contracting the immunodeficiency virus that causes the infection.
Specifically, the PrEp protocol calls for using the same drugs that are administered to carriers of the virus, and prevents its development in the bloodstream. Taking these precautions when one is HIV-negative effectively prevents possible infection.
PrEP use 90% higher than last estimated
February 4th, 2016
Last month, AIDS Healthcare Foundation issued a smirking attack on the Centers for Disease Control, mocking the low number of people who are availing themselves of pre-exposure prophylaxis.
“…according to CDC only 21,000 people are on the drug in the United States. Any objective observer has to conclude that most patients don’t want to take Truvada and doctors are not recommending it.”
Although there are dozens of references to this estimate, I have not yet been able to find the source. However most appear to be in November 2015, and use language like “currently” to discuss the number of total participants.
But, irrespective of the exact date in which 21,000 was a valid estimate, it certainly is no longer so. The following is from Gilead’s Quarter Four 2015 conference call which took place on Tuesday:
Public health programs to prevent HIV transmission are also underway, including efforts to raise awareness about the use of Truvada for prep. Today more than 40,000 patients in the US are receiving Truvada for a preventative indication.
In other words, PrEP use is about 90% higher than when last reported/estimated.
I very much doubt that participation doubled in the last two months. Likely, the estimates were based on older data and were understated to begin with.
But I do think that this illustrates something that I’ve observed and which I’ve heard discussed; It appears to me that there is a very sharp upturn in people becoming aware of the benefits of PrEP and choosing to avail themselves of this added protection from HIV. There is a cultural upswell which has changed the issue from fear to hope.
There have been several pivotal moments in the fight against the HIV/AIDS pandemic. The identification of the virus in the 80’s allowed for the first wave of protection, condoms. The discovery of anti-retroviral treatment in the mid 90’s, with it’s every increasing fine-tuning made the fight one about the value of life, not about survival. As viral loads became undetectable, Treatment as Prevention (TasP) became the next wave of protection and transmission prevention.
I believe that PrEP is equally revolutionary. This is the third moment in the fight which we will look back upon as there being a before-PrEP and after-PrEP way of life. This is the first time in the lives of many gay men my age in which there is no longer a component of fear in every sexual encounter.
Good news from DC
February 3rd, 2016
Over the past several years, the city government of Washington, DC, has dedicated itself to a comprehensive and concerted effort to reduce the number of new infections of the human immunodeficiency virus (HIV). It appears that the effort is working. (Blade)
A preliminary version of the city’s annual HIV/AIDS Surveillance Report shows that newly reported HIV cases in D.C. during 2014 declined for the seventh consecutive year.
The report, which the D.C. Department of Health released on Tuesday, shows there were 396 new HIV cases in 2014, a 29 percent decrease from the 553 new cases reported in 2013.
Whitman-Walker Executive Director Don Blanchon said the declining number of new HIV infections in D.C. reflects the value of community wide testing, treatment on demand and prevention efforts that include pre-exposure prophylaxis or PrEP, which involves providing a daily “prevention pill” to people who are HIV negative.
“Simply put, it is saving peoples’ lives and reducing new infections,” he said. “Today’s update reaffirms that we are on the right path to getting to zero new infections in a given year.”
We appear to now be in possession of the tools that we need to end the HIV/AIDS pandemic. Combining testing with TasP (Treatment as Prevention) and PrEP (pre-exposure prophylaxis) and treating the virus as a public health matter instead of a behavioral matter are the steps that are working in the nation’s capital. As the social acceptance of PrEP increases (as it has tremendously in Los Angeles over the past year), we should expect to see even more improvement in the upcoming year.
AHF files complaint against Gilead
January 21st, 2016
Earlier this month, AIDS Healthcare Foundation and its president Michael Weinstein issued a press release accusing Gilead of creating a direct-to-consumer advertisement which encouraged situational PrEP use in violation of FDA guidelines.
As we illustrated, it was filled with falsehoods and insinuation and made claims that even at the most casual glance proved to be false.
Well now AHF has gone one step further. They’ve issued a letter of complaint against the maker of pre-exposure prophylaxis (PrEP).
On Thursday, AHF sent a letter to Dr. Stephen Ostroff, M.D., Acting Commissioner of the U.S. Food and Drug Administration (FDA), alerting him to the fact that Gilead financed a video ad campaign promoting situational use of its AIDS treatment, Truvada, for PrEP, misleading viewers into believing that Truvada is safe and effective for use on a situational basis, despite knowing that the drug is not FDA approved for such off-label use.
So why does Weinstein and his organization continue a campaign of deception? I think there is a purpose behind the complaint.
As anyone who actually watched the video knows, it did not promote off-label use. And it wasn’t launched by Gilead. So that’s not the issue. AHF knows that their letter does not reveal any wrongdoing and I don’t think that’s their intent.
Rather I suspect that Weinstein is hoping that the theme of the video (“I like to party”) will frighten the FDA and will elicit a fear based response along the lines of “you can’t promote drug use!!!”
This isn’t about truthful marketing, it’s about punishing Gilead and hindering the advancement of Truvada as a tool against the spread of HIV. And if Weinstein can imply that Gilead tacitly supports the use of illicit drugs, that might be sufficient to push politicians to apply pressure.
So this is where Weinstein’s recommendations for punishing Gilead become interesting:
In contravention of statute and regulations, Gilead launched an ad campaign to mislead viewers into believing that Truvada is safe and effective for use on a situational basis despite knowing that the drug is not approved for such use. Consequently, the ad campaign constitutes impermissible off-label promotion, and we urge the FDA to take immediate action to (1) require Gilead to cease and desist all such off-label promotion; (2) require Gilead to publically [sic] correct the misinformation disseminated by the ad campaign; and (3) impose any sanctions permitted by law.
But Gilead hasn’t performed any off-label promotion which it can cease or desist. And sanctions would not hold up in any court. So what would this mean in practical terms?
A clue is found earlier in the press release:
Gilead, which we believe has been deliberately mounting an under-the-FDA-radar, guerilla-style marketing and media campaign for PrEP for the past three years by funding scores of community and AIDS groups across the nation to promote PrEP…”
AHF wants to put pressure on Gilead to cease funding other community and AIDS groups. Yes, it appears that Weinstein and AHF want to reduce the funds that community groups across the country use to fight transmission and treat those infected with HIV. That is unthinkable, but that is what they are asking.
And as despicable as this seems, it might not to be a novel attitude for AHF. They have been accused by many AIDS activists of a long pattern of seeking to diminish funding for other groups so as to funnel more funds, more program support, more connections, and more political power to AHF and Weinstein.
And as it is primarily community based HIV activists who are encouraging and driving the effort to get those persons at high risk for HIV transmission on the preventative drug regimen, these are the voices that Weinstein and AHF need most to silence in order for their campaign against PrEP-based HIV prevention to succeed. That these local activists are the front-line warriors in the fight against the HIV pandemic is immaterial, and the message seems clear: they must be taught that standing up against Weinstein and AHF comes with consequences.
I’m beginning to think that “vile” and “abhorrent” are adjectives that need a revival.
Michael Weinstein doubles down on “PrEP = Party Drug”; lies about video
January 8th, 2016
Public Health Solutions is a NYC based non-profit that performs both research and outreach on public health matters. As part of their focus, they support the increased use of pre-exposure prophylaxis as a prevention for the transmission of HIV.
A couple of months ago, Public Health Solutions uploaded three videos to their YouTube channel; one about PrEP and love, one targeting African-American men, and one targeting young men who party. The videos were part of a video intended to drive high-risk individuals into a clinical survey.
Here is “I Like to Party”:
Although the visuals of the video only show drinking in a bar, the implied message is that some young men use substances as a part of sex. And, indeed, the video campaign deviser said as much. (HuffPo)
The “Time2PrEP” campaign from Public Health Solutions is a series of video shorts that talks to different individuals across the queer spectrum about their experiences with PrEP and why they utilize the groundbreaking medication. Kenny Neal Shults of ConnectedHealthSolutions.com told The Huffington Post:
“When we sat down to consider the best audiences for the campaigns we knew only one thing for certain — we wanted to address gay men who might fall under the puritanical ‘Truvada Whore’ classification. That is, we wanted to reach men whose sexual and recreational drug behaviors both put them at a greater risk for both contracting HIV and being stigmatized for even considering going on PrEP. It seemed obvious to us that judging the men who could benefit most from PrEP for the behaviors that we think they should abandon and replace with consistent, unfaltering condom use was not our job. Our goal as HIV prevention professionals is to reduce HIV infections, and to communicate to those at high risk that they don’t deserve to be punished with HIV for ‘misbehaving.’ I mean, that’s the tacit implication of these reactionary pulpit platforms isn’t it; you either use a condom every time — behave — or you’re shamed and set apart from the rest of the community.”
Today it seems that Michael Weinstein of AIDS Healthcare Foundation has become aware of the video. And he’s decided to use it to further his attack on PrEP and those who use it. And, as seems consistent with Weinstein, his statement is long on accusation and short on facts.
AHF’s press release starts with a statement that is shockingly lacking in truth.
In what looks to be the first direct-to-consumer drug advertising paid for by Gilead Sciences, Inc. for use of its AIDS treatment, Truvada, as pre-exposure prophylaxis (PrEP) to prevent HIV infection in non-infected individuals, Gilead has paid for an ad that violates Food and Drug Administration (FDA) guidelines for PrEP by promoting off-label use of the drug by encouraging situational PrEP use for those who “… like to party.”
Oh so many lies.
First this is not a direct-to-customer drug advertising. It is an online video by a non-profit organization that never ever mentions the name of any drug.
Next, the video was not “paid for by Gilead Sciences, Inc.”, or not in the sense that Weinstein claims. Mary Ann Chiasson, the Vice President, Research and Evaluation at Public Health Solutions clarified.
As the Project Director, I can set the record straight. The time2prep project was funded by a grant from Gilead for educational videos about PrEP targeted to high risk men who have sex with men in New York City. The videos were designed to be provocative and to encourage men to go the New York City Department of Health PrEP/PEP website to learn more. Gilead played no role whatsoever in determining the content of the videos. In fact, I’m not sure anyone at Gilead has ever even seen the videos.
But the big lie, the heinous smarmy lie is this: “…an ad that violates Food and Drug Administration (FDA) guidelines for PrEP by promoting off-label use of the drug by encouraging situational PrEP use…” Further in the press release, Weinstein states,
When I referred to PrEP as a party drug two years ago, it created a nationwide scandal. Now Gilead—in what looks to be its first official paid advertising for Truvada as PrEP—explicitly promotes PrEP as a party drug for situational use in direct violation of FDA regulations. This is illegal and we will seek to hold them accountable for their irresponsible and illegal advertising,” said Michael Weinstein, President of AIDS Healthcare Foundation, which has criticized and cautioned against the widespread deployment of PrEP as a community-wide public health strategy, such as the CDC’s recommendation that 1.2 million individuals go on PrEP, but supports its use on a case-by-case basis decided upon between a medical provider and his or her patient.
If indeed this was a promotion of PrEP for situational use, rather than as part of a daily regimen, that would be in violation of FDA regulations. The FDA has approved Truvada for PrEP under certain conditions. While I would certainly phrase some of these requirement differently, AHF’s press release lists them:
Guidelines issued by the FDA for PrEP for individuals include 1) an initial baseline negative HIV test; 2) daily adherence to the Truvada medication; 3) ongoing periodic HIV testing to ensure the individual on PrEP remains HIV-negative; and 4) continued use of other prevention methods, such as condoms.
AHF’s points 1 and 3 cannot be determined one way or another from the video. But we can clearly see whether the video promotes daily adherence and condoms.
At 0:03 JD Phoenix (a young porn actor) reaches for items on his counter as he heads to a bar. They consist of condoms, lube, his keys and a baggie with pills of some sort (it is not clear as to the nature of the pills). From this we conclude that condoms are a part of Phoenix’s sexual encounters.
At 0:21 Phoenix’ alarm goes off on his phone informing him that it’s “time to prep!” He then reaches for a daily pill organizer and takes that day’s blue pill. From this it is clear that Phoenix is on daily adherence to the drug.
So Weinstein’s claims about “situational use” appear to be false. And his threat about “holding accountable” seem nothing more than empty threats used to bolster his own implied moral superiority.
And, of course, Weinstein couldn’t pass up the opportunity to portray himself as a great prophet:
It now appears AHF President Michael Weinstein made a prophetic comment to an Associated Press reporter in April 2014 when he offhandedly referred to PrEP as a “… party drug.” Since then, both he and AHF have been repeatedly and harshly criticized by the gay and AIDS communities for the observation, while Gilead itself now funds and promotes party use of Truvada as PrEP in violation of the law and FDA regulation.
Neither Gilead nor anyone else is promoting “party use” of Truvada as PrEP in this video. Or certainly not more than the other two videos promoted “black use” or “love use.” It’s a video targeting a high-risk community. That’s all.
But Weinstein has latched only the word “party” and sees it as validation for his opposition to PrEP. He objects to the idea that people who use drugs might use Truvada to allow them to have unfettered sex. Naughty dirty drug-induced porn star sex. And it’s “irresponsible” for Gilead, or anyone else, to help these party sex people remain HIV negative.
It’s hard to ignore the implications of Weinstein’s position. If party people shouldn’t proactively protect themselves from HIV transmission, does that mean that they deserve what they get? Is HIV the wages of sin?
And, really, it seems to me that this is what is behind Weinstein’s campaign of shame, it’s all about demonizing people who have sex in ways of which Weinstein disapproves.
And I don’t think the prophet reference is casual. I think that is how he sees himself, as a great moral leader casting down as whores and riffraff those who oppose him and declaring the one and only true and holy way to have sex.
AHF’s Michael Weinstein mocks the CDC about PrEP
December 22nd, 2015
In 1987 there was little to no hospice care available for dying AIDS patients. Several activists united and petitioned LA County Board of Supervisors for funding and the AIDS Hospice Foundation was born with Michael Weinstein at its helm.
In 1995 – 1996, antiretroviral medication changed the face of HIV. Those infected with the virus no longer could expect an onset of opportunistic maladies followed by an early painful death. Now HIV, if properly treated, has no significant impact on quality of living or life expectancy. And the need for specialized AIDS hospice care diminished significantly.
So Weinstein rebranded the organization as AIDS Healthcare Foundation, and began offering medical services to those infected with HIV. Over time, AHF has grown tremendously, with revenues in the hundreds of millions of dollars (much of it through either grants or Medicare) and programs dotting the globe. Also growing has been Weinstein’s political power (and compensation – about $400,000 in 2012).
Michael Weinstein has not been hesitant to use his connections and power, using public media attacks and lawsuits as his primary methods. In 2012, they spent over a million dollars on legal fees.
Many of Weinstein’s efforts have been controversial, and most come across as heavily moralistic. Taken cumulatively, they paint a picture of a man and an organization determined to stop others from having sex in ways in which he disapproves.
In 2007, Weinstein decided that Viagra was being used by people who were doing drugs. Disapproving, AHF held a press conference accusing Pfizer, the maker of Viagra, of contributing to HIV and announced a lawsuit against them over their marketing and demanding that they contributed to AHF. (Bay Area Reporter)
The Los Angeles-based AIDS Healthcare Foundation has charged the pharmaceutical company Pfizer with “promoting Viagra as a party drug … leading to more infections with sexually transmitted diseases such as HIV,” according to its president Michael Weinstein.
AHF filed suit in a Los Angeles court Monday, January 22 to force the company to end those ads, begin an education campaign on the responsible use of Viagra, and pay an unspecified sum to the organization to help care for people infected with HIV.
Weinstein had no facts to back up his assertions.
When pressed during a telephone conference call Monday to back up his assertion with data, Weinstein mentioned recently speaking with a group of black youth who said crystal meth “use is rampant” within their community.
I can’t find the results of that lawsuit, so it may have been nothing more than a bluff or an attempt at extortion.
Also in 2007, AHF began running ads in Indian newspapers accusing Cipla, an Indian company, of price-gouging. They did not get the support of local non-profit organizations who saw a conflict of interest. At the time, a leading Gilead exec was on AHF’s Board and they provided funding to Weinstein’s organization. (Gilead denied any connection with Weinstein’s effort.) (IndiaTimes)
Cipla had refused Gilead’s offer to sell the latter’s anti-AIDS drug Viread under a licensing agreement. Cipla is also the only Indian company opposing Gilead’s patent application for its blockbuster anti-HIV drug Viread in India.
In recent years, Weinstein has decided that he disapproves of people watching bareback porn and waged a war of accusation and innuendo against producers. Even though there is testing and prevention efforts in porn – both gay and straight – Weinstein and AHF seemed determined to stop its production altogether and in all circumstances.
In 2012 AHF spearheaded an initiative on the ballot in Los Angeles County which required porn actors, gay or straight, to wear condoms during anal or vaginal sex. Weinstein was not shy about his desire to monitor other’s desire. (Weinstein op-ed)
The fact that most straight porn is made without condoms sends a horrible message that the only kind of sex that is hot is unsafe.
Though opposed by the Libertarian Party, the Republican Party, and local newspapers, Measure B passed the vote with 60% of the vote. And, as could be expected, the $6 billion industry – and its economic benefits – moved out of Los Angeles County with sadly ironic consequences. (SF Weekly)
Last year, after Measure B pushed several companies to Nevada, the industry saw its first on-set transmission in over a decade. Though the performer tested negative for HIV before his shoot, the test used was not the RNA plasma test that is the standard here in California. By the time he shot the scene, his viral load had increased to the point where he could transmit the virus to someone else.
Undeterred by real life consequences, Weinstein presses on seeking a statewide initiative forcing his ideas about acceptable porn production throughout California. There may be an initiative on the 2016 ballot to mandate Weinstein’s views.
In 2012, as the result of a county audit finding that AHF had overcharged LA County by millions of dollars, Weinstein sued the County in an effort to punish Supervisor Yaraslovsky, with whom Weinstein had feuded. (LA Times)
The lawsuit arose out of an audit by the county, which claimed the foundation had overcharged $1.7 million for its AIDS services by billing for costs that should have been allocated to other sources. The judge did not rule on which side was correct, only saying that the county has the right to audit its contractors.
Weinstein, defending his political tactics, told the paper that regardless of who was billed for the costs, the money was spent serving patients: “We would not have gotten to where we are today if we hadn’t fought like hell on behalf of our clients and our mission.”
A U.S. District judge ruled for the county this week. “Rather than a sincere attempt to vindicate their First Amendment rights,” the paper quotes the judge saying, “the court fears that plaintiffs instituted this action in an effort to obtain a tactical advantage in their ongoing political battles.”
To illustrate his conclusion, he included an excerpt from an email Weinstein sent to a foundation staff member shortly before the suit was filed:
“It is time to take the gloves off,” Weinstein wrote, according to the written decision reported in the Times, “We need to go after Zev [Yaroslavsky] directly and hard. He is the real power behind our problems with the county on porn, the audit and fee-for-service. Plus he is a lame duck and an arrogant jerk. His Berman-Waxman power base is dead and he and others need to be taught a lesson. The voters are with us.”
But it isn’t just the big-dollar fights and power plays that have caused controversy. So too have many of AHF’s public pleas for the public to get tested.
In Los Angeles, one can’t get away from AHF’s billboards. And they seem to share a common theme: sex is dirty and bad and people who want to have sex with you are liars who want to give you diseases.
One such campaign featured a number of couples of various races and sexes with the tag line “Trust Him?”
Though nothing in the ads tells you why one would not trust the other, but Weinstein apparently assumes that sex must include some sleazy component and had this to say about the immensely unpopular billboards. (Poz)
“While infidelity is nothing new, the level of risk in contracting STDS from bed-hopping partners is at an all-time high. We want to remind couples that STDs linger around much longer than a wandering eye and that secret sexual experiences can often produce much more than what one bargained for.”
This stigmatic view of sex and trust is both reductive in personal responsibility and stigmatizing towards HIV-positive people. It suggests that people living with the disease are akin to criminals who lie in order to have sex, or even intentionally spread the virus. Sure, the people behind the AHF campaign may argue differently. However, it is hard to ignore the criminal theme of the advertisements that, by default, further marginalize people living with HIV and keeps fear in the forefront of safer sex messaging. As one Facebook user stated, “This does not say ‘fear HIV.’ It says, ‘fear people living with HIV.'”
In addition to all the ways that Weinstein doesn’t want people to have sex, he also has opinions about how they meet. Earlier this year, another of AHF’s billboard campaigns went on the direct attack against hook-up sites.
“They’re tone deaf,” Michael Weinstein, president of AHF, told the Guardian. “It would have been much wiser for them to say that they’re concerned about their customers and look forward to working with us to help people get the checkups that they need. This would not have been the global story that it has become if they had not responded that way.”
And lest you think these ads come across as sex-negative,
“There are consequences to hooking up,” Weinstein told the Guardian. “That’s not a moralistic judgement. It’s just a fact and minimizing that is important.”
But nothing has set Weinstein and AHF apart from the HIV/AIDS community more than Weinstein’s obstinate opposition to pre-exposure prophylaxis. The battle between anti-PrEP forces (Weinstein and AHF) and pro-PrEP forces (The Centers for Disease Control, the World Health Organization, AIDS Project Los Angeles, amFAR, Gay Men’s Health Crisis, the National Minority AIDS Counsel, and virtually every gay and AIDS/HIV advocate that seeks to see an end to the transmission of the Human Immunodeficiency Virus) has turned into all out war.
The opening salvo was fired by Weinstein on April 7, 2014 (AP)
“If something comes along that’s better than condoms, I’m all for it, but Truvada is not that,” said Michael Weinstein, president of the AIDS Healthcare Foundation. “Let’s be honest: It’s a party drug.”
Obviously, Truvada is not a party drug. It is not a euphoric, a hallucinogen, a mood enhancer, nor does it have the hallmark of any other pharmaceutical whose primary purpose is to feel good. What Weinstein meant here is what he meant when he accused Viagra of being a party drug: that it was used by people doing drugs and having bad bad sex. That it prevented these naughty naughty gay boys from infecting each other with HIV was secondary to his objection to their behavior.
In August 2014, Weinstein started running ads in gay newspapers which, at first glace, appeared to say that PrEP was not very effective at preventing transmission.
Those who read the text would learn that any effectiveness was low due to low adherence – not exactly a surprise for research in high-risk and third world populations. But even if you get beyond the graph, Weinstein extrapolated from that data a conclusion set that is not supported in science: Low adherence means low effectiveness in preventing HIV and effectiveness measures whether Truvada works in the real world.
In other words, Truvada doesn’t work.
This infuriated those who have been taking strides to eliminate HIV transmission in the real world. They particularly noted the dishonesty of Weinstein who never notes that for those who DID adhere to the drug protocol effectiveness was 99% or better.
But Weinstein seems uninterested in facts. He has positions. And a sizable salary based on continued services to those who become newly infected each year.
In fact, there have been raised questions about the ethics of AFH’s testing facilities and how they feed a stream of income into the organization. In April of this year, three former staffers filed a whistleblower lawsuit against AHF:
The plaintiffs accuse AHF of an “organizational-wide criminal effort” across at least 12 States in the form of kick-backs to AHF clients and staffers. They believe that AHF has defrauded governmental programs out of tens of millions of dollars, based on their own experience with the agency going back to at least 2010.
The three plaintiffs, all former managers at AHF who were in a position to be familiar with agency policy, also include Mauricio Ferrer of Florida and Shawn Loftis of New York.
When someone tested positive in an AHF clinic, the suit claims, they were offered cash or other inducements to be linked to care in AHF clinics. Furthermore, AHF staff were provided commissions when they successfully linked someone with a positive test result to AHF services. This procedure was developed first in Los Angeles and then spread across all States where AHF has a presence.
Of additional concern is whether AHF’s (grant funded) testing centers inform those who test HIV negative that they have an options to persue PrEP. Although some communities, like West Hollywood, require all testing facilities to give PrEP referral information, many do not.
And Weinstein has made it clear that he is the face and voice of opposition to PrEP. While some, like Larry Kramer, initially had concerns, they’ve come to see the potential of the drug. Kramer joined Peter Staley and others earlier this month in releasing a statement that reads in part:
We – AIDS activists, new and old, aged 24 to 80 – have just broken bread in the same apartment where GMHC was formed, coming together for a lively discussion on how to reduce HIV infections among gay men and trans women. Although we may not see eye-to-eye on every issue we debated tonight, we all agree that Pre-Exposure Prophylaxis (PrEP) is highly effective at protecting a person from HIV infection. While PrEP isn’t for everyone, any individual who thinks they are at risk of getting HIV should have easy access to it, without judgement.
Weinstein appears to be the sole hold-out. But he is always ready to speak to any news source which is looking for “controversy” on the issue.
At the heart of Weinstein’s objections is the assertion that people at greatest risk won’t take the drug consistently. Which may be true. But it’s very implausible to assume that those who don’t have enough structure in their lives to take a pill once a day do have enough structure to have condoms ready and use them every time. Of the two, a daily pill requires far less forethought. Weinstein’s argument is laughable.
Also conveniently ignored is the consequences of occasional lapses. Failing to use a condom just one time can result in HIV transmission. But failing to take the pill just one time, or two times, or three times a week still provides enough protection to prevent transmission. In testing, those whose blood revealed adherence to the protocol four times per week have nearly 100% effectivity.
And, unlike condoms, PrEP doesn’t break.
As a corollary argument Weinstein insists that those who use PrEP won’t use condoms, which will lead to an increase in other STIs. And that too might be true. But it raises the natural question: if we find a true vaccine or a cure for HIV, will Weinstein oppose that measure as well because it would mean less condom usage? Will he insist that some continued HIV infection is a small price to pay for preventing increased gonorrhea?
That may be less rhetorical of a question than one might imagine. Weinstein has actually penned an op-ed to the LA Times calling on the federal government to cease funding for the search for a vaccine for HIV. Framed as a complaint against the wasting of funds that could otherwise be used (by AHF, I presume) to pay for treatment, it still is a chilling idea that the head of a prominent HIV/AIDS care organization opposes the search for a vaccine which could end the pandemic.
Although the opinions of both the activist and the science community have reached near consensus about the efficacy and value of PrEP as a tool in the fight against the transmission of HIV, Weinstein has been effective in his opposition. He has sown doubt in the gay community as to whether PrEP works. He has done his best to shame those who use this “party drug”. At least in part, he has contributed to the slow uptake in PrEP usage in the gay community.
And, having slowed the PrEP movement, now he’s decided that it’s time to mock the Centers for Disease Control for their struggle in convincing gay men that this preventative measure is neither shameful not ineffective.
You see, you shouldn’t push PrEP, but treatment. After all, if you pay AHF to treat people once they’ve contracted HIV, then their virus is brought down to undetectable levels and they are non-infectious. And as for PrEP, leave it to the Truvada whores who have multiple partners and never use condoms.
But the word is – finally – getting out. I see PrEP becoming a regular discussion point in some subsets of West Hollywood. Activists in New York are becoming more vocal. San Francisco City government is dedicating city resources. Social approval is on the uptick and the community – though originally fearful of another “solution” – has had time to observe and see how things went for the earliest guinea pigs.
Weinstein should get his gloating out of his system. Because I think that PrEP is going to become as common as condoms were in the 90’s and AHF is going to have to come up with some other business plan.
South Africa approves PrEP
December 9th, 2015
South Africa has joined the United States and France in approving the use of Truvada as pre-exposure prophylaxis (PrEP) in the prevention of the transmission of the human immunodeficiency virus (HIV). (The Citizen)
Medicines Control Council (MCC) held their 75th meeting from November 27-28, where Truvada, the HIV prevention drug, was approved.
MCC approved the use of the fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine to include pre-exposure prophylaxis of HIV (commonly referred to as PrEP).
As South Africa’s public healthcare system is woefully understaffed and underfunded, it is not clear how well this step will be implemented in that nation’s most vulnerable population. However the wealthiest 20% of South Africans use private healthcare so there is some hope that the availability of PrEP could reach at least that portion of the population.
PrEP, at last
December 9th, 2015
The last step in my quest for pre-exposure prophylaxis (PrEP) is complete. My liver is functioning fine and I received clearance to begin the process. I’ve taken my first pill and in about seven days I’ll be effectively immune from the virus.
In a few weeks I’ll return to the doctor for tests to determine whether my body is acclimating to the medication or if side effects have occurred. And, going forward, I’ll require testing every three months.
But finally! Hallelujah!
Getting Prep, Step Two
December 6th, 2015
Since late October I have been trying to get a prescription for Truvada to be used as pre-exposure prophylaxis (PrEP) to prevent the possible contraction of HIV. It has not been an easy process and has involved being dumped by my primary physician and a complicated search for a replacement.
But finally I found care through APLA’s Gleicher / Chen Health Center and two weeks ago I went in for a series of tests, both general health and sexual health. On Thursday I returned for my results.
I was happy (though not very surprised) to learn that I did not test positive for HIV, gonorrhea, chlamydia, or syphilis. Blood pressure was fine. My triglycerides are just slightly high, but so is my “good” cholesterol. In general, I’m a healthy man.
Except one test wasn’t present. Although the clinic had requested the usual full analysis, the lab hadn’t run the tests necessary to evaluate my liver. And testing liver function is absolutely necessary to issuing a prescription for PrEP.
So the wait goes on.
On Monday, I’ll take the trip back to the clinic to draw more blood. And at some point on Tuesday I should know whether my liver is functioning properly and, assuming that all is well, I should be able to start the program.
Planned Parenthood WeHo to offer PrEP
December 6th, 2015
Planned Parenthood is an organization that can be, at times, politically polarizing. Depending on where one gets their news, they may think of Planned Parenthood as either an abortion mill selling baby parts or a necessary provider of women’s reproductive health in underprivileged communities. But in some areas they are becoming something unexpected: an access point for pre- and post-exposure prophylaxis (PrEP and PEP). (scpr)
Planned Parenthood Los Angeles says it will begin offering two powerful anti-HIV drugs at its clinics next year. The effort will begin at the group’s newest health center in West Hollywood, which opened Tuesday.
The reproductive health provider joins 27 public and private health care clinics across the county in providing one or both of these medications to those most at risk of contracting HIV, according to the Los Angeles Department of Public Health.
I don’t know how accurate their count is, but if there are only 27 clinics across the country providing PrEP or PEP, then Planned Parenthood’s participation is not only welcome, it’s essential. There are roughly 4.8 million gay or bisexual men in the country and the Centers for Disease Control recommends that a quarter of them, 1.2 million men, be on PrEP. There is no way that this goal is achievable through 27 clinics. [As a reader noted, it’s County not Country. Duh!! Shouldn’t have missed that. But still 27 is far too few for the more than 100,000 gay/bisexual men in LA County.]
Planned Parenthood offers a sliding scale, which will be of relief to younger gay men who may be uninsured. THey are starting with their clinic in West Hollywood but expect all 20 of their clinics in Los Angeles to provide PrEP and PEP by the end of 2016. Let’s hope that soon spreads to areas in which access may be even less available.
Australian gay men form a ‘Dallas buyers club’ for getting PrEP
December 1st, 2015
As in every nation in the world other than the US (and soon France), Truvada has not been approved in Australia for pre-exposure prophylaxis (PrEP). Thus it is not covered through the Pharmaceutical Benefits Scheme and must be paid out of pocket, a cost of about $1,200 per month.
However, there are a number of pharmacies in India that make a generic version of Truvada (for example Cipla makes and sells Tenver-EM) and a group of gay Australian men have decided not to wait for official government approval. They are going through a pharmacy in Africa to get the generic version of PrEP. (SMH)
To get around this, a group of men have started a website called “PreP access now” to help people order cheaper generic versions of the drug from multiple online sources, including Africa for about $60 a month.
One of its founders, Steve Spencer, said dozens had ordered the drug with the group’s help since it began in the middle of the year. It is now offering free orders for people who cannot afford the $60 monthly fee because the African pharmacy offers one free order for every two made.
“A bunch of us gay men who saw nothing happening said ‘stuff it’ we’re going to come together and make a change,” he said. “Our numbers are increasing every day, but it’s the government’s responsibility to ensure the health of Australians, and… to ensure equal and easy access to PrEP if we want to end new HIV infections in Australia.”
I find this a bit concerning. While Cipla and other Indian companies have a long track record and their drugs are considered reliable, African pharmacies have less credible reputations. I hope that these guys are having the drugs spot-checked for accuracy.
France supports PrEP
November 28th, 2015
One of the fascinating things about the use of pre-exposure prophylaxis (PrEP) as a tool for preventing the spread of HIV is that, until this week, the United States alone has supported this measure and encouraged its use.
In the US, costs are covered by all insurers (it’s seen as a preventative measure which will result in lower costs in the long run). Some regions (though certainly not all) have established funds which can take care of those without insurance, and the CDC and other private and/or public health services have committed to finding a way to get anyone who wishes to be on PrEP to be able to acquire the medication. Finally, Gilead (the manufacturer of Truvada) has established programs to cover costs. For many in the US (though certainly not all), the out of pocket cost for being on PrEP is zero.
But if you live in Canada or the UK or Sweden, PrEP is not publically available. There are clinical trials and, should you be fortunate enough to be part of the trial, your costs are covered. But otherwise, the cost is born entirely by the patient. A Canadian told me recently that he pays about $1,200 per month for his Truvada prescription.
However, this week another nation has committed to this step in the prevention of HIV transmission. (AIDSMap)
In a historic move, France has become the first country outside the USA, and the first country with a centrally-organised, reimbursable health system, to approve no-expense pre-exposure prophylaxis (PrEP) for people who need it.
The French Minister of Health, Marisol Touraine, announced today that PrEP would be available from mid-December, and reimbursable through the French health system from the beginning of January.
In addition to the daily regimen procedure, France will also support incident based prevention (two pills two hours before sex and one pill each of the next two days).
CDC: not enough doctors are prescribing PrEP
November 25th, 2015
As I have discussed in a series of articles, obtaining pre-exposure prophylaxis (PrEP) for HIV is not simply a matter of asking your physician. Depending on your health insurance, it may be extremely difficult to get a prescription for Truvada, the medication that with proper use prevents HIV infection. For example, for the 10 million residents of Los Angeles County, there is only one clinic that provides PrEP and accepts Blue Shield HMO coverage.
It would appear that this scarcity is not limited to Los Angeles, and this concerns the Centers for Disease Control. (http://www.cdc.gov/nchhstp/newsroom/2015/vital-signs-prep-press-release.html)
“PrEP isn’t reaching many people who could benefit from it, and many providers remain unaware of its promise,” said CDC Director Tom Frieden, M.D., M.P.H. “With about 40,000 HIV infections newly diagnosed each year in the U.S., we need to use all available prevention strategies.”
“PrEP has the potential to dramatically reduce new HIV infections in the nation,” says Jonathan Mermin, M.D., M.P.H, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. “However, PrEP only works if patients know about it, have access to it, and take it as prescribed.”
The CDC is now recommending that about 25% of gay men take PrEP, based on a number of criteria. It has awarded about $216 million to organizations that are targeting at risk communities.
NYC aggressively attacks HIV using PrEP and PEP
November 25th, 2015
There are about 3,000 new diagnoses of HIV infection each year in New York City. And the City has decided that this is far too much. (Gay City News)
The plan, which was first proposed by leading AIDS groups in 2014, relies largely on using anti-HIV drugs in HIV-positive and HIV-negative people to reduce the number of new HIV infections in New York State from the current roughly 3,000 a year to 750 annually by 2020.
The tools are there. With pre-exposure and post-exposure prophylaxis, along with antiretroviral medication for HIV positive persons, the transmission of the virus is preventable. Even in the heat of the moment. Even if drugs or alcohol are impeding rational decision making. Even if a condom breaks.
Moving on the Plan to End AIDS, the City Council will spend $6.6 million to fund pre-exposure and post-exposure prophylaxis programs and efforts to aid people with HIV in staying on anti-HIV drugs so they remain non-infectious.
While $6.6 million is a large number, it is nearly negligible in the City’s budget. And if this allocation can cut HIV transmissions by three-quarters in five years, it is an investment that is well spent.