Showing posts with label Prep. Show all posts
Showing posts with label Prep. Show all posts

November 9, 2019

Because Gilead Has No Money and Have Not Made Enough on HIV It Doesn't Want To Release The PREP Patent

                                                Image result for gilead and prep

The Department of Health and Human Services is suing Gilead Sciences over the patent rights to Truvada, Gilead’s HIV prevention drug better known as PrEP, or pre-exposure prophylaxis.
PrEP is a pill taken once daily that is 99 percent effective at preventing HIV transmission, according to the Centers for Disease Control and Prevention.
The lawsuit, filed Wednesday in U.S. District Court for the District of Delware, alleges that CDC researchers began studying the preventive use of HIV treatment drugs — like tenofovir, or TDF, and emtricitabine, FTC, the two compounds in a Truvada tablet — as early as 1998, before Gilead sought a patent.
Crucially, the lawsuit alleges that the government owns the PrEP patent for both Truvada and Descovy, Gilead’s next generation PrEP approved last month, setting up the possibility that both HIV prevention drugs could see drastic price reductions. 
“HHS recognizes Gilead’s role in selling Truvada and Descovy to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV,” HHS Secretary Alex M. Azar II said in a statement. “However, Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do.”
In response, Gilead said the government’s patent claims were “invalid.”
“We are surprised that the government has requested that a district court judge and jury look at the same issues of patent validity that the Patent Office will be deciding,” Gilead said in a statement Thursday. “We will be asking the district court to stay the litigation until the Patent Office has an opportunity to undertake the review that we already have requested.”


The PrEP4All Collaboration was formed in summer 2018 to advocatethat the U.S. government “break the patent” by exercising its “march-in rights” and requisition Truvada for emergency public health purposes.
James Krellenstein, another member of the collaboration, said that shortly afterward the group’s founding he received a phone call from one of the doctors who discovered PrEP.
“He gave me a ring and said, ‘You should know that in addition to the government having march-in rights on the patents that protect Truvada, the federal government actually owns independent patents that protect the use of Truvada and Descovy as PrEP.” That led Krellenstein and others to research the various patents that apply to the compounds, formulations and uses of these drugs for prevention purposes. “He was advocating very, very strongly because he was appalled about the price gouging that Gilead was doing with his invention and the massive barriers that caused for uptake,” Krellenstein said of the doctor who called him.
Christopher J. Morten, an NYU researcher and a lawyer for the PrEP4All Collaboration, said, “Gilead knew at least from 2008 that it was at risk of liability of patent infringement if it sold Truvada or Descovy as PrEP.”
The lawsuit lays out a timeline that alleges Gilead contributed nothing more than donated Truvada tablets to multimillion-dollar human trials that were funded by the U.S. government and philanthropic donors.


On Aug. 2, 2004, Gilead Sciences received FDA approval for Truvada as a drug to treat, not prevent, HIV. At the time, Truvada was considered one of the least toxic combination HIV-treatment tablets. But in 2004, research was already underway on whether the drugs contained within Truvada tablets could also be an effective way to prevent transmission of HIV.
That is because, “in the mid-1990’s, high doses of subcutaneous tenofovir alone had been shown to have prophylactic activity in macaques exposed intravenously to simian immunodeficiency virus (SIV), a virus similar to HIV,” the lawsuit states.
A report published in 2004 by the AIDS Partnership California and Center for HIV Prevention and Treatment Services shows that in the same year that Gilead’s Truvada received FDA approval for use in treating HIV, five separate human trials were planned in countries around the world to test the efficacy of tenofovir alone as PrEP. According to that report, the studies were sponsored by the CDC, the National Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates Foundation. But those studies failed to show that tenofovir, or TDF, alone could protect against sexual transmission; protests in Cambodia led the government to shut down the trials
“While two-drug regimens would generally be considered more toxic, the CDC researchers hypothesized that the inclusion of FTC — as an effective antiretroviral drug with relatively low toxicity — could add more protection than seen with TDF alone. The CDC researchers were the first group to take the innovative FTC/tenofovir prodrug combination path in PrEP preclinical or clinical studies,” the lawsuit states.
The lawsuit also states that CDC researchers discovered the proper dosage, used proprietary animal modeling techniques, and painstakingly recreated the environment of sexual transmission in macaques.
2008 report on the results of a CDC primate trial by government-funded researchers showed that a combination of the two drugs found in Truvada worked better than TDF alone. That study states that the authors have a competing interest: They “are named in a U.S. Government patent application related to methods for HIV prophylaxis.” That study said that the promising results of the macaque trial “support PrEP trials for HIV prevention in humans and identified promising PrEP modalities.” According to the lawsuit, those patent applications were filed in 2006 and 2007 and approved in 2015.
After the 2008 study showed that a dual drug regime worked better than a single drug, ongoing human trials were modified to include TDF and FTC, instead of TDF alone. The 2010 results of one of those modified trials, the iPrEX study, effectively proved that Truvada worked as PrEP in men who have sex with men and transgender women.
According to a 2017 AVAC report, these human trials received commercial funding from Gilead of up to $2 million per year — largely the cost of donating the drug — while combined public and philanthropic funding was $29 million to $62 million per year. 
“While Gilead’s public statements emphasize the amount of money it has spent to ‘support the clinical trials that led to the approval of Truvada for PrEP,’ that claim is disingenuous,” HHS wrote in a press release. “Its support of early clinical trials was typically limited to only the donation of study drugs. Only after the commercial success of Truvada for PrEP did Gilead increase its funding of PrEP clinical trials, and in particular, trials related to Descovy for PrEP.”
Following the successful results of the iPrEX and other studies, in July 2012 the FDA approved a second use for Truvada: as a HIV prevention pill for high-risk populations like gay men and injection drug users. Gilead did not advertise Truvada for prevention because it was still controversial. Prescribing guidelines for clinical providers were not published until 2014. Television ads only began in May 2018. In the meantime, Gilead earned billions from sales of Truvada — $3 billion in 2018 alone.


The HHS press release states that the Patent and Trademark Office granted four patents to HHS for PrEP. “These patents entitle HHS to license CDC’s PrEP regimens and receive a reasonable royalty for their use. Two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed to licenses with HHS.”
Krellenstein said the PrEP4All Collaboration’s next task is ensuring that whatever royalties the U.S. government may obtain from its lawsuit against Gilead — which could be in the billions — are spent on ensuring the drug gets to the estimated 900,000 at-risk people who are still not taking it.
“The government must ask to both simultaneously increase access to the drug” by lowering the price, allowing an earlier generic, or providing the drug for free to clinics, Krellenstein said, and use any royalties obtained “to fund a national prevention program that guarantees anyone in the country who wants it can get it.” 

November 1, 2019

Preventing A Person From Becoming HIV Should Be Free and This is Why


Hot take, but PrEP—that is, preexposure prophylaxis, a once-daily FDA-approved drug sold under the brand name Truvada that reduces the risk of HIV transmission among HIV-negative individuals by 99% when taken daily—should be as readily available as condoms at a gay bar. Just pour a bunch of those little blue babies into a fishbowl—or, better yet, put ‘em in one of those big, round, bubble-shaped gumball machines they have at supermarkets and the Chinese takeout place down the street from my apartment, except that instead of having to put in a quarter to get a week’s worth of pills, you don’t put in any money because it’s free. 
No one likes Mike & Ikes anyway, those goddamn candy queer baiters. PrEP for breakfast! Gay utopia now! Or at least make it available over the counter…for free…and coupled with a complimentary seltzer, while we’re at it. Definitely don’t make it $2,000 out of pocket, which Truvada manufacturer Gilead has the absolute, unnerving gall to charge. Researchers at the Centers for Disease Control and Prevention have found that Black and Latino men who have sex with men are significantly less likely to be aware of PrEP, to have discussed PrEP with their health care providers, or to have taken PrEP in the last year compared to their white counterparts. 
You might think that these stats have something to do with insurance coverage or health care access, but the researchers say that neither of those two variables was a factor. Apparently, it has more to do with how Black and Latino men who have sex with men—a clinical term that includes, but isn’t limited to, gay, bisexual, and queer men and sometimes trans people assigned male at birth (I reached out to the CDC for clarification on that last one, and I’ll update if I hear back)—are less likely to discuss PrEP with their providers in the first place, perhaps due to stigma or maybe thanks to structural racism within health care and how it might influence their providers’ decision to bring it up in the first place.
Again, it feels disingenuous to talk about who does or doesn’t know about PrEP without repeating that Gilead charges upwards of $2,000 out of pocket for a one month supply of Truvada. A lot of private insurance companies and even Medicaid, in some states, cover that cost, but still—that’s astronomical! Black and Latino men who have sex with men are already at disproportionately high risk for HIV transmission; more than 40 percent of all people diagnosed with HIV in 2017 were Black, while just over a quarter of them were Latinx. So, why not remove some of the barriers by... literally removing some of the barriers, such as cost? Abolish the entire profit-driven health care system we’ve got going on in the U.S. and replace it with, I don’t know, everything’s free fishbowl at the gay bar idea has to be better than what we currently have, right? 

March 9, 2019

PREP Use Among Men in Risk for HIV is Up 35% But Still Too Low


By Tim Fitzsimons
Thirty-five percent of gay and bisexual men at high risk of HIV infection were using PrEP, or pre-exposure prophylaxis, the daily pill that prevents HIV infection, in 2017, according to data released Thursday by the Centers for Disease Control and Prevention. In 2014, just 6 percent of these men used PrEP.
However, despite the nearly 500 percent jump in PrEP use among men who have sex with men, the CDC notes “PrEP use remains too low, especially among gay and bisexual men of color.”
The study was presented Thursday in Seattle at the 2019 Conference on Retroviruses and Opportunistic Infections, a major annual HIV/AIDS conference, and was based on more than 8,000 interviews in 20 American cities. 
The data showed varying use among racial and ethnic groups. More than 40 percent of white gay and bisexual men at high risk of HIV used PrEP in 2017, while only 30 percent of their Latino counterparts and 26 percent of their African-American counterparts did so. The updated data highlights the fact that minorities access PrEP at lower rates than whites, despite being at higher risk of HIV infection.
The data also found high awareness of PrEP, which is also known by its brand name, Truvada, among all gay and bi men: Eighty-six percent of African-Americans know about it, as do 87 percent of Latinos and 95 percent of whites.
“The study’s findings suggest that efforts to increase PrEP awareness and use among populations at risk is working, but it remains underutilized,” according to a press memo distributed by the CDC. The CDC notes that the federal government’s “Ending the HIV Epidemic: A Plan for America,” which aims to reduce new infections by 90 percent by 2030, will rely heavily on ramping up PrEP use. Many people struggle to access PrEP because of its high cost — roughly $2,000 per month list price — and complex insurance procedures.
“Of the estimated one million Americans at substantial risk for HIV and who could benefit from PrEP, fewer than 10 percent are actually using this medication,” the CDC noted, referring to low uptake overall among heterosexual and injection-drug-using populations that are also at high risk of HIV infection.
The CDC said it is funding government and private health organizations’ efforts to spread awareness of PrEP, and “developing new ways to connect gay and bisexual men of color and transgender people to PrEP."

November 21, 2018

Every Person in Danger of HIV Should Have Available The Prevention Pill }}Medical Panel Says

  It's Not a long-term vaccine but it will do the same job...keep you from HIV even if your partner has it!
 One PILL will Keep HIV Away, So Why Would You become HIV by not taking Pill???? YOunger guys are mostly taking it but people that should know better are not!
A Truvada pill. The drug, used to treat people with HIV, also helps prevent the virus from infecting healthy people

An influential panel of medical experts recommended for the first time Tuesday that physicians offer preventive medication to anyone at high risk of acquiring HIV.
The U.S. Preventive Services Task Force estimated that 1.2 million people are eligible for the daily drug regimen, which is very effective at preventing HIV infection, but only 78,360 took the medication in 2016. About 40,000 people were newly diagnosed with HIV that year.
John Epling, a member of the task force and a professor of community medicine at the Virginia Tech Carilion School of Medicine and the Carilion Clinic, said routine discussion of the medication has not permeated primary care. He said he suspects that some doctors are not having conversations with patients who should be considered high risk.
“It’s just one of those things that haven’t diffused all the way through primary care yet,” Epling said in an interview. “The more familiar territory is in using condoms and avoiding multiple sexual partners.” The task force’s draft recommendations are aimed at persuading more doctors to bring up the subject of preventive drugs with their patients, he said. [Is HIV prevention pill right for you? CDC outlines how to tell whether you should be on the medication]
Pre-exposure prophylaxis, known as PrEP, is a combination of two drugs — tenofovir disoproxil fumarate and emitricitabine — made by Gilead Sciences and marketed as Truvada. Taken daily in a single pill, the FDA-approved medication greatly reduces the chance of acquiring HIV, according to research cited by the task force. The Centers for Disease Control and Prevention says that PrEP cuts the risk of contracting HIV through sex by more than 90 percent and reduces the risk by more than 70 percent for intravenous drug users.
Side effects — mainly nausea and mild, reversible kidney problems — are minor, but patient adherence to the drug program varied between 30 percent and 100 percent in research considered by the task force, an independent panel of experts on preventive medicine. 
The drug also is very expensive, at nearly $1,676 for a 30-day supply, according to Gilead. Most insurance covers the drugs, but critics have cited out-of-pocket costs as perhaps the biggest obstacle to staying on the medication.
In a statement, a Gilead spokesman disagreed, adding that “the CDC estimates that less than one percent of people who are indicated for Truvada for PrEP have an unmet need for financial assistance . . . Beginning September 1 of this year, we increased our patient support programs by raising the annual co-pay assistance from $4,800 to $7,200 and doubling patient eligibility for the Medication Assistance Program from six months to 12 months.”
Growth in the use of PrEP has been rapid, according to a 2018 study led by epidemiologists at the Rollins School of Public Health at Emory Universityin Atlanta. Its use rose from 3.3 people per 100,000 population in 2012 to 36.7 people in 2017. 
But use of the medication is more than twice as frequent in the Northeast than it is in the South, the researchers found, even though a disproportionate number of new HIV diagnoses occur in Southern states.
The development of effective therapies and better prevention have changed HIV from a death sentence to a manageable disease that people can live with for decades. The CDC estimates that 1.1 million people in the United States are infected with HIV, including an estimated 15 percent who don’t know they have it, the task force reported.
According to the CDC, new HIV diagnoses are disproportionately concentrated among injection drug users and black and Latino men who have sex with other men.
The task force singled out four groups of people it considers to be at high risk for HIV:
* Men who have sex with other men and have a partner with HIV, a recent sexually transmitted infection or inconsistently use condoms; * Heterosexuals who have a partner with HIV, a recent sexually transmitted infection or inconsistent condom use with a partner whose HIV status is unknown and is at high risk for contracting the virus;
* Injection drug users who share needles or are at risk of acquiring HIV through sexual activity.
* Sex workers or people trafficked for sex.
As it did in 2013, the task force also recommended that all people ages 15 to 65 and all pregnant women be screened for HIV.
The proposed recommendations are open for public comment until Dec. 26.
 Washington Post

September 14, 2018

We Have A Chemical HIV Cure (PREP) For Not Getting The Virus Yet Only 4% of Gay and Bi Men Are Using It

The Williams Institute—Only 4% of sexually active gay and bisexual men in the U.S. use Truvada as pre-exposure prophylaxis ( PrEP ) and 25% of young sexually active gay and bisexual men have never been tested for HIV.

The Williams Institute at UCLA School of Law finds that only 4% of sexually active gay and bisexual men in the United States use Truvada as pre-exposure prophylaxis ( PrEP ), which the Centers for Disease Control and Prevention regards as a highly effective tool to prevent the transmission of HIV.

In addition, researchers found that most sexually active gay and bisexual men aged 18-25 are not tested for HIV annually, as recommended by the CDC, and 25% of young men have never been tested.

"Our findings suggest that health education efforts are not adequately reaching sizable groups of men at risk for HIV infection," said the study's principal investigator Ilan H. Meyer, Distinguished Senior Public Policy Scholar at the Williams Institute. "It is alarming that high-risk populations of men who are sexually active with same-sex partners are not being tested or taking advantage of treatment advances to prevent the spread of HIV."

This is the first study to report on estimates of HIV testing and use of PrEP among gay and bisexual men using a national probability sample in the United States. In the study, researchers examined gay and bisexual men in three age groups: young ( 18-25 ), middle ( 34-41 ) and older ( 52-59 ).

Key findings
PrEP Use 
Only 4% of sexually active gay/bisexual men of all age groups use PrEP.
Visiting an LGBT health clinic and searching online for LGBT resources were associated with greater likelihood of PrEP use.

Slightly more than half ( 52% ) of young sexually active gay and bisexual men were familiar with PrEP as HIV prevention, compared with 79% of men aged 34-41.
Bisexual and non-urban men were less familiar with PrEP compared with gay-identified and urban men.
Most ( 68% ) men who were familiar with PrEP as HIV prevention had a positive attitude toward PrEP use—despite the low level of usage.

HIV Testing 
One quarter ( 25% ) of young gay and bisexual men had never tested for HIV in their lives, compared to approximately 8% of the middle and older groups of men.
45% of young sexually active gay and bisexual men had tested for HIV at least annually, compared with 59% of men aged 34-41 and 36% of those aged 52-59.

Black gay/bisexual men were more likely than White men to meet recommendations for HIV testing, which may be due to recent efforts to target Black men for HIV testing.
Visiting an LGBT health clinic and being out as gay or bisexual to health care providers were associated with greater likelihood of HIV testing.

"The extremely low rate of PrEP use, while not surprising given barriers to access in various parts of the country, is disappointing," said lead author Phillip L. Hammack, Ph.D., Professor of Psychology at the University of California, Santa Cruz. "I worry especially about younger men who didn't grow up with the concerns of HIV that men of older generations did. The low rate of HIV testing probably reflects a degree of complacency and cultural amnesia about AIDS."

"In the early days of the AIDS epidemic, gay and bisexual men had to rely on LGBT community sources to receive information about HIV prevention," said Meyer. "Our findings suggest that contact with LGBT community resources—health clinics and online information—still serves an important role in HIV prevention."

Truvada is currently the only FDA-approved form of PrEP.

The report, "HIV Testing and Pre-Exposure Prophylaxis ( PrEP ) Use, Familiarity, and Attitudes among Gay and Bisexual Men in the United States: A National Probability Sample of Three Birth Cohorts" appears in PLOS ONE and is co-authored by Phillip L. Hammack, Ph.D., Professor of Psychology at the University of California, Santa Cruz, Ilan H. Meyer, Ph.D., Distinguished Senior Public Policy Scholar at the Williams Institute, Evan A. Krueger, MPH, Research Coordinator at the Williams Institute, Marguerita Lightfoot, Ph.D., Professor of Medicine at the University of California, San Francisco, and David M. Frost, Ph.D., Senior Lecturer at University College London.

Research reported in this article is part of the Generations Study, supported by the National Institute of Child Health and Human Development ( NICHD ) of the National Institutes of Health, under award number R01HD078526. 
The Williams Institute at UCLA School of Law, a think tank on sexual orientation and gender identity law and public policy, is dedicated to conducting rigorous, independent research with real-world relevance.
—From a press release

August 6, 2018

Instead of keeping it Like A Secret Let's Celebrate Gay Men Can Have Sex Without Fear

Have you heard of the anti-AIDS drug PrEP? Most straight people are unaware of it. In 2015, the World Health Organization said “the efficacy of oral PrEP has been shown in four randomized control trials and is high when the drug is used as directed.” 
PrEP (Pre-exposure Prophylaxis) is a drug that allows you to have as much sex as you want, without a condom, and remain HIV-negative. If you use it, you probably won’t catch HIV. POZ magazine says that it has “100 per cent efficacy for those who stick to the treatment.”
Doctors recommend everyone use condoms, because although PrEP is very effective as a protection against HIV, it does not guard against the transmission of other sexually transmitted diseases.
Recently, Patrick William Kelly — a gay academic from Northwestern University who is writing a “global history of AIDS” — sounded the alarm about PrEP. For many straight people, Kelly’s discussion of PrEP may be the first they have heard of this revolutionary drug. 
Kelly’s concern is that the popularity of PrEP will cause gay men to stop using condoms. He worries:
“An entire generation of gay men has no memory or interest in the devastation [AIDS] wrought. AIDS catalyzed a culture of sexual health that has begun to disintegrate before our eyes. What is there to be done to bring it back?…The nonchalant dismissal of the condom today flies in the face of the very culture of sexual health that gay men and lesbians constructed in the 1980s.”

Doctors still recommend that everyone use condoms because although PrEP is effective as protection against HIV, it does not guard against the transmission of other sexually transmitted diseases. (Shutterstock)

There is one sentiment that is missing from Kelly’s article. Why doesn’t he celebrate the fact that gay men — and everyone else — can now have sex without fear of death? PrEP makes sex safer for everyone. It is just one new tool in the “safe sex arsenal.” Why not be happy about the fact that PrEP will undoubtedly save many lives?

Not a lethal illness anymore

Some might ask — isn’t AIDS still a lethal illness? Not so much. 
The gold standard in HIV treatment” (highly active antiretroviral therapy or HAART) was first introduced at the 1996 Vancouver International AIDS Society (IAS) Conference. According to Dr. Julio Montaner, director of the British Columbia Centre for Excellence in HIV/AIDS, “this was a pivotal moment, when HIV infection became a chronic manageable condition.” 
In 2014, The Globe and Mail reported that worldwide deaths from AIDS were massively decreasing
“In 2013, 1.5 million people died from AIDS-related causes worldwide, compared with 2.4 million in 2005, a 35 per cent decrease.” 
This state of affairs seems particularly significant when one considers hysterical early predictions concerning the effects of the disease. In 1987, Oprah Winfrey stated confidently that “research studies now project that one in five — listen to me, hard to believe — one in five heterosexuals could be dead from AIDS at the end of the next three years.” 
This never happened.

In this 1989 photo, protesters lie on the street in front of the New York Stock Exchange in a demonstration against the high cost of the AIDS treatment drug AZT. The protest was organized by ACT UP, a gay rights activist group. (AP Photo/Tim Clary)

It’s absolutely true that AIDS affects different demographics, ethnicities and geographies differently, and that gay men are not the only population to be affected by it worldwide. But the improvement in the lives of HIV-positive people everywhere is only in part due to the tireless efforts of doctors, researchers and health-care workers. 
It is also due to the tireless efforts of gay men everywhere — many of whom became safe-sex activists during the last 35 years, distributing pamphlets, marching and just generally spreading the news. 
So why would a gay professor characterize PrEP as a bad thing? Why is he worried that gay men — en masse — will suddenly start practising unsafe sex?
Kelly is the victim of another kind of infection — the notion that gay men are criminals whose desires must be controlled. 
This criminalization of homosexuals goes back as far as the notion of sodomy. 

Viewing homosexuality as criminal

In the England of Henry VIII, the punishment for sodomy was deathIndia today is still struggling to legalize same-sex encounters. 
In 1972, gay liberation theorist Guy Hocquenghem flatly stated in his book Homosexual Desire: “Homosexuality is first of all a criminal category.” 
Hocquenghem went on to suggest that even though the late 19th century brought a tendency to view homosexuality through the more “tolerant” lens of illness, the human need to view homosexuality as criminal is persistent.
“Certainly as we shall see later, psychiatry tends to replace legal repression with the internalization of guilt. But the passage of sexual repression from the penal to the psychiatric stage has never actually brought about the disappearance of the penal aspect.” 
Both the sexuality of gay men and the sexuality of women are a threat to the primacy of patriarchal male heterosexual desire. Heterosexist culture believes this threat must be controlled. The LaBouchere Amendment in England (1885) was used to incarcerate Oscar Wilde for his homosexuality as a crime of “gross indecency.”
But Labouchere was an amendment to legislation designed to control female prostitution  — a law that angered many 19th-century trailblazing feminists. 
When AIDS appeared in the early 1980s, some heterosexuals saw it as primarily a gay disease (AIDS was first called GRID — gay-related immune deficiency). They worried that gay men might infect straight people, especially children. 
In his influential book of essays, Is The Rectum A Grave?, Leo Bersani suggests that when small-town Americans wanted to ban HIV-positive hemophiliac children in schools, what they actually feared was the spectre of “killer gay men” acting too much like women:
Women and gay men spread their legs with an unquenchable appetite for destruction. This is an image with extraordinary power; and if the good citizens of Arcadia, Florida could chase from their midst a very law-abiding family it is, I would suggest, because in looking at three hemophiliac children they may have seen — that is unconsciously represented — the infinitely more seductive and intolerable image of a grown man, legs high in the air, unable to refuse the suicidal ecstasy of being a woman. 

A doctor holds Truvada pills, shown to help prevent HIV infection. (AP Photo/Jeff Chiu)

AIDS was not the first thing to make straight people think gay men had to be controlled. It simply fit like a glove on a fear of homosexuality that was already culturally endemic. 
Our society seems addicted to the notion that homosexuality is something uncontrollable and potentially lethal. So when AIDS came along, as the long-time AIDS worker Simon Watney wrote, it was “effectively being used as a pretext throughout the West to justify calls for increased legislation and regulation of those who are considered to be socially unacceptable.”
The concern over gay male imagined libidinal insanity is a throwback to an old trope. Gay men don’t need to be controlled; at least not any more than anyone else. And if you think otherwise? Well, it’s based on prejudice. Not fact.
This page was published on Aug 1, 2018 on The Conversation by,

July 2, 2018

The Pill With The Capability to Stop HIV is Getting Priced Out of Reach

Public health officials are expanding efforts to get the HIV prevention pill into the hands of those at risk, in a nationwide effort to curb infections. But the officials are hitting roadblocks — the drug's price tag, which has surged in recent years, and changes in insurance coverage that put a heftier financial burden on patients.
Since brand-name Truvada was approved for HIV prevention six years ago, its average wholesale price has increased by about 45 percent. Now, the drug — which rakes in billions of dollars in annual global revenue for its manufacturer, Gilead Sciences — carries a list price of close to $2,000 for a 30-day supply. 
Most insurers cover the pill, also known as pre-exposure prophylaxis, or PrEP. It has been shown to be more than 90 percent effective in HIV prevention when taken daily, according to the Centers for Disease Control and Prevention.
But patients can get stuck with out-of-pocket costs that make the medicine unaffordable.
"If there is an example of the dysfunction in the American pharmaceutical system, it is this case," says James Krellenstein, a member of the AIDS advocacy group ACT UP New York. "We have the most effective tool for ending the HIV epidemic, and one reason we're unable to scale up because it costs so [much] unnecessarily."
As policymakers and the health system debate how to control ever-climbing drug prices, experts say this case underscores how patients are left holding the bag.
Private health plans are making patients responsible for a larger share of drug costs. And more are restricting the use of the "copay coupons" pharmaceutical companies have used to shield patients from out-of-pocket expenses. Insurers say the drug companies use coupons to steer consumers toward pricier meds. One way health plans are limiting their use is by no longer allowing them to count toward patients' deductibles. "This is one more thing that is going to push people off their medications," says Jim Pickett, a senior director at the AIDS Foundation of Chicago.
Jared Wile, who lives in Chicago, started taking PrEP about three years ago when he was dating someone with HIV. Wile, who has a $2,750 deductible, used a coupon to obtain the drug. He never paid anything out-of-pocket, he says.
Gilead waives up to $4,800 in out-of-pocket expenses for commercially insured patients.
That changed for Wile this past May when he learned the coupon no longer counted toward his deductible and that he would have to pay the full cost of the prescription — $1,600 per month — until he hit his deductible. Wile says he felt "blindsided" and stopped taking the medication.
Gilead spokesman Ryan McKeel says the company has made extra efforts to help patients overcome financial barriers. He cites assistance programs for uninsured and underinsured people.
"We have designed our assistance programs with the intent that people can benefit from their full value, and we cannot control the actions or decisions of health insurers," McKeel said via email.
The federal Centers for Disease Control and Prevention estimates that more than 1 million people are at high risk of contracting HIV, but Gilead says only about 167,000 people currently take PrEP.
Beyond the money crunch
Price is one of many barriers — alongside patients' lack of awareness and doctors' hesitation to prescribe — that threaten to exacerbate the already stark disparities in PrEP use and HIV infection rates.
One major disparity is along geographic lines. The South, for example, accounts for over half of new HIV diagnoses but only about 30 percent of new PrEP users, according to data from AIDSVu, which maps HIV disease and PrEP use. HIV rates and PrEP use also vary by race and ethnicity.
"We are not necessarily seeing that those most at risk are the ones starting PrEP," says Kristin Keglovitz Baker, the chief operating officer of Howard Brown Health, a Chicago health center.
Gilead has recently gone all-in with advertising to reach people at risk, including print campaigns and TV ads that will air through the summer. Since 2012, it has spent $28 million to fund U.S. organizations that seek to raise awareness of HIV, says McKeel, the company spokesman.
"We recognize that many people who are at high risk for HIV infection still face challenges in accessing Truvada for PrEP, and we are in regular dialogue with public health officials, advocates and physicians to better understand and, where possible, help to address these challenges," he added.
But price is also an impediment for publicly funded programs, which have limited budgets and are now shelling out more cash for the prevention effort.
"If it was only pennies ... we would be throwing it around," says Joey Mattingly, an assistant professor at the University of Maryland School of Pharmacy. "Because of how costly it is, we have to control it."
Some states — California and Florida among them — have launched PrEP assistance programs that can help patients cover the cost of the medication, along with required lab work and medical visits.
Beyond these state-based programs, some public health departments and HIV service organizations are hiring PrEP navigators to help patients traverse the maze of copays and deductibles and to improve recruitment and retention of new PrEP users.
Washington, D.C.'s health department has doubled down on prevention, and Truvada is key in that effort, says Michael Kharfen, the department's senior deputy director for HIV/AIDS, Hepatitis, STD and TB Administration.
Insurance usually covers PrEP, and patient assistance programs should fill any financial gaps, he says. But when that isn't feasible, the department steps in, distributing free Truvada starter packs to at-risk patients.
Kharfen says the city has in the past three years spent almost a million dollars just on Truvada pills, which it purchases at a discounted rate through the federal 340B program, which benefits certain health care providers that treat low-income people. And because of new publicity efforts, he expects the department will need to buy and distribute more pills — posing a conundrum.
Treating more people is net positive, he says. But "how do we sustain this?"
Medicaid programs generally cover PrEP, so they confront a similar situation. Outreach efforts lead to more beneficiaries who take the drug, but that, in turn, could subject the states' Medicaid budgets to financial hardship.
States are spending millions of dollars on the drug. California's Medicaid program, for example, spent about $50 million in 2017 and expects the costs to continue climbing. But officials said the expense is offset by long-term savings in preventing new HIV cases.
Massachusetts' Medicaid program spent about $22 million on Truvada that same year — about $18,000 per beneficiary, according to a spokeswoman for the agency's Executive Office of Health and Human Services. Those figures don't account for rebates the state receives from Gilead, which are undisclosed and considered proprietary information.
A complex solution and no competition
PrEP is only one part of HIV prevention, so help to pay for the pill is only one piece of the puzzle.
Patients also need regular HIV testing and medical care, which add to the cost borne both by patients and the health system. Some experts warn that Truvada's high price point could financially undermine such broad prevention efforts.
Competition could help.  
A generic version of the drug, manufactured by Teva Pharmaceuticals, is available abroad and gained approval for use last year from the federal Food and Drug Administration. When it becomes available in the United States, it could bring down prices, though it's unclear when that will happen. Gilead's own forecasts reflect that expectation, showing declines in future revenue from Truvada.
"When generics enter, brands lose market share," says David Howard, a health economist and professor at Emory University, who previously worked in the pharmaceutical industry.
For now, though, Truvada is the only PrEP option available in the U.S., he says. "From a company standpoint ... their best strategy is to make as much money as they can."
Kaiser Health News, a nonprofit news service covering health issues, is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN's coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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