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Facts We Learned at the House Hearing On PrEP

5/20/2019

129 Comments

 
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By Benjamin Ryan

On May 16, the House Committee on Oversight and Reform held a three-and-a-half hour hearing about the pricing of Truvada as pre-exposure prophylaxis (PrEP). You can watch the whole video here. The following facts about PrEP were established at the hearing:

  • The current list price for a month of Truvada is $1,780.
  • Medicaid as well as clinics that care for underserved populations and thus have access to 340B pricing receive about a 75 percent discount off of Truvada’s list price. 
  • Gilead’s donation to the Centers for Disease Control and Prevention (CDC) of enough Truvada to cover 200,000 uninsured people for 10 years will be in addition to the drug Gilead already provides to uninsured people through the company’s existing payment assistance program.
    • The CDC estimates that of the 1.1 million people in the United States who are at risk of HIV and therefore good PrEP candidates, 200,000 are uninsured. So the donation would provide Truvada to all of this group should these individuals seek PrEP.
    • The precise details of the donation to CDC are currently being worked out.
    • Gilead will not count the list price of Truvada as a charitable tax deduction for this donation, but will count the manufacturing price. Gilead says that the claim that the manufacturing cost is only $5 per month is inaccurate, and that the true cost is higher.
  • If Descovy is approved as PrEP, as it probably will be by the end of the year, the donation to the CDC will be of free Descovy rather than Truvada.
    • Descovy is associated with improved biomarkers of kidney and bone health compared with Truvada when these drugs are used as PrEP. (Note that it may remain unknown whether Descovy actually provides a clinically significant benefit over Truvada by actually preventing the rare outcomes of bone fractures and kidney disease.) 
  • PrEP is covered by insurance, including private insurers and Medicaid.
  • Ninety-eight percent of PrEP users who use the Gilead copay card—which covers out of pocket costs associated with Truvada up to $7,200 annually with no monthly limit—pay zero dollars for the drug each month.
  • The first generic version of Truvada, manufactured by Teva Pharmaceuticals, will hit the market on September 30, 2020.
    • This is expected to lower the cost of the drug by about 10 percent to 15 percent. 
  • Six months later, on March 30, 2021, multiple generic versions of Truvada will enter the market, which should reduce the cost of the drug dramatically. (Tim Horn of NASTAD, who testified at the hearing, recently estimated to me that the new cost at that point, which is 22 months from now, would be about $30 per month.)
  • PrEP is predominantly used by white men who have sex with men (MSM), despite the fact that the rate of new HIV infections is much higher among black MSM in particular.
  • There was a disagreement at the hearing over how many people are currently taking PrEP. Gilead estimates that just over 200,000, people are currently on Truvada for prevention. (The company has always insisted that the PrEP-use estimates it releases each quarter represent current users.) However, Rochelle Walensky, MD, MPH, from Harvard insisted that this figure represented people who have ever taken PrEP. 
    • It is, in my opinion, very difficult to determine who is correct in this dispute, since Gilead does not release the data behind its estimates. Also, when academics estimate PrEP use figures, their own estimates come out on a considerable delay. So they do not provide an estimate of current users, but of those using PrEP a year or more previously. 
    • Note that there is no specific prescribing code that differentiates Truvada’s use as PrEP from its use as treatment, which is why figuring out how many people are on the drug for prevention is so difficult and requires a certain amount estimating. Once multiple generics enter the market, such estimates will likely become even harder to conduct.
  • The major global PrEP trials that proved its efficacy were largely funded by the National Institutes of Health, the Bill & Melinda Gates Foundation and the CDC. 
  • Gilead scientists were essentially uninvolved in the iPrEx study that was published in 2010 and which first proved PrEP’s efficacy among MSM.
    • The New England Journal of Medicine paper, in fact, says the following: “Gilead Sciences donated both [Truvada] and placebo tablets and provided travel-related support for meetings conducted by non-Gilead investigators. The role of Gilead Sciences in the development of the protocol was limited to sections regarding the handling of the study drugs. Neither Gilead Sciences nor any of its employees had a role in the accrual or analysis of the data or in the preparation of the manuscript. [The National Institute of Health's Division of Acquired Immunodeficiency Syndrome (DAIDS)] agreed to give Gilead 30 days to comment on the manuscript, but there was no agreement to accept suggestions.” 
  • A Yale Law School study, admitted into the record, found that the CDC holds the patents to Truvada's use as PrEP. Gilead claims those patents are invalid.
  • And finally, a personal observation: It's amazing that we've come so far in the United States that Congress can hold a three-and-a-half hour hearing that is largely about preventing the spread of HIV through condomless anal sex between men, and not one person says anything even the slightest bit homophobic or sex negative. Instead, while many people in the room disagreed with one another over matters of policy and capitalism, all clearly agreed that promoting the use of Truvada as prevention is a worthy goal. 
  • To quote Tim Horn: "We're all in this together."
 



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With 6th ID’d Case of PrEP Failure, Assertions That This Will Remain Rare

10/8/2018

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By Benjamin Ryan

For the sixth time, researchers have documented a case of a man who has sex with men (MSM) contracting HIV while, according to multiple sources of evidence, he was adhering well to the daily regimen of Truvada (tenofovir disoproxil fumarate/emtricitabine) as pre-exposure prophylaxis (PrEP) against the virus. Given PrEP’s increasingly wide use around the world—an estimated 180,000 people, the vast majority of whom are MSM, are using it in the United States alone—the fact that so few PrEP-failure cases have reported to date helps back the scientific community’s adamant assertion that such cases will in all likelihood remain rare.
 
Case in point: A recent analysis conducted in King County, Washington, which includes Seattle and that recently saw a case of PrEP failure, indicated that transmissible HIV that is resistant to both of the drugs included in Truvada, emtricitabine and tenofovir disoproxil fumarate (TDF), is itself rare. 

However, the strain of HIV that the man in the new case report contracted only had mutations associated with resistance to emtricitabine; his virus demonstrated susceptibility to TDF. His is the third documented case of an individual contracting a strain of a TDF-susceptible strain of HIV while, according to multiple sources of evidence, adhering well to the daily PrEP regimen. 
 
The first reported case of PrEP failure, described in February 2016 at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, involved a Canadian MSM who was apparently taking Truvada routinely and who contracted a strain of HIV that was highly resistant to emtricitabine and showed reduced susceptibility to TDF. Since that time, five other cases, including this new one, have been reported at scientific conferences or elsewhere.
 
Presenting their findings at the IDWeek conference in San Francisco, researchers provided a case report of a 21-year-old Latino man who has sex with men, cisgender women and transgender women who started daily PrEP through a municipal sexually transmitted infection (STI) clinic. He was prescribed 30 days of Truvada with two refills, with instructions to return for monitoring every three months.
 
Rapid HIV antibody tests as well as pooled viral RNA tests (which look for presence of the virus) indicated the man was HIV negative upon his first assessment for PrEP as well as at three, six and 10 months after starting Truvada for HIV prevention. Between starting PrEP and acquiring HIV, he was diagnosed with urethral chlamydia once and urethral gonorrhea three times.
 
At his clinic visit 13 months after starting PrEP, the man reported recently taking crystal meth and engaging in condomless receptive anal sex with a male partner. He said that he had not taken meth nor had he engaged in this type of sex for more than one year prior. He reported excellent adherence to the daily Truvada regimen at this time. A test conducted on a sample he gave at this visit indicated he was negative for HIV antibodies.
 
However, five days after that 13-month clinic visit, the result of his HIV RNA test came back indicating that he had a viral load of 559.
 
The man was quickly notified that he had a detectable HIV viral load. He was quickly linked to care for the virus and put on Truvada plus Tivicay (dolutegravir) and Norvir (ritonavir)-boosted Prezista (darunavir) as antiretroviral treatment for the virus. At the visit when he was prescribed this treatment regimen, he had a viral load of 1,544 according to RNA testing; he also tested positive for HIV antibodies at that time, indicating he was officially HIV positive.
 
The man reported four recent sex partners, one of whom was a man living with diagnosed HIV who was not in medical care for the virus.
 
Researchers conducted genetic testing, specifically genotyping and phenotyping testing, of the HIV in the plasma sample the man in the case report gave that yielded the first positive viral load result as well as a sample taken the day he started HIV treatment. The scientists also conducted genetic testing known as single-genome sequencing on HIV’s genetic material encoded into human cells, called proviral DNA, analyzing a sample taken seven days after the man started treatment for the virus. 
 
Tests indicated that the man had contracted HIV with the resistance mutations known as L74V, L100I, M184V and K103N. M184V in particular is associated with resistance to emtricitabine. Four of the five other documented cases of PrEP failure have involved a man contracting HIV with the M184V mutation; three of those cases also involved virus that harbored either of two specific mutations, called K70R and K65R, that cause reduced susceptibility to TDF. 
 
The tests conducted for the new case report indicated that this particular man’s virus was indeed susceptible to the TDF. In other words, one, but not both of the drugs in Truvada was likely effective against the strain of HIV that this man contracted while taking PrEP regularly.
 
The single-genome sequencing indicated the man likely contracted HIV during the previous few weeks.
 
As for the HIV-positive partner whom the man indicated as a possible source of his infection, that man’s virus had the same viral genotype and the same viral mutations, indicating he was indeed the likely source. Such a finding also indicated that the man in the case report likely did not develop drug resistance to the components of Truvada while on PrEP. His HIV-diagnosed sexual partner, about whom there was no evidence in HIV surveillance databases indicating he had ever had a fully suppressed viral load thanks to antiretroviral treatment, was linked to medical care of the virus. At this man’s first medical appointment, he had a viral load of 15,000, which is well above the threshold (of approximately 1,500) generally considered necessary to render an individual living with the virus infectious through sex.
 
To help determine if the man on PrEP had indeed been adherent to his daily Truvada regimen as he asserted, the investigators took hair samples the day he started HIV treatment, conducted dried blood spot testing based on a sample taken two days later and also looked at a stored plasma sample from the 10-month visit. The hair sample indicated consistent Truvada use during the preceding six months. The dried blood spots indicated that during the preceding six weeks, the man had taken at least four doses of Truvada weekly—the minimum researchers estimate is needed for maximum protection against HIV among MSM. The plasma sample indicated that the man did not have HIV 10 months after starting PrEP and that he had recently taken a Truvada dose prior to giving the sample.
 
“Individuals taking PrEP and health care providers,” the case report authors concluded, “should be aware that PrEP failure is very rare, but not impossible, even with consistent adherence.”

To read the conference abstract, click here.

For a complete archive of nearly 300 PrEP-related articles, go to benryan.net/prep.
 

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Perhaps 4% of Gay & Bi Men Took PrEP During Year Ending March 2017

9/19/2018

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This discouragingly low figure notwithstanding, estimated PrEP use has risen swiftly since that 12-month period.
By Benjamin Ryan

A recent study of a representative, yet small sample of HIV-negative men who have sex with men (MSM) in the United States found that just 4 percent took Truvada (tenofovir disoproxil fumarate/emtricitabine) as pre-exposure prophylaxis (PrEP) during the 12-month period between March 2016 and March 2017. Additionally, a troublingly high proportion of younger MSM reported that they had never been tested for HIV.
 
The Centers for Disease Control and Prevention (CDC) has estimated that about 25 percent of MSM between the ages of 18 and 59 years old are good candidates for PrEP.
 
While the low rate of PrEP use among the new study’s participants is concerning given the high rate of HIV transmission among MSM, Gilead Sciences estimates that a fast increasing population of people use Truvada for prevention in the United States. It is likely that the vast majority of PrEP users are MSM; the prevention modality has not taken off in significant numbers among women. 
 
According to Gilead estimates, 125,000 U.S. residents were taking PrEP as of the first quarter of 2017, when the new study’s enrollment period ended. The pharmaceutical company estimates that by mid-2018, this figure had increased by about 45 percent, to 180,000 people.
 
A separate recent study found that the proportion of PrEP-using MSM participants of studies that reported on the use of Truvada for prevention has about doubled annually since 2012.
 
Publishing their findings in PLOS ONE, researchers behind the new study analyzed data from a national probability sample of 470 HIV-negative MSM from three age cohorts, those 18 to 25 years old, 34 to 41 years old, and 52 to 59 years old. The men, who were participants in the Generations Study and were recruited from all 50 states and Washington, DC, completed surveys between March 2016 and March 2017.
 
A total of 25.2 percent of the men in the younger cohort said they had never been tested for HIV, compared with 7.7 percent of those in the middle cohort and 7.8 percent in the older cohort. A respective 45.3 percent, 58.5 percent and 36 percent of the men in each cohort reported testing for the virus annually, as the CDC recommends for sexually active MSM. 
 
After adjusting the data for various factors, the study authors found that, compared with the men in the older cohort, the men in the younger and middle cohort were each 2.1-fold more likely to test for HIV annually. Blacks were 4.4 times more likely than whites to test for the virus each year.
 
Men who perceived themselves as at risk for HIV, who visited an LGBT-specific clinic, and who were out of the closet to their health care providers were a respective 1.9-fold, 2.8-fold, and 3.2-fold more likely to test annually for the virus compared with men who did not meet each of these specifications.
 
Twenty-one, or 4.1 percent, of the respondents said they were taking PrEP, with no significant variations in this proportion based on age cohort. Bisexual men were 90 percent less likely than gay men to use PrEP. Also, visiting an LGBT clinic was associated with a 9.2-fold increased likelihood of using Truvada for prevention.
 
A respective 52 percent, 79 percent, and 57 percent of those in the younger, middle and older age cohorts said they were familiar with PrEP. Having a high school education versus less education and being tested for HIV versus non being tested were associated with a respective 2.9-fold and 4.2-fold increased likelihood of being familiar with PrEP. Identifying as bisexual versus gay or other sexual identities and living in a nonurban area versus an urban area were associated with a respective 80 percent and 70 percent reduced likelihood of being familiar with Truvada’s use as HIV prevention. 
 
Among those men who said they were familiar with PrEP, 68.4 percent had a positive attitude about it, a rate that did not vary significantly between age groups. However, after the researchers controlled the data for various variables they found that younger men were 3-fold more likely to express a positive attitude about PrEP than older men.
 
Compared with gay or bisexual men, those who expressed a different sexual identity, such as queer, were 70 percent less likely to express a favorable attitude about PrEP. And compared with white men, Latinos were 70 percent less likely to express a positive attitude about Truvada’s use as prevention. A feeing of connection to the LGBT community was associated with a 2.3-fold greater likelihood of looking favorably upon PrEP, compared with not having such a connection.
 
“Our findings suggest the need to reinvigorate HIV prevention efforts to promote testing and awareness of PrEP, especially among younger gay and bisexual men and those who may not have access to LGBT communities and LGBT health providers,” the study authors concluded. “[T]here are many barriers to access to [PrEP], including affordability and lack of knowledge or access. PrEP awareness may increase with access. 
 
“In the meantime,” the authors continued, “public health efforts focused on promoting HIV testing and PrEP awareness need to be more inclusive of diverse populations of gay and bisexual men, especially those in rural areas who are less affiliated with the LGBT community, so that they and their health care providers can make informed decisions about PrEP use in managing risk for HIV.”
 
For a complete archive of PrEP reporting, go to benryan.net/prep.
 
 


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Gay & Bi Men Study Participants' Reported PrEP Use Has Nearly Doubled Annually

9/17/2018

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That’s according to a CDC review of studies from recent years that reported PrEP-use data among men who have sex with men.
By Benjamin Ryan

​In recent years, there has been a near annual doubling of the proportion of U.S. men who have sex with men reporting use of Truvada as pre-exposure prophylaxis among MSM participating in studies that reported data on PrEP use. 
 
Publishing their findings in the journal AIDS, Centers for Disease Control and Prevention (CDC) researchers identified 72 studies published between 2006 and 2018 that met their search criteria, which included reporting on PrEP use. Sample sizes ranged between 30 and 6,483 people.
 
Fifty-five of the studies were based in the United States. The most common target populations were MSM (58 studies), young adults (15 studies), transgender people (10 studies) and African Americans (8 studies). 
 
Throughout the studies, 5 percent of all MSM who were indicated for PrEP use, meaning they were good candidates according to prescription guidelines, took Truvada for prevention. On average, the proportion of MSM reporting PrEP use doubled annually, from 1.9 percent during the years before 2012, to 10 percent in 2012, 3.2 percent in 2013, 5.6 percent in 2014, 14.4 percent in 2015, and 24.5 percent in 2016.
 
This study is limited by the fact that it was based on self-reported use of PrEP and may not reflect actual use. Also, the findings are not generalizable beyond the population of MSM who participated in these studies. And there may have been some overlap between the men who participated in the various studies.
 
In a previous CDC modeling study, published in 2016, researchers projected that if 40 percent of MSM in the United States used PrEP, this would cut expected HIV infections in the nation by 33 percent. In 2017, the CDC’s Division of HIV/AIDS Prevention set a target of increasing the number of PrEP users by fivefold by 2020.
 
Given the apparently steep increase in the number of MSM taking PrEP in the United States, the CDC concluded in its new paper that “if current efforts to promote effective PrEP use are maintained, we may see maximum coverage of PrEP use within several years and may meet these assertive U.S. national objectives.”
 
What the CDC paper does not mention, however, is that numerous sources have indicated that PrEP use has remained largely relegated to white MSM older than 25. Such a stubborn demographic trend may ultimately stymie PrEP’s power to reduce the national HIV infection rate.
 
According to Gilead Sciences’ most recent estimate, 180,000 people in the United States were taking PrEP as of the middle of 2018.

For a complete archive of PrEP reporting, go to benryan.net/prep. 



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Physician-Assisted Suicide: What is a Dignified Death?

4/14/2016

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In November 2014, I joined the nation in grieving the death of Brittany Maynard. The 29 year-old, after being diagnosed with terminal brain cancer, had moved to Oregon to take advantage of a state law that allowed her to end her life by taking lethal physician-supplied medications. Maynard’s story, with its heartbreaking warp and politically charged weft, has catalyzed sorely needed dialogue about how our society manages fatal illness. State legislatures across the United States are now seeking to join the five states that have already done the just and compassionate thing by passing so-called death-with-dignity laws.
 
And now Canada’s progressive new prime minister, Justin Trudeau, has introduced legislation that would legalize physician assistant suicide for our neighbors to the North.
 
I’m hopeful for the legislation's passage and that more terminally ill Americans will soon have the option to end their lives on their own terms if they so choose. However, I’m troubled by the verbiage that typically defines the political movement behind legislation permitting this choice. To say that ending life before the final stages of a fatal disease amounts to “death with dignity” is to imply that dying of the actual illness is intrinsically undignified. This implication pains me, because it does a disservice to the memory of the person I loved most.
 
The day of Maynard’s death happened to be the 16th anniversary of the devastating call I received in my college dorm room when I was 20 years old. It was my father on the phone, informing me that my mother had been diagnosed with a glioblastoma multiforme (the same tumor Maynard had). This notoriously insidious malignancy of the brain meant that fate had already foreclosed upon any possibility for life-saving treatments. Mom was going to die, and it would be a quick and horrible death.
 
My mother was a woman of words. A voracious reader with a degree in English from Duke, she dedicated much of her life to cultivating and sharing her love of language. She taught high school English while my father was in medical school, and later led monthly poetry workshops in each of the lower grades of the K–12 school in Seattle that my two brothers and I attended. (“The Poetry Lady,” my classmates fondly called her, as if she were a fairy from the linguistic heavens.) In her mid-forties, she embarked on a master’s program in comparative literature at the University of Washington, setting her sights on a PhD thereafter and picking up three Romance languages along the way.
 
Since she first opened a copy of The Tale of Benjamin Bunny for us to treasure together, the written word was her greatest gift to me. I would devote my own life to the cause.
 
So it was the cruelest irony that this gift was robbed of her first.
 
The time she most needed to hold fast to her words—when she was in the thick of preparing for her PhD orals—they began slipping through her fingers. A stutter crept up on her as a harbinger of the steep mental and physical decline that would follow hard upon. An MRI would show that the tumor, already the size of an egg by the time of Mom’s diagnosis at the age of 54, was lodged in the left parietal lobe of her brain, right where language is formed. As her ability to communicate crumbled, she regressed to a wide-eyed, child-like state, eventually using a small set of words in the place of all others.
 
“What about the children, of the children, of the father?” she kept pleading at one point. I took this to mean that her concern over what would become of the rest of the family held such a preeminent place in her thoughts that our identifiers us were among the few words she still held close.
 
But what about dignity? Was the end of her life undignified? Mom, who inscribed with a loving, calligraphic hand her gift of my first dictionary when I was 10 years old, would want me first to determine the precise meaning of the word.
 
To have dignity is to adhere to key social mores. The Oxford English Dictionary defines the word as “the quality of being worthy or honorable.” Someone dignified is “befitting elevation of aspect, manner, or style.”
 
In life, my mother was eminently dignified. The word most often used to describe her was “lovely.” A stylish beauty, she carried herself with remarkable grace, and was polite and giving to a fault.
 
But just as we don’t hold a small child to the same social standards as an adult, neither can we expect someone dying of a gruesomely debilitating disease, one that has in effect reduced her to infancy, to mind her Ps and Qs and to hold the stiff upper lip her puritanical heritage demanded of her.
 
On the other hand, many people facing death surely hold high expectations of their own dignity and of how they will be perceived—be that in relation to their behavior or their physical being.
 
What was most remarkable about Mom’s death was that she did maintain an angelic, largely selfless quality throughout the 10 weeks between her diagnosis and her descent into a coma. Even as the right side of her body was progressively paralyzed, as her face swelled up and the rest of her wasted away, as she lost control of her bodily functions and suffered excruciating pain, she remained largely concerned with the rest of us. She was angry and felt cheated out of life, but seemed more focused on the tragedy of missing out on what would happen next with my brothers and me than on seeing her own trajectory cut short. As she did what she could to coax me out of my own crippling depression over losing her, she said she would be an angel and watch over me.
 
She kept her trademark naughty playfulness to the end. We were inundated with friends and family—one of my brothers referred to the house as a “three-ring circus of grief”—and on occasion she suffered a visit from some unsavory character. But she saw fit to joke about such, yes, indignities. “You have to have a sense of humor about this,” she said with a wink.
 
Even in her last waking days, when she could barely speak or move at all, she still made light of things by switching between giving me a mock evil eye and then opening her face wide in a campy expression of horror.
 
It was a blessing that Mom was able to die at home. Because what is truly undignified is how our health care system typically forces people to experience death. All too often the dying are condemned to end their days in a foreign hospital setting, riding toxic waves of false hope through agonizing treatments that only extend life by months, and at great cost to the quality of life.
 
What is beautiful about legislation that allows terminally-ill Americans—and will hopefully soon do the same for Canadians—the choice to end their lives as they see fit is that these laws acknowledge the certainty of their mortality while asserting that granting them this choice is grounded in firm ethics. If modern medicine has given us the power to extend life at times to absurd lengths, it should also grant the fatally ill the authority to die when they choose.
 
While some of the terminally sick may make the choice to die early because they do indeed fear a loss of dignity, others will be motivated to do so for entirely different, but just as valid, reasons. Thus, we should erase the presumptuousness and the value judgment from the language we use to describe the laws that permit this choice. After all, as my mother taught me, language has great power and words must be chosen carefully. Using death-with-dignity nomenclature means opting for alliteration over substance. We should not emphasize the supposed motivation behind making the choice to die, but the freedom to make the choice.
 
I can’t ever know what my mother would have done if she had been granted such an option. But I do know that in her own death she showed her greatest dignity.

Benjamin Ryan is an editor at large at POZ magazine, where he covers the science of HIV and hepatitis C. His work has also appeared in The New York Times, New York, The New York Observer, The Nation, The Atlantic, The Marshall Project, Men’s Journal, Out and The Advocate. He graduated cum laude with a degree in English from Columbia University in 2001.

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September 04th, 2015

9/4/2015

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