The Raquel Rose

Pill that prevents HIV - 14K!?!?

cloud_9

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Jun 14, 2005
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http://www.theprovince.com/health/sexual-health/pill+prevent+limited/7207404/story.html

LOS ANGELES (Reuters) - The first preventive pill for HIV has been hailed as a landmark in the fight against AIDS in the United States, but experts say only a small percentage of those at risk will benefit from it.

U.S. health regulators last month approved Gilead Sciences Inc's Truvada -- already used globally to treat the human immunodeficiency virus -- for preventing the infection in healthy people at high risk of contracting the virus that causes AIDS.

A number of factors will limit the drug's use for preventing HIV, including the fact that in the United States many people most at risk of infection, as well as their sexual partners, do not have consistent access to healthcare. Even for those with coverage, insurance reimbursement for a $14,000-a-year drug is expected to be tricky.

In addition, therapy with the drug would require otherwise healthy young people to take a pill each day, plus show up for HIV testing every three months.

"There are a number of rather significant implementation challenges," said Dr. Stephen Morin, director of the Center for AIDS Prevention Studies at the University of California at San Francisco. "Part of it has to do with the requirement to take a pill a day, which could be addressed by a more long-term administration of the drug."

Scientists are exploring a variety of tactics for using AIDS drug formulations to prevent HIV infection, including long-acting injections, gels and vaginal rings.

About 50,000 new HIV infections are reported each year in the United States. T he number of patients taking Truvada to prevent HIV will likely be "a lot less" than that, said Howard Jaffe, head of the Gilead Foundation and a member of the company's senior management since 1991.

Gilead declined to give its own sales estimate.

"We are not expecting a meaningful increase or uptick in Truvada use from it," Jaffe said, referring to the FDA prevention approval. "We do expect it to enter into the conversation with regard to certain high-risk populations."

He said use of Truvada to prevent HIV infection will likely be most important outside of the United States, as developing countries where AIDS remains an epidemic look for additional ways to curb transmission of the virus.

Gilead has deals, mainly with generic drugmakers in India, to produce low-cost versions of its drugs for use in sub-Saharan Africa and other developing regions.

Dr. Paul Volberding, director of the Center for AIDS Research at the University of California at San Francisco, says Truvada could become a valuable tool for "a small fraction of people" who understand they have a high risk of exposure -- mainly female sex workers whose clients won't use condoms and gay men who decide they are going to engage in riskier sex.

"There is an easy consensus now that somebody that is on treatment and fully suppressed has either zero, or close to it, risk of transmitting the virus," Volberding said.

He and others emphasized that wider testing for HIV -- and treatment of already infected patients -- are the keys to reducing HIV incidence.

Of the 1.2 million Americans estimated to be infected with human immunodeficiency virus, almost 20 percent of them do not know it, according to the U.S. Centers for Disease Control and Prevention.

A recent study by the CDC found that 41 percent of U.S. HIV patients are under continual care of a doctor and just 28 percent had the viral infection under control.

PREVENTION THROUGH PREP

The U.S. Food and Drug Administration in July approved Truvada for adults who do not have the virus but may engage in sexual activity with HIV-infected partners, a concept known as pre-exposure prophylaxis (PrEP). The approval was for use in combination with safer sex practices, such as condoms.

The drug, which combines two anti-HIV drugs in one pill, was already approved for use with other antiretroviral agents to treat patients 12 and older who are infected with the virus. Antiretrovirals are designed to block various steps in replication of the virus.

Critics, including the AIDS Healthcare Foundation, a non-profit provider of HIV/AIDS medical care, argue that Truvada was shown to be only partially effective in preventing HIV transmission, can cause side effects including kidney problems and may cause healthy people to become resistant to it.

No U.S. public money has been allocated for treating uninsured individuals who do not already have AIDS, and some doctors question the degree to which insured patients would be covered.

"I would find it very difficult for there to be a provision to support funding for such a program when we have (HIV-positive) patients on waiting lists," said Murray Penner, deputy executive director at the National Alliance of State and Territorial AIDS Directors, which represents public-health departments.

State AIDS Drug Assistance Programs (ADAPs), which provide HIV treatment to low-income and uninsured patients, had 9,000 people on waiting lists a year ago. T hat number fell to 700 in mid-August after emergency federal funding was released, although many recession-battered states have tightened income criteria, reducing the number of eligible patients.

ADAPs generally have a total of more than 200,000 people enrolled in them over the course of a year, Penner said.

A ROUNDING ERROR IN SALES TERMS

Gilead, like other drugmakers, sells its HIV pills to ADAP programs at a significant discount.

"When we talk to our physician consultants who target HIV patients, they say they are not going to use much of it (Truvada) for prevention," said Phil Nadeau, an analyst at Wall Street firm Cowen & Co.

Any use of Truvada for preventing HIV infection "seems to be a rounding error in our estimates for treating HIV," he said, projecting Gilead's 2012 sales from the drug at $3.1 billion.

RBC Capital Markets described the prevention indication as a "niche" opportunity for Gilead, while Morgan Stanley said it "looks like a modest opportunity but many questions remain."

The CDC has recommended since early 2011 that high-risk gay and bisexual men should use the drug to protect against HIV.

Large insurers such as UnitedHealth Group Inc, WellPoint Inc and Aetna Inc say they cover Truvada for prevention as well as treatment of HIV, but are still deciding whether to institute rules about authorization.

Doctors remain skeptical that insurers will pay for Truvada without complicated documentation showing why a patient is high-risk and whether PrEP is the best preventive measure.

"It's not quite clear to me whether or not I'm going to be prescribing it," said Dr. Mehri McKellar, an infectious disease expert at Duke University in North Carolina. She described one HIV-positive patient whose male partner had not been infected.

"They had read about PrEP, but they use condoms 100 percent of the time," she said. "This is not supposed to at all replace condom use. It's not clear whether we should be talking about PrEP."



Read more: http://www.theprovince.com/health/s...vent+limited/7207404/story.html#ixzz25p4QVKKC
 

the old maxx50

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I am still unclear on why you have to take the drug every day if you don't have HIV.

I understand taking the drug if you are exposed to AID every day with the likelihood of being infected .. If you have a job dealing wit infected people or blood produced ,, or you insist on having unprotected sex with an aids infected person , or just unprotected sex with a high risk partners.. ..I ask why would you keep doing that ..
. So if you are no longer exposed to HIV or AId ,can yu stop taking the drug with out developing HIV or AIDs
 

jesuschrist

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I wonder what the side-effects are, especially in the long term.
Also - wouldn't a consequence of this just be the future development of an even more vicious and elusive virus?
 

JClay

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Critics, including the AIDS Healthcare Foundation, a non-profit provider of HIV/AIDS medical care, argue that Truvada was shown to be only partially effective in preventing HIV transmission, can cause side effects including kidney problems and may cause healthy people to become resistant to it.
This is similar to the post-exposure prophylaxis cocktails they give to people after they have potentially been exposed, except, obviously, you administer it pre-exposure.

I am honestly more curious to see where gene therapy might take us. They have already demonstrated in one circumstance that it is possible for someone with a dominant expression of CCR5-D32 to donate bone marrow to a HIV-positive recipient and to have that person subsequently repeatedly test negative for HIV. Obviously that was a very unique and happy set of circumstances, and not one that everyone can take advantage of, but it illuminates a possible new direction in which to focus research.
 

Bartdude

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I am honestly more curious to see where gene therapy might take us. They have already demonstrated in one circumstance that it is possible for someone with a dominant expression of CCR5-D32 to donate bone marrow to a HIV-positive recipient and to have that person subsequently repeatedly test negative for HIV. Obviously that was a very unique and happy set of circumstances, and not one that everyone can take advantage of, but it illuminates a possible new direction in which to focus research.
I remember that - wasn't it a guy who got cancer, and then was cured of his HIV infection with the chemo they were using to fight the cancer?
 

JClay

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Jun 21, 2007
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Yes and no. The guy - Timothy R Brown, also known as the "Berlin patient" - did have both AIDS and cancer. It wasn't the chemo that cured him of HIV, though - it was the bone marrow transplant. CCR5-D32 is a mutation of the protein CCR5 that blocks one of the primary means by which HIV infects the immune system - when Brown got the transplant, his body started producing HIV-resistant blood cells and his viral load essentially dropped off to zero. They did multiple biopsies on tissues throughout his body and everything has come back negative.

Anyway, looks like they managed to replicate that success.

http://www.msnbc.msn.com/id/48338421/ns/health-mens_health/#.UBLlG7Se5c8

Be interesting to see where things go from here.
 

the old maxx50

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The more I read about HIV and AIDs ,, The less I understand about people .. I am not says Aids is any one;s fault ,, but the spread of it is the fault of people putting themselves in risky sexual situations and then not getting tested regularly .

It seem that men and women ,, don;t like protected sex .. and many want the monogamous relationship so they can skip the condom ...But they still don;t do the common sense thing of getting tested before they start those practices ,But of course one of then all ready has been engaging in unprotected sex .and not considering the danger

Of course a condom is not a sure fire defense against getting infected no matter how safe you play , If the person you are having intimate contact has Aids then you have a high chance of getting it infected And that is the reality of the business that we are engaged in .. the more people you see the more likely one will have Aids , no matter who they are If we wear a condom , don't do kissing , DATY, Digets, Greek,, and have no contact we cum or vaginal fluids , And get tested . every month at least.. if not more when we are very active .. Then we would hope that our tests come back negative for HIV.

If you are not doing that .. then you know where the problem lies .. For those of use that enjoy doing DATY , Digets , kissing Greek, BBBJ,CIM,COB and come in contact with each others bodily fluids .. we can not say we don;t know of the dangers .. and definitely should not hesitate to get tested .. In reality for every one that is aware and takes precautions there are a 100 who , don;t know , or don;t care ,, and take no precautions .. And then there are those who don;t have sexx they are the safest for now .
 

JClay

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Jun 21, 2007
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So HIV can be 'cured' by getting a bone marrow transplant??
In theory, yes. In practice, there are a lot of factors to consider, mostly relating to complications resulting from having a bone marrow transplant, particularly graft-vs-host disease.
 

Bartdude

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Of course a condom is not a sure fire defense against getting infected no matter how safe you play , If the person you are having intimate contact has Aids then you have a high chance of getting it infected And that is the reality of the business that we are engaged in .. the more people you see the more likely one will have Aids , no matter who they are If we wear a condom , don't do kissing , DATY, Digets, Greek,, and have no contact we cum or vaginal fluids , And get tested . every month at least.. if not more when we are very active .. Then we would hope that our tests come back negative for HIV.

If you are not doing that .. then you know where the problem lies .. For those of use that enjoy doing DATY , Digets , kissing Greek, BBBJ,CIM,COB and come in contact with each others bodily fluids .. we can not say we don;t know of the dangers .. and definitely should not hesitate to get tested .. In reality for every one that is aware and takes precautions there are a 100 who , don;t know , or don;t care ,, and take no precautions .. And then there are those who don;t have sexx they are the safest for now .
You are being more than a little alarmist, and putting information out there that is dubious. HIV is certainly a concern that we need to protect ourselves against, and we should always be playing as safe as reasonably possible. But some of what you said is needlessly hysterical.

In the end, the basics of your post are good - that we have to be careful and play safe. But I'd say the vast majority of new HIV infections happen through ridiculously unsafe practices - injection drug use, unprotected anal/vaginal intercourse, and the like.

I would search up the Health Nurses posts in the Health Forum to get a more accurate picture of HIV risk.
 

the old maxx50

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I was not trying to be an alarmist actually I all way believe that we are safe as long as every one follows those steps , and even if they don't we are still safe doing unprotected sex,, as long as every one involved get regular test.. .. It all become unsafe when one client is HIV positive ,and either dose not know ,, or does . There are many ways for people to get exposed to Aids .. sexual, drug use ,blood .. but they all so can be any one not just the people we commonly associate with unsafe practices We don't truly understand how it can happen some time .. All though we have all set our own levels of risk tolerance .. to partake in the sex trade

AS for the condom it only protects your dick nothing else .. and if she wears a condom it only protects her vagina As for many thing else we may do .. there is a higher risk for an STI , but again some on must have it in order to pass it it on There is no danger if it is not prescient . and that is why we test.

The articular that prompted my comments was attached to the site where Ms Sarah got her post.

The female face of HIV: 'We don't have to care for ourselves'

Shawn Thew / EPA

US Secretary of State Hillary Clinton appeared on a large video screen at the 19th International AIDS Conference this week. Many presentations target women, who make up more than a quarter of new HIV infections in the U.S.
By Maggie Fox, NBC News

Del’Rosa Winston thought she’d done everything right. She kept herself in steady employment, and waited until she was married to start having children. When her marriage ended, she started having regular HIV tests, just in case. So when she settled into a new, steady relationship, she never dreamed she’d end up infected with the AIDS virus.

“I had a job. I had been in the military. I was educated," said Winston, a soft-spoken, well-groomed woman with fashionably cropped red hair. "I just got it from a straight man in a monogamous relationship."

More than a quarter of new infections in the United States every year are in women, and of the 1.1 million Americans with the AIDS virus, 280,000 are women, according to the Centers for Disease Control and Prevention. Black women are especially vulnerable – their infection rate is 15 times the infection rate for white American women.
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Winston’s smooth skin and easy smile represent the hidden face of the AIDS epidemic in the United States – the people who don’t look like “typical” HIV patients. The 50-year-old mother of three hopes that speaking out at the 19th International AIDS Conference, being held in Washington, D.C., will help reduce the stigma and ignorance that fuel the spread of the virus.

“There are so many people who are getting it because they loved someone,” Winton told NBC News in an interview. Winston couldn’t wait to be in a steady, safe relationship so she could stop using condoms, which she found uncomfortable to use. Her boyfriend, who has since died, told her he had no idea he was infected. But he was, and so was Winston. “We didn’t fit the parameters of what an HIV-positive person looked like,” she said.

She can remember the moment in 1990 when she was told her test came back positive. “The room was gray,” she said. “Like stainless steel. I know there were objects in it but I couldn’t see them. I just flowed like water to the floor.”

Health experts at the conference say they are trying to find new and better ways to reach not only the people at the highest risk – young gay and bisexual men – but others, like Winston, who may not intuitively know how easily and insidiously the virus can move during a moment of passion. “Everyone’s at risk, whether you have the greatest trust relationship or not,” Winston, who now works as an HIV counselor in Atlanta, said.

Health experts are also trying to figure out some of the factors that make women vulnerable and keep them from protecting themselves even if they do understand the risks. Winston has some ideas – women are often too busy looking after others. “We put everyone else first – kids, school, even the PTA. We get into the mind frame that we don’t have to care for ourselves,” she said.

Another factor may be domestic abuse. A team at the University of California San Francisco published a study on Monday showing that physical and sexual abuse and trauma are major factors affecting which women become infected.

“For a long time we have been looking for clues as to why so many women are becoming infected with HIV and why so many are doing poorly despite the availability of effective treatment,” said Dr. Edward Machtinger, who led the study. “Women who report experiencing trauma often do not have the power or self-confidence to protect themselves from acquiring HIV.”

Their team did a study called a meta-analysis, looking at data from other studies involving 5,900 women. They found 30 percent of women infected with HIV had post-traumatic stress disorder, or PTSD, compared to 5 percent of the general population. Twice as many women with HIV reported they had been victims of partner violence as women without the virus, they found.

Kat Griffith thinks she knows why. The slender redhead from Peoria, Illinois has been HIV positive for 21 years and she blames a violent boyfriend from high school. “I had a jealous and controlling partner who called me names, demeaned me,” she said. “I had no self-esteem.”

But Griffith went away to college and, she thought, started a fresh new life. “I knew that HIV could affect me and I thought I asked all the right questions,” she said. “But my abuse made me feel I was not worthy of protection." Her college boyfriend infected her.

Women may often put others first but they also lack a good way to protect themselves, Griffith noted.

For years, researchers have been looking for ways to protect women against the virus. There’s been hit-and-miss progress with microbicides – gels or creams that women can use quietly to reduce the chance they’ll become infected during sex. On Tuesday, researchers will announce the start of an advanced, Phase 3 trial of a device called a vaginal ring impregnated with dapivirine, a drug used to treat people with HIV. Researchers will enroll 3,500 women in the two-year study to be conducted in Africa, where half of all HIV patients are women.

Studies have shown that microbicide gels or creams can work - at the last AIDS conference in Vienna in 2010, researchers reported on one that reduced a woman’s risk of infection by 39 percent. But other studies haven’t done so well and experts fear inconsistent use may be one problem.

A flexible, silicone ring may be easier to use and less intrusive than a gel that must be applied before and after sex, the researchers hope. So does Griffith. “After 30 years, we still do not have a completely female controlled prevention technique,” she said.
 
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