Swiss HIV Study Confirmed in Canada: Treatment Eliminates Transmission

 A few years ago, we reported on this blog a Swiss Study that concluded that when HIV-positive individuals receive treatment that reduces their viral loads to "undetectable" levels (less than 40 copies per ml blood at the time), the transmission of the virus to negative partners was virtually impossible.  The study was so certain in its results that it lead to changes in Swiss law concerning criminalizing HIV+ individuals having sex.

That news was received with mix results, as the 30 year old "wear a condom!" message, long losing steam but still a cornerstone of government-funded HIV programs, began to be replaced with a common sense message of universally treating the virus as a better prevention approach. The move to "attacking the virus" rather than "restraining the individual" has not been met without resistance, especially by HIV agencies used to receiving government funding merely by placing baskets of condoms around town and telling people to 'wrap up.'

Now, a more comprehensive study validating the Swiss findings was released in Canada this past month.


According to this review of multiple studies, released by National AIDS Treatment Advocacy Policy (NATAP),  heterosexual serodiscordant couples have an almost non-existent risk of HIV transmission if the HIV-positive partner has an undetectable viral load as a consequence of successful antiretroviral (ARV) therapy,  Presenting their findings at the Third International Workshop on HIV and Women in Toronto, researchers pooled data from six different studies of serodiscordant heterosexual couples, including the famous HPTN 052, which found a 96 percent risk reduction due to ARV therapy.

Three of the studies provided data on HIV transmission rates, ARV history and viral load of the HIV-positive partner. These studies included a combined 991 couples with 2,064 person-years of follow-up. The researchers found a transmission rate of 0.0 per 100 person years.

Three additional studies, including HPTN 052, had information on just rates of transmission and treatment history, covering 5,233 couples. Factoring in these studies with the other three, the researchers found a pooled transmission risk of 0.14 per 100 person years. In other words, if 1,000 serodiscordant couples in which the HIV-positive partner is on ARV therapy with an undetectable viral load had sex for one year, about one or two of the HIV-negative partners would become infected with the virus.

All four of the transmissions in the six studies took place before six months had passed since the HIV-positive partner began ARVs and therefore may not have yet reached an undetectable viral load. Taking this into account, the researchers conducted another analysis excluding the data from these transmissions. In this case, the risk of transmission was also 0.0 per 100 person years.

To read the conference abstract, click here.

Demand FDA Approve Rapid Over-the-Counter HIV Test

[Action Alert! We have ONE WEEK to submit comments to the FDA - instructions below]


According to the Center for Disease Control in Atlanta, (the "CDC"):

- 1.2 million people in the United States (U.S.) are living with HIV infection.

- One in five (20%) of those people – or about one-quarter million people are unaware of their infection. That’s the equivalent of the entire population of Jersey City, New Jersey; Orlando, Florida; or Buffalo New York living with an infectious disease and not knowing it.

- 50,000 new cases of HIV infection every year in the United States since the epidemic began.

- An estimated 17,774 people with AIDS died in 2009, and nearly 619,400 people with AIDS in the U.S. have died since the epidemic began.

The scientific and medical communities are united in their belief that one of the most effective ways to control the spread of HIV is through early detection (testing) and early treatment (Anti retroviral drugs that reduce the viral load to undetectable levels).
And so, the fact that a rapid-test to detect HIV has been available for over a decade, but is still illegal to sell over-the-counter in drug stores, is nothing short of criminal.

On November 3, 2005, (six and a half years ago) the Blood Products Advisory Committee of the FDA wrote:

Over the past four years, FDA has approved a number of rapid HIV tests of low complexity, which are simple to use, require no special storage conditions and provide a highly accurate test result within 20 minutes for the detection of antibodies to HIV. Two of these tests were found to be simple enough to perform that they received a CLIA waiver, expanding the availability of testing.

But here’s the kicker. The FDA continued:

Since 2002, all rapid HIV tests were approved as restricted devices, with sales and use restrictions in place. Sale is restricted to clinical laboratories …and [t]he test is approved for use only by an agent of a clinical laboratory...[The] FDA has discussed HIV home-use test kits and home-use collection kits over the past 10 years in various forums…In the course of these discussions, appropriate regulatory criteria were identified for home-use specimen collection kits for HIV testing, but not for home-use HIV test kits. With improved test kit technology (ease of use, freedom from biohazards, and excellent performance characteristics), we believe it may be feasible to identify regulatory criteria for home-use HIV test kit.


Yesterday, while walking through my local pharmacy, I saw at-home pregnancy tests; tests to detect cocaine, marijuana, and a list of other drugs in one’s system; and of course, the blood glucose tests that many diabetics use on a daily basis. But in spite of the available technology, no home tests for HIV…even though the FDA itself concluded in 2005:

“Benefits of HIV home-use test kits include anonymous testing potentially leading to more people knowing their HIV status, empowerment of consumers in healthcare decisions, earlier diagnosis of HIV infection and therefore earlier intervention.”

And yet, in the decade that has passed since the rapid tests were denied for private home use, 500,000 new HIV cases have occurred. Of those, 100,000 people do not even realize they are infected.

Why does this continue?

The FDA is concerned that “Risks of HIV home-use test kits include inappropriate use of the test or test result, including misinterpretation,” “obtaining a test result without live counseling,” and “and use by minors.”

Yeah? And so what? Aren’t those the possibilities with any of the above mentioned at-home tests sold in a drug store? Would we rather that minors who are uncomfortable in a clinic simply walk around with HIV and infect others as their own health deteriorates for unknown reasons? Are they suggesting that pregnancy is a condition that does not require a support system?

Thousands of individuals would use a test at home rather than go to a clinic. People in rural communities who are reluctant to show their faces in a clinic where everybody-knows-everybody; men or women who have cheated on a partner; young people still ill-at-ease with discussing their activities; those for whom English is not a first language and for whom clinical translations are not readily available; those who are high-profile members of their communities; and those who were raised with a fear or stigma of HIV and AIDs - would all be more likely to test at home than walk into a clinic.

The reasons for denying the public access to these tests are entirely unacceptable.

In a perverse reversal of roles, it is the HIV clinics themselves who have been partly responsible for the delay in releasing these tests to the public. The very clinics and “AIDS Service Organizations” or “ASOs” who exist to help HIV positive persons navigate complex legal and medical support systems have a vested interest in keeping these tests out of public hands. Annually these agencies report the number of people to whom they provided services to private donors, government agencies who fund them on a ‘per-person-served’ basis, and to United Way Charities, which requires a “Number Served” figure as part of their funding formula. Thus, some of those agencies that are most vocal about “supporting” the HIV community are actually the very agencies that have given life to the idea that the FDA should prohibit private, at-home testing because it wouldn't be accompanied by “live counseling.”

A recent survey of over 1,500 people by "Who's Positive" revealed the gap in support between persons living with HIV and those with a clinic-based livelihood or agency role. The survey found:

"The survey gathered responses from 1,569 participants, 74% of which said that they would support an OTC rapid, oral swab HIV test that could be purchased in a retail store, if approved by the FDA. Other key findings include:

66% of the respondents who identify as a HIV-positive consumer support an OTC HIV test
80% of those aged to 30 support an OTC HIV test"

But then went on to show lower support by those with a vested interest in maintaining clinic control"

"A majority or nearly 52% of those who identified as a paid member of an HIV/AIDS organization support an OTC HIV test
47% of those who identify as one who performs HIV testing support an HIV OTC test"

It is hypocritical, self-serving, and dangerous.

On the other hand, the public often views medical technology companies with a critical eye…but in this case, it has been just such a company – OraSure Technologies – which has been fighting for a decade to obtain FDA approval to market it’s 20-minute, at-home anonymous test kit.

And once again, the issue is scheduled to be discussed before the FDA Blood Products Advisory Committee. OraSure has applied – again - for the approval of its OraQuick(R) Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter market at a meeting scheduled for May 15, 2012.

The Company will be presenting its findings from a study of 5,800 subjects who believed they were HIV negative. When enrolled in a test-phase using their at-home testing product across 20 sites nationwide, more than 100 of them tested HIV positive.

The FDA has issued the following public notice, permitting public comment in person or in writing. You know what to do:

On May 15, 2012, the FDA Blood Products Advisory Committee will meet from 8:30 a.m. to approximately 5:00 p.m. to discuss the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test.

The meeting will take place at the Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, MD, Tel: 1-301-977-8900.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made on or before May 8, 2012 by submitting them to:

Bryan Emery or Rosanna Harvey
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1277
FAX: 301-827-0294
or via e-mail: Bryan.Emery@fda.hhs.gov or email: Rosanna.Harvey@fda.hhs.gov

Oral presentations at the meeting from the public will be scheduled between approximately 1:30 p.m. and 3:15 p.m. Those individuals interested in making formal oral presentations should notify Bryan Emery or Rosanna Harvey on or before April 30, 2012, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. Those making a request to speak will be notified regarding their request by May 1, 2012.
The notice and complete description of the May 15 and May 16 meetings (as well as the link to the webcast for the hearings) is available on the FDA Website

[pictures: thanks to Tom Donohue of "Who's Positive"]

Iowa's Ignorance and HIV

In 1998, Iowa politicians enacted a law that criminalized potential HIV transmission as a Class B felony. The sentence designates the ‘carrier’ as a felon, imposes a sentence of up to 25 years in prison, and assigns him lifelong sex-offender status, even if the contact was consensual. Under the law, a person aware of his or her positive HIV status does not actually have to transmit the HIV virus, they only have to engage in intimate contact with another person.

The penalty exceeds that for manslaughter.

Since the law was enacted, 26 people have been convicted under the law; nine people currently sit behind bars. The cost to taxpayers is an estimated annual cost of $31,500 per inmate, plus medical costs of $24,000 annually per inmate.

The cost to the incarcerated is the destruction of their life for the crime of being human and having an illness.

Last year, the Iowa legislature defeated an effort to repeal the law, considered the most backwards and punitive (I would add ‘medieval’) in the country. Of course, this is Iowa, a state where right-wing fundamentalists are well-organized in the electoral processes and have handed presidential caucus victories to Pat Robertson in 1988 and Mike Huckabee just four years ago. Reason and Science need not apply...

Supporters of the law have a well-honed mantra that follows this general pattern:

“HIV/AIDs is a deadly disease that is a death sentence. When you know you have it and you are intimate with someone, you are infecting them, and committing an assault on them that is as dangerous as any other form of slow murder.”

In reality, much of the support for this law comes from those who look down on all sexual activity in general, and consider homosexuality in particular to be an abomination. Puritanical theology is the root of their desire to punish these people, not health. Nonetheless, in the battle of legislative processes, and insuring under the US Constitution that no excessive punishments be imposed for ‘crimes,’ it is important to address their stated reasoning above…and certainly time to educate the legislators and the public. I have been wanting to post this for a while, and the Iowa law was the tipping point.

1. HIV is not AIDs. Say that out loud. Again. HIV (Human Immunodeficiency Virus) is a virus that attacks the immune system, as do thousands of viruses. The HIV virus may lead to AIDs as a long-term complication of the viral attack, but HIV is not AIDs any more than blindness or neuropathy is the same thing as diabetes. One may cause the other, but they are not the same thing.

2. HIV is not a death sentence. Gay activists often (appropriately) refer to the 1980s as a health holocaust, as entire neighborhoods were decimated. But times have changed significantly, and thousands of men and women live normal healthy lives for decades with the HIV virus under control. In other words, HIV is now a manageable medical condition, not the end of life.

3. As viruses go, transmission of the HIV virus is very, very difficult. It is not transmitted by close contact, or sharing food or drinking glasses, or by breathing on each other, or by kissing (unlike many other viruses). It is not transmitted through saliva, sweat, or urine. Unlike many prevalent STDs such as syphilis, gonorrhea, herpes, HPV, and genital warts (none of which carry the penalties imposed in Iowa), it is not transmitted through oral sex.

Repeat: in the 30+ year history of HIV, there is not one single scientific case study that has documented transmission via fellatio. Period. In order to be on the ‘safe side,’ many doctors and government-funded clinics will publicly state that this is a ‘hypothetical’ route of transmission. But as for documenting a single case – it doesn’t exist…and privately, the medical community knows this. In July 2002 a study was concluded in Spain of serodiscordant couples (one HIV positive, One HIV Negative), where they evaluated for risks of HIV transmission through unprotected oral sex. In over 19,000 unprotected oral-genital contacts with HIV-infected partners, there was not a single case of seroconversion to HIV. (http://hivinsite.ucsf.edu/insite?page=pr-rr-05)

Even vaginal and anal transmission of the virus is unlikely. According to the Guidelines for the Management and Post Exposure Prophylaxis of Individuals who Sustain Nonoccupational Exposure to HIV, ANCAHRD/CTARC Bulletin, February 2001, the risk of transmission as a result of receptive anal sex is approximately three per cent. Other experts place the risk as low as 1 in 1300. (http://aids.about.com/od/hivaidsstats/f/infectionrisk.htm)

4. HIV positive individuals who have their virus controlled with medication can not transmit the HIV virus. (http://www.aidsmap.com/page/1429357/)

“…Swiss HIV experts have produced the first-ever consensus statement to say that HIV-positive individuals on effective antiretroviral therapy…are sexually non-infectious… After review of the medical literature and extensive discussion [the] Swiss Federal Commission for HIV / AIDS resolves that, “An HIV-infected person on antiretroviral therapy with completely suppressed viraemia (“effective ART”) is not sexually infectious, i.e. cannot transmit HIV through sexual contact.”

The statement officially defines a ‘suppressed viraemia’ (or “Undetectable Viral Load,” the common US parlance) as a viral load that has been suppressed to less than < 40 copies/ml for at least six months. (For comparison, someone not controlled on medication may have a viral load of 500,000 to over 1 million copies/ml). At the time this statement was made, that was the most sensitive that HIV tests could detect; today, these tests can detect viral loads of only 20 copies/ml, which means someone declared to have an Undetectable Viral Load has even fewer copies of the virus in their system than the limit established by the original Swiss statement. Finally, the Commission specifically stated that “courts will have to take into account the fact that HIV-positive people on antiretroviral treatment…cannot transmit HIV sexually in criminal HIV exposure and transmission cases….Unprotected sex between a positive person on antiretroviral treatment…and an HIV-negative person, does not comply with the criteria for an “attempt at propagation of a dangerous disease” according to section 231 of the Swiss penal code nor for “an attempt to engender grievous bodily harm” according to section122, 123 or 125.”

Iowa politicians, take note.

The current law in Iowa, then, locks someone up in a cage for up to 25 years and brands them a sex offender for engaging in normal human activity that has no chance of endangering someone else…simply because of their ‘status’ as a branded individual. The law is not based in science or humanity or health, but expresses a punitive, uneducated, and fearful attitude towards what they do not wish to understand.

Rest in Peace, Finally, Mark

Mark Parsons was a big-hearted man, a philosopher, a theologian in his own right, a housemate for over a year, and, most of all, a wonderful man and a true friend.

He wrote the following last night, before taking his life this morning. The message is universal:

Hate creates Hate and here is proof

"I am a gay man with AIDS. I have been living with it for 27 years now. I always see bible thumping christians pontificating about the evils of homosexuality but did you know an even more incideous hate exitsts very close by where the people have access to you heart and Soul? Your sisters perhaps? You know, the "I love you but wish you weren't gay thing". Always a but.......Here is a quote from my Loving sweet sinister, [name ommitted by me]

You fucking AIDS faggot! I wish you would die fucking soon so me and the rest of our family can catch a break! Will you please fucking die and get it over with!

This is the woman I chose to be my health care proxy. I know, that is kind of like a jew asking hitler over for dinner. But i have a forgiving heart, but after all haven't I been forgiven by so many! But I thought this would be a good lesson for ME because now I will know the results of manifesting Hate in the world. I have always wondered what that was like and Now I will now. What I may do with the information I am not really sure. I will let you know in a follow up. I can't really recall ever manifesting hate before. I wonder if it will make me feel guilty. Probably not because guilt really only comes from judging doesnt it? Ulnimately the lesson will be mine. I wonder if all the "Loving" people in my life will turn on me. That would be interesting. Maybe I will get suid but thats no problem because i don't have anything. Or i guess I could go to jail but they at last will provide three hots and a cot."

Love you always, Mark....

Humanity, Love, and Heartbreak...

This post is for all who believe that "Gay Marriage" is not "real marriage," who believe that people with AIDS "get what they deserve," and who are so devoted to free markets in health care that they lose sight of humanity. If you read it prepare to have your heart ripped out. It was authored, and is reposted annually on this day, by Joe Jervis of Joe.My.God. (The Village Voice's choice as Best Blog in NYC)


I Will Hold You Ten Times

1. I will hold you, Daniel.

2. The lesions don't bother me, I will hold you.

3. I will pretend nothing is wrong when you want me to pretend and when you want me to hold you, I will hold you.

4. I will make plans with you to go to your favorite places that we both know you can no longer go and I will sit with you and look at your pictures of these places and I will hold you.

5. I will ride with you on the train to your doctor's office and when you get sick in the station, I will hold you.

6. I will see the Post-It notes you put all over the house reminding yourself to do everyday things like "Turn off stove" and "Lock front door" and I'll pretend the disease isn't robbing your mind and when you tell me something for the third time in ten minutes, I won't let you know, I will hold you.

7. I will go to Safeway with you because you need to get out into the world, and when the diarrhea overwhelms you and you shit your pants in the middle of the store, I will call us a cab and in the cab, I will hold you.

8. I will make you mix-tapes of our favorite songs from last summer, just like you asked me to, and when the memories make you sad instead of happy and you throw the tapes in the trash, I won't get angry, I will hold you.

9. I will sit up all night with you because the fevers and night sweats won't let you sleep. In the morning, I will change your drenched sheets and help you out of the shower and when you weep from the sight of your withered body in the mirror on the bathroom door, I will hold you.

10. I will hold you, Daniel.

Fiscal Conservatives: Ending DOMA is a responsible step

Robert and Carl* are a gay couple who have been together for several years. They live in a state that permits same-sex marriage, and recently tied the knot in a Church ceremony. Like many other married couples, they have established a stable home and are active members of their community. Carl is healthy but lives with a manageable medical condition. Like approximately 1.1 million other Americans, Carl is HIV positive.

Today, HIV positive people are living long, normal, healthy lives…as long as they receive proper medical care. Highly Active Anti-Retroviral Therapy (HAART), a combination of three medications, is now the standard treatment to battle HIV. While quite effective one of the major downsides of treatment is cost. Carl’s three medications run about $2,200 per month…a figure that is quite typical. This, of course, does not include approximately six blood tests and physicians appointments per year, bringing his treatment costs to about $3,000 per month.

The US Congress recognized the steep cost of treatment when they reauthorized the Ryan White Care Act in 2009 by a vote of 408-9. This Act authorizes the expenditure of over $2 billion annually to assist with HIV outreach and treatment. It is the ‘payer of last resort,’ and income guidelines are applied towards recipients, but still it is estimated that some 30% of HIV positive individuals receive some assistance through this program.

More comprehensive coverage, of course, is available through private insurance. More than 25% of Americans work for an employer that offers domestic partner benefits; 51% percent of Fortune 500 companies offer domestic partner health benefits; and 37% of all Americans live in states where some legal protection of same-sex partner arrangements exist (marriage, civil unions, or domestic partner benefits.)

Back to Robert and Carl.

Robert has a full-time, secure job, and both he and his employer contribute towards Roberts’ health insurance. When Robert married Carl, they looked forward to Carl’s being added to Roberts policy as a spouse, thus providing not only coverage for Carl’s HIV medicine, but for the entire range of normal health care for which the typical American might visit the doctor or the hospital. Robert, who had been married before, had already had his children (and formerly, an ex-wife), on his family policy.

Enter the federal Defense of Marriage Act (“DOMA”).

Under DOMA, the federal government agencies are prohibited from recognizing the validity of same-sex unions of any kind, even when they are authorized under state law. This is a significant change to federal-state relationships, since Family Law issues have always been decided at the state level. As a result, in Rhode Island, Alabama, and Alaska first cousins may legally marry, while in Louisiana, New Hampshire, and Pennsylvania such marriages are illegal. The Federal government dos not take a stand on this issue: they accept first-cousin marriages from Alaska as legal, but would reject the validity of first-cousin marriages illegally performed in Pennsylvania. In other words, the federal government normally accepts the states’ definition of marriage as authoritative in the matter of marriage.

Under DOMA, however, the federal government will not consider a same-sex marriage, validly performed under state law, as a valid marriage under federal law. And that has serious federal income tax implications.

When Robert added Carl, his lawful spouse, to his family health insurance, his HR office informed him that since Carl was not a spouse under federal law, Robert would have to pay taxes on “imputed income” to Carl. “Imputed Income is the addition of the value of cash/non-cash compensation to an employees’ taxable wages,” and both federal income taxes and FICA (Social Security) taxes are assessed against the value of this imputed income.

Robert was shocked when he saw his next paycheck. In order to cover the imputed value of providing health insurance to his spouse – an action that is never applied to an opposite-sex spouse – his employer had withheld an additional $450/month from his paycheck.

As a middle-class income-earner, the loss of an additional $5,400 annually was too much to absorb. Robert removed Carl from his health insurance policy, and Carl applied for – and received – HIV coverage under the Ryan White Act.

The sad reality is that without DOMA, Carl could have been added to a private insurance policy just as any other spouse could be, without the punishing effect of federal taxes associated with imputed income.

Because of DOMA, American taxpayers will now pay a minimum of $36,000 annually for Carl. And this is just a single instance of a pattern that is replicated across the nation.

There are over 1.1 million HIV positive Americans. 30% receive assistance through the Two Billion dollar plus Ryan White Care Act. Close to half might currently or eventually be eligible for private insurance coverage through spouses, civil unions, domestic partnership arrangements, or company policies.

Fiscal Conservatives, take note: one of the single most significant actions you could take to reduce spending and taxpayer burden, while improving health care provisions for hundreds of thousands of Americans, is to repeal the provision of DOMA that prohibits federal recognition of valid state marriages.

The only real question is whether you believe that punishing homosexual couples is a more important public policy goal.

*Robert and Carl are not their real names, but they are real people and the dollar figures and story are entirely accurate.
--------------------------

SOURCES:

CDC 'HIV Prevalence Estimates -- United States, 2006' MMWR 57(39), 3 October 2008
http://health.msn.com/health-topics/articlepage.aspx?cp-documentid=100057404
http://aids.about.com/od/hivmedicationfactsheets/a/drugcost.htm
AIDS Drug Assistance Programs (ADAPs) - Henry J. Kaiser Family Foundation Fact Sheet
U.S. Census Bureau. “County Business Patterns: 2000.”
Human Rights Campaign, “State of the Workplace: 2006.”
http://www.haasjr.org/index.php
http://definitions.uslegal.com/i/imputed-income/