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Precum infectivity when on treatment
Jan 14, 2010

I'm on treatment for a year now and since I and my girlfriend don't like condoms we asked my doctor if we could make unprotected sex sometimes since my viral load is undetectable. My doc recommended to minimize the unsafe sex and to not come inside my girlfriend since sperm could carry a high quantity of virus. He said that precum even if not undetectable has a low viral load which should be even lower when on treatment decreasing very much the chances of transmission and to a negligible level. I was reading your last responses and it seems that you're not convinced of the risk acceptance when on treatment. There are many experts here in Europe who seems quite relaxed about the fact that HAART has proven to be very effective even as prevention tool. So who's right? American and European opinions seems conflicting on this point.

Response from Dr. Frascino

Hi,

Actually, I don't think opinions on this topic really differ all that much anywhere in the world. We all agree that effective combination antiretroviral therapy that drives the HIV plasma viral load to undetectable levels for a considerable period of time significantly decreases the HIV-transmission risk (thereby making it a preventive tool). However, nearly everyone also agrees that the transmission risk, while significantly reduced, is not completely eliminated. Consequently, safer sex practices (condoms) remain an imperative, in my opinion. The ultimate decision on how much risk you and your girlfriend are willing to accept is between the two of you. Personally I could never put the person I love most on this planet in jeopardy of contracting this scourge. (See below for additional information.)

Dr. Bob

Your position on treatment as prevention is not correct (SWISS REPORT, 2010) Jan 14, 2010

Several times you claim that effective treatment decreases the risk but does not eliminate it. Well I guess it's more an assumption than a certainty. I don't know any study which strictly confirms what you're saying. Instead there's a study ongoing which should give an answer to this question. In the meantime telling that treatment does not eliminate the risk for transmission is wrong since we still don't know it precisely. It would be more correct to say that until the trial is completed and the results confirms that HAART is able in reducing to a negligible level or even eliminate the risk, traditional safe sex methods are still recommended.

Response from Dr. Frascino

Hello,

Sorry, I disagree. We have documented cases of mother-to-child transmission, despite the mother having an undetectable viral load. There are also case reports of male-to-female transmission via unprotected vaginal sex, despite the male having an undetectable viral load. How often this happens we don't know, but we do know it occurs. Until we know more, the only logical advice is to continue using condoms for all penetrative sex. (See below.) Stay tuned. We'll keep you posted as this story evolves.

Dr. Bob

The real meaning of undetectable (UNDETECTABLE VIRAL LOAD, 2010) Jan 9, 2010

Hi Dr.

Hope you had an excellent 2009 and I pray for you that 2010 will be full of good health. Hope you can answer my question. Does undetectable Viral Load & VL <20cp/ml refers to the same thing? What is the difference? If there is no difference, then why the same lab is reporting the result in two different ways? Thank you so much for your kindness.

Response from Dr. Frascino

Hi,

Undetectable means the HIV plasma viral load is below the lower limit of detection for the particular test assay that is being used. Early viral load tests could only test down to 10,000 copies. Newer tests were able to test down to 500 copies of the virus per milliliter of plasma. The even newer ultrasensitive viral load assays can test all the way down to 25 or 50 copies/ml. We now have ultra-ultrasensitive assays available in some research laboratories that can test down to a single copy per ml! However, even in HIV-positive patients with HIV plasma viral loads below 1 copy/ml, this does not mean they have zero virus in their body. HIV still exists inside cells in the blood, lymph nodes and other body compartments.

In your case, "undetectable" and VL < 20 cp/ml (viral load less than 20 copies per ml) means you have an "undetectable" HIV plasma viral load and the lower limit of detection for the assay used was 20 copies per milliliter. Your blood has fewer copies than the lowest number detected by this test. So it's less than 20 copies per milliliter. I hope that helps clear up any confusion.

While we are on the topic of "undetectable" viral loads, I should take the opportunity to clear up common misunderstandings about this terminology:

1. Undetectable does not mean cured! There is no cure for HIV/AIDS (yet).

2. Undetectable does not mean noninfectious (that you cannot transmit the virus to others)! We have cases documenting HIV transmission from a man with an undetectable viral load to his HIV-negative wife via unprotected vaginal sex. There are also cases of mother-to-child transmission, despite the mother having an undetectable viral load.

3. Undetectable does not mean the virus cannot be detected anywhere in the body. Despite having an undetectable viral load in the blood (plasma), the virus would still be readily detectable in other tissues and body compartments.

4. Effective combination antiretroviral therapy does not kill the virus! Rather it merely suppresses viral replication. Consequently, if someone with an undetectable viral load on combination antiretroviral therapy stops taking his drugs, the virus will soon start reproducing again and the viral load will skyrocket to levels near to where the viral load was before treatment was begun.

Be well. Stay well. Happy 2010!

Dr. Bob

Straight & Final Question + Donation Info Jan 5, 2010

Hi Bob,

Thank you for your response to 'STRAIGHT QUESTION (TRANSMISSION VIA ORAL SEX 2010) One last and important question: should the Swiss study consensus that those on HAART are effectively non-infectious be ignored? Further to your mail, it seems so - given the problem other STD's, broken membranes & so on ( I mean you can't really ask a potential sexual partner if they have just eaten a bag of crisps - chips as you say there) Also I've read that even though plasma is 'viral free', seminal fluid still contains the virus to some degree. So maybe the old Swiss should be a bit more mindful about how non-medical people interpret such statements.

How to I donate - you are a star and provide light where there is darkness ( a bit biblical but true)

Thanks

A 'less confused' London Boy

Response from Dr. Frascino

Hello Less Confused London Boy,

The Swiss Report actually did not state that those on HAART are effectively non-infectious! That's an incorrect interpretation of the data they presented and does not accurately characterize their conclusions. Read through my comments on the Swiss Report in the archives of this forum (I'll repost a sample below) for a better understanding of the report and what it means.

Donation information for The Robert James Frascino AIDS Foundation can be found on the foundation's Web site at (www.concertedeffort.org). I'm delighted you have found this forum "enlightening!"

Happy 2010! Be well.

Dr. Bob

PROJECT INFORM: HIV Sexual Transmission Under HAART: Project Inform Comments on the 2008 Swiss Report By Alan McCord and Paul Dalton

August 3, 2008

In January 2008, the Swiss AIDS Commission issued a controversial report on the transmission of HIV in heterosexual mixed status couples. The report stated that HIV is not likely to be passed on when the positive partner fully adhered to a potent HIV regimen, had undetectable viral load for at least six months, and did not have any other sexually transmitted infection (STI) during that time, even despite sex without condoms.

What ensued after its publication has been tumultuous community discourse and opinion pieces worldwide. Some have denounced the Swiss government as being irresponsible. Others responded with "no comment". Few others, like Project Inform, invited this as a way to discuss issues faced by people living with and affected by HIV.

At the 2008 International AIDS Conference in Mexico City, a Sunday afternoon session, HIV Transmission under ART, provided a forum to discuss this report. Seven panelists attempted to clarify the persistent questions that have lingered ever since. Project Inform attended this session of about 300, which expands our earlier coverage of this topic.

The outcry over the Swiss report stems from the perception that they were saying that people who take effective HIV drugs can stop having safer sex or abandon their condom use without infecting their partners. The panelists were clear: this is not their message. Some have criticized other aspects of the report, arguing it failed to address other important issues, such men who have sex with men.

The possible implications for others living with HIV are about as diverse as the outcry has been. Project Inform believes the report and the conversations it has spurred can help inform these discussions for a wide range of people living with HIV. The main issues brought up by the Swiss Report are broadly outlined below.

Provide Accurate Information

The report provides a good deal of applicable data, much buried beneath the vocal backlash. Physicians, community health professionals, and others who interact with HIV-positive people and their partners can and must provide information clearly and accurately. The basic model of fully informed decision-making that has defined Project Inform's approach to HIV treatment decisions is just as applicable to this situation.

Use This as a Tool

We should encourage sophisticated discussions of the issues facing mixed status couples. After nearly three decades of the epidemic, a great deal is known about how HIV is and is not passed. Each partner, along with their doctors, can be encouraged to discuss these issues. These data, when discussed alongside a person's needs for true sexual intimacy, can lead to fuller and more honest discussions between sexual partners.

There's a great degree of disagreement over the effect this report might have on sexual practices and condom use. Lacking any real world data, people are left mostly to conjecture. One of the panelists shared findings from an anonymous survey he helped administer to people with HIV. He stated the report was widely well received by people with HIV, and did not have a marked influence on sexual practices. Interestingly, many did report feeling more able to honestly discuss their sexual practices with their doctors after the report.

Some of the panelists feared the Swiss report would lead to less condom use. One audience member asserted his belief that the report said that condom use was not needed when people were on suppressive HAART. Others felt that the report was likely to increase adherence to both treatment and safer sex practices.

Get Regular Health Care

One undeniable take-home message from the Swiss report is the critical importance of having accurate medical information to make informed decisions. Vast inequalities in access to things like viral load tests and STI screening must be accounted for in settings worldwide.

Some panelists felt that these differences render the report largely meaningless to most people with HIV. Project Inform sees it differently. It is much like the early data on combination therapy: information that might have only applied to small numbers of people at that time can have profound implications for far more people down the line. As seasoned AIDS activist Heidi Nass puts it, 'progress in progress.'

Push This Discussion to Test for HIV

The report underscores the need to reach those who are undiagnosed or untested. These discussions can only work when people know their HIV status. Most estimates in the US find that around 1 in 4 people with HIV do not know they have HIV. Project Inform encourages testing as a way to take control of one's life.

Explore New Ways to Prevent HIV

The report highlights the role that effective treatment plays in preventing new infections. Project Inform recently revised its mission statement to include biomedical prevention methods to help reduce new infections. This includes interventions such as Pre-Exposure Prophylaxis (PrEP), vaginal and rectal microbicides, and male circumcision, among others. These alternate prevention methods should be considered as being additive and synergistic to behavior interventions such as condom use. Therefore, no one method should preclude the others. The more choices one has, the better. The better the data are, the more confidence people can have in their choices.

One of the stories leading in to this meeting was the CDC's announcement that the number of new HIV infections in the US was 40% higher than previously estimated. This disturbing statistic highlights the crucial need for new prevention methods. The Swiss statement has the potential to help, as it underscores the connection between effective treatment and prevention.

Understand the Limitations of the Report

In some parts of the world, it's a privilege to have access to the spectrum of health care that's necessary to fully inform these decisions. For most people, this just isn't possible. Some health care systems are overburdened and cannot accommodate the discussions. For many, viral load or STI tests are just not available. For others, medical infrastructures barely exist. Though the world has reacted to this report, it may very well not apply to most of the planet.

Another obvious weakness of the report is that the authors only had data from studies of heterosexual sex to guide them. In the US, the CDC estimates that just over half of new HIV infections are among men who have sex with men, reinforcing the importance of studying the impact of treatment on prevention among this group.

Adapt the Limitations of the Report

Too often critics of the Swiss report have used its limitations to dismiss the report entirely. This is both scientifically and ethically unsound. No study, or review of studies, is above critique. Science works best when studies and reports are examined honestly, taking into account both their strengths and weaknesses.

Some have said it's premature to talk about these kinds of data until such time that there are more mature and definitive results. One panelist reminded the audience of the experience of male circumcision where 17 years elapsed between the emergence of supportive circumstantial evidence of its role in reducing HIV infection rates, and the definitive results from prospective, randomized studies.

Although the medical resources may not be available to most who face these issues, it is still possible to encourage conversations with couples on issues that they can do something about. This includes encouraging each partner to disclose his/her status, to discuss their fears, or to even start engaging in safer sex, among many others.

Practice Safer Sex

The Swiss report does not suggest individuals abandon using condoms or other safer sex practices. In fact, it spotlights the necessity for a couple's continued diligence in this area. One panelist argued that condom use without treatment provides similar levels of protection as treatment without condoms. It is common and fairly uncontroversial to recommend that people with HIV use condoms regardless of whether they're on treatment. The report argues that the best possible prevention comes from combining treatment and condoms. Accurate information on transmission risk should drive these decisions.

Understand This Report in Its Context

At various points throughout this epidemic, many medical, social and behavioral issues have emerged. We have grappled with the risk of casual transmission and the risk of oral sex -- each without the benefit of definitive research. In these cases, observations and an understanding of the mechanics of HIV transmission helped mold recommendations that have stood the test of time.

What now is taking place is a study called HPTN 052 is currently enrolling and is designed to answer the risks of transmission under HAART. The results likely won't be available until 2016, at which point we may look back and wonder what the commotion was all about. We also might ask ourselves, as many have in light of the male circumcision saga, how many new infections could have been prevented in the meantime?

Raise New Research Questions

Much new data need to be uncovered to more fully answer the concerns raised by the community. How do STIs play a role in transmission and at what level? Do different strains of HIV affect its transmission? Do different classes of HIV drugs affect the levels of HIV in genital tract secretions differently? How do viral load blips affect the likelihood of transmission? How much do we know about HIV transmission through oral, vaginal or anal sex? Pursuing these and other questions are critical to help better inform those faced with these decisions.

The Asymmetry of Risk

One interesting point raised by a panelist was the asymmetry of risk. If you say something is dangerous, and it turns out not to be so, there's usually little consequence. However, if you claim something is not risky and it turns out to cause harm, the repercussions can be catastrophic. This can lead groups to be overly conservative in protecting their own interests. Looked at in this light, the Swiss statement is remarkable.

Also worth pointing out is how little attention has been paid to issues of pleasure, intimacy and stigma facing people with HIV throughout these public debates. While researchers might not place much emphasis on these issues, they're of great importance to people living with HIV. They have profound implications for their day-to-day lives, not to mention their emotional and sexual well being. A full discussion of treatment and prevention must take these issues into account, or risk being of little use to people living with HIV.

Project Inform encourages sophisticated conversations among mixed status couples and others. As we have stated in our March 2008 response to the Swiss Report, we encourage all sexually active individuals to learn their status by regularly testing for HIV; we encourage treating HIV as early as individuals are ready to start and the medical information suggests; we encourage adhering to HIV treatment while practicing safer sex; and we encourage the honest conversations between partners and their providers on the medical and behavioral issues of transmission.

PROJECT INFORM POSITION PAPER

Statement Regarding Findings of the Swiss Government on the Transmissibility of HIV Infection by HIV-Positive People Receiving Antiretroviral Treatment March 12, 2008

In February 2008, the Swiss AIDS Commission reported on the results of studies suggesting that HIV positive individuals receiving effective antiretroviral treatment do not appear to be at significant risk of transmitting the virus to their HIV-negative partners in the absence of condom use during sex. The Swiss report reviewed data from four studies conducted among heterosexual couples. One study involving 393 couples of mixed HIV status concluded that when an HIV-positive individual adhered to treatment with approved HIV antiretrovirals, had an undetectable viral load for at least six months, and did not suffer from any other sexually transmitted infections, the HIV-negative partner did not become infected as a result of unprotected sexual intercourse. However, another study found that 6 out of 43 HIV-negative partners did become infected with HIV as a result of sexual activity; apparently because their HIV-positive partners were not completely adherent to an antiretroviral treatment regimen.

Concern has been raised that the results of the Swiss report will be taken to mean that HIV-positive people receiving antiretroviral therapy can discontinue the practice of safe sex or condom use. Project Inform welcomes the opportunity presented by the report to talk with the community about the interrelatedness of HIV testing, treatment for HIV infection and the prevention of HIV transmission.

The Swiss report supports what have long been considered to be the dual benefits of antiretroviral treatment. First, effective therapy is likely to significantly increase longevity and quality of life for people living with HIV. Second, by reducing the amount of virus present in blood, semen, vaginal secretions and other sexual fluids, antiretroviral therapy helps to reduce the potential for HIV-positive individuals to transmit HIV to their partners during sexual intercourse.

Advertisement Project Inform does not encourage HIV-positive people receiving treatment for their infection to dispense with safe sex or condom use. Drawing on the Swiss report and other data: We encourage all individuals who have been sexually active within the past ten years to learn their HIV status if they have not already done so, and to be tested for HIV at least once a year if they continue to be sexually active. Knowing one's HIV status is the vital first step we must all take to preserve our own health and, if HIV-positive, fulfill our desire to avoid transmitting the virus to others. We encourage all people who know that they are HIV-positive to consult with qualified medical providers and our National HIV/AIDS Treatment Hotline in order to make well-informed decisions about when to enter treatment with HIV antiretrovirals. While current Federal guidelines strongly encourage treatment for HIV-positive people whose CD4 (T cell) counts are at or below 350, substantial evidence suggests that the earlier HIV-positive people enter treatment, the better the outcomes of their treatment may be. And as the Swiss report suggests, being adherent to effective HIV treatment can reduce the transmission of HIV to others.

We encourage HIV-positive people, whether receiving treatment or not, to continue to engage in safe sex and condom use with HIV-negative individuals and individuals of unknown HIV status. Neither HIV treatment or safe sex practices alone have been shown to be 100% effective in preventing the transmission of HIV infection. But in combination with one another, the two strategies provide a strong means of preventing the further spread of HIV in our communities.

Finally, data indicate that it is possible for HIV-positive people to be re-infected with HIV as a result of having sex with one another. Data are inconclusive, however, about the extent to which re-infection actually occurs. Project Inform encourages HIV-positive people to consider the use of condoms during intercourse with other HIV-positive people in order to avoid potential re-infection and, as importantly, to avoid receiving or transmitting sexually transmitted infections other than HIV during sexual intercourse.

(SUPERINFECTION, 2009) (SUPERINFECTION DEBATE 2009) Apr 9, 2009

i can hardly believe how blatantly you spin the facts, Dr. You say a person with undetectable viral load 'conclusively' has been proven to be able to pass that virus onto others. Then you tell the reader to "(read below)". The article below also says "(read below)", and the next and the next, and finally, if the reader has enough diligence to finally find your cite, they find discover the article about the German study of a single case, where the strains aren't even identical, and that they admit they are relying on the patient's word of fidelity, which they admit if iffy at best. And in the same article, is the Swiss study which has a completely different conclusion on the topic. this is your idea of 'conclusivity'? When you take such a hardline approach, it really weakens the credibility. i don't care if you print this or not.. i'm posting it in the forums.

Response from Dr. Frascino

Hello,

Relax Max and take a hard look at the facts! As you will note in my response to which you took such umbrage, I posted the entire article by Michael Carter related to the findings suggesting HIV can be transmitted from MSM with undetectable viral loads. It included the criticism of the report. That way the readers can draw their own conclusions. I found the phylogenetic analysis compelling. The viral strains "suggested a close relationship between the virus in the patient and his partner." I agree with the authors of this report who suggest that HIV transmission can occur despite an undetectable HIV plasma viral load. Yes, as with many case report studies there are some weaknesses that can be pointed out. However, there are glaring weaknesses within the Swiss report as well. (I've discussed these at length in the archives. Have a look!)

It's important to note that additional studies have now concluded that there can be a detectable HIV viral load in semen even when the HIV plasma viral load is undetectable! This could explain a mechanism for transmission.

All major AIDS agencies and the scientific community have concluded that the Swiss study suggests that in heterosexual partnerships the risk of HIV transmission is low in the presence of effective combination antiretroviral therapy. However, the risk is not zero! (Note the Swiss study did not study MSM! A major "weakness.")

There are a number of potential problems and unseen risks if an individual where to decide his partner's undetectable status was sufficient to prevent HIV infection. Drug resistance could develop causing a spike in viral load without the patient or partner knowing. Nonadherence to the drug regimen could cause a transient increase as well. A concurrent STD in the patient can increase HIV viral load in a patient who was previously undetectable. Conversely an STD in the partner could potentially make him or her substantially more susceptible to contracting the virus.

Adding all these facts together, I feel the evidence is quite convincing that unprotected sex cannot be considered safe even if the partner claims to be "undetectable". The case report merely adds more weight to my assessment. OK?

As a prevention strategy for individuals the use of combination antiretroviral therapy (cART) alone cannot be recommended or considered effective. However, as a population strategy effective cART has real synergies with condom use in reducing HIV transmission.

Public health projection models indicate that if individuals relied only on "undetectable viral load" for HIV prevention and this resulted in reduced condom use, there would potentially be a substantial increase in HIV incidence. To sum up, the balance of scientific evidence continues to show that undetectable viral load in the blood does not equal zero risk for HIV transmission.

As always the choice to be safe or sorry remains yours.

Dr. Bob



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