"Undetectable" "PrEP" and new realities.

PrEP has become widely available in the US, and the reality that an “undetectable” viral load means that the person with HIV is unlikely to transmit HIV seems to be widely understood.  How what choices does an HIV negative person have to remain negative?   How can a positive guy integrate this into having responsible sex?

“Pre-exposure prophylaxis” means that an HIV-negative person takes Truvada to prevent infection.   PrEP is highly effective against HIV.  It offers no protection at all against other STDs, including Hepatitis C, syphilis,  gonorrhea, etc, and condoms do offer some protection against these.   Still, if a guy finds that he’s not using condoms consistently in high-risk situations, or even if he wants to be condom-free once in a while, it is a viable option. 

The downside of Truvada protection is that it is a medication that has side effects. Anyone taking it for long periods should be checked out, There have been reported cases already of men using PrEP getting hepatitis C, so it isn’t really a license just to let yourself go in all situations.   

What does “undetectable”  really mean?   In one study, the risk is statistically close to zero, and this is great news.   There are a couple of caveats, though.

In studies, patients are constantly reminded of safe sex practices.  Study populations are probably less likely to transmit HIV in the first place.  In this setting patients are carefully monitored for STDs, which might not be the case in the real world.   Real-world settings are probably less safe.

More importantly, ALL of the studies (and even the “Swiss Non-Study”) the majority of study subjects have been straight.  Even in PARTNERS, 60% of study subjects were straight, meaning much less (almost no) anal intercourse.    As anal sex is about 20 times more likely to transmit HIV than vaginal sex, it’s easy to make a case that we actually do not know the risks of unprotected anal sex when a positive partner has an undetectable viral load.   Is it lower?  I think we have to assume it is much lower, but not zero.

If you are a negative man, take charge of your health by reducing your risk of HIV infection by using condoms, PrEP, reducing numbers of partners, etc.   In the settings of hookups, baths, random encounters, I would never trust my health to someone saying “I’m negative,” or “I’m undetectable.”  In an encounter with a guy you know to be positive, I think you can be comfortable knowing that if he is undetectable, that it’s safer to be with him than with a person of unknown status, and in the setting of a relationship, unprotected sex may be negotiable, according to your own comfort level, but it the two of you seem to be at risk for other STDs, I’d make that decision very carefully…..

For Poz guys?.   You can know that you are far less likely to transmit HIV than before, and this is great.   I think that you should still disclose your status (perhaps mostly to scare away the idiots that don’t understand reality), and you need to protect yourself from other STDs, and Hepatitis C.  I do worry that with ever decreasing use of condoms, the setting is perfect for big increases in Hep C transmission.

So, it’s all better, but the song remains the same.   Protect yourself and others, and the best protection is still openly and intelligently discuss HIV status.

Hey, I haven't posted for a while, and the world has changed since 2014 with widespread availability of PrEP in the USA, and increasing understanding that when you reduce the viral load to "undetectable," the odds of infection with HIV are greatly decreased.

Still, some things have not changed, and I wanted to display this UNAIDS document about the continuing importance of condoms in controlling the world HIV epidemic:

Condoms are a critical component in a comprehensive and sustainable approach to the prevention of HIV and other sexually transmitted infections (STIs) and are effective for preventing unintended pregnancies. In 2013, an estimated 2.1 million people became newly infected with HIV^[i] and an estimated 500 million people acquired chlamydia, gonorrhoea, syphilis or trichomoniasis.^[ii] In addition, every year more than 200 million women have unmet needs for contraception,^[iii] leading to approximately 80 million unintended pregnancies.^[iv] These three public health priorities require a decisive response using all available tools, with condoms playing a central role.

Male and female condoms are the only devices that both reduce the transmission of HIV and other sexually transmitted infections (STIs) and prevent unintended pregnancy.

Laboratory studies show that condoms provide an impermeable barrier to particles the size of sperm and STI pathogens, including HIV.^[v] [vi] Condoms, when used consistently and correctly, are highly effective in preventing the sexual transmission of HIV. Research among serodiscordant couples (where one partner is living with HIV and the other is not) shows that consistent condom use significantly reduces the risk of HIV transmission both from men to women and women to men^{[vii] [viii] [ix]} Consistent and correct use of condoms also reduces the risk of acquiring other STIs and associated conditions, including genital warts and cervical cancer.^[x] With a failure rate of about 2% when used consistently and correctly, condoms are very effective at preventing unintended pregnancy.^[xi] [xii]

Condoms have played a decisive role in HIV, STI and pregnancy prevention efforts in many countries.

Condoms have helped to reduce HIV transmission and curtailed the broader spread of HIV in settings where the epidemic is concentrated in specific populations.^[xiii] Distribution of condoms has been shown to reduce rates of HIV and other STIs in sex workers^{[xiv] [xv] [xvi]} and men who have sex with men.^[xvii] In India^{[xviii] [xix]} and Thailand^[xx]increased condom distribution to sex workers and their clients in combination with other prevention interventions were associated with reductions of transmission of both HIV and other STIs. Zimbabwe^[xxi] and South Africa are two high-prevalence countries where increased condom use was found to contribute to reductions in HIV incidence.^[xxii]

A recent global modelling analysis estimated that condoms have averted around 50 million new HIV infections since the onset of the HIV epidemic.^[xxiii] For 2015, 27 billion condoms expected to be available globally through the private and public sector will provide up to an estimated 225 million couple years protection from unintended pregnancies.^{[xxiv] [xxv]}

Condoms remain a key component of high-impact HIV prevention programmes.

Recent years have seen major scientific advances in other areas of HIV prevention. Biomedical interventions including antiretroviral therapy (ART) for people living with HIV can substantially reduce HIV transmission. While the success of ART may alter the perception of risk associated with HIV, studies have shown that people living with HIV who are enrolled in treatment programmes and have access to condoms report higher condom use compared to those not enrolled.^[xxvi]

Condom use by people on HIV treatment and among serodiscordant couples is strongly recommended. ^[xxvii] Only when sustained viral suppression is confirmed and very closely monitored, and when the risk of other STIs and unintended pregnancy is low, it may be safe not to use condoms.^{[xxviii] [xxix] [xxx]}

Oral pre-exposure prophylaxis (PrEP)—where antiretroviral drugs are used by HIV-negative people to reduce their risk of acquiring HIV—is also effective in preventing HIV acquisition, but is not yet widely available and is currently only recommended as an additional tool for people at higher risk, such as people in sero-discordant relationships, men who have sex with men and female sex workers, in particular in circumstances in which consistent condom use is difficult to achieve.^[xxxi] Voluntary medical male circumcision (VMMC) can reduce the risk of HIV acquisition by 60% among men, but because protection is only partial, should be supplemented with condom use. ^[xxxii]

Hence, condom use remains complementary to all other HIV prevention methods, including ART and PrEP, in particular when other STIs and unintended pregnancy are of concern. The roll-out of large-scale HIV testing and treatment, VMMC and STI control programmes, and efforts to increase access to affordable contraception all offer opportunities for integrating condom promotion and distribution.

Quality-assured condoms must be readily available universally, either free or at low cost.

To ensure safety, efficacy and effective use, condoms must be manufactured according to the international standards, specifications and quality assurance procedures established by WHO, UNFPA and the International Organization for Standardization^{[xxxiii] [xxxiv]} and made available either free or at affordable cost. Condom use in resource-limited settings is more likely when people can access them at no cost or at subsidized prices.^{[xxxv] [xxxvi]}

Most countries with high HIV rates continue to heavily depend on donor support for condoms. In 2013, only about 10 condoms were made available to every man aged 15-64, and on average only one female condom per eight women in sub- Saharan Africa. HIV prevention programmes need to ensure that a sufficient number and variety of quality assured condoms are accessible to people who need them, when they need them. Adequate supplies of water based-lubricants also need to be provided to minimize condom usage failure, especially for anal sex, vaginal dryness and in the context of sex work.^[xxxvii]

Despite generally increasing trends in condom use over the past two decades, substantial variations and gaps remain. Reported condom use at last sex with non-regular partners ranges from 80% use by men in Namibia and Cambodia to less than 40% usage by men and women in other countries, including some highly affected by HIV. Similarly, among young people aged 15 to 24 years, condom use at last sex varies from more than 80% in some Latin American and European countries to less than 30% in some West African countries.^[xxxviii] This degree of variation highlights the need for countries to set ambitious national and subnational targets and that in many settings there are important opportunities for strengthening demand and supply of condoms.

Programmes promoting condoms must address stigma and gender-based and socio-cultural factors that hinder effective access and use of condoms. 

Effective condom promotion should be tailored for people at increased risk of HIV and other STIs and/or unintended pregnancy, including young people, sex workers and their clients, injecting drug users and men who have sex with men. Many young women and girls, especially those in long-term relationships and sex workers, do not have the power and agency to negotiate the use of condoms, as men are often resistant to using condoms. Within relationships, the use of condoms may be taken to signal a lack of trust or intimacy.

However, few programmes adequately address the barriers that hinder access and use of condoms by young people,^[xxxix] key populations^[xl] and men and women in relationships. In some contexts, sex workers are forced to have unprotected sex by their clients.^{[xli] [xlii]} and carrying condoms is criminalized and used as evidence by police to harass or to prove involvement in sex work^{[xliii] [xliv]} These practices undermine HIV prevention efforts and governments should take actions to end these human rights violations.^[xlv] Condom programmes should ensure that condoms and lubricants are widely available and that young people and key populations have the knowledge, skills and empowerment to use them correctly and consistently.^[xlvi] Condoms should also be made available in prisons and closed settings,^{[xlvii] [xlviii]} and in humanitarian crises situations.^[xlix]

Adequate investment in and further scale up of condom promotion is required to sustain responses to HIV, other STIs, and unintended pregnancy. 

Despite the low cost of condoms, international funding for condom procurement in sub-Saharan Africa has stagnated in recent years.^[l] Collective actions at all levels are needed to support the efforts of countries that depend on external assistance for condom procurement, promotion, and distribution and to increase domestic funding and private sector investment in condom distribution and promotion.^[li]

Although condoms are part of most national HIV, STI and reproductive health programmes, condoms have not been consistently distributed nor promoted proactively enough.^[lii] National condom distribution and sales can be strengthened by applying a total market approach that combines public sector distribution, social marketing and private sector sales.^{[liii] [liv]} Administrative barriers that prevent programmes and organizations from providing sufficient quantities of condoms for distribution need to be removed. In high-HIV prevalence locations condom promotion and distribution should become systematically integrated in community outreach and service delivery, and in broader health service provision.

---

^[i] UNAIDS. 2014. World AIDS Day Report 2014.

^[ii] WHO, Dept. of Reproductive Health and Research. Global incidence and prevalence of selected curable sexually transmitted infections.

^[iii] UNFPA/Guttmacher Institute. 2012. Adding It Up: Costs and Benefits of Contraceptive Services.

^[iv] Sedgh G et al. Intended and Unintended Pregnancies Worldwide in 2012 and Recent Trends. Studies in Family Planning, 2014, Vol 45. 3, 301–314, 2014.

^[v] Carey RF et al. Effectiveness of latex condoms as a barrier to human immunodeficiency virus-sized particles under conditions of simulated use. Sex Transm Dis 1992;19:230-4.

^[vi] WHO/UNAIDS. 2001. Information note on Effectiveness of Condoms in Preventing Sexually Transmitted Infections including HIV.

^[vii] Holmes K et al. Effectiveness of condoms in preventing sexually transmitted infections. Bulletin of the World Health Organization, 2004, 82 (6).

^[viii] Weller S et al. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane Database Syst Rev. 2002;(1):CD003255.

^[ix] Smith DK et al. Condom effectiveness for HIV prevention by consistency of use among men who have sex with men in the United States. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):337-44.

^[x] Also see: http://www.cdc.gov/condomeffectiveness/brief.html

^[xi] Trussell J. Contraceptive efficacy, in: Hatcher RA et al., eds., Contraceptive Technology: Twentieth Revised Edition, New York: Ardent Media, 2011, pp. 779–863.

^[xii] Kost K et al. Estimates of contraceptive failure from the 2002 National Survey of Family Growth. Contraception, 2008; 77:10-21.

^[xiii] Hanenberg RS et al. Impact of Thailand's HIV-control programme as indicated by the decline of sexually transmitted diseases. Lancet, 1994, 23;344(8917): 243-5.

^[xiv] Ghys PD et al. Increase in condom use and decline in HIV and sexually transmitted diseases among female sex workers in Abidjan, Cote d’Ivoire, 1991–1998. AIDS, 2002, 16(2):251–258.

^[xv] Levine WC et al. Decline in sexually transmitted disease prevalence in female Bolivian sex workers: impact of an HIV prevention project. AIDS, 1998, 12(14):1899–1906.

^[xvi] Fontanet AL et al. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS, 1998, 12(14):1851–1859.

^[xvii] Smith D et al. Condom efficacy by consistency of use among MSM: US. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, abstract 32, 2013.

^[xviii] Boily M-C et al. Positive impact of a large-scale HIV prevention programme among female sex workers and clients in South India. AIDS, 2013, 27:1449–1460.

^[xix] Rachakulla HK et al. Condom use and prevalence of syphilis and HIV among female sex workers in Andhra Pradesh, India - following a large-scale HIV prevention intervention. BMC Public Health, 2011; 11 (Suppl 6): S1.

^[xx] UNAIDS. 2000. Evaluation of the 100% Condom Programme in Thailand, UNAIDS Case Study.

^[xxi] Halperin DT et al. A surprising prevention success: Why did the HIV epidemic decline in Zimbabwe? PLoS Med. 2011. 8;8(2).

^[xxii] Johnson LF et al. 2012. The effect of changes in condom usage and antiretroviral treatment coverage on human immunodeficiency virus incidence in South Africa: a model-based analysis, Journal of the Royal Society Interface. 2012, 7;9(72):1544-54.

^[xxiii] Stover J. 2014. Presentation. UNAIDS Global Condom Meeting, Geneva, November 2014.

^[xxiv] In line with standard assumptions, 120 condoms are required for 1 couple year of protection. Projected condom sales for 2015 cited based on: Global Industry Analysts. 2014. Global Condoms Market. May 2014.

^[xxv] Stover J et al. Empirically based conversion factors for calculating couple-years of protection. Eval Rev. 2000 Feb; 24(1):3-46.

^[xxvi] Kennedy C et al.  Is use of antiretroviral treatment (ART) associated with decreased condom use? A meta-analysis of studies from low- and middle-income countries (LMICs). July 2014 h International AIDS Conference. Melbourne, WEAC0104 - Oral Abstract Session.

^[xxvii] Liu H et al. Effectiveness of ART and condom use for prevention of sexual HIV transmission in sero-discordant couples: a systematic review and meta-analysis. PLoS One. 2014 4;9(11):e111175.

^[xxviii] Swiss AIDS Federation Advice Manual: Doing without condoms during potent ART. Swiss AIDS Federation, 2008.

^[xxix] Fakoya A et al. British HIV Association, BASHH and FSRH guidelines for the management of the sexual and reproductive health of people living with HIV infection. HIV Medicine, 2008, 9: 681-720, 2008.

^[xxx] Marks G et al. Time above 1500 copies: a viral load measure for assessing transmission risk of HIV-positive patients in care. AIDS 2015, 29:947–954.

^[xxxi] WHO. 2015. Technical update on Pre-exposure Prophylaxis (PrEP), February 2015. WHO/HIV/2015.4.

^[xxxii] WHO. 2007. New Data on Male Circumcision and HIV Prevention: Policy and Programme Implications. WHO/UNAIDS Technical Consultation on Male Circumcision and HIV Prevention: Research Implications for Policy and Programming Montreux, 6 – 8 March 2007 Conclusions and Recommendations.

^[xxxiii] WHO, UNFPA and Family Health International. 2013.  Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 revised April 2013.

^[xxxiv] International Organisation for Standardisation. 2014. ISO 4074:2014 Natural rubber latex male condoms -- Requirements and test methods. http://www.iso.org/iso/catalogue_detail.htm?csnumber=59718.

^[xxxv] Charania MR et al. Efficacy of Structural-Level Condom Distribution Interventions: A Meta-Analysis of U.S. and International Studies, 1998–2007. AIDS Behav, 2011, 15:1283–1297.

^[xxxvi] Sweat MD et al. Effects of condom social marketing on condom use in developing countries: a systematic review and meta-analysis, 1990–2010. Bulletin of the World Health Organization 2012, 90:613- 622A. doi: 10.2471/BLT.11.094268.

^[xxxvii] Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA/FHI360 Advisory note. 2012.

^[xxxviii]Source: Data from a database of Demographic and Health Surveys (DHS) available at statcompiler.com (verified January 2015).

^[xxxix] Dusabe J, et al.  “There are bugs in condoms”: Tanzanian close-to-community providers’ ability to offer effective adolescent reproductive health services. J Fam Plann Reprod Health Care 2015;41:e2.

^[xl] Key populations are defined groups who, due to specific higher-risk behaviours, are at increased risk of HIV irrespective of the epidemic type or local context. Also, they often have legal and social issues related to their behaviours that increase their vulnerability to HIV. These guidelines focus on five key populations: 1) men who have sex with men, 2) people who inject drugs, 3) people in prisons and other closed settings, 4) sex workers and 5) transgender people. In consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. World Health Organization 2014.

^[xli] Global Commission on HIV and the Law. Risks, Rights & Health. 2012

^[xlii] UNAIDS. 2014. The Gap report.

^[xliii] Open Society Foundations. 2012. Criminalizing condoms. How policing practices put sex workers and HIV services at risk in Kenya, Namibia, Russia, South Africa, the United States and Zimbabwe. http://www.opensocietyfoundations.org/reports/criminalizing-condoms.

^[xliv] Bhattacharjya, M et al. The Right(s) Evidence – Sex Work, Violence and HIV in Asia: A Multi-Country Qualitative Study. Bangkok: UNFPA, UNDP and APNSW (CASAM). 2015.

^[xlv] WHO; UNFPA; UNAIDS; NSWP; World Bank. 2013. Implementing comprehensive HIV/STI programmes with sex workers: practical approaches from collaborative intervention. 2013.

^[xlvi] Vijayakumar G et al. A review of female-condom effectiveness: Patterns of use and impact on protected sex acts and STI incidence. International Journal of STD and AIDS, 2006, 17(10):652-659.

^[xlvii] UNODC/WHO/UNAIDS. 2006. HIV/AIDS Prevention, Care, Treatment and Support in Prison Settings A Framework for an Effective National Response.

^[xlviii] UNODC/ILO/UNDP/WHO/UNAIDS. 2012. Policy brief. HIV prevention, treatment and care in prisons and other closed settings: A comprehensive package of interventions.

^[xlix] Inter-Agency Standing Committee (IASC). 2003. Guidelines for HIV/AIDS interventions in emergency settings. Task Force on HIV/AIDS in Emergency Settings.

^[l] UNFPA. 2015. Contraceptives and condoms for family planning and STI/HIV prevention. External procurement support report 2013.

^[li] Foss AM et al. A systematic review of published evidence on intervention impact on condom use in sub-Saharan Africa and Asia. Sex Transm Infect 2007, 83:510–516.

^[lii] Fossgard IS et al. Condom availability in high risk places and condom use: a study at district level in Kenya, Tanzania and Zambia. BMC Public Health 2012, 12:1030.

^[liii] UNFPA-PSI.  2013. Total Market Approach Case Studies Botswana, Lesotho, Mali, South Africa, Swaziland, Uganda. http://www.unfpa.org/publications/unfpa-psi-total-market-approach-case-studies

^[liv] Barnes, J et al. 2015. Using Total Market Approaches in Condom Programs. Bethesda, MD: Strengthening Health Outcomes through the Private Sector Project, Abt Associates.

The PARTNERS Study. Throw condoms away?

There has been a lot of talk about the PARNTERS Study, which looked at a large number of couples, gay and straight, for several years.    There is some very encouraging news about prevention!   No cases were found in this study where a straight partner seroconverted, and no gay partners seroconverted from their regular partner.   This is great news.


Still, a couple of precautions:

There were new HIV infections in gay men in this study, but all were found to have been the result of sex outside of the primary relationship.     

If the positive partner had a virological failure during the trial, which did happen, that couple was excluded from the analysis.   

Statistically, you can't say this is "zero" transmissions.     The study isn't over, and what can be said so far is that the rate for gay men could be as low as zero, or as high as 4%.  Without drowning in statistics, let me quote another writer:

"A non-technical explanation of these risks, based on the PARTNER results so far, is that the risk of transmission occurring for one couple over ten years (based on having sex 45 times a year) could be as high as 4% for the average participant, and that the risk from anal sex could be as high as 9%. For receptive anal sex this reaches 32% risk over ten years. There is also a 2.5% chance that these risks could be higher."

This is good news, but it does not mean everyone can go to the bathhouses and not care.

1.  Everyone with HIV is not on HAART with undetectable viral loads.  In fact, only about 1/3 of patients are on meds and undetectable.

2.  The most infectious are the newly infected, who don't know their results, still

So, the study documents what we already know:  HIV treatment really does dramatically reduce infections.   How should we apply this to our lives?

After a discussion of status, two adults may decide how best to protect a negative partner from a new HIV infection

In any encounter, someone who wants to remain HIV negative should assume, always, that the person they are going to have sex with is HIV positive and not on treatment until proven otherwise.

What does this change? 

The following link is a good review of the study, and some discussion 


http://i-base.info/htb/24723

Another post about transmission of HIV by people with maximally supressed viral loads.

http://www.cdc.gov/hiv/prevention/resear ch/art/

What is the Risk of Sexual HIV Transmission for HIV-infected Persons With Undetectable Viral Load?

ART is considered effective when it consistently suppresses plasma viral load to undetectable levels. However, sexual transmission of HIV from an infected partner who was on ART with a repeatedly undetectable plasma viral load has been documented.8 An infected partner's genital (seminal or vaginal) fluid viral load may play a greater role than plasma viral load when evaluating the risk of sexual transmission of HIV. The likelihood of HIV transmission in the setting of ART is influenced by a number of factors, several of which are described below.
The Meaning of “Undetectable” Viral Load: Persistence of Virus in Plasma and Seminal Fluid
Periodic blood plasma viral load monitoring is used to measure ART effectiveness. The goal of effective ART is the long-term suppression of plasma viral load, usually defined as the maintenance of a level of HIV virus that is below the threshold detectable by available tests. While plasma viral load tests are reliable, they have limitations: virus levels below a minimum concentration may not be detected. Studies have shown that persistent virus is found in peripheral blood mononuclear cells9, 10 even when individuals have sustained undetectable plasma viral load levels.

Genital fluid viral loads are not routinely measured in persons on ART. Although ART reduces concentration of virus in seminal fluid,11 virus persists within cells present in seminal fluid of some men who are on ART with undetectable plasma viral load.12-13 ART also is associated with decrease in cervicovaginal fluid viral load; however, ‘breakthrough' shedding has been observed in some studies.14-17 Therefore, the potential for transmission exists despite sustaining undetectable viral load while on effective ART.

Transient Increases (“Blips”) in Viral Load

Several studies have observed that individuals on effective ART who achieve long-term suppression of viral load to undetectable levels may exhibit periodic temporary increases in plasma viral load (blips). These are generally small increases ( between approximately 50 and 1000 copies/mL), and are estimated to last for short periods (<3 and="" are="" be="" because="" blips.="" conceivable="" correlate="" currently="" data="" enhanced="" fluid="" genital="" however="" in="" increases="" insufficient="" is="" it="" load="" magnitude="" make="" may="" might="" missed="" nature="" of="" on="" regarding="" related="" risk.="" risk="" routine="" sexual="" span="" statements="" testing.="" that="" the="" there="" they="" to="" transient="" transmission="" viral="" weeks="" with="">
Correlation Between Plasma and Genital Fluid Viral Load and Resistance to ART
Although ART reduces viral load in both plasma and seminal fluid, undetectable plasma viral load may not always predict undetectable seminal fluid viral load. A recent review of 19 studies, which compared plasma and seminal fluid viral loads, indicates that while blood and genital fluid viral load are often correlated, this is not always the case.21 Thus, a person with an undetectable plasma viral load may still shed virus in genital fluid at higher levels, which poses risk for transmission.
Several additional factors may affect genital fluid viral load. For example, sexually transmitted infections (STIs) such as gonorrhea and chlamydia have been shown to transiently increase viral load in genital fluids.22-23 Individuals with active STIs may therefore be more infectious, despite a low or undetectable plasma viral load. Moreover, as individuals with STIs may not have any symptoms, it may be impossible for either partner to be aware of this increased risk.
Some of the variation in genital fluid viral load may be due to differences in the degree to which different ART medications enter genital fluid. Recently developed research methods allow for measurement of drug concentrations in seminal and vaginal fluids, which can then be compared to drug levels measured in blood. This research has found that some ART medications achieve higher concentrations in genital fluids than others.24-27 For instance, nucleoside/tide reverse transcriptase inhibitors (NRTIs) penetrate to a greater extent in male and female genital secretions than do protease inhibitors (PIs). Further work of this type may eventually aid in selection of antiretroviral medications in order to reduce sexual transmission. However, more data collected via these methods and better understanding of the degree to which this approach might be effective is needed before specific recommendations can be made.
In addition to differences in viral load between plasma and genital fluids, there may also be differences in the resistance characteristics of virus in these two locations. HIV may become resistant to ART medications through mutations that occur during replication and through exposure to insufficient or inconsistent levels of HIV medications. This may happen when ART medications are not taken according to the prescribed schedule or doses are skipped. In addition, drugs which do not enter the genital fluid as well may help promote the development of resistance in the genital fluid specifically. Some researchers have noted that within an individual, the resistance characteristics of virus isolated from genital fluid may differ from those of virus isolated from plasma.28-30
In summary, for couples in which one member is HIV-infected, treatment of the infected partner with effective ART and suppression of viral load to undetectable levels should greatly reduce the risk of transmission to the uninfected partner. However, this risk is not eliminated and it may not be maximally reduced at all times due to some of the factors discussed above. Moreover, the likelihood of transmission may be expected to increase with repeated exposures over time. In a model which estimated transmission risk in the setting of suppressed viral load (<50 10="" 11="" 215="" 3="" 425="" 5="" 70="" a="" additional="" among="" analysis="" and="" art="" be="" chance="" cohorts="" compatible="" condoms="" copies="" couples="" data="" e.g.="" estimated="" event="" events="" expected="" female-to-male="" for="" from="" further="" heterosexual="" however="" important="" in="" including="" individual="" intercurrent="" is="" it="" load="" male-to-female="" male-to="" male="" meta-analysis="" methods="" minimize="" ml="" no="" number="" observed="" occurring="" of="" one="" order="" over="" per="" person-years.32="" persons="" population="" possibility="" preventive="" reason="" receiving="" recognize="" risk="" serodiscordant="" span="" stis="" that="" the="" this="" to="" transmission.="" transmission="" transmissions.31="" transmissions="" use="" viral="" was="" with="" within="" without="" years="">

A couple of post from articles about transmission risks for men with HIV who have "undetectable" viral loads

" 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention, June 30-July 3, 2013, Kuala Lumpur

Mark Mascolini

In the first study to track HIV shedding in semen over time in men who have sex with men (MSM) with sustained HIV suppression in blood, 7.6% of men with undetectable virus in blood had intermittent shedding in semen that was not linked to an asymptomatic sexually transmitted infection (STI) [1]. HIV levels in peripheral blood mononuclear cells (PBMCs) predicted HIV detection in semen.

Research shows that an undetectable viral load in plasma does not guarantee an undetectable load in semen--and therefore may not eliminate the risk of sexual HIV transmission. But most data on this issue come from cross-sectional studies involving heterosexual men in medically assisted reproductive programs. A French team conducted this study to address these questions in a longitudinal study involving MSM. 

The study involved HIV-positive adult MSM on a stable antiretroviral regimen with a plasma viral load below 50 copies for at least 6 months. No men had clinical symptoms of an STI, and all agreed to abstain from sex for 48 hours before giving semen and blood samples. The researchers collected paired semen and blood samples at a baseline visit and 4 weeks later. They also measured PBMC-associated HIV DNA and tested men for syphilis and other STIs. Based on a 3% to 5% rate of genital HIV shedding in heterosexual men, the investigators calculated that they would need 150 men to find at least one blood-semen discordance if prevalence was as low as 3%.

The researchers recruited 153 MSM with a median age of 44 years (range 27 to 67). Median time since HIV diagnosis was 10.4 years, and median nadir and current CD4 counts were 247 and 637. Median PBMC HIV DNA stood at 229 copies per million cells (range 70 to 2099). These men had taken a stable antiretroviral regimen for a median 2.1 years (range 0.3 to 12.4) and had an undetectable viral load for a median 3.3 years (range 0.5 to 13.7). Almost two thirds of men (63%) had a stable partner, though 63% with a stable partner also had casual sex with a median of 10 other men in the past 3 months (range 1 to 160). 

HIV could be detected in 23 of 304 semen samples at a median level of 145 copies/mL (range 50 to 1475) to yield a prevalence of 7.6%. Five men (3.2%) had HIV detectable in semen at the baseline visit but not week 4, while 2 (1.3%) had HIV detectable in semen at both visits, and 14 (9.1%) had HIV detectable at week 4 but not the baseline visit. HIV could not be detected in 74% of semen samples by an ultrasensitive assay. 

Thirty-two of 157 men (20.4%) had an asymptomatic STI detected, and 2 men had two STIs. Ureaplasma urealyticum was the most frequent STI, affecting 18 men, followed by syphilis in 6, Gardnerella vaginalis in 4, Chlamydia trachomatis is 3, and Neisseria gonorrhoeae in 2. 

Multivariate analysis identified two factors associated with detectable HIV in semen: A current CD4 count between 554 and 735, compared with a lower count, cut the odds of HIV in semen 70% (odds ratio 0.3, 95% confidence interval [CI] 0.1 to 0.9, P = 0.027). And HIV DNA in PBMCs above versus below 318 copies per million cells tripled the odds (odds ratio 3.1, 95% CI 1.2 to 7.7, P = 0.015). HIV detection in semen was not associated with STIs, CDC stage, nadir or current CD4 count, duration of undetectable HIV in plasma, adherence to antiretroviral therapy, or number of sex partners. 

The researchers noted that seminal HIV prevalence in this study was significantly higher than in a recent cross-sectional study of heterosexual French men (7.6% versus 3.1%, P = 0.016) [2]. Whether these levels of HIV in semen are infectious, they added, remains to be determined. "


1. There is viable HIV in the semen of many men who have "undetectable" viral loads.

2. How big a risk for infection this presents is unknown, but I'd be it's not zero.

I've been asked recently my thoughts about Qpid.me, a service that notifies authorized users of a member's HIV status.

To some degree, I think these services, and I believe there are several, are already obsolete because of Orasure's home test kits, but this is what I think.

Many men are worried about such aps making stigma worse.  I disagree.  There is just a certain population of men that is going to act on the abstract fear of winding up like "Philadelphia," and you cannot reach them.  The guy who turns and runs from a text would already have turned and run when you just told him, as you were going to do, anyway.   It still stings, but Qpid would only alter the timing.  

On the other hand, there some essential problems with any text-based ap that attempts to identify people with or without HIV:

Of the estimated 1.2 million HIV infected people in the USA, 240,000, or 20% are unaware of their infection.  For gay men in urban areas, the figure is 44%.  16% of these had NEVER been tested.   Of recently infected gay men "unaware" of their status, 45% had been tested within Qpid's 12 month window.  Dependence on any 12 month old lab result is highly likely to lead to new infections, not to prevent them.

I'm sure the prevalence of texting phones is high in gay men, but it is not universal, and any service that requires testing within 12 months is going to face the same issues that testing itself faces.  Fear of a positive result will discourage people from signing up.  Positive men have no reason to sign up in the first place, no matter how honest they are about disclosure.  If the percentage of users remains small, the value of the service is low, even if the test results given were immediate and accurate. Qpid offers zero protection against those who lie about their status, as they simply won't be subscribers, and given the "low penetration" of the service," someone who uses it is going to find a lower percentage of users than "certified negatives."  I simply cannot imagine many men saying, "Since you don't have Qpid, I won't go home with a horny man who looks like a Colt Model."  Sexual decisions are, for better or worse, almost never that mathematical. 

I suppose it's possible it might encourage a few kind of nerdy and paranoid men to be tested, and that's a good thing.  The bottom line is that only safer sexual practices, honest discussion, and education can really help.

In short, I think Qpid cannot deliver reliable laboratory information that increases safety, because it depends on old results in a population with lots of recent infections.  I do not believe it could ever reach a percentage of users that would allow it to be of use in the first place…

and I hope they have a team of lawyers specialized in HIPAA issues, because they're going to need it.

Home HIV tests

The FDA recently approved a home test kit for HIV that will allow you to buy a test, and get a result within an hour.   There is a number to call to get information and counseling, but the result will be right there.

There are, as with anything, plusses and minuses.   For people who cannot be seen getting tested, and there are many, this test will be a huge advance.  They will be able to get result, and move forward to seek therapy on their own.   It is thought that this will be a particular help to communities where "stigma" deters people from testing.   If it works out that way, it is estimated that up to 40,000 new HIV infections will be avoided every year.

I have concerns for sexually active gay men.   While the test is good, and based on the "orasure" technology that has been used for years, there are a couple of problems.   First, these tests only measure antibodies, unlike the latest blood tests, which also measure virus itself.   The home test has a three month window period.   Tests done in a medical lab using blood have reduced the window to a week or so.   In young people hooking up on the net, this is vital.

Secondly, when done at home, this test has a very significant false negative rate.  For every 12 truly positive tests, there will be one person who gets a negative result, but who is, in fact, positive.   Using this test to screen sex partners for bareback sex could easily allow lots of new infections.

I do not believe this test is ideal for sexually active gay men, and it is a very bad idea to use test results from the home HIV test to make decisions about bareback sex.