BEYOND AIDS ANNOUNCES CONTINUING EDUCATION AND ANNUAL MEETINGS, REDLANDS, CA, SAT. 11/17/12

Update on Treatment and Prevention of HIV and Syphilis

A Continuing Education Seminar Co-Sponsored by the

Beyond AIDS Foundation and the Infectious Disease Association of California

When:               Saturday, November 17, 2012

Where:             Redlands Community Hospital, Weisser Education Pavilion

  350 Terracina Blvd., Redlands, CA 92373

Schedule:

8:00-8:50 a.m.:       Registration, Coffee

8:50-9:00 a.m.:       Welcome and Introduction

                                  Deanna Stover, PhD, RN, FNP-BC, CNS, Pres., Beyond AIDS Foundation;

                                  Executive Director, Community Programs, Redlands Community Hosp.

9:00-9:45 a.m.:       What’s New in 2012 Guidelines for Antiretroviral Treatment of Adults/Adolescents with HIV          

                                  Ronald Hattis, MD, MPH

9:45-10:30 a.m.:    From Routine Testing to Viral Load Suppression: New York City HIV Interventions

                                  Monica Sweeney, MD, MPH

10:30-11:00 a.m.:  Break; pharmaceutical displays*

11:00-11:45 a.m.:   HIV Testing & Partner Notification Requirements in California: Keeping it Simple and Legal

                                  Ronald Hattis, MD, MPH; demonstration with I. Jean Davis, PA, DC, PhD and Trista Baker, LVN

11:45-12:30 p.m.:  Syphilis Update: Lessons Learned from an Outbreak Associated with the Adult Film Industry       

                                  Peter Kerndt, MD, MPH

12:30-1:30 p.m.:    Lunch (included with registration; pharmaceutical displays will be open)

1:30-3:30 p.m.:       Annual Meetings of Beyond AIDS and Beyond AIDS Foundation, including report on International AIDS Conference and discussion of strategy  for controlling U.S. HIV epidemic, incl. “treatment as prevention.”

                                  Seminar participants invited to attend but handouts only available if intent included in RSVP (see below).

Accreditation:

Physicians: The Infectious Disease Association of California (IDAC) is accredited by IMQ/CMA to provide CME to physicians, and designates this educational activity for a maximum of 3.0 AMA PRA Category 1 Credits^TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.  This credit may also be applied to HIV Specialist certification.

CEUs (3 units) for nurses and others will be available through Redlands Community Hospital.

                        

Map and directions: http://www.mapquest.com/maps?address=350%20Terracina%20Blvd&city=Redlands&state=CA&zipcode=92373

From 10 Freeway, take Alabama exit; south on Alabama. At end of road turn right on Barton, and soon after turn left onto Terracina Blvd.  Pass Olive, then take 1st entrance into hospital grounds on right. Weisser Education Pavilion is a separate building to right of main hospital. Enter building from the right (north) side. Parking available in hospital lots at no charge.

Registration:   

Course registration fees (checks) will be collected at check-in.

Physicians, nurse practitioners, physician assistants, and doctorate-level professionals: $60      

Nurses and all others: $30                      

Special discounts:          Members of Beyond AIDS: No charge*                 

                                                Members of IDAC: $10             Redlands Community Hospital Employees: $10

RSVP required:  

To reserve seating, food, handouts, e-mail foundation@beyondaids.org or leave phone message at 888-239-2437.  Include in your message name, phone number, e-mail address, and whether also attending afternoon B.A. meeting.

*Membership:  

Attendees may join Beyond AIDS at registration check-in and have course registration fee waived.

Information on the organization and membership available at www.beyondaids.org.   Dues: Regular $50, couples $75, students $25.

BEHIND THE SCENES: VOLUNTEERS ARE KEY TO AIDS CONFERENCE SUCCESS

Hayes distributing conference bags and programs

Frank E. Hayes is not a youngster or college student. He has an important full-time job at the Washington State Health Department, as the Coordinator for Health Education and Risk Reduction for HIV and Hepatitis. In his spare time, he also serves as a member of the Advisory Council of Beyond AIDS.  But when he heard at the beginning of April 2012 that volunteers were being sought to work at the upcoming International AIDS Conference in July in the other Washington (DC), for no pay and no travel reimbursement, he rushed to sign up. So many other people did too, mostly from the U.S. but also from other countries, that volunteer registration was closed after only two weeks.

Hayes checking badges for security

1500 volunteers were initially sought, and about 1000 actually served throughout the conference. The received yellow T-shirts, but transportation and housing were at their own expense.

Volunteers filled many essential roles, including helping to plan the conference and to coordinate activities, assisting with registration, greeting visiting delegates and assuring security by verifying proper credentials. They also acted as guides, staffed various offices and activities, and assisted in a display area known as the Global Village. Only occasionally were they free to attend actual conference sessions. However, they bonded socially, and many new friendships developed.

Volunteers cheer for photo near end of conference

Judging from discussions with Hayes and other volunteers during the conference, morale and esprit de corps was excellent. Many gathered on the last day for a group photo, at which they were heard to whoop and cheer.

These volunteers were the unsung heroes who made the conference run smoothly. They were a key to its success, and indirectly, to the spirit of global unity that was evident during the conference.

For a more complete report on the XIX International AIDS Conference from the perspective of Beyond AIDS' President, see next posting.

SAD POSTSCRIPT: The following message was received from Justin Hahn, a colleague of Frank Hayes at the Washington State Health Department, on July 25, 2013, when we inquired about his welfare, since we had not heard from him in some months:

"I am so sorry to say that Frank Hayes passed away on February 18, 2013.  Frank was diagnosed with a malignant brain tumor shortly after returning home from the International AIDS Conference last year. Frank was enjoyed and loved by his friends and co-workers. His laugh could be heard across a large room. Some of us at the office spent considerable time with Frank in the hospital and later in the care facility where he made his transition. I personally got to know Frank so much better during this time and I feel so lucky for it. Frank was a loving and generous man."

REPORT ON XIX INTERNATIONAL AIDS CONFERENCE, WASHINGTON, D.C.: BEYOND AIDS PRESSES FOR EFFECTIVE CONTROL STRATEGY

The Beyond AIDS Foundation actively participated in the XIX International AIDS Conference, which was held in Washington, DC, July 23-27, 2012 with a theme of "Turning the Tide Together."  Ron Hattis, who is Secretary of the Foundation (as well as President of the Beyond AIDS membership organization), was the main official Beyond AIDS delegate. He met with a series of government HIV/AIDS officials and participated actively in sessions on "treatment as prevention," early treatment, linkage of testing to prevention, interrupting drug-related transmission, etc. as well as scientific sessions on antirival resistance and new drug development.  Hattis used these opportunities to promote and distribute the new Beyond AIDS position statement and recommendations on how to control the U.S. epidemic, which had just been approved by the Board and Scientific Committee (see next posting on this blog).

Sweeney and Hattis confer during conference

Vice-President Monica Sweeney, who also is Deputy Health Commissioner for HIV Prevention and Control at the New York City Health Department, attended associated national meetings both before and during the conference. The two Beyond AIDS leaders touched bases as they pursued separate tracks.

Advisory Council member Frank Hayes participated in a different role, as one of almost 1,000 volunteers helping the conference to run smoothly (see separate posting above).

This was the fist international AIDS conference to be held in the U.S. since the sixth one in 1990, which Hattis had also attended 22 years earlier. Since then, conferences had been held biennially all around the world, but the U.S. had been boycotted because of American visa requirements obstructing entry of HIV positive individuals. Those restrictions were ended by President Obama, which once again made the U.S. eligible to host the conference. Over 20,000 delegates reportedly attended, from all over the world, including many with HIV.

President Obama did not personally appear at the conference, which disappointed many participants. However, he provided a video message, hosted a reception at the White House honoring persons living with HIV, and his administration was represented by HHS Secretary Katherine Sibelius, Secretary of State Hillary Clinton,and others. Former President Bill Clinton also made an appearance, representing his foundation, which has done a great deal to make HIV/AIDS drugs available at more affordable cost to populations in developing countries.

MEETINGS AND TESTIMONY

  
Since several of the Beyond AIDS recommendations are directed at the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and Health and Human Services administration (HHS), Hattis arranged meetings with leaders of those agencies.   

Fauci and Hattis discuss NIH and Beyond AIDS recommendations

Dr. Anthony Fauci has headed the center at NIH in charge of AIDS since 1984, and his remarkable career has included research into how HIV destroys the immune system, and oversight over the development of effective drugs to fight the disease. Fauci agreed with Hattis on potential drawbacks such as potential drug resistance, that might occur with largescale use of pre-exposure prophylaxis (PrEP) to treat uninfected persons at risk of exposure. They also agreed that the greatest opportunity to reduce HIV transmission rested with earlier and more widespread treatment of persons who are actually infected. Hattis asked for greater publicity of new treatment recommendations endorsed and posted by NIH, which permit treatment of all HIV-infected persons regardless of CD4 counts; but Fauci did not think that getting the word out was an NIH responsibility.               
In fact, it turned out that the leaders of each agency thought that another agency should do this. Beyond AIDS will need to continue to work to encourage a joint effort for this publicity and physician education.

Fenton chats with Hattis at CDC display area

CDC officials, including Dr. Kevin Fenton, director of the center that includes HIV/AIDS, and Dr. Jonathan Mermin, who is in charge of CDC's HIV/AIDS prevention divisions, claimed that they agreed with and were already working on several of the Beyond AIDS recommendations. These include using case reports to trigger prevention outreach for new HIV positives, targeting screening and prevention toward groups which the the most recent cases have been detected, better monitoring of partner services nationwide, and screening for hepatitis C and other STDs along with HIV. Fenton and Mermin asked that Beyond AIDS acknowledge this progress. Accordingly, the Beyond AIDS recommendations were amended after the conference to add in several places that "we applaud and encourage the intent of CDC leaders as communicated to us, to proceed in this direction." However, Beyond AIDS has not been able to find any CDC recommendations to date that have yet implemented these approaches, and will look for actual proof of accomplishments by 2013.

PACHA members hear testimony, July 25, 2012

Hattis also testified before a special public "community engagement" session of the Presidential Advisory Council on HIV/AIDS (PACHA), calling for that council to support the Beyond AIDS recommendations, which were distributed to the members. Two current Beyond AIDS Foundation leaders, Sweeney and Dr. Frank Judson, are former members of the council. 

The PACHA hearing was also an opportunity for a brief introduction to Dr. Grant Colfax, the new Director of National AIDS Policy at the White House, who will be responsible for updates to the National AIDS Strategy.  Dr. Colfax's last employer had been the San Francisco Department of Public Health, which received an award from Beyond AIDS in 2008 for innovations during Dr. Colfax's tenure. Two previous directors of that office, Jeffrey Crowley and Dr. Joseph O'Neill, were also contacted during the conference.

Hattis meets with Valdiserri on HHS coordination for HIV/AIDS

Another valuable meeting was with Dr. Ron Valdiserri, a former CDC official who is now Deputy Assistant Secretary for Health and Infectious Diseases at HHS. This role includes overseeing HIV/AIDS policy at the HHS headquarters level. For those duties, he is the successor to Christopher Bates, with whom Beyond AIDS had met several times over the years. PACHA is staffed by Valdiserri's office. Many points of agreement on strategy for controlling the U.S. epidemic were reached, and the Beyond AIDS relationship with HHS at this level was renewed.

OPTIMISM AND CAUTION

Many of the speakers at the conference spoke optimistically of "a generation without HIV," based on progress in a number of countries (though not so far in the U.S.) in reducing HIV incidence; and also on the promise of "treatment as prevention." The concept that treatment could help control the epidemic had actually first been written up some 15 years earlier by Hattis as a faculty member at Loma Linda University, together with one of his medical residents, Dr. Holly Jason Kibble (see posted articles on the Beyond AIDS Web site of 1996 and 1997, and history of of concept in the Beyond AIDS position statement). Over just the last few years, increasing evidence has built up that adequate treatment indeed can reduce infectiousness to the point that it can be a powerful weapon in stopping the spread of the disease.

Condom Demonstration and Display at AIDS Conference

The Beyond AIDS statement notes, however, that for "treatment as prevention" to work, infected persons must be identified before they have passed on the virus. As soon as persons with new infections are discovered by screening, they should be referred for immediate treatment, interviewed for contacts/partners who likewise need testing (and treatment if already infected), and helped to discontinue transmission-prone behavior. Some of those additional elements in what could be a highly successful strategy were little heard at the conference, and the Beyond AIDS Foundation will continue to press for them.

POLITICAL CONTROVERSIES AND ISSUES

Every international AIDS conference has involved political protests and expression by activists, mostly from the gay communities in the U.S. and a few other countries. Beyond AIDS has often disagreed with some of the positions of these activists, while agreeing with others. In the early years, activists had demanded more rapid development of effective drugs for AIDS, which was laudable. However, they had also opposed HIV reporting, an area of strong disagreement. Beyond AIDS was in the forefront of a ten-year political struggle, ultimately successful, to achieve HIV reporting in all 50 states. 

At this year's conference, there seemed to be four main political protest issues that were frequently heard, and the first two of them (but not the last two) run counter to Beyond AIDS philosophy: 

1) So-called "criminalization of HIV." This related to complaints about cases in which some HIV positive persons have been prosecuted for intentional transmission or for exposure of others without either informing their partner or taking precautions. The argument was that this would deter HIV testing (just as activists once claimed that reporting would deter testing, a prophecy which did not come true). The slogan was "Take a test, risk arrest," which ironically discourages that very testing. Sean Strub, the founder of Poz Magazine, advisor to the Positive Justice Project, and maker of a film entitled "HIV is Not a Crime," was the leading advocate of this position.   

Beyond AIDS takes exception to this stance. Beyond AIDS has long advocated that HIV positive individuals, "after appropriate notification and counseling, be held accountable for preventing transmission to others." By analogy, having a driver's license and a car does not risk arrest, but driving drunk or negligently or intentionally running someone over does, and driving is not deterred by that requirement. Similarly, gun ownership is not deterred by the fact that using a gun to murder someone is a crime. On the other hand, anecdotes suggested that some prosecutions may have been unfair. Laws should take into account an infected person's efforts to protect partners, and criminal prosecution should be reserved for the most egregious cases that endanger lives.

2) Fear that an emphasis on treatment as a public health measure would result in mandated treatment, with forced exposure to toxic drugs. Ironically, some of the same activists who demonstrated years ago for research and development of effective drugs are now afraid of being corralled into taking them. Strub even called for written consent before anyone could receive treatment for HIV/AIDS.  

Fortunately, this issue seemed to be a significant concern of only a small minority at the conference. Beyond AIDS strongly supports encouraging patients to start on treatment as soon as possible, both for their own benefit and to prevent transmission. On the other hand, there was general agreement at the conference that treatment ultimately remains voluntary and an issue to be discussed by patients and their health care providers; and that "human rights" concerns should be considered in developing policies on mass early treatment as a prevention strategy.

3) U.S. visa restrictions that still prohibit persons who have been sex workers or used injection drugs within the last ten years. There was general consensus that this prevented attendance by some potential international delegates who might have provided insight about dealing with those populations, and a group of sex workers from India held their own conference in protest. Beyond AIDS has no policy opposing  easing or allowing exceptions to this restriction, which seems excessive.

4) Laws in many countries that make homosexual behavior illegal, forcing gays underground and making it difficult for public health programs to reach them and to enlist their support for testing and treatment. Beyond AIDS opposes discrimination or stigmatization for either sexual orientation or HIV infection.

Weinstein, flanked by West and Smiley, at AHF Rally

AIDS Quilts, with Rally Stage in Background

There was another political push that appeared to be a consensus issue typical of AIDS conferences, for more money for treatment and prevention. This year, there was particular concern that the U.S. and other countries across the world might decrease their HIV/AIDS budgets because of global recession. 

The AIDS Healthcare Foundation (AHF) staged a rally at the Washington Monument on July 22, under the leadership of its President Michael Weinstein, the day before the conference began. The theme was "Keep the Promise," implying that the federal government should maintain and increase the support of HIV treatment just when it needed to be expanded and could be the key to reversing the epidemic. 

A large stage was erected, large swaths of AIDS quilts were on display, and an impressive array of speakers including Andrew Young, Al Sharpton, Tavis Smiley, and Cornel West; and entertainers Margaret Cho and Wyclef Jean. Unfortunately, the rally drew only hundreds rather than the hoped-for thousands of participants. However, the crowd was enthusiastic, and carried that spirit forward to the conference that followed.


 

A STRATEGY TO CONTROL THE U.S. HIV/AIDS EPIDEMIC, WITH KEY ROLES FOR CONTROL AT SOURCE, “TREATMENT AS PREVENTION”

 Ronald P. Hattis, MD, MPH, President, Beyond AIDS

ronhattis@beyondaids.org         www.beyondaids.org

NOTE: This position statement was originally prepared July 2012 and approved by the Board of the Beyond AIDS Foundation, and the Scientific Committee serving the Beyond AIDS Foundation. It was distributed at the XIX International AIDS Conference that month in Washington, D.C.  It was edited 8/4/12 after input from the conference; changes are subtly highlighted in brown font. Portions of the text highlighted in red are linked to Web references, and were last updated along with text adjustments in August 2013. Further changes to the section on pre-exposure prophylaxis were approved by the Foundation Board in December 2013 and appear subtly highlighted in purple font. The document briefly reviews the history of "treatment as prevention"; concisely outlines an integrated public health prevention strategy for the U.S. (also worth consideration globally), with greater emphasis on control of infection at the source including "treatment as prevention" as a centerpiece; and ends with a set of ten recommendations for action by U.S. agencies. The strategy and recommendations are highlighted in bold.  Comments are welcome, on this blog or by e-mail.

TWO APPROACHES TO THE CONTROL OF COMMUNICABLE DISEASES

Each year in the United States, an estimated 48,00-56,000 new HIV infections have occurred for the last several years. This trend has defied the full range of current and longstanding public health efforts to reduce this incidence. Efforts to date have tended to be directed mostly to population groups identified to be at risk, and to some extent to the general populations of countries or communities. They include education about the disease, as well as promotion of measures such as condom promotion and avoidance of needle sharing.

An alternative approach has been successfully utilized for other communicable diseases for which (like HIV) no vaccine or environmental control measure exists, and for which antimicrobial treatment can lead to a loss of infectiousness (through cure, as with syphilis, or suppression, as with tuberculosis). That approach focuses more heavily on control of infection at the source, helping each infected person to prevent passing on the organism. This reduces the microbial reproductive rate, R0 (a concept pioneered in the U.K. by Anderson and May).  

In our opinion, control of transmission at the source has been underemphasized for HIV/AIDS as a component of overall disease control and prevention. It is often said that if we do the same things over and over, we should not expect better results. 

Control of a communicable disease at the source generally requires identification of all or most infected persons, as soon as possible after infection occurs. Thereupon, methods of control can involve 1) reducing transmission-prone behaviors of those persons, or introducing barriers to the organism during such behaviors, and 2) reducing the shedding of the infectious organism by infected persons. In the absence of spontaneous recovery, the latter method generally requires antimicrobial therapy. Now that the second method has been proven to work for HIV/AIDS, both methods can be incorporated into a coordinated strategy for more effective control the disease.

THE EMERGENCE OF "TREATMENT AS PREVENTION"

Hattis and Jason Kibble first proposed the use of treatment as a major weapon to reduce HIV transmission at Loma Linda University in 1996, citing evidence that even the primitive treatment available up to that time with AZT alone could reduce both heterosexual and perinatal transmission. The concept was endorsed by the California Medical Association in that year; however it did not achieve national attention at that time. GlaxoSmithKline convened an advisory Board in 2002 to discuss the subject, and a mathematical model that year by Blower et al. using data from the San Francisco gay community predicted that treatment could eventually eradicate an epidemic with 30% seroprevalence.  

The use of treatment to prevent new infections was frustrated in part because the U.S. guidelines for HAART regimens from2001 until 2012 called for delaying treatment until CD4 counts dropped to levels that often took 5-10 years to occur. Starting treatment at a count of under 500 has been been referred to as “early” compared with under 350, but waiting until either level is reached permits much if not most transmission to occur before treatment has a chance to kick in preventively.

However, interest in “treatment as prevention” surged between 2009 and 2011, and peaked as a 9-country study published in August 2011 by Cohen et al. showed that antiretroviral treatment could reduce infections inserodiscordant partners by up to 96%. HIV “treatment as prevention” was named by Science Magazine as the scientific “breakthrough of the year” for 2011.  Modeling has meanwhile suggested that the resulting reduction in incidence might finally be able to control or even eventually end the epidemic in South Africa or in other countries that can bring all cases into early treatment.

Meanwhile, on March 29, 2012, new guidelines for antiretroviral treatment of HIV in the U.S. were issued by the National Institutes of Health (NIH), which encouraged treating all infected patients, regardless of CD4 counts, although some sub-populations are at highest priority for treatment. Immediate treatment was advocated primarily for the long-term benefit of the patient; however the guidelines did mention prevention as a secondary benefit. For public health however, prevention of transmission is a primary concern. The International Antiviral Society-USA followed soon after in July 2012 with similar guidelines, and likewise noted reduction of transmission in its rationale.

Some prominent federal health officials, and local public health departments in NewYork City and San Francisco, are already advocating publicly for early onset of treatment for its preventive benefits. Nevertheless, in a review of the current National AIDS Strategy and of posted Centers for Disease Control and Prevention (CDC) guidelines, we do not yet find at the national level any coordinated or comprehensive public health strategy document that lists treatment as prevention as a key strategic component for controlling the HIV/AIDS epidemic. We also do not yet find official guidelines that show how it integrates with other prevention strategies. 

At the XIX International AIDS Conference in Washington, DC in July 2012, "treatment as prevention" was a central topic, leading to probably over-optimistic predictions of a "generation without HIV" and even of the eradication of the disease. Despite the general enthusiasm, a minority of activists even voiced alarms that there could be forced treatment for public health purposes, raising the need to address human rights concerns. Actually, although the concept is simple, achieving the degree of penetration of treatment, and the longterm maintenance and adherence, necessary for "treatment as prevention" to steadily reduce incidence (and ultimately prevalence) of HIV/AIDS will be complicated and gradual, subject to the vagaries of voluntary individual choices and behaviors and group cultural responses, and prone to many pitfalls and limitations.  

In countries like the U.S., where patients with advanced disease already have treatment available but it has not reduced HIV incidence, the key to reduced incidence will be earlier onset of treatment than has been available until now, i.e., as soon as possible regardless of CD4 count, and before most transmission has occurred. However, although the phrase "test and treat" was heard at the conference, there was relatively little discussion of achieving early onset of treatment by systematic linkage to care immediately upon positive testing or of reporting. There was also little discussion of similar linkage to partner services. Representatives of most countries continued to plan based on treating everyone with a CD4 count of under 350, or in some cases under 500/ml, due to limited resources, as well as treatment guidelines in Europe and elsewhere that have not yet been adjusted to permit earlier use of antiretroviral drugs. This may be very helpful in countries where incidence is already declining, and/or where the majority of infected persons have had HIV for many years and have low CD4 counts. However, it is unlikely to achieve a turnaround in the U.S., or in other countries with similar epidemic trends and treatment practices.

AN INTEGRATED HIV CONTROL STRATEGY FOR THE UNITED STATES

The demonstrated preventive benefits of treatment, combined with the authorization of treatment for all infected persons, permit a more successful overall prevention strategy than was available until now, stressing control of transmission at the source, in which early and continuous “treatment as prevention” would be the central and most effective new element.

Such an integrated public health prevention strategy could include these critical elements:

·       Early identification of infection, through screening programs more effectively targeted at the demographics with the most recent transmission, and through routine testing in healthcare settings;

·     Outreach by public health to all newly reported case-persons and/or their providers, with referrals when indicated), to assure that persons with newly identified HIV infections are linked to immediate onset of effective treatment that suppresses viral load; that initial partner services are performed; and that referrals to prevention case management be available to assist with changes in high-risk behavior as indicated;

·       Incorporation of prevention into ongoing care of patients with HIV, including:

a) Routine questioning and counseling regarding sexual and drug-related behavior, 
b) monitoring of treatment adherence;

c) Monitoring of viral load suppression;

d) Ongoing questioning about new partners, and assuring confidential notification and voluntary testing through partner services.

None of these elements is really new; all have been successfully used before to some degree, individually or with some but not all of the others, in various prevention programs. (Even treatment has been used to prevent perinatal infections.) However, they are not universally practiced, nor are they fully integrated as a system in most public health jurisdictions. 

Prevention grants do not yet require the review of the epidemiology of recent HIV infections for purposes of retargeting testing and other outreach. Some states (Massachusetts) still require written consent for testing, while others have provided exemptions from written consent, but either impose complex pre-test requirements (California) or do not permit opt-out testing (New York). Reported case data in many locations is so severely sequestered that it cannot be utilized for prevention outreach, nor has there been funding for this to be done routinely.

“Prevention with Positives” programs have proven effective, but there are not enough of them, and case patients with high-risk behavior histories are not systematically referred to them upon being reported. Ryan White funding provides support groups and case managers on a large scale, but these are often neither trained nor required to deal with prevention issues. Partner services are not performed for all patients even when first diagnosed, let alone on an ongoing basis as they acquire new partners. Funding and training for this essential activity are inadequate in many jurisdictions, even though it permits the highest theoretical yield of potentially preventable infections, as well as the earliest possible identification of new infections. 

Treatment providers often fail to address recent risk behavior and treatment adherence at each visit, and viral load suppression and monitoring are often sub-optimal. Word about initiating treatment immediately, and on new guidelines for treating all infected patients, has not yet reached many providers. Many clinics still have large posted signs recommending treatment when the CD4 count is below 500, as per the last set of guidelines from 2011.

Emphasizing control at the source should not of course imply the abandonment of efforts to reduce risk behavior of the general population, and especially on the part of persons with high-risk behavior patterns. In fact, the most effective proven methods should be promoted more widely and effectively than at present. Efforts to increase abstinence and reduce multiple partners have proven effective in actually reducing HIV incidence and prevalence in Uganda and a few other countries, but at times when the population was seeing AIDS deaths all around them. They require a massive effort to change the culture of an entire society, something for which the will and commitment have not been seen in the United States. Barrier protection for oral sex is rarely addressed in public health programs anywhere. The relative priority of such approaches in partnership with source-based interruption of transmission should be considered. 

CONCERNS ABOUT PRE-EXPOSURE PROPHYLAXIS

A complicating recent element is the FDA approval of emtracitabine/tenofovir (Truvada) for pre-exposure prophylaxis (PrEP), and the controversies it has engendered. It will take tremendous efforts and greatly increased financing to provide antiretroviral treatment to the 72% of U.S. persons with HIV not yet receiving it according to CDC (higher in many countries, where the expansion will also be much harder to afford). The toxicity and cost of treatment can be justified for persons who are actually infected, but are more problematic for persons who might merely be exposed. There are good precedents for post-exposure treatment, but not for pre-exposure treatment for a communicable disease where equivalent protection can be achieved by treating the infected persons. 

There is a puzzling inconsistency between CDC recommendations for PrEP, and its recommendations of 2005 for non-occupational HIV post-exposure prophylaxis (nPEP). The latter call for preventive treatment with 3 drugs, only if there has been definite exposure to a known infection, or to a likely infection in which case a risk-benefit discussion has been conducted between the provider and the patient regarding a specific exposure. For PrEP, 2 drugs are used, and there is no such limitation. Other concerns include likely substitution by some people of PrEP for regular condom use, possible ineffective episodic use, and potential drug resistance due to sub-optimal two-drug treatment, e.g., when persons using PrEP already have acquired HIV infection, or if they become infected despite PrEP.

Treatment of a defined population of already-infected persons should logically be much more cost-effective, and should have a higher risk-benefit ratio, than treating a larger, ill-defined population of persons, including many who will not even become exposed. On the other hand, we recognize that some persons who engage in high-risk behavior refuse to use condoms, and that some infected persons may refuse both to take treatment and to use condoms. Therefore, a limited adjunctive role for PrEP can be justified, at least for the time being. With an increased emphasis on identifying all infected persons, and in turn on linking and retaining all infected persons to treatment that suppresses viral load, the need for PrEP should decrease over time.

In addition, there are persons who cannot avoid unprotected exposure to HIV, e.g., partners in sero-discordant couples who do not have the power to refuse sex, and where the source refuses treatment and condom use; for partners of patients in early treatment whose viral loads have not yet become undetectable; or for partners of infected persons, where condoms are deferred because pregnancy is intended and treatment of both partners is substituted. In such situations, PrEP for the partner, concurrent with treatment of the infected person, might provide the best available protection. Unfortunately, concurrent treatment of both partners was not studied prior to the approval of PrEP, so there were no data to guide CDC and FDA recommendations. 

BEYOND AIDS RECOMMENDATIONS

Our organization, Beyond AIDS, has worked since 1998 to promote underutilized public health strategies for HIV/AIDS that have shown promise with other communicable diseases. Many of our efforts have focused on a greater emphasis on control of HIV at the source, including our ultimately successful 10-year campaign for HIV reporting, and our advocacy of partner services, for using reporting for prevention purposes, for more routine screening with an aim to earlier detection of infections, and for “de-exceptionalizing” in general the public health response to HIV/AIDS.  We therefore are drawn to the above approach, but agree that strategy should be based on science and cost-effectiveness, and recognize continuing debate about what it can practically achieve, and the need for human rights assurances.

Beyond AIDS recommends the following ten steps:

1. CDC should continue to review the evidence, and should perform cost-effectiveness and risk-benefit estimates, to determine the full potential and limitations of “treatment as prevention.” These should be contrasted with similar calculations for pre-exposure prophylaxis (PrEP). Human rights concerns should be fully addressed as well. The Scientific Committee serving our educational and research arm, the Beyond AIDS Foundation, includes experienced medical epidemiologists and infectious disease specialists, alumni of the Epidemic Intelligence Service, and former members of the Presidential Council on HIV/AIDS (PACHA). We would be pleased to participate in any future consultation on this issue.
2. The National AIDS Strategy, CDC recommendations and grant criteria, and PACHA recommendations should all be updated to present a clear and consistent direction on how “treatment as prevention” will be applied; and on the application of the other elements of the comprehensive prevention approach proposed above. The revised recommendations should give increased emphasis to control of transmission at the source, and should address a cost-effective balance between this and efforts targeted toward entire at-risk populations.
3. As soon as possible, and independent of the above review, the Health Resources and Services Administration (HRSA), NIH and CDC should collaborate (including determination of the lead responsibility and funding) on vigorously publicizing, to all HIV providers in the U.S., and soon after to the HIV/AIDS community, the changes in recommendations on when to start treatment as per the March 2012 treatment guidelines, and their benefits for both clinical care and prevention.  Guidelines for incorporation of prevention into treatment (including the four elements outlined above) should also be promoted for providers. These efforts should be supplemented by publicity and discussions with international governmental health agencies and NGO foundations funding HIV/AIDS treatment globally, with the recognition that resource limitations may temporarily dictate later treatment onset in some jurisdictions.
4. CDC prevention grants, in the next renewal cycle, should  require recipient departments and agencies to frequently review the demographics and transmission dynamics of the most recently acquired infections, and to adjust the targeting of testing and prevention programs. We applaud and encourage the intent of CDC leaders as communicated to us, to proceed in this direction.
5. Pressure and financial incentives should be applied to encourage those states that still impose legal barriers or special pre-test requirements, to simplify their HIV testing processes and to eliminate all impediments to routine opt-out testing.
6. Integrated screening for HIV together with other sexually and bloodborne diseases of public health importance, for which millions of persons are not aware of their infections (e.g., hepatitis C), should be considered. (This would seem an appropriate project for unified  involvement by the NCHHSTP at CDC, and we applaud and encourage the intent of CDC leaders as communicated to us, to proceed in this direction.) The development of test panels for multi-organism screening should also be promoted. Such an effort would benefit from CDC and NIH assistance in developing methodology, and from efforts by private industry to develop reagent kits and testing equipment. New testing methodology would also require FDA approval, and test panels would require Current Procedural Terminology (CPT) code approval by the American Medical Association's CPT Editorial Panel, and acceptance by the Centers for Medicare and Medicaid Services (CMS), to assure compensation.
   
7. Prevention grants should require that reporting data be utilized for outreach to newly reported patients or their providers, for purposes of partner services, linkage to treatment, and risk triage with referral for prevention case management counselors or groups as appropriate. We likewise applaud and encourage the intent of CDC leaders as communicated to us, to proceed in this direction.
8. Where grants already require the provision of partner services, better monitoring by CDC and other funding agencies should determine the degree of compliance, and the outcome. We understand that this, too, is planned by CDC, and look forward to improved performance.
9. Ryan White funding for HIV support groups and social work case management should include cross-training on prevention issues, and requirements that these be addressed.
10. Indications for pre-exposure prophylaxis should be clearly prioritized by FDA and CDC, with the highest priority assigned to situations of ongoing unavoidable exposure (which might be called intra-exposure prophylaxis). Most antiretroviral treatment resources should be dedicated to infected persons, for whom combined clinical benefits and “treatment as prevention” can be achieved, and both risk-benefit and cost-effectiveness ratios are expected to be maximal. Studies should be facilitated, to determine the added benefit of antiretroviral regimens, for partners of infected persons who are already being treated, at detectable and undetectable viral loads, and with and without condoms.