Hoover Institution: Reshaping Global Health, Time for a Structural and Philosophical Shift

via Hoover Institution Stanford University, by Mark Dybul, Peter Piot, and Julio Frenk

Excerpt:

However, the focus on specific diseases has imposed and exposed fault lines in delivering services in places where many suffer from multiple health issues at the same time or at varying points in their lives. Although studies have shown that hiv interventions have reduced overall mortality and that malaria and immunization programs have reduced childhood mortality in the near term, it seems highly likely that more lives will be durably saved if a person afflicted by different health problems has access to services for all of them. Although there are limited supportive data, we believe it is likely that an integrated approach focused on the health of a person and community is more cost-effective than a silo approach focused on a specific disease or health threat. Yet, existing global health institutions were designed for specific diseases and have not effectively shifted to embrace a broader vision. It is time for a Bretton Woods-style agreement to guide a new international health strategy and rationalize its structure.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

The Impact Generic Drugs Have on the Cost of HIV Treatment

via Huffington Post, by Dean Baker

Drugs are cheap. Patent monopolies are expensive. These are simple facts that everyone should know but for some reason few do.

The point here is simple; the vast majority of drugs are cheap to produce. Chain drug stores sell hundreds of generic drugs for $5-$7 per prescription. They can do this profitably because few drugs require expensive chemicals or manufacturing processes.

However, many brand drugs sell for hundreds or even thousands of dollars per prescription. This is due to the fact that drug companies have patent monopolies on these drugs. The government will arrest anyone who produces these drugs without the permission of the patent holder. Since drugs can be essential for people's health and/or life, if they can find a way to pay any price demanded by the drug companies, they will.

The higher prices due to patent monopolies are the reason that many people have difficulty paying for drugs. If all drugs were sold in a free market as generics, paying for drugs would not be a serious issue except for the very poor.

Of course, patent protection is the way in which drug companies finance their research. It costs a lot of money to research new drugs and then test them to establish their safety and effectiveness and bring them through the Food and Drug Administration's approval process.
However, there are more efficient mechanisms than patent monopolies to finance drug research. Vermont Senator Bernie Sanders is proposing one such mechanism, a prize system, be adopted to support research on AIDS drugs.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Microbicides 2012 Conference: “Someday, our ARV-prevention tools will be as sexy as the I-Phone!”

Original content from the Mapping Pathways blog team

This is the second part of a two-part blog series on highlights and discussions from the Microbicides 2012 conference that recently concluded in Sydney. Here, Jim Pickett re-emphasizes the importance of adherence in clinical trials (a big topic of discussion at the conference) and his optimism about the future of the HIV prevention and treatment landscape. Read Part I here.

MP: Can you give us some examples that illustrate the issues surrounding adherence?

JP: The Partners PrEP trial and the FEM-PrEP trial are good case studies to illustrate the issues surrounding adherence in an HIV prevention clinical trial. Partners PrEP reported very high levels of adherence while the FEM-PrEP trial had to be stopped in April 2011 due to “futility.” Studies later indicated that while many of the FEM-PrEP participants said they adhered to the medication schedule, blood tests indicated that many did not.

A built-in support system and the risk perception of participants are the key here. In Partners PrEP, serodiscordant couples were enrolled together into the trial. One partner was HIV positive while the other was negative. The HIV risk of the HIV-negative partner was not theoretical; it was real. HIV was in their life and they were in it together.

FEM-PrEP involved women recruited on their own, with no consideration whether they were in a serodiscordant relationship – or any relationship for that matter. The risk of HIV was not present in the form of a partner who already had it, but it was, in fact, present in their environment where there was very high HIV incidenceIV HIV . It is interesting that many of these women did not believe themselves to be at a high risk of HIV, despite this high incidence.

Human beings are very good at rationalizing risks and saying “it can never happen to us.” I can drive fast and will never get into a car accident. If I feel a certain behavior is not risky, or that I can “get away with it”, I will not take steps to protect myself.

We don’t want to create tools where only people who are married or in a relationship are able to use the tools successfully. That would be crazy. But we do have to think about how important those social relationships are and use the lessons learned to devise new tools and new trials that give us answers – and develop things that work for all kinds of people, regardless of relationship status, sexual orientation, or whether their potential HIV exposure comes from unprotected vaginal intercourse, unprotected anal intercourse, or from the sharing of syringes during injection drug use.

MP: Are there any trials coming up that you are excited about?

JP: I’m very excited by the upcoming MTN-017 rectal microbicide safety and acceptability trial that will enroll approximately 186 gay men, other men who have sex with men, and transgender women at trial sites in South Africa, Peru, Thailand, and the United States. Participants will go through three eight-week cycles: One cycle of having a daily Truvada tablet, another cycle of applying a “rectal friendly” reformulated tenofovir gel every day, and a cycle of applying the gel before and after having sex.

What impresses me is the level of community involvement sought and obtained to help design this trial. The trial team, and advocates such as myself, visited each of the sites mentioned, had day-long meetings with community members, captured all their observations, and made adjustments to the trial design from the input received. We have to listen to the voices of the communities. We can’t just show up and conduct trials.

MP: What are your other thoughts on the HIV prevention and treatment landscape?

JP: I always like to compare the HIV prevention and treatment landscape to the evolution of computers and phones. Years ago, computers were the size of a house. It took time for the computer to evolve from its clunky beginnings to its current look where we can carry it around in our pocket and it can do more things than we ever could have imagined. Now we have phones and computers that are completely intuitive and easy to use.

Similarly, the HIV landscape has evolved over the years. Before 1996, we had a handful of drugs that didn’t always work great. They were toxic and had to be taken multiple times a day. When protease inhibitors came out in 1996, people near death’s door were brought back to life. But they also had to suffer through a whole host of side effects like nausea, diarrhea, and body disfigurements.

Now, new-age ARV medication can combine three drugs into one pill that has to be taken just once a day. The side effects are minimal and you don’t have to worry about requirements like eating it on a full or empty stomach, or having it refrigerated.

We are now in the clunky computer stage of ARV-based prevention. But, things will keep getting better. We can’t get to the streamlined phase before going through the clunky phase. We have to learn to crawl before we can run. Someday, our ARV prevention tools will be as sexy as the iPhone.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. Read Part I of Jim’s interview here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Researchers Report Low Number of People Living with HIV That Adhere to HIV Treatment and Care

via AIDSmeds.com, by Tim Horn

Only one in five people living with HIV meet the criteria for being established and retained in care, according to a new analysis involving 12 clinics across the United States to be published in a forthcoming issue of the Journal of Acquired Immune Deficiency Syndromes. Though the authors warn that the data involving nearly 23,000 people enrolled in the HIV Research Network are not representative of retention rates in the country, the results nevertheless underscore a need for improvements in keeping those living with the virus connected to care.

As John Fleishman, PhD, of the Agency for Healthcare Research and Quality in Rockville, MD, and his colleagues write: HIV care is a continuum. One end reflects the estimated 1.2 million people believed to be living with HIV in the United States; the opposite end reflects the low rate (28 percent) of people living with HIV in the country who are successfully engaged in HIV care, receiving antiretroviral therapy and maintaining undetectable viral loads.

Provision of care is problematic at intermediate points in this continuum. “An estimated 21 percent of persons living with HIV in the U.S. are unaware of their infection,” the authors note. “Among those aware of their HIV infection, initial linkage to care is often delayed. After patients have been linked with a provider and have made an initial visit, they must still remain in care, with regular visits over a long time period.”

The study conducted by Fleishman’s group examined these later, but essential, stages in the HIV care continuum, notably rates of establishment and retention in care. These rates were determined using three main measurements.

“Establishment” applied to patients who made follow-up visits for longer than six months after showing up once for HIV care. “Retention” applied to patients who had been seen at least twice at HIV Research Network clinics, with visits separated by 90 days, in each year following their initial visit. The researchers also considered the rate of patients lost to follow-up—those who stopped their HIV Research Network clinic visits without notifications.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Microbicides 2012 Conference: Adherence – the A-word on everyone’s lips

Original content from the Mapping Pathways blog team

In part I of this two-part blog series, Jim Pickett talks about his experiences at the recently concluded Microbicides 2012 conference in Sydney and the buzz among advocates and trial designers today.

MP: What were some of the highlights for you from the conference?

JP: The conference in itself was great with many interesting and informative presentations. A highlight for me was that conversations about rectal microbicides were integrated throughout the conference and not just in one or two presentations. Rectal microbicides got a lot of attention.

From a Mapping Pathways perspective, we submitted an oral abstract that was accepted and I think the presentation I did was well received. We generated a lot of conversations about the work we have been doing and are planning to do in the upcoming year.

A Canadian colleague presented on their country’s plans for integrating ARV-based prevention into their national prevention plan and one of their planned activities is to develop a Canadian version of Mapping Pathways. This stems from a consultation in Ottawa I participated in last year – so it was gratifying to see Mapping Pathways being picked up by others – and presented at an international conference.

MP: Are there any major themes that emerged from this conference?

JP: Adherence, the A-word, was a very big topic throughout the entire conference. We realized that we have to make HIV-prevention or treatment products people like and will want to adhere to. We have to figure out how tools like PrEP and microbicides fit in people’s lives, and funding should be put in place to better understand what people want, how they have sex, and the role of pleasure, love and intimacy, among many other “real world” realities. Right now, only about two percent of the budget of any study is used for the socio-behavioral aspect – that is, understanding participants’ motivations, documenting adherence, and exploring the communities they are a part of.

Adherence is especially crucial for PrEP to move into the real world. Participants in trials come to the clinic for monthly visits that include a host of prevention services and counseling on condom use and adherence to the study product. If adherence is an issue in such a controlled environment, how big of an issue will it be in the real world where they are not getting that level of intensive support?

A scenario where a trial has to be stopped because people did not take the drug is a major concern because it leaves us more questions than answers. We get no answers on the efficacy of the drug – we are left thinking “what if the person had taken it as instructed?”  We cannot afford to spend millions on trial after trial where we find out finally that people did not take the drug as instructed.

Sure, the lack of adherence could be telling us about acceptability – and if we are making products that people are having a hard time adhering to, is this product really acceptable? By the same token, this is an iterative process – what we have is what we have right now, and the only way to determine if the drug works is if people take it. We can’t improve on the delivery if we can’t answer that question. It is a bit of a conundrum.

MP: What are some of the strategies discussed to tackle the issue of low adherence?

JP: The first step, as mentioned, is to increase funding for the socio-behavioral components of the trial. We need to do better at finding the “right” trial participants. Imagine a case where two people are being recruited for an HIV study trial. One is a person who wants to do the study to the best of his or her abilities and is motivated by the aims of the study. The other person is motivated by the access to healthcare and the little monetary incentive provided by participation in the study. Would both their levels of adherence be the same? This isn’t to cast judgment on anyone – but really, we need to answer the study question – and we can’t do that if people don’t follow the study protocol.

Another interesting strategy being discussed more and more is separating the people who counsel the participants during the trial (adherence counseling) from the people who record user experiences taking, or not taking, the study product. If the same person performs these two functions, participants who form a bond with their adherence counselors during the course of the trial may be unwilling to disclose exactly how well they adhered to the program. The end goal is to find better ways to capture the data and make participants feel completely relaxed about being honest about their user experience. If they did not take the drugs as instructed, that’s ok. But we want to know why.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. Stay tuned for part II of the blog.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

An Outlook on What to Expect for the Future of HIV Treatment

via TheBody.com, by By Joel Gallant

2012 promises a number of changes and advances in the way we treat and prevent HIV infection. There is growing enthusiasm for widespread use of antiretroviral therapy (ART), regardless of CD4 count, both for treatment and prevention. New drugs and co-formulations are coming this year that will expand treatment options and simplify drug regimens, especially for initial therapy. At the same time, political and economic realities may prevent us from being able to implement broad-scale treatment and prevention efforts, and the coming of generic drugs, while cost-saving, may put limits on our choices of antiretroviral drugs.

When to Start

 San Francisco and New York City now recommend ART for everyone with HIV, regardless of CD4 count and viral load. Current U.S. treatment guidelines already come close to that aggressive standard. They recommend ART for anyone with a CD4 count below 500, and say that everyone else should consider treatment. Treatment is also recommended at any CD4 count for people with additional conditions, including pregnancy, HIV-associated nephropathy (HIVAN), hepatitis B or C, older age, high viral load, rapid CD4 decline, and high risk for heart disease.

In the minds of many HIV experts, ART is now the "default" -- recommended unless there's a good reason not to treat. Reasons why not to treat? People who aren't ready or willing to start should wait until they are. Some people have no way to pay for treatment, an increasingly common scenario even in the United States. We don't know what to do with "elite controllers" -- people whose viral loads are already undetectable without therapy. Assuming normal and stable CD4 counts, it would be hard to show a benefit to starting ART in those individuals.

How did we get to this point, where ART is recommended for virtually everyone else? First, we're recognizing that HIV isn't just a disease of immunosuppression due to CD4 decline. Untreated HIV has consequences even for people with high CD4 counts, due to the inflammation and immune activation caused by ongoing replication of the virus. Shutting off viral replication may help to reduce the long-term risk of conditions such as heart disease, cognitive decline, loss of bone density, and malignancies by reducing HIV-associated inflammation.

We also know that treating people with HIV lowers their risk of infecting others. In fact, the HPTN 052
study demonstrated that ART was 96% effective at preventing transmission to negative partners, a far greater efficacy than we've seen with any other form of prevention so far, including condoms, circumcision, microbicides, vaccines -- probably even "abstinence." Put simply, if everyone with HIV were on treatment with an undetectable viral load, we would see virtually no new cases.

Evidence of the benefit of early ART is clear, but the decision to treat early must also consider the cost of therapy, in order to weigh the costs against the benefits. Once-daily regimens are now the norm; a growing number of single-tablet regimens (STRs) are becoming available; tolerability and safety are high. Weighing the financial cost against the benefits is more complicated, since it involves economics and politics rather than science. This is where the prevention benefits of ART become so important. Some people may be unwilling to pay for universal ART for individuals, but if universal treatment can slow or even stop the epidemic, perhaps they'll see it as money well spent. (At least, that's what they should be thinking!)

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

CROI 2012: Results of iPrEx Trial Show Effective Dosage of PrEP

via AidsMap.com, by Gus Cairnes

Further testing of drug levels in the blood and immune cells of gay men participating in the iPrEx trial of tenofovir/FTC (Truvada) pre-exposure prophylaxis (PrEP) has found that HIV infection in men assigned to Truvada was associated with a lapse in taking the drug after initially adhering reasonably well, rather than never having taken it at all, which was what the researchers originally thought. The research was presented at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), in Seattle.

The testing also found that only a minority of participants appeared to be taking their drugs as prescribed, seven days a week, but that protection levels were very high – in the order of 96% of infections prevented – as long as participants took four or more doses a week.

Drug levels plummet three months before infection

 The results of iPrEx, a large multi-country study of PrEP in gay men, were announced in 2010 and showed an overall efficacy of 42% – in the trial subjects as a whole, four out of ten HIV infections that would otherwise have happened were prevented if subjects were given Truvada pills to take daily rather than placebo pills. When drug levels were tested in the 48 participants who became HIV-infected on Truvada, and a random sample of uninfected participants, it was found, perhaps not surprisingly, that drug was detectable in only 10% of the infected participants but also, perhaps more surprisingly, in only 50% of the uninfected ones.

New measurements have now looked back at drug levels in stored samples in the months prior to infection and compared with drug levels in the same time period in uninfected participants. In the uninfected participants, consistently 45% or so had detectable drug in their samples across the whole length of the study – confirming that at least half of the participants simply never took their pills. In the infected participants average adherence rates started off the same as in the uninfected. They showed a slight decline in the first year of the trial but then declined to 10% in the three months preceding infection. This suggests a role for quarterly adherence reinforcement.

What levels of tenofovir are protective?

 The researchers also wished to find out what levels of tenofovir in the blood were associated with protection against HIV. They did this by comparing drug levels in iPrEx participants with drug levels in a small study called STRAND, presented at last year’s conference (Liu),which gave participants directly-observed doses of tenofovir twice, four time or seven times a week and then measured drug levels in their hair. By then comparing the levels of protection seen in participants with specific drug levels in iPrEx, the researchers were able to compute what drug level was protective.

In iPrEx the average drug levels seen in infected people were consistent with less than one dose of tenofovir a week, but drug levels in those who were not infected were consistent with only about three doses a week. Only 18% of iPrEx participants had drug levels consistent with taking seven doses a week. The investigators used very sensitive tests to look at levels of metabolised tenofovir inside cells and found that a reduction of 90% in the risk of HIV infection correlated with a drug level of 16 femtomols per mol (fm/M – 16 in every million billion molecules by weight). The average level associated with seven doses a week in STRAND was about 38 fm/M and with four doses a week about 32 fm/M.

This enabled them to calculate that the protection offered by taking four doses of tenofovir a week was high, and more or less the same as taking seven doses – that is, in the order of 96%, with a minimum likely protectiveness of 90%. They also calculated that absolutely perfect adherence would offer 99% protection. Taking two doses a week (consistently) would still offer 72% protection, though within wide confidence intervals (56% to 96%) while the 42% level of protection actually seen in iPrEx was consistent with participants taking, on average, one dose a week.

This study has important limitations. STRAND did not measure FTC levels so the iPrEx researchers could not calculate what extra protection was offered by that drug. They also could not measure drug levels at the actual moment of exposure – they were measured at anything between 15 and 90 days after infection. And of course the ‘number of doses a week’ measure is purely an average – most participants probably had much more irregular patterns of taking their pills, with (amongst the 50% who took it at all) periods of good adherence interspersed by periods off drug, maybe correlated with times on and off sex. But it does give a guide to the likely minimum levels of tenofovir that people need to maintain in order to be protected from HIV.



[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Researchers Make New Guidelines for HIV Treatment

via News Medical

Leading AIDS experts at Johns Hopkins and other institutions around the world have issued new guidelines to promote entry into and retention in HIV care, as well as adherence to HIV treatment, drawn from the results of 325 studies conducted with tens of thousands of people infected with HIV, the virus that causes AIDS.

The guidelines are believed to be the first ever to focus exclusively on how best to get those newly diagnosed with HIV into treatment plans and to help them adhere to lifelong drug and check-up regimens.

Some 50,000 Americans each year are diagnosed with the potentially deadly, but now-treatable infection, and more than a million Americans already are known to be HIV positive.

However, experts worry that barely two-thirds of Americans with HIV disease, some 69 percent, have ever used potent antiretroviral drug therapy, or ART, to keep viral levels in the blood low. Still fewer, they say, 59 percent, continue their drug therapy, and less than a third, or 28 percent, have achieved near total viral suppression to keep the disease in check by carefully complying with treatment regimens and getting regular tests for viral load.

"Clearly, there is lots of room for improvement in how we, as care providers, can get new patients into treatment and help them adhere to the often strict drug regimens needed to suppress the viral disease and prevent drug resistance," says guidelines co-author and infectious disease specialist Larry W. Chang, M.D., M.P.H.

The need is urgent, he says, because other research has shown that patients who miss follow-up medical
visits within the first year after they begin outpatient drug treatment for HIV infection tend to be out of compliance with regimens, and, over the long term, die at twice the rate of those who keep their appointments.

Chang, an assistant professor at the Johns Hopkins University School of Medicine, was one of 31 experts worldwide, including three faculty members at Johns Hopkins, who drafted the guidelines on behalf of the International Association of Physician in AIDS Care, or IAPAC.
The guidelines were published online this week in the Annals of Internal Medicine and the publication was timed to coincide with the 19th annual Conference on Retroviruses and Opportunistic Infections in Seattle.

Read the Rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Positively Aware's HIV Drug Guide is a "Must Have"

viaSan Diego Gay and Lesbian News.com

The Positively Aware 16th Annual HIV Drug Guide, widely recognized throughout the country as the “must-have” reference tool for HIV service providers and consumers alike, is now available.

There are now 30 FDA-approved HIV therapies to choose from, and finding the most effective and appropriate medication regimen is vital to success in treating HIV. The guide provides important information to individuals living with HIV as well as their caregivers on how best to manage their treatment.

This 80-page issue of Positively Aware devotes a full page to each approved HIV medication, plus four experimental medications, three of which are slated for approval later this year: the integrase inhibitors elvitegravir and dolutegravir (the latter now available through expanded access), the new upcoming single-tablet regimen known as the “Quad,” and the pharmaco-enhancer boosting agent cobicistat.

The pullout drug chart, sponsored by Walgreens, includes dosing information, as well as food and liquid requirements for the drugs, along with a photo to help easily identify each medication. Readers will also find detailed information on side effects, drug interactions, and current trends in HIV care and treatment.
This year’s guide also has an updated and expanded article on HIV drug co-pay and patient assistance programs being offered by pharmaceutical companies, including an easy to read chart, plus information on AIDS Drug Assistance Programs, Medicare, and Medicaid.

“It’s so critical that people know that there is help available when accessing and paying for treatment,” Positively Aware Editor Jeff Berry said. “There is no reason why anyone should be denied access to lifesaving medication based solely on an inability to pay for their drugs or co-pays, or because they cannot afford health insurance.”

One of the most popular features of the guide is the viewpoint given on each medication from a well-respected physician and an activist. Contributors to this year’s Drug Guide include Dr. Joel Gallant, professor of medicine and epidemiology at the Johns Hopkins University School of Medicine’s Division of Infectious Diseases, and associate director of the Johns Hopkins AIDS Service; activist Joey Wynn, director of public policy at Broward House in Fort Lauderdale, Florida; Renata Smith, PharmD, clinical assistant professor in HIV/infectious diseases at the University of Illinois at Chicago; and Associate Editor Enid Vázquez.

“Positively Aware’s Annual HIV Drug Guide is a great source for cutting edge treatment information, not only for those of us who prescribe these drugs, but for our HIV-positive patients as well,” Gallant said. “I was happy to be asked again to contribute to this year's edition — it’s always an enjoyable project.”

Positively Aware is an internationally known and respected magazine devoted to HIV treatment and health. It has a circulation of over 100,000, and is published bi-monthly by Test Positive Aware Network (TPAN). Founded in 1987, TPAN is Chicago’s oldest peer-led AIDS service organization and specializes in treatment information, support services, and prevention.

To order copies of the magazine, call (773) 989-9400 or distribution@tpan.com. For more information about TPAN and Positively Aware magazine visit tpan.com and positivelyaware.com.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Mobile testing units show success in linking people to HIV care and treatment

via aidsmap, by Carole Leach-Lemens

Linkage to facility-based HIV care from a mobile testing unit is feasible, South African researchers report in the advance online edition of the Journal of Acquired Immune Deficiency Syndromes.

In a stratified random sample of 192 newly diagnosed individuals who had received CD4 test results, linkage to care was best among those who were ART eligible, Darshini Govindasamy and colleagues found.

The lower the CD4 cell count the greater the linkage to care: all of those with CD4 counts at or under 200 cells/mm3, two-thirds of those with CD4 counts of 201-350 cells/mm3 and a third of those with CD4 counts over 350 cells/mm3 linked to care.

An estimated two million people died as a result of HIV/AIDS in sub-Saharan Africa in 2008. South Africa now has the largest ART programme in the world, yet half of those in need of treatment do not get it. And a large number of those who do present for care, present late with low CD4 cell counts increasing their risk of early death.

In South Africa traditional HIV counselling and testing (HCT) sites at stationary facilities have increased and consequently so have the numbers tested. Yet this has not resulted in increased numbers on treatment and in care.

Transport costs, being male and having a low CD4 cell count have been well documented as the primary barriers of non-linkage to care.

Successful early diagnosis of HIV has to be accompanied by strategies that assure timely linkage to care and treatment so improving health outcomes.

Mobile testing units offer several advantages: people are often tested at an earlier stage of HIV; it is easier for hard-to-reach and high-risk populations to test; and they are cost-effective. However, maintaining on-going HIV care may prove difficult, requiring referral to stationery facilities.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

TLC+ Strategies in 4 US Cities: San Francisco, Los Angeles, Birmingham, and Washington D.C.

via Project Inform, by Mark R. Vogel

Despite significant advances in the treatment and prevention of HIV, the number of new HIV infections in the United States holds steady at about 50,000.1 Furthermore, 21% of individuals infected with HIV in the United States are not aware of their status, and an estimated 33% of those who know that they are HIV-positive are not engaged in care and treatment for their disease.2 Another 38% of newly diagnosed individuals test positive for HIV so late that they receive an AIDS diagnosis at the same time as, or within a year of testing positive.3 Clearly, novel prevention strategies, ways to engage individuals in care sooner after infection, and methods to maintain them in care and treatment needed.

One such strategy is the Test, Link to Care, Plus Treat (TLC-Plus) approach. TLC-Plus addresses several aspects of the healthcare system that can be improved to help those with HIV live longer and healthier lives while also reducing transmission of the virus to others. The National HIV/AIDS Strategy places testing, linkage to care, treatment and support services at the center of efforts to improve the health outcomes of HIV-positive individuals and to prevent new infections.4

This paper examines successful components of TLC-Plus programs in four jurisdictions and specific strategies used to achieve desired health outcomes, as described by public health officials in each. It is our hope that these strategies may be used to inform the development of TLC-Plus programs across the country. Consideration is also given to funding and to the role of electronic medical records, in Louisiana, in assisting patients who have fallen out of (or never entered into) care.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.] 

Kaiser/UNAIDS study finds drop in overall disbursements for AIDS response in 2010, seven out of 15 governments report reductions

Via the Kaiser Family Foundation.

Funding disbursements from donor governments for the AIDS response in low- and middle-income countries fell in 2010, dropping 10% from the previous year’s level, according to an annual funding analysis conducted by the Kaiser Family Foundation and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The study found that donor governments disbursed US$ 6.9 billion in 2010 for HIV prevention, treatment, care and support--US$ 740 million less than in 2009. The decrease was due to a combination of three main factors: actual reductions in development assistance, currency exchange fluctuations, and a slowdown in the pace of U.S. disbursements, which was not a budget cut.

Of the 15 governments surveyed, seven--Australia, Germany, the Netherlands, Norway, Spain, Sweden and the United States--reported a year over year decrease in their disbursements as measured in their own currencies. The figures presented in the report are in US dollars, consistent with international standards and other reporting mechanisms.

Due to currency fluctuations, when measured in US dollars, Australia showed a slight increase in its AIDS funding contribution even though it contributed less in its own currency. Conversely, there was a slight decrease in Denmark’s contribution despite the country’s increased funding level in its own currency.

"AIDS is a smart investment even in this difficult economic environment. We have to look beyond the near-term costs and recognize the long-term benefits," said Michel Sidibé, Executive Director of UNAIDS. "Donors need to make and follow through on commitments today to reduce costs in the future."

The overall drop in disbursements was primarily attributed to a reduction in disbursements by the United States, the largest donor nation, which accounted for 54% of total donor disbursements in 2010. While the United States Congress appropriated similar levels of funding for the AIDS response in 2010 as in 2009 (approximately US$ 5.5 billion in each year), disbursements from the United States declined from US$ 4.4 billion in 2009 to US$ 3.7 billion in 2010. This slowdown stems from new requirements established by Congress for the United States President’s Emergency Plan for AIDS Relief (PEPFAR). Some funds appropriated in 2010 will be disbursed in later years.

"With U.S. funding delayed but not eliminated to this point, this year’s drop in spending may be a temporary blip, though its impact on services may be real," said Drew Altman, Kaiser Family Foundation President and CEO.

Read the rest here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Treatment As Prevention: We Urgently Need Policy Guidance

Via PLoS, by Nathan Ford.

The International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome has been hailed as a landmark conference for HIV prevention. Just as the AIDS conference in Vancouver in 1996 marked the beginning of the international effort to roll out antiretroviral therapy globally, so Rome will likely be remembered as the beginning of a new era in biomedical prevention.

The results of the HTPN 052 discordant couples trial, which found the greatest incidence reduction of any prevention intervention evaluated to date, were met with a standing ovation. This trial found a 96% reduction in HIV transmission and a 40% reduction in serious complications, in particular tuberculosis (TB), among patients starting ART early, at CD4 350-550 cells/mm³.

Implementation of this strategy is, however, hampered by lack of guidance from the World Health Organization. Draft guidelines for the provision of ART in discordant couples have been in process for many months, and their release was first announced in May, and then again July. However, by the end of the conference it remained unclear when the guidelines would be released, or what they would say.
Rumours spread in the conference corridors that WHO had been pressured to delay the release. Some suggested the issue at stake was to find the right balance in investment between the results of HTPN 052 and those of the recently completed pre-exposure prophylaxis trials that also reported a substantial prevention benefit.

There are at least three reasons why such a trade off is wrong.

First, providing ART earlier is desirable for more reasons than reduced HIV transmission: the HIV-positive individual receives treatment at a stage in their disease that developed country guidelines already consider therapeutically beneficial; their risk of developing incident diseases, in particular TB, is substantially reduced; reducing TB incidences confers the additional public health benefit of reducing the risk of TB transmission.

Second, discussions about whether to give ART to HIV-positive or HIV-negative individuals are ethically problematic. Economics has long been described as the ‘dismal science’, but it is hard to think of a more dismal economic proposition than to delay giving ART to people already infected with the pathogenic HIV virus in order to give the drugs to HIV-negative individuals instead.

Third, there are fundamental practical differences to the two approaches. Implementing the results of HTPN 052 means further extending what is already happening (giving ART to HIV-infected individuals); in contrast, giving ART to HIV-negative, at-risk individuals requires extensive operational research to help define what is essentially an entirely new programmatic approach.

Read the rest here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

At Home or in Rome, Online Resources to Keep You Connected to IAS 2011

via IAS

The 6^th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) kicks off on Sunday, 17 July and promises to offer a wealth of important scientific news, including the first full presentation on HPTN 052 and new data on a wide-range of topics including elite controllers, gene therapy, effectiveness of existing treatment regimens, co-infections, microbicides, PrEP, task-shifting, and decentralization of care.

There are a number of online resources for those following at home and those attending the conference. All can be accessed through the conference website.

Programme-at-Glance

The Programme-at-a-Glance (PAG) will include slides with audio from more than half of the sessions, including all plenary sessions and most oral abstract sessions. Audio/slides for most sessions will be posted within six hours, though in some cases it will take 12-24 hours.

Abstracts

Abstracts will be available through the PAG and posted at the time of presentation.

Rapporteur Reports

Rapporteurs will prepare summaries of all sessions along with daily summaries in each track, available here.

Blog

The Conference Blog is live and already has posts from a variety of guest authors. We’ll be posting more this week and tracking key developments during the conference and encourage your feedback, thoughts and ideas.

Twitter

We are tweeting – @ias2011 – and encourage you to tweet and re-tweet along with us, using #IAS2011.

Facebook

Follow IAS 2011 on Facebook for updates on and links to key sessions and developments, as well as photos, video highlights and interviews.

YouTube

The IAS 2011 YouTube channel has past interviews and talks from conference speakers and leadership and we’ll be adding more from the conference.

Photo Library

Free, high-resolution photos for use by the media and others (with appropriate credit) will be available through the IAS 2011 online media centre.

Online Partners Coverage

News Reports by NAM
NAM will offer news stories on major scientific presentations on aidsmap.com and publish a free daily news bulletin in English and translated into French, Portuguese, Spanish and Russian. Sign up here to receive the bulletin via email.

Scientific Analysis by CCO Clinical Care Options’ (CCO) online coverage at clinicaloptions.com will begin the week of 17 July and include expert audio highlights, capsule summaries of important clinical data, downloadable slidesets and more.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Gilead Deal: More AIDS Patients May Get Cheaper Drugs

Ranbaxy Laboratories recently entered into a deal with Gilead Sciences that will allow the Indian pharmaceuticals company to manufacture generic versions of three new HIV medications.

Via Associated Press:

Gilead Sciences Inc. will allow some of its AIDS drugs to be made by generic manufacturers, potentially increasing their availability in poor countries, particularly in Africa, officials said Tuesday.

In the first deal of its kind, the pharmaceutical company has agreed to allow four of its AIDS drugs to be made by generic drug companies at a cheaper cost in return for a small proportion of royalties, United Nations health officials said.

Most of the 33 million people worldwide who have HIV, the virus that causes AIDS, live in Africa. One of the drugs will also be used to treat people with hepatitis.

The deal was negotiated by the Medicines Patent Pool, part of a U.N.-led partnership that raises money for AIDS, tuberculosis and malaria by things like taxing airplane tickets. Among the partnership's 29 member countries, only Chile, France, Korea, Mali and Niger are actually implementing the airline tax.

"We will continue to work with Gilead and others to expand access to all people living with HIV in developing countries," said Ellen 't Hoen, executive director of the Medicines Patent Pool.

Gilead will receive from three to five percent royalties on its four drugs, which will be supplied to about 100 countries.

Until now, its drugs have been mainly sold in rich countries, and profits from the new deal are expected to be a tiny fraction of those Gilead gets from the West.

Typically, patients in poor countries have to wait for years until the patents expire on new drugs before they can be made more cheaply by generic companies.

Read the rest here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

India says EU deal won't hit AIDS drugs supply

Via Reuters, by Nita Bhalla.

India has promised not to link a proposed trade deal with the European Union with limiting its production of generic HIV/AIDS drugs, the United Nations said on Thursday, giving hope to millions of infected patients but underlining the hurdles for the controversial pact.

The EU and India began negotiations in 2007 on a free-trade agreement which could generate two-way trade annually worth about $134 billion. But campaigners, including the U.N., have voiced concerns over how it could block India's ability to produce anti-retroviral (ARV) drugs and prevent the world's poor from accessing cheaper treatment.

"The Government of India reaffirms its full commitment to ensure that quality generic medicines, including anti-retroviral drugs, are seamlessly available, and to make them available to all countries," India's Commerce Minister Anand Sharma was quoted as saying in a statement issued by the Joint United Nations Programme on HIV/AIDS (UNAIDS).

"India will also use the flexibilities allowed under (the copyright pact) TRIPS, including the use of compulsory licensing, to ensure that people living with HIV have access to all life-saving medicines."

Sharma made the comments in a meeting with UNAIDS Executive Director Michel Sidibe, who on Tuesday told Reuters in an interview that millions of people around the world would die if the deal blocked India from producing generic medicines.

An estimated 15 million people are eligible for ARVs in low-and middle-income countries, yet currently only about 6.6 million people have access to treatment. India's pharmaceutical industry produces about 86 percent of the first-line cheap generic drugs, most of whom live in Africa.

Generic ARVs cost about $137 per person per year, a fraction of the price of patented ARVs used to treat the human immunodeficiency virus (HIV) that causes AIDS, and are sold by western pharmaceutical firms, say experts

Read more here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]