Retention of pre-ART patients poor in sub-Saharan Africa

Via AIDSMap, by Lesley Odendal.

 More than two-thirds of people who tested positive for HIV but weren't yet eligible for treatment when diagnosed were lost from care, according to a systematic review of pre-antiretroviral (pre-ART) care in sub-Saharan Africa, published this month in PLoS Medicine.

Studies included in the review report a substantial loss of patients at every step of care, starting with patients who do not return for their initial CD4 count results and ending with those who do not initiate ARVs despite eligibility, according to Sydney Rosen and Matthew Fox of the Center for Global Health and Development at Boston University, who conducted the review.

The study was conducted in order to evaluate the extent to which patients diagnosed with HIV are being lost before starting treatment.

28 studies which reported on the proportion of adult patients retained between any two points between testing positive for HIV and initiating ART in sub-Saharan African HIV/AIDS care programs were included. Results were categorised into stages of pre-ART care with ranges  reported for the proportions of patients retained in each stage.

Stages were categorised as follows:

• Stage 1: from HIV testing to receipt of CD4 count results or clinical staging
• Stage 2: from receipt of CD4 count results or clinical staging to ARV eligibility
• Stage 3: from ARV eligibility to ARV initiation

The review found that the median proportion of patients retained in Stage 1 was 59% (ranging from 35%–88%); Stage 2, 46% (31%–95%); and Stage 3, 68% (14%–84%).  'Loss to care' was defined as failing to reach the next step in the care sequence for any reason (death or discontinuation), but each study’s own criteria for determining which patients died or discontinued care were also included.

There are several key reasons for the poor retention of pre-ART care patients. As most patients are asymptomatic during the pre-ART period, they may not perceive themselves as requiring medical care. Patients may also not come to the clinic for monitoring and may choose to ‘‘wait and see what happens’’  if they "lack resources for transport, risk losing employment by taking time off work, or fear being recognised as a client of an HIV clinic," write the authors. Those presenting with a low CD4 count are likely to have died before reaching stage 3. Patient mobility may also be a factor contributing to low retention rates.

 Read the rest here.

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

Retention in HIV Care between Testing and Treatment in Sub-Saharan Africa: A Systematic Review

Published in the July 2011 Issue of PLoS Medicine.

 

Background

Improving the outcomes of HIV/AIDS treatment programs in resource-limited settings requires successful linkage of patients testing positive for HIV to pre–antiretroviral therapy (ART) care and retention in pre-ART care until ART initiation. We conducted a systematic review of pre-ART retention in care in Africa.

 

Methods and Findings

We searched PubMed, ISI Web of Knowledge, conference abstracts, and reference lists for reports on the proportion of adult patients retained between any two points between testing positive for HIV and initiating ART in sub-Saharan African HIV/AIDS care programs. Results were categorized as Stage 1 (from HIV testing to receipt of CD4 count results or clinical staging), Stage 2 (from staging to ART eligibility), or Stage 3 (from ART eligibility to ART initiation). Medians (ranges) were reported for the proportions of patients retained in each stage. We identified 28 eligible studies. The median proportion retained in Stage 1 was 59% (35%–88%); Stage 2, 46% (31%–95%); and Stage 3, 68% (14%–84%). Most studies reported on only one stage; none followed a cohort of patients through all three stages. Enrollment criteria, terminology, end points, follow-up, and outcomes varied widely and were often poorly defined, making aggregation of results difficult. Synthesis of findings from multiple studies suggests that fewer than one-third of patients testing positive for HIV and not yet eligible for ART when diagnosed are retained continuously in care, though this estimate should be regarded with caution because of review limitations.

 

Conclusions

Studies of retention in pre-ART care report substantial loss of patients at every step, starting with patients who do not return for their initial CD4 count results and ending with those who do not initiate ART despite eligibility. Better health information systems that allow patients to be tracked between service delivery points are needed to properly evaluate pre-ART loss to care, and researchers should attempt to standardize the terminology, definitions, and time periods reported.

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

IN CONVERSATION WITH DR. SONALI KOCHHAR: PrEP in India

Dr. Sonali Kochhar, medical director India of OneWorld Health and one of the two Indian women chosen for the prestigious 2011 Yale World Fellows leadership initiative, provides a thoughtful discussion on PrEP within the Indian context.

MP: Could you please briefly introduce yourself, and tell us how you got involved in the field of HIV prevention?

SK: I was the Medical Director, India for the International AIDS Vaccine Initiative for seven years and was involved in the preparation and conduct of the first ever AIDS vaccine trials conducted in India.

I got involved in the field of HIV prevention because early on in my medical training, I saw firsthand how diseases like HIV not only severely impacted the person infected but also their whole families. The severe stigma and discrimination associated with the disease in developing countries like India only worsens the issues. Seeing women being disowned by their families and children thrown out of schools and shunned by society convinced me that it is imperative that safe, effective and accessible preventive options are found at the earliest to prevent these tragedies. History has shown that vaccines are often the most powerful and cost-effective disease prevention tools available. It is hoped that a preventive AIDS vaccine will stem the global HIV pandemic.   

MP: What are your thoughts on PrEP, particularly within the Indian context?

SK: There is mounting evidence that pre-exposure prophylaxis might prove to be an important new prevention approach. The results of from the iPrEx trial were promising in showing that in MSM and transgendered women who have sex with men, daily TDF/FTC (tenofovir disoproxyl fumarate plus emtricitabine, Truvada) reduced the risk of HIV by 44 percent.

If proven safe and effective in all populations[1], PrEP could help address the urgent need for a female-controlled prevention method for women who are often unable, because of cultural and financial barriers, to negotiate condom use.

It could be used by men and women at risk due to sexual or drug-using behaviors, when combined with prevention measures like reducing the number of sexual partners, HIV counseling and testing, condom use, use of sterile syringes etc.

  

MP: What are the particular pros and cons, challenges, or issues of rolling out PrEP here? Do you think it should be made accessible to everyone?

SK: There are numerous questions about the implementation of PrEP outside of the research setting especially in the context of countries like India with problems like the lack of a strong evidence base on which to formulate decision making, an unregulated health sector and a highly vulnerable population often severely disadvantaged in terms of income, education, power structures and gender.

These include whether the intermittent use of the drugs will be effective, how the cost will be borne and how would the health and safety of PrEP users be monitored. The impact of PrEP may be strongly diminished or even reversed by behavioral disinhibition (increased risky sexual behavior because people may feel protected against HIV infection), especially in scenarios with low coverage and low effectiveness. PrEP would need to be used with other preventive modalities but it is not certain how this can best be done.

Large-scale PrEP use might encounter problems such as poor adherence and resistance. One of the problems of intermittent use, besides reduced effectivity, is possible emergence of resistant viruses.

If clinical trials demonstrate efficacy of PrEP, as many expect, the demand for its provision may increase rapidly. Indian Policymakers, Program Planners and Public Health Workers will need to prepare for this. This will include the development of national testing and assessment protocols, behavioral interventions, ensuring uninterrupted supply of PrEP and monitoring the population-level impacts of PrEP use.

To support the use of PrEP as a population-level prevention strategy, I feel that the following issues need to be resolved:

1) PrEP drugs – The challenges encountered in countries like India would include ensuring financing for an uninterrupted supply of drugs, training and retaining health workers; establishing and maintaining clinical, laboratory, and public health infrastructure; overcoming barriers to accessing care such as stigma, lack of awareness, and geographical distance; implementing appropriate monitoring and evaluation systems; sustaining patient adherence; and managing drug-related toxicity and resistant infections. Guidelines for PrEP eligibility, optimal PrEP dosing, necessary adherence, route of administration and channels for PrEP prescription and monitoring would need to be developed.

2) Safety screening – To address the risk of new HIV infection, including the acquisition of drug-resistant HIV and the development of secondary resistance in PrEP users, repeated and frequent HIV testing would be required. This will require  laboratory costs and infrastructure expansion. PrEP may only be cost effective for individuals at high risk for HIV. Side effects of PrEP like loss of bone density or renal impairments, will require ongoing clinical and laboratory monitoring.

3) Integration of PrEP as part of comprehensive care – As PrEP implementation requires clinical assessment, prescription, routine testing, and long-term monitoring of PrEP users, it will require a frequent and stable interface between PrEP users and clinical providers in an ideal scenario.

MP: Looking at the big picture, who do you think would benefit most from PrEP?

SK: Keeping in mind the above mentioned challenges, initial efforts might target members of known high-risk groups, such as sex workers, high-risk men who have sex with men, HIV negative individuals in serodiscordant sexual partnerships, and high-risk injection drug users.

MP: Is there any experience that stands out to you from your time on the field, which had an impact on you or that you can’t forget?

SK: Working with vulnerable populations like transgender individuals and men who have sex with men (MSM) was really an eye opener. These are people who often have nothing to their name (often not even a roof over their head), are disowned by society and their families and are completely discriminated and stigmatized against.[2] Yet a number of them were keen to help spread awareness about HIV/AIDS, prevention options and vaccines so that others may benefit from the information and not get infected with HIV. This degree of humanity is truly remarkable.

Dr. Sonali Kochhar is currently the medical director for India at OneWorld Health, where she leads efforts to develop safe, affordable, and accessible drugs and vaccines for diseases prevalent in the developing world.

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[1] Since the time of this interview – two additional studies – the Partners PrEP study and the CDC Bostswana study have shown that PrEP works in heterosexual individuals.

[2] To know more about HIV/AIDS in LGBT communities,  read HIV Prevention and LGBT Communities: Syndemics, Resilience, and Real Change.

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

HIV researcher plans new PrEP study

Via Now Chelsea, by Sam Spokony.

Few methods of HIV prevention have been as promising, or as controversial, as pre-exposure prophylaxis (PrEP). After a history of underground practice and off-label prescriptions, the approach has recently begun to receive serious attention from researchers, policy makers and health care advocates.

An outgrowth of post-exposure prophylaxis (or PEP, a short-term antiretroviral treatment that has been used since the early 90s to decrease the likelihood of HIV infection after exposure to the virus, either occupationally or through sex), PrEP is a similar antiretroviral that can be taken by HIV-negative individuals in order to help prevent them from seroconverting (being infected).

The results of a Phase III clinical study known as iPrEx were published in the New England Journal of Medicine on November 23, 2010. The study showed that, in a group of 2,499 gay men, PrEP — in the form of a combination of drugs under the brand name Truvada — was 44 percent effective in preventing HIV seroconversion.

Under the guidance of Dr. Roy Gulick (director of the Weill Cornell Medical College HIV Clinical Trials Unit), a new experiment called the NEXT (Novel Explorations of Therapeutics) PrEP Study will begin this fall. It will include 400 at-risk, HIV-negative gay men, and will take place over 48 weeks at 12 sites across the U.S. and Puerto Rico.

The NEXT PrEP Study will differ from iPrEx in that its primary experimental group will receive a daily regimen of the drug maraviroc (brand name Selzentry). The control group will receive Truvada, and two other experimental groups will receive combinations of maraviroc and either tenofovir or FTC (the two individual drugs that make up Truvada). A major goal of the study, along with testing the HIV-prevention efficacy of maraviroc, will be to gauge the side effects of the drug on participants.

“The longest any HIV-negative person has taken PrEP in a clinical study is 12 weeks,” Gulick told Chelsea Now in a July 23 phone interview. [This is inaccurate. The participants in iPrEx, for instance, were followed about 14 months - MP] “Now, since this is a drug we’re giving to healthy people, the next step is exploring further to prove that it is both safe and tolerable for them.”

Read the rest here.

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

Treating HIV Sooner Would Save South African Lives and Money

Via Science Daily.

If the South African government followed a recent recommendation by the World Health Organization to start antiretroviral therapy (ART) for HIV-infected residents earlier in the progress of the disease, the policy shift would start saving the country money after 16 years and would extend thousands of lives for dozens of years, according to a new study.

In 2009, the WHO recommended that people start ART when a key measure of immune system strength, the CD4+ cell counts, reaches a concentration of 350 per microliter of blood. South Africa has instead decided to stick with the old standard of waiting until only 200 cells per microliter remain, reflecting a more compromised immune system.

"South Africa, the country with the most people living with HIV/AIDS in the world, has not yet adopted the WHO treatment initiation criteria," said Mark Lurie, a Brown University epidemiology professor and senior author of the study published online July 20 in PLoS One. "We used a mathematical model to predict the impact of adopting the new WHO guidelines on HIV prevalence, incidence, and cost. We found that changing the treatment guidelines would have a profound impact on HIV incidence. It would require, over five years, an additional 7 percent investment, resulting in 28 percent more patients receiving HIV treatment. After 16 years, the cumulative net costs reach a break even point."

In addition, the models developed by Lurie's team show South Africa saving more than 120,000 life-years by 2040. Life-years are determined by multiplying the number of people who will still be alive by the number of years of extra longevity.

The reason why the higher up-front investment in ART ultimately would save South Africa money and lives, the authors wrote, is because more aggressive ART treatment would curb the epidemic's spread. Reduced infectivity from the drugs would outweigh the longer period of time in which HIV-infected people would be alive and therefore able to spread the virus.

Read the rest here.

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

A Trade Barrier to Defeating AIDS

Via the New York Times, by Tina Rosenberg.

Earlier this month, [the Medicines Patent Pool, a new organization trying to make AIDS drugs better, cheaper and available sooner to people who need them in poor countries] received its first donation of rights from a pharmaceutical manufacturer, Gilead Sciences.   It is an important step  — but the terms Gilead negotiated are also confirmation of a dangerous new trend: middle income countries as a target market for drug makers.  In the past, pharmaceutical companies have lowered prices in these countries to increase sales.  The new strategy is to treat people in Egypt, Paraguay, Turkmenistan or China — middle-income countries, all — as if they or their governments could pay hundreds or even thousands of dollars a year each for AIDS drugs.   This low-volume high-profit strategy might make  business sense.   But in terms of the war against AIDS, it means surrender.

In the world’s most impoverished countries, AIDS drugs are cheap.   It wasn’t always that way.  Until well into the Clinton administration, the United States government pressured even the poorest countries shamelessly if they tried to bring down the prices of medicine.   Even newly democratic, AIDS-ravaged South Africa became the object of an all-out assault by the Clinton administration to get the country to repeal a law allowing it to break medical patents, a step that was perfectly legal under world trade rules.  Washington was not interested in the health consequences.   (A U.S. trade negotiator who worked on South Africa at the time told me that he had been unaware that AIDS was a major problem there.)    Public outrage over South Africa ended Washington’s pressure on poor countries.   In 2000, President Clinton issued an executive order pledging that sub-Saharan African countries would not face trade sanctions for laws promoting access to AIDS medicines.

The order continues to be largely respected, and the group of countries who are generally able to get access to the cheapest drugs has grown to include the poorest countries from around the world — Afghanistan, Tajikistan, Bangladesh, Burma.    Gilead’s agreement with the Medicines Patent Pool covers these countries.

But countries just above this cutoff line are on their own.  “There are countries that are considered to be “middle income” that will never be able to afford the high prices charged by innovative pharma companies,” said reader A. Grant of New York.  These nations are also losing the discounts that major manufacturers of AIDS drugs used to offer them.  According to Médecins Sans Frontières, which tracks drug prices, prominent manufacturers of AIDS drugs have stopped offering discounts to middle-income countries, or now require that countries negotiate those discounts one by one.

Read the rest here.

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

HIV Prevention and LGBT Communities: Syndemics, Resilience, and Real Change

How can justice be better served for the lesbian, gay, bisexual and/or transgender (LGBT) community? This remains one of the biggest questions in the US – the last few months have seen a country-wide discussion on this issue, sparked off by what is being called an “epidemic” of suicides by gay teenagers.[1] “People are talking about the important ways through which the US, in the coming generation, can begin to honor the rights of LGBT communities – I believe, in time, that would reduce the incidence of HIV infection,” says Julie Davids, Director of National Advocacy and Mobilization at the AIDS Foundation of Chicago and Coordinator at the HIV Prevention Justice Alliance.

There is strong data on the “syndemics” phenomenon[2] (synchronous epidemics) in the lives of gay men. Gay men often face violence, abuse, marginalization and rejection by parents, friends and peers – there is compelling data that these conditions make them far more vulnerable later in life to substance use and abuse, intimate partner violence, and contracting HIV. The syndemics discussion has also led to an increasing focus on the idea of resilience. Says Julie, “Although HIV is very widespread among gay men, the majority of gay men are not HIV positive – what helps them remain HIV negative? As someone who believes very strongly in the idea of gay and queer liberation, I believe that members of LGBT communities create resilience, have innovative ways of living and of structuring families and lives that can be extended to broader society for better health outcomes and happier lives.”

There is a concerted effort to steer prevention efforts away from an earlier reliance on fear tactics and a vocabulary based on vulnerability. The gay men’s health movement and their allies in the HIV/AIDS community are increasingly emphasizing resilience and trying to create a scale of measuring this quality in the lives of gay men – and hopefully extend this to other communities as well. “There are a number of programs – like Project CRYSP, Lifelube, the Gay Men’s Health Crisis, and the Gay Men's Health Summit – that confront the conditions that drive the syndemic among gay men and build resilience and resourcefulness in gay communities[3]. Other projects doing fantastic work in this field include the Gay City Health Project in Seattle, Magnet in San Francisco, and William Way in Philadelphia,” says Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago, chair of IRMA, and a member of the Mapping Pathways team. In fact, Jim recently checked in with Dr. Ron Stall, an expert in gay men’s health, to get his views on syndemics and the HIV/AIDS epidemic among gay youth and adults, as well as the idea of resilience. You can read the eye-opening interview here.

The approach to HIV prevention could also benefit from elements of asset-based community development: focusing on the assets of a community, the skills and experiences that are available, can help illuminate the path forward and create sustainable solutions.

“We can’t do it all on our own though,” says Julie, “so it’s important to continue to push for government policies that honor the human rights of all people – specially now that there is a focus on the impact of bullying of LGBT people. We need to made sure doesn’t just end up contributing to mass imprisonment – another social driver of HIV in our country. Creating merely a punitive system doesn’t really solve the problem – it just results in more imprisonment, thus exacerbating health issues like HIV. Many people who are bullies have been bullied themselves. We need policies and mechanisms to increase parental acceptance of gay and gender variant children, strengthen communities to support all their LGBT members rather than rejecting them, and help people proactively stand up to bullying. Addressing the root causes will bring about real, long-term change.”

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[1] To know more, take a look at The New York Times’ “Coming Out” project, which captures compelling first-person accounts by gay teenagers.

[2] Syndemics: A set of linked health problems involving two or more health conditions, interacting synergistically, and contributing to excess burden of disease in a population. Learn more about the syndemic among gay men that drive the HIV/AIDS epidemic by accessing Ron Stall’s presentation here.

[3] Take a look at Jim Pickett’s presentation on this 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.]

From 'what if' to 'what now': implementing the new prevention technologies

Via AIDSMap, by Gus Cairns.

 

Two consecutive sessions at the sixth International AIDS Society conference in Rome yesterday were devoted, now we have convincing scientific data on the benefits of treatment as prevention and PrEP, to putting these new prevention methods into practice.

“We have moved from ‘What if?’ to ‘What now?’” was the comment of Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC), on what else we need to know, what barriers need to be addressed , and what resources might be required, to maximise the promise of antiretroviral-based prevention.

Anthony Fauci, Director of the US National Institute of Allergies and Infectious Diseases (NIAID), said: “We now have a solid scientific foundation to say that even in the absence of a vaccine we have the capacity to end the epidemic. I can’t go to the US President and say: 'We can cure HIV.’ But I can say ‘Ending the epidemic is scientifically doable’.”

Earlier, however, Nancy Padian from the Office of the US Global AIDS Coordinator had outlined formidable challenges still to be answered if antiretroviral treatment could bring about this goal.

She said that questions still needing answers include whether antiretroviral drugs (ARVs) really are a durable and reliable means of viral load suppression over a period of years and whether increasing the proportion of people on treatment would lead to increased levels of resistance. The biggest practical question, however, was whether treatment as prevention would work in situations where a high proportion of transmissions came from people with acute, recent HIV infections.

The biggest barriers to treatment as prevention, however, are stigma and lack of resources. Implementing ARV-based prevention would not only be expensive in terms of drugs; it would require added human resources and increased training and task-shifting for prevention counsellors so they can deal with biomedical data. There would also be added costs in terms of tests and monitoring.

The other big barrier will be the stigma of being tested, she said, particularly for at-risk populations in societies where injecting drug use, male-male sex, or sex work were criminalised and stigmatised. Treatment as prevention would require people not simply to test and then go to more supportive community organisations for prevention advice; it required a much closer relationship with medical personnel who might be prejudiced or feared to be so.

Mitchell Warren issued a call to action to implement the new strategies, but his presentation was tempered by realism. “We have evidence, we have data, and we now need to make decisions,” he said.

Read the rest here

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

Sharing Patents to Wipe Out AIDS

Via the New York Times, by Tina Rosenberg.

Not since the announcement in 1996 that antiretroviral therapy could effectively control H.I.V. has there been a season of AIDS news as hopeful as this one.  Trials of a new microbicide have brought positive results; ongoing studies of circumcision are showing that it gives strong, lasting, protection; a man has been cured of H.I.V. infection and new animal and clinical trials are raising hopes that he won’t be alone.

The research with the most immediate and dramatic impact, however, examines two novel ways to use those antiretroviral drugs.  People with H.I.V. who start their antiretroviral therapy as soon as they are diagnosed, instead of waiting for their immune systems to degrade, have a near-zero chance of passing the virus on to their sexual partners. This is the AIDS vaccine we’ve been waiting for — a 96 percent drop in infection rates is far better protection than any actual AIDS vaccine could  provide.  It has also now been shown that giving one antiretroviral pill a day to people who don’t have H.I.V. but are at very high risk for catching it can reduce their risk by two-thirds or more.

Taken together, these two methods of using antiretroviral drugs not just to treat AIDS, but also to prevent its spread, offer real hope of ending the epidemic.  But there’s a catch:  they require providing these drugs to millions, perhaps tens of millions, more people than are getting them now.  Someone has to pay for all this.

That’s why it matters that last week, Gilead Sciences, one of the most important manufacturers of AIDS drugs, became the first drug maker to join something called the Medicines Patent Pool, a two-year-old organization that was established by Unitaid, an international body dedicated to buying AIDS drugs. In joining the patent pool, Gilead agrees to let generic pharmaceutical companies copy four of its drugs for sale at very low prices in poor countries.  Gilead will get a small royalty for every copy sold.

Read the rest here.

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

How Sexy Sex Can Help Prevent HIV Transmission

Last month, a special supplement of Health Research Policy and Systems featured an article written by Anne Philpott and Wendy Knerr of The Pleasure Project. The write-up, ‘Strange bedfellows: bridging the worlds of academia, public health and the sex industry to improve sexual health outcomes’, discusses the public health community’s approach to HIV prevention, which is mostly focused on disease and the negative outcomes of sex. The authors make a case for an alternative approach based on the positive, liberating and pleasurable aspects of safer sex. The Pleasure Project, a largely volunteer-run organisation based in India and the UK, is a programme that adopts exactly such an approach. Their tagline says it best: ‘Putting the sexy back into safer sex’.

Mapping Pathways checked in with Anne Philpott to get her thoughts on how such an approach can help prevent HIV. “We believe you can have safer sex if you know how to have good sex. Pleasure is the primary reason people have sex” explains Anne, “yet it is almost completely absent in the public health domain – in programming, education and research. Since HIV is spread mainly through sexual transmission, efforts to prevent HIV need to consider the role that sexual pleasure and desire play in sexual behaviour.”

Anne’s personal ‘light-bulb moment’ took place at a microbicides session during an HIV/AIDS conference. “The speaker kept using terms like ‘insertive probe’ and ‘receptive cavity’, and for the longest time I thought he was discussing the technical cellular dynamics of microbicides or something like that. Turned out he was trying to talk about penetrative sex – for me, that was a moment of total frustration with the public health world. Why can’t we just say ‘penis’ and ‘vagina’?”

The Pleasure Project carries out advocacy about the importance of pleasure in sexual health, trains health professionals and educators about the eroticisation of safer sex, conducts research to build the evidence base, and pushes for safer sex in the erotic media industry. It sees itself as a bridging organisation – bringing pleasure into the world of public health and bringing public health into the world of pleasure – and works to make sure that the lessons are learned across the two different worlds.

What is one of the key lessons for the public health community? “Sex sells. People in the commercial world use sex to sell things like cars, toothpaste, pens…almost anything! Why not use sex to sell safer sex?” says Anne. “While working at a firm that made female condoms, I noticed how women would bring up the positive elements of the condom and how it actually increases sexual pleasure. We need to focus on things like that along with conveying the message of protection. That’s what will help motivate more and more people to practice safe sex – fear tactics only work up to a point.”

The Female Health Company, which manufactures markets and sells female condoms, seems to agree wholeheartedly. The company has provided key support to organisations advocating for a more positive, pleasure-focused approach to the female condom. “The innovative approach of eroticising the female condom is already having an impact,” says Robbie Nelson, the company’s programme and sales director. “The NGOs we work with, which have had pleasure trainings from The Pleasure Project, are not only making it easier for people to talk about condoms, but they are showing people how sex can be fun with condoms.”

The Pleasure Project’s strategy certainly seems to be working: Their website gets more than 5,000 unique visitors each month – interestingly enough, there’s been a recent surge in hits from Turkey and countries in the Middle East. The Global Mapping of Pleasure (‘A directory of organizations, programmes, media and people who eroticize safer sex’) has been downloaded more than 20,000 times. The organisation is now also pushing for greater research into the pleasure potential of new HIV-prevention products like microbicides. Numerous other initiatives, such as LifeLube, are also attempting to combine the idea of pleasure with HIV prevention. Together, these organisations may kickstart something of a sexual revolution in the public health community’s efforts to combat HIV.

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

ARV Access Fears Across the World

A slew of recent articles have appeared in the news lately which express concern over the availability and accessability of many countries including Swaziland (PlusNews), Indonesia (Jakarta Globe), and middle-income countries around the world (below). This comes on the heels of the Ranbaxy-Gilead deal which has the potential to greatly increase the supply of these life-saving drugs.

Bad News for Drug Prices in Middle-Income Countries

Middle-income countries with large numbers of people living with HIV will no longer benefit from preferential pricing when buying antiretroviral drugs from large pharmaceutical companies, according to the annual Médecins Sans Frontières drug pricing report, Untangling the Web of ARV Price Reductions.

“The main bad news in the study is the fact that a number of pharmaceutical companies will no longer be providing preferential pricing to middle-income countries like Brazil, China, India and Thailand,” Nathan Ford, medical director at MSF’s Campaign for Access to Affordable Medicines, said at the launch of the report at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome.

According to the report, pharmaceutical firm ViiV Healthcare – owned by Pfizer and GlaxoSmithKline – no longer offers reduced prices to middle-income countries, even when their programmes are fully funded by the Global Fund to fight HIV, Tuberculosis and Malaria.

Merck has also ceased to offer discounted prices to all lower middle- and upper middle-income countries, proposing instead to negotiate discounts on a case-by-case basis. Previously, Merck offered middle-income countries discounts that were still up to 10 times the price of generic versions. Of particular concern is the price of UN World Health Organization-recommended third-line drug, raltegravir – an integrase inhibitor that blocks retroviral replication – which costs up to US$5,870 per person per year in Brazil, compared with $675 in sub-Saharan Africa.

Janice Lee, pharmacist at MSF’s Campaign for Access to Essential Medicine, noted that drug company discount programmes were not a long-term solution, and governments would have to start using trade-related aspects of intellectual property rights (TRIPS) measures to override patents; in the past, Brazil and Thailand have used compulsory licences – when a government allows someone else to produce the patented product or process without the consent of the patent owner – to lower prices in their countries.

The report notes that Abbott excludes low- and middle-income countries from differential prices for the standalone heat-stable ritonavir 100mg tablet. It blocks the enzyme protease, required by HIV to make new viruses. A spokesman for Abbott said the company’s long-standing pricing policy would protect the poorest people living with HIV.

"Abbott’s preferential pricing policy for ritonavir has been in place, unchanged, for a decade,” Dirk van Eeden, director of HIV communication and policy at Abbott, told IRIN/PlusNews via email. “It includes all African and least developed countries, where the outright majority of patients with HIV live.”

ViiV Healthcare also defended its pricing policy, saying it was committed to ensuring access to its medicines.

Read the rest here.

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

Capitalizing on Scientific Progress

A report released this morning by HIV Vaccines and Microbicides Resource Tracking Working Group at the IAS conference in Rome "found that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision.":

"2010 has been a year of retrospection, a time for looking back over the 30 years since the first published report of the mysterious illness that would come to be known as AIDS. As sobering as this anniversary has been, it has also been a time for some optimism and calls to end the epidemic. These calls may not be simply wishful thinking, fueled as they have been by promising research results over the past two years in vaccines, microbicides, pre-exposure prophylaxis using antiretrovirals (PrEP), and antiretroviral treatment as prevention—results that have energized the entire HIV prevention field.

The first good news came at the end of 2009, when researchers in the RV 144 Thai vaccine trial reported that a vaccine combination had reduced risk of infection by 31 percent—the first clinical evidence that a preventive AIDS vaccine would be possible. Then, in July 2010, the CAPRISA 004 trial team announced its findings–that use of 1% tenofovir (TDF, also known as Viread®) vaginal gel reduced women’s risk of HIV infection by 39 percent—providing the first proof that a microbicide would be possible. This news was followed in November 2010 by the announcement from the iPrEx trial team that daily oral tenofovir/emtricitabine (TDF/FTC, also known as Truvada®) had reduced risk of HIV infection by an estimated 44 percent overall in men who have sex with men (MSM) and transgender women, and proved for the first time that HIV prevention using PrEP would be possible. And finally, in early 2011, the HIV Prevention Trials Network (HPTN) 052 trial established that use of antiretroviral therapy (ART) by HIV-positive individuals reduced transmission to their partners"

Source: HIV Vaccines and Microbicides Resource Tracking Working Group

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

IAS 2011: The Conference So Far

As you probably know, Mapping Pathways is in Rome this weekend for IAS 2011, the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention. We are very excited to be there, but in case you couldn't join us here is what has been happening the last few days:

Every day the conference is in session, the International AIDS Society releases a press release describing details and highlights from each day. The first three can be found here, here, and here. Another important press release from the conference discusses treatment as prevention.

Lancet has published several articles about the conference and treatment as prevention as well.

Science Speaks: HIV & TB News along with several other sources including IAS itself are live-blogging the event or publishing frequent updates. Keep an eye out here and elsewhere for more exciting news from Rome.

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

South Africa's Government Mulls State Pharmaceutical Company

Via Mail & Guardian, by Nickolaus Bauer.

The [South African] government was mulling the formation of a state-owned pharmaceutical company, African National Congress (ANC) secretary general Gwede Mantashe said at Luthuli House on Tuesday.

Mantashe was addressing reporters at the ruling party's headquarters in Johannesburg following an ANC lekgotla (meeting) on July 17.

"There is a need and this is in line with our Polokwane resolutions. At the moment South Africa consumes 25% of the world's ARVs [antiretrovirals], and it's with this in mind that we are looking at starting a state-owned pharmaceutical company," Mantashe said.

According to research carried out by the ANC into HIV/Aids infection rates, South Africa has 17% of the world's HIV-positive people.

"We had an idea for a state-owned mine company. That company is now running a coal mine and will open another one soon," he said.

Mantashe assured reporters the company would not threaten the pharmaceutical industry.

"There is a need and this is in line with our Polokwane resolutions. This doesn't mean the pharmaceutical industry will close down. The state-owned pharmaceutical company will operate within the industry," he said.

Read the rest here.

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

Roll Out Treatment as Prevention

Via the International AIDS Society.

The Lancet, a leading global medical journal, published an editorial comment today that emphasizes the critical role of expanding access to HIV treatment under a “Treatment as Prevention” strategy to stop the HIV pandemic.

The publication of the editorial comment coincides with the opening of the 6^th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) taking place in Rome, Italy from July 17-20. The conference, the biggest open scientific AIDS conference in the world, will feature numerous presentations on Treatment as Prevention.

The commentary – by Dr. Julio Montaner, director of the BC Centre for Excellence in HIV/AIDS (BC-CfE) and Past President of the International AIDS Society (IAS) – strongly reinforces the view that the benefits of highly active antiretroviral therapy (HAART) extend beyond the remarkable effectiveness of the treatment to prevent the onset of AIDS and prolong life, to dramatically reduce HIV transmission.

Based on HAART’s effectiveness in reducing transmission, Dr. Montaner is calling on the international community to support an immediate and expanded roll out of HAART under the Treatment as Prevention strategy, as pioneered by the BC-CfE in British Columbia, Canada.

“Treatment as Prevention is one of the most important and promising additions to the range of prevention strategies available to us today,” said Dr. Elly Katabira, President of the IAS and Chair of IAS 2011. “Dr. Montaner’s column is a rallying call for the universal endorsement and funding of this approach for the benefit of our future generations.”

The Treatment as Prevention strategy advocates for widespread HIV testing and facilitated access to free HIV treatment for all medically eligible HIV-positive individuals. Current HIV treatment reduces the level of HIV in the blood to undetectable levels, thus improving the health of HIV-positive individuals. At the same time, the treatment decreases the level of HIV in sexual fluids to undetectable levels, thereby reducing the likelihood of HIV transmission by over 90 per cent.

“The evidence is clear: treatment conclusively prevents morbidity, mortality and transmission,” said Dr. Montaner. “We now have ample and compelling evidence that treatment prevents HIV transmission during pregnancy and breastfeeding, as well as in sexual and injection drug use settings. The challenge remains to optimize the impact of this valuable intervention. Failure to do so is not an option.”

A recent study by the US National Institutes of Health (NIH) reported that immediate use of HAART led to a 96% decrease in the risk of HIV transmission among heterosexual couples where one partner is HIV positive.

“These results are a real scientific breakthrough and a game changer in the response to HIV,” said Michel Sidibé, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS). “We must embrace Treatment as Prevention as part of a combination prevention strategy to achieve our collective vision of zero new infections and zero AIDS-related deaths.”

The Treatment as Prevention model has been embraced by UNAIDS and the World Health Organization within the Treatment 2.0 initiative, announced last year as a central pillar of the global strategy to respond to HIV.

In February 2011, in consultation with the BC-CfE and the Chinese Centre for Disease Control and Prevention (China CDC), China became the first country to incorporate Treatment as Prevention as part of its national HIV/AIDS strategy to control HIV/AIDS over the next five years.

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To read the Lancet article, click here.

You can also read an excellent article in the New England Journal of Medicine here, and the accompanying editorial here.

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

The research agenda for antiretroviral prevention – now it gets complex

Via AIDSMap, by Roger Pebody.

We now know that starting antiretroviral therapy early, pre-exposure prophylaxis (PrEP) and vaginal microbicides can all have an impact on HIV transmission, Victor de Gruttola told a satellite session at the International AIDS Society conference in Rome on Sunday. But researchers now need to do more than establish efficacy, he said.

Studies need to identify the mechanisms by which interventions do and do not work in different communities.

They need to get to understand the characteristics of sexual networks, sexual behaviour and local epidemiology that influence their effectiveness. And they need to compare the impact of providing a stand-alone intervention with that of combined packages of interventions.

Other speakers at the satellite, which had been organised by AVAC and the European AIDS Treatment Group, emphasised the importance of implementation research – identifying barriers to the implementation of prevention interventions and developing strategies to overcome them.

Both Victor de Gruttola from the Harvard School of Public Health and Timothy Hallett from Imperial College London suggested there is no single best intervention – or even best package of interventions, but that this will depend on the characteristics of different communities and epidemics.

For different settings, researchers need to identify the combination of prevention interventions which could keep the spread of HIV under control. They also need to establish the breadth of programme coverage that is required.

Timothy Hallett presented some results from a basic mathematical model which aimed to identify the impact and cost of providing antiretroviral therapy to 80% of people at a number of different CD4 counts, PrEP to varying proportions of young people, PrEP to most people of all ages, or a combination thereof.

For each level of spending, Hallett identified the programme that would have the greatest impact – at the lowest levels of spending identified, this would be antiretroviral therapy alone. Should there be budget available to fund more than making therapy available for all with diagnosed HIV, policy makers should then provide PrEP for young people, and then for people of all ages.

But the model’s results change if baseline assumptions shift. If the costs of PrEP are actually lower than Hallett estimated (because drug prices come down), or if it turns out to be more expensive to get people diagnosed early and on to treatment (because testing promotion has less impact than anticipated or because new health services need to be provided), strategies with a greater reliance on PrEP would start to make more sense.

And the modelling studies need to consider other issues. Interventions – and combinations of interventions – will have different levels of effectiveness in different places, depending on a vast range of local factors which researchers are only beginning to get to grips with.

For example, Victor de Gruttola mentioned assortativity: the tendency for people who have many sexual partners to choose partners with the same characteristic. When this is the case, interventions will have less impact than when there is less assortativity.

Other important local factors are the number of transmissions that are due to people who are themselves recently infected, the proportion of people with HIV who are diagnosed and linked to care and the proportion of HIV-negative people who can be provided with an intervention.

Read the rest here.

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