Activists Protest Against Obama's PEPFAR Budget Cuts

via Plus News

Almost a thousand Swazi and South African HIV activists marched to the United States consulate in Johannesburg on 22 March 2012 to demand that the US continue supporting the Global Fund to Fight AIDS, Tuberculosis (TB) and Malaria, and safeguard funding of its President's Emergency Plan for AIDS Relief (PEPFAR), which US President Barack Obama's latest proposed budget will cut by 12 percent.

The march organizers - a coalition of international and regional HIV organizations, including the global medical charity, Médecins Sans Frontières (MSF), the World AIDS Campaign, and the AIDS Rights Alliance Southern Africa - also called on the British and Australian governments to join their American counterparts in kick-starting a response to solve the Global Fund's financial crisis.

Without an emergency donor meeting, the Fund - already in need of at least US$ 2 billion - will only secure additional funding at its next scheduled replenishment in 2014.

"We're not asking for charity, we are asking for social justice," said Daygan Eagar, a researcher at the South African human rights organization, Section27. "The US spends more money in one day of war than we're asking for the Global Fund."

Representatives from MSF, Section27 and the South African AIDS lobby group, Treatment Action Campaign, were to meet with consular and PEPFAR representatives to discuss their concerns.
The demonstration was also endorsed by the two million-member Congress of South African Trade Unions (COSATU). It followed similar protest action at US representative offices in Swaziland, according to Siphiwe Hlophe, a founder of the NGO, Swaziland for Positive Living (SWAPOL).

"If we are here, if we are laughing, it is because we are on drugs," she told the crowd. "Before the Global Fund we didn't have food, we didn't have pyschosocial support, we didn't disclose our HIV status - that all started when the Global Fund came. Look at how many of us are here today - that is the Global Fund."

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Jim Yong Kim: Obama's Choice for President of the World Bank

via The Washington Post, by By Elizabeth Flock and Hayley Tsukayama

President Obama’s surprise choice to head the World Bank is a physician and a major figure in the global health world.

Jim Yong Kim has served as Dartmouth College’s president for the past three years, but has devoted much of his life to improving health outcomes in the developing world. Obama highlighted Kim’s health development background as major factors in his nomination.

Along with Paul Farmer and others, Kim co-founded Partners in Health, an international health and social justice organization. He served as Director of the World Health Organization’s HIV/AIDS department, where he scaled up treatment, prevention, and care programs in developing countries. He has also worked on international tuberculosis policy.

“Dr. Kim has been a strong supporter of global public health,” said Tarik Jasaveric, a spokesman for the World Health Organization. “At WHO, Dr. Kim was instrumental in creating and implementing the 3 by 5 Initiative, which saw millions of people in the developing world gain access to anti-retroviral Therapy for HIV for the first time.”

The initiative, launched in 2003, sought to treat 3 million new patients infected by the disease by 2005. It reached its goal in 2007, The Washington Post reported. In 2006, he was named as one of Time Magazine’s “100 Most Influential People” for his work on that campaign and his efforts combating drug-resistant tuberculosis in Peru.

Kim also co-founded the Global Health Delivery Project, a joint initiative designed to improve public health in disadvantaged populations by “systematizing the study of global health delivery” and “rapidly disseminating knowledge to practitioners.”

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High HIV Prevalence Calls for Stronger Commitment Towards Treatment and Care in Thailand

via Press Tv Bangkok, by Sonia Labboun

The concern is that the disease is increasingly affecting youngsters; about 25% of the total diagnosed patients are in the working group aged between 30-34 years old.

Experts say that schools and universities lack the means to give a proper education about the dangers of HIV and how the disease is transmitted, making this group age an ideal focal for its spread.

In a move to show the government's commitment to combat the disease, the National Health Security Office has announced a subsequent budget of nearly $100 million for HIV care and treatment and is already planning to increase the amount to almost $114 million for 2013.

In a major blow to global pharmaceutical firms, Thailand issued licenses for cheap HIV drugs between 2006 and 2008, a move that has angered industries from the US, Germany and Switzerland who until recently had the monopoly in HIV treatments.

Recently The world bank has pointed out at the fiscal burden of HIV, they say it shouldn't be considered only as a health problem, but also as an economic problem because of the huge costs in treating patients, highlighting as well the importance of effective prevention in order to lessen future costs.

In early 1990s, Thailand has overcome predictions that four million of the 65 million population could become infected by 2000 thanks to successful Aids education and prevention campaign that the current government wishes to revive.

The government is concerned that even though a cheap alternative for HIV treatments is available, the number of new infections is still rising. Experts blame it on poor education at schools and lack of prevention campaign in the media; deficiencies which the current government has promised to take action on."

Check out a video here.

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

PrEP May Be Crucial in Effectively Preventing HIV

via The Boston globe, by Sean Cahill

Initial results from clinical prevention trials of pre-exposure chemoprophylaxis (PrEP), in oral pill form indicate that PrEP could be the “game changer” needed to more effectively fight HIV. PrEP involves taking antiretroviral medications to prevent HIV.

PrEP has shown partial efficacy with men who have sex with men (MSM) and heterosexuals. Biomedical prevention interventions such as PrEP have great potential, especially if coupled with traditional prevention approaches, expanded testing, and linkage to treatment and care. Modeling demonstrates the most effective deployment of PrEP will be in combination with scaled-up HIV treatment of people who are known to be HIV-positive, as this was shown to reduce infections.

Guidance from the US Public Health Service and the World Health Organization is expected later this year. The Food and Drug Administration announced February 13th that it would review Gilead Science’s application to use FTC-TDF (brand name Truvada) for PrEP by June 15th. Demonstration projects to develop real world best practices for implementing PrEP are underway or set to launch soon in the United States and in sub-Saharan Africa. While the cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to providing coverage. Low-cost generic medications could enable access in low-income countries. The prioritization of highly vulnerable populations could increase the cost-effectiveness of PrEP. Providing PrEP is also much less expensive than treating someone for HIV over the course of a lifetime. Recent modeling of PrEP implementation coupled with scaled up treatment—focusing on MSM in San Francisco, the general adult population in Botswana, and serodiscordant couples in South Africa—predicts that PrEP could significantly reduce HIV incidence and prevalence.

In February 2012, The Fenway Institute released an analysis of PrEP implementation issues, titled Pre-exposure prophyalxis for HIV prevention: Moving toward implementation. This report summarizes the state of PrEP and microbicide research as of early 2012, looks at willingness to use PrEP among various populations, addresses concerns about PrEP that could present obstacles to implementation, offers strategies for effective implementation, and examines policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV. Based on a review of published research and interviews with policy makers, funders and other stakeholders, it examines regulatory developments and planning underway both within the U.S. and globally.

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Protecting the Future: In conversation with Dr. Melissa Wallace

Original content from the Mapping Pathways blog team

Dr. Melissa Wallace is the Adolescent Project Leader at the Desmond Tutu HIV Foundation (DTHF) in South Africa. She is trained as a health psychologist and has been working in the field of HIV.

MP: How did you get involved in the field of adolescents and HIV prevention and treatment?

MW:My PhD in the U.K was on the topic of cancer and the physical changes that result from cancer treatment – hair loss, amputation and scarring – and how people come to terms with these changes.  On reading the literature, I realized there was very little that had been done with adolescents who were dealing with these changes, which was strange considering that adolescence is a period in life when people are most aware of their appearance and their bodies. So it was that decision to focus on adolescents during my PhD that led me on this road. After returning to South Africa, I realized that the biggest health problem facing us was HIV, and adolescents as a group were contributing a lot to the epidemic. This made me keen to work in this field.

MP: What is the reason behind DTHF’s focus on adolescents?

MW:In South Africa, we have a generalized HIVepidemic. However, there are some sub groups more at risk for HIV acquisition and adolescents are one of the groups most at risk.This is something that the DTHF has recognized for some time. If you look at graphs of HIV incidence for adolescent boys and girls – they reach the age of about 14-15 and suddenly the graphs become steep as incidence rises, and this is particularly the case for adolescent girls.  The fact is that they are often in relationships where they have very little control. There is also high gender inequality, poverty and less access to health services. All these factors play a role in putting adolescents at a high risk.

Also adolescence, in general, is a difficult time in one’s life. It’s a time where people are trying to find their identity, are curious, and have a higher chance of indulging in risky behavior. This may be sexually risky behavior or willingness to indulge in substance abuse. This is an age when kids break away from their parents more and peers become more of an influence. This makes them more likely to take risks in general.

In South Africa, there are also a lot of contextual factors that drive this epidemic for adolescents, particularly girls. For instance, there’s a lot of trans generational sex: girls having sex with much older male partners who are much more likely to be exposed to HIV already. There’s also a lot of transactional sex – girls and boys who will have sex for goods or money. Meaning that even though these youngsters may not be sex workers, there is a financial incentive for them to have sex. This is exacerbated by poverty.

MP: What are your current projects on the topic of adolescents and HIV prevention?

MW:We are working on a number of projects, including a follow-up study to a big three-year study that looked at building capacity for conducting vaccine trials among adolescents in South Africa. We recognized that there might be several biomedical prevention interventions at varying stages of development that could be licensed for use and unless we run trials with adolescents and build capacity, they wouldn’t be licensed for use with them. We also recognized that any prevention interventions targeting adolescents in particular would be best implemented prior to sexual debut. 

We developed six sites around South Africa and implemented adolescent friendly sexual health services at these sites. We also thought in detail about ethical and legal issues involved in conducting trials with adolescents, such as whether they could be recruited and whether parents would allow them to take part in this study. We did this by running a ‘mock’ HIV vaccine trial, using the (already licensed) HPV vaccine as our product. This gave us the opportunity to explore a number of key feasibility, ethico-legal and socio-behavioural questions.

Another study we’re hoping to start in the next couple of months is the FACTS 002 trial – which is an offshoot to the FACTS 001 trial (FACTS 001 is looking at the efficacy of tenofovir gel in adult women). FACTS 002 will be different in that it will address the safety and acceptability of tenofovir gel in girls who are a bit younger; participants’ age would range from 16-17 years old. The study will also address issues of adherence to the gel and how adolescents would feel about using it.

Another exciting project in its early stages is an MP3 project (methods of prevention) awarded to us by the NIH (National Institutes of Health). This project looks at feasibility and acceptability of a number of prevention methods that may become available in the future to adolescents. With all the progress with ARV based prevention methods, we envisage there may be a whole range of options available to people – and adolescents - to protect themselves from HIV. We’ll be running individual pilot studies on PrEP, microbicides and medical male circumcision and looking at issues around acceptability and feasibility and adherence. Finally, we will conduct a study in which we introduce a range of prevention options to adolescents and find out why and how they would make decisions about preferred prevention strategies, and what factors are important to them in making these decisions. This is a project we are really excited about since there’s not much that’s been done in this area with this age group.

FACTS 001 and the MP3 project will both take place at our brand new Youth Centre in the township of Masiphumelele. The Youth Centre itself has adopted a philosophy that we are hoping will contribute to a comprehensive prevention strategy for adolescents.  The Centre provides recreation services, education services and a reproductive health clinic together under one roof, for young people between the ages of 12 and 22. Our goal is to provide a safe, non-judgemental environment where young people can develop skills, learn and have fun, and enjoy a supportive environment where they are equipped to make the healthy choice in all aspects of their lives, including those issues related to HIV.

MP: What is the hardest part of your job?

MW:Sometimes the enormity of the problem feels overwhelming.  HIV is such a vast problem in South Africa and some of the structural factors – gender, equality, stigma and poverty make it that much harder to overcome. Sometimes, no matter what one does, the socio-economic circumstances are hard to get around. But I feel that we are at least doing something positive and impactful. There’s also a constant need to find funding to continue what we do and it is sometimes a challenge to be chasing that all the time to try and continue the work that we’re doing.

MP: Why does this work matter? Why does it excite you? 

MW: This work matters because, as a group,adolescents in South Africa are the most at risk for HIV, and we have a big opportunity to change the course of this epidemic if we target this group. Creating an impact prior to sexual debut will have the biggest positive impact on fighting this epidemic in the long term. 

This is a group that has been overlooked in healthcare a lot, partly since people see adolescents as harder to work with, so while there is established pediatric and adult care, adolescents are not afforded the same specialized care, something which is badly needed. There are also a number of other perceived challenges that come with working with this group. For instance, there are legal issues around conducting research and providing services to young people, as well as additional challenges like confidentiality and parental consent. To help deal with these issues, we have drafted a set of guidelines: Who gets the results from an HIV prevention study? Where does our responsibility lie: if we hear of something disturbing, do we notify the parents or higher authorities? These are the kinds of questions the guidelines seek to cover.

And finally and most importantly, at the risk of sounding cheesy, taking care of these adolescents is like taking care of the future of our country. Adolescents will grow up to be the adultsin our society, so whatever we can do now to protect their future is important.Particularly within the South African context, considering the poor socio-economic circumstances, these kids may feel that they don’t have a future worth staying HIV negative for–but it is our job to convince them otherwise andto make them feel excited and positive about their lives. This may be the key in helping them want to protect their HIV-negative status.

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

Researchers at CROI 2012 Report an Increase of ARV Drug Resistance in the U.S.

via Aidsmeds.com, by Tim Horn

New surveillance data from the U.S. Centers for Disease Control and Prevention (CDC) suggest that about two in 10 individuals infected with HIV in recent years involved strains of the virus harboring mutations conferring at least partial resistance to one ore more available antiretroviral (ARV). The report was presented Wednesday, March 7, at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle.

The U.S. Variant, Atypical, and Resistant HIV Surveillance (VARHS) system, in which HIV specimens from newly diagnosed individuals are tested for drug-resistance mutations, was established by the CDC to provide the clearest picture to date of the scope and type of resistance in the United States.

The analysis reported at CROI included a total of 10,338 resistance profiles from eight U.S. regions; this consisted of 2,339 profiles from individuals with recent infections (confirmed using a specialized antibody test or a negative HIV test results within six months before diagnosis) and 7,999 profiles from individuals with confirmed long-standing HIV infection (individuals diagnosed with AIDS within six months of testing positive for the virus). Regions represented in the analysis were Seattle, Los Angeles, Chicago, Colorado, Michigan, Louisiana, New York and South Carolina.

The system uses standard genotypic resistance testing, which identifies specific viral mutations associated with drug resistance. Because neither the recently infected individuals nor the subjects with established infection included in the analysis had yet started treatment, the presence of any HIV drug resistance mutations in their blood would indicate that the resistant virus was transmitted to them at the time of their infection.
Overall, 15.2 percent of all samples included in the analysis had evidence of at least one transmitted drug resistance mutation.

Among the recently infected individuals, 19.1 percent had evidence of at least partial resistance to at least one drug in a particular ARV class, compared with 14.7 percent of the individuals with long-standing HIV infection. This difference was found to be statistically significant, meaning it was too great to have occurred by chance.

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

Evidence-Based Recommendations Presented on ART Adherence and Care

via Annals of Internal Medicine, by Melanie A. Thompson, MD

Description: After HIV diagnosis, timely entry into HIV medical care and retention in that care are essential to the provision of effective antiretroviral therapy (ART). ART adherence is among the key determinants of successful HIV treatment outcome and is essential to minimize the emergence of drug resistance. The International Association of Physicians in AIDS Care convened a panel to develop evidence-based recommendations to optimize entry into and retention in care and ART adherence for people with HIV.

Methods: A systematic literature search was conducted to produce an evidence base restricted to randomized, controlled trials and observational studies with comparators that had at least 1 measured biological or behavioral end point. A total of 325 studies met the criteria. Two reviewers independently extracted and coded data from each study using a standardized data extraction form. Panel members drafted recommendations based on the body of evidence for each method or intervention and then graded the overall quality of the body of evidence and the strength for each recommendation.

Recommendations: Recommendations are provided for monitoring of entry into and retention in care, interventions to improve entry and retention, and monitoring of and interventions to improve ART adherence. Recommendations cover ART strategies, adherence tools, education and counseling, and health system and service delivery interventions. In addition, they cover specific issues pertaining to pregnant women, incarcerated individuals, homeless and marginally housed individuals, and children and adolescents, as well as substance use and mental health disorders. Recommendations for future research in all areas are also provided.

The availability of potent antiretroviral therapy (ART) has resulted in remarkable decreases in HIV-related morbidity and mortality in the past 15 years (1, 2). Entry into and retention in HIV medical care is critical to the provision of ART, and adherence to ART is among the key determinants of HIV treatment success (3–6). More than 2 decades of targeted research in these areas has produced a varied and complex evidence base that, to date, has not been fully evaluated or distilled into concrete recommendations for how to best monitor or support HIV care and ART adherence.

Recent data from the U.S. Centers for Disease Control and Prevention reveal that only 28% of persons with HIV in the United States have achieved viral suppression while receiving ART (7). Of those who knew they had HIV, only 69% were linked to care, and only 59% were retained in care (8). These figures and comparable global data (9, 10) challenge us to explore best practices for improving entry into and retention in care on a global scale. Only with successful care linkage and retention can ART be accessed. Once patients are in care and are receiving treatment, high levels of adherence are required to prevent the selection of resistance mutations and subsequent virologic failure (11). In a global pooled sample of 33 199 adults taking ART in over 84 observational studies, only 62% of persons achieved adherence of at least 90% of doses (12). These data underscore the need for concise and clear evidence-based recommendations to help care providers monitor and support ART adherence.

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CROI 2012: Researchers Compare Differences in Progession to AIDS Between Races

via POZ Treatment News, by Tim Horn

Some sobering news from the Women’s Interagency HIV Study (WIHS): Black women living with HIV are more likely to progress to AIDS and twice as likely to die of its complications compared with white women living with HIV, according to new results from the cohort presented Tuesday, March 6, at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle. Though black women were significantly less likely to adherence to antiretroviral (ARV) therapy in the analysis, their risk of AIDS-related deaths were still significantly higher after accounting for this.

Eighty percent of HIV infections globally occur in women and people of African descent, but the majority of studies on antiretroviral (ARV) therapy have been conducted in men of European descent, Kerry Murphy, MD, of Albert Einstein College of Medicine in New York and her WIHS colleagues explained in their introduction comments.

Though previous data from the WIHS—one of the largest and longest cohort studies following women living with HIV in the United States—pointed to better survival among white women in the United States, the finding was not statistically significant, at least not when the results were published in 2005. The study has been under way since 1993, with sites in Brooklyn, the Bronx, Chicago, Los Angeles, Northern California and Washington, DC.

With additional follow-up data now available, the WIHS researchers again revisited potential associations between race, AIDS-related deaths, non-AIDS related deaths and the new AIDS-related illnesses in the cohort.

Included in the analysis reported by Murphy and her colleagues at CROI were 1,471 women living with HIV on continuous ARV therapy.

Compared with white women in the cohort, black women were twice as likely to die of an AIDS-related complication. This finding was statistically significant and accounted for other known predictors of AIDS death, including high depression scores, high pre-treatment viral loads, low pre-treatment CD4 cell counts, hepatitis C coinfection and a history of illicit drug use.

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The Impact 'Treatment as Prevention' has on HIV Incidence in Africa

via AidsMap.com, by gus Cairns

A longitudinal study from KwaZulu Natal province in South Africa is the first study from the global south to relate an increase in the proportion of adults on HIV treatment to a fall in HIV incidence, the 19th Conference on Retroviruses and Opportunistic Infections was told last week.

The study found evidence of a threshold effect; incidence started to fall once the proportion of all adults diagnosed with HIV in the area who were on treatment exceeded 30%.

Meanwhile, a study that took place in a week-long intensive health campaign in Uganda, as well as studies from areas as diverse as San Francisco and Swaziland, documented large increases in the proportion of people with HIV who are on treatment.

Falls in incidence in KwaZulu Natal

National surveys in South Africa have found evidence of significant falls in HIV incidence in recent years, but have related this to behavioural change rather than treatment. In the study presented at CROI, of a rural area of northern KwaZulu Natal centred on the mining town of Somkhele (Tanser), the researchers found a relationship between HIV treatment and a fall in infections.

They made use of a population-based HIV surveillance survey that has sampled 10,000 adults a year from 2004 onwards, by identifying 16,558 people who had taken at least two HIV tests during this period in order to gauge incidence rates. They then compared these data to individually linked data from the district-based HIV treatment and care programme.

Adult HIV prevalence in the area is high – 24%. The rate of new infections peaks at 8% a year in women in their early 20s and 5% a year in men in their late 20s. HIV testing rates are also high; researchers estimate that only 30% of the HIV-positive population is undiagnosed, a low proportion for Africa, and 75% of HIV-negative adults who have tested for HIV have done so more than once.

Since 2004, there has been a huge scale-up of HIV treatment, with 20,000 patients starting antiretroviral therapy since then, and by 2001 more than 40% of all adults diagnosed with HIV were on antiretroviral therapy (ART), and over 60% with a baseline CD4 count below 350 cells/mm3. HIV treatment at this CD4 threshold was only introduced in August 2011; previous to this it was 200 cells/mm3.

HIV incidence between 2004 and 2011 averaged 2.64% a year but was lower after 2009, when for the first time more than 30% of the diagnosed population was on ART. It was 3.0 to 3.5% 2007-09 but fell to 2.5% in 2010 and 2.0% in 2011.

After adjusting for HIV prevalence in the immediate area and demographic and behavioural variations, the researchers found that for every 10% increase in the proportion of adults on ART, the HIV incidence rate fell by 17%. Incidence was 40% lower when over 30% of the adult population was treated than when fewer than10% were. 

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

The World Bank Reports the Need for Greater HIV Prevention Measures in Africa

via Voice of America News, by Joe DeCapua

The World Bank says significantly better HIV prevention efforts are needed in Africa. It says a slow global economy and uncertain donor aid make preventing new infections a necessity.

A new World Bank report says the world’s economic woes are causing “anxiety about maintaining and expanding AIDS treatment programs in low income countries.”

Co-author Elizabeth Lule said concerns about tight budgets coincide with much progress being made against the disease.

“HIV prevalence, especially among young people, is going down in southern Africa. In countries where there’s highest burden, young people have better knowledge. They’re using condoms consistently. They’re reducing partners. So there is a lot of progress,” she said.

Also in recent years, studies have shown that giving antiretroviral drugs to HIV negative people can protect them from becoming infected. And there’s been progress in vaccine research, although an effective vaccine is still considered years away.

Fiscal dimension

“We shouldn’t just be looking at HIV/AIDS as a health problem, but also as an economic problem because of the huge costs that are incurred in treating people as well as prevention. And we highlight the importance of continuing to use effective prevention in order to contain future costs,” she said.

The report is called The Fiscal Dimension of HIV/AIDS in Botswana, South Africa, Swaziland and Uganda.

“There’s been very limited analysis on the fiscal dimension of HIV/AIDS for countries to understand the future liability that they take on, especially if they do not reduce new infections. They would only be adding to the burden,” she said.

Lule, the World Bank’s acting director for regional integration in Africa, said treating HIV/AIDS can only be done on a long term basis.

“When a person gets HIV/AIDS it usually takes a number of years before they develop full-blown AIDS. But then once you put them on treatment you cannot stop. And they may survive, of course, for a long time and the countries have to incur those costs. And then the more new infections you have the more people you have to treat in the future. And therefore the higher costs that countries would have to incur,” she said.

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[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!)

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

PrEP trial helps some couples work through relationship disharmony

Original content from the Mapping Pathways blog team

In an interesting development, many of the couples involved in a pre-exposure prophylaxis (PrEP) trial in Kenya and Uganda saw the trial as a way for them to save their strained relationships.

The trial was the Partners PrEP study and the couples involved were serodiscordant couples (heterosexual couples in which one partner was HIV negative and the other was HIV positive). The objective of the study is to see whether having this medication in the bloodstream prevents the HIV uninfected partner from getting HIV. According to researchers, a whopping 99 percent of the prescribed doses were taken, as opposed to other new prevention technology trials where the level of adherence has been significantly lower. .

The reason behind this became obvious once the researchers did a little digging. It was often found that when the HIV-negative individual first found out that their partner was HIV positive, it tended to create a crisis in the relationship with the HIV-negative partner having doubts about his/her own safety as well as the faithfulness of the HIV-positive partner. Many couples saw condoms as expensive and uncomfortable and, as a result, their physical intimacy reduced to a minimum.

The couples struggling with this situation saw the PrEP trial as a means to resolve the crisis in their relationship. They understood that though PrEP was unproven, it might still offer a ray of hope for them: protection for the partner who was HIV negative and an option that could help potentially restore intimacy.

Suddenly, rebounding from the hostility that had begun to characterize their relationship, trial investigators observed that the couples became very keen to keep follow-up appointments and replenish their pill supplies. Study participants received adherence and relationship counseling and the couples cited the counselors as a crucial source of support. Partners reminded one another to take their pills on time, and even the children got involved at times, asking their parent to take their doses according to schedule. The couples started to use mobile phone alarms to time their doses and made sure that, despite hectic workloads, the dosage schedules were adhered to.

Of course, not all couples found harmony in their relationships during the PrEP trial. For some, the discord did not end: some quarreled and accused the other partner of perceived infidelities and some partners accused the others of indifference and opposition to the treatment. However, these cases were overshadowed by the ones that saw PrEP as a new beginning for their relationships.

Said one participant “My husband reminds me to take my drugs the moment the time is up. Even before the radio mentions the time, he quickly reminds me that I need to swallow my drugs. If he knows I am travelling somewhere, he tells me to carry my drugs. He doesn’t want me to leave my drugs behind.”

The main takeaway for researchers was that partnered relationships provided strong support for PrEP adherence. One partner knowing the HIV status of the other and supporting him/her through the trial enhanced the quality of findings of the trial and, more importantly, helped in some cases to sustain the relationship through a rocky period.

Read more about this study here.  And for a first-hand example of how love can play an important part in HIV prevention and treatment, read about an Indian couple’s Modern Day HIV Love Story. 

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

Dr. Grant Colfax is Appointed Director of White House Offices of National AIDS Policy Position

via PR Newswire

San Francisco AIDS Foundation applauds President Obama's selection of Dr. Grant Colfax to become director of the White House Office of National AIDS Policy. Dr. Colfax is uniquely suited to continue the momentum established under his predecessor, Mr. Jeffrey Crowley, in advancing the ambitious goals outlined in the president's National HIV/AIDS Strategy and moving us closer to an AIDS-free generation.

"Dr. Colfax has been instrumental in the decline of new HIV infections in San Francisco in recent years," said San Francisco AIDS Foundation CEO Neil Giuliano. "His unique blend of experience serving on the front lines of the epidemic, implementing the national strategy at the local level, working as a direct service provider within the Ryan White CARE system, and conducting cutting-edge research makes him the right person at the right time to lead the Obama administration's efforts to end HIV/AIDS in the United States."

The Office of National AIDS Policy provides essential leadership in addressing the U.S. HIV/AIDS epidemic. As director, Dr. Colfax will be required to take a fresh look at how resources can be targeted to reduce HIV infection rates, increase access to treatment, and decrease HIV-associated health disparities related to sexual orientation, race, gender, and socio-economic status in hard-hit communities across the country. His track record in San Francisco demonstrates he is well suited for this challenge.

"Dr. Colfax will play a critical role over the next several years to ensure the implementation of the Affordable Care Act and HIV service integration to address the health care needs of people living with HIV," said Ernest Hopkins, director of legislative affairs at San Francisco AIDS Foundation. "Having worked closely with him on complex issues and having seen his consensus-building skills among diverse populations, including communities of color, I am confident that the AIDS community will have a strong advocate within the administration. I know Dr. Colfax will work to ensure that the coming changes to our health care system are made thoughtfully, carefully, and with a strong focus on improving the health status of the most vulnerable people."

As director of the HIV Prevention and Research Section at San Francisco Department of Public Health, Dr. Colfax elevated the role of community-based health research in local planning and funding decisions and instituted innovative, evidence-based HIV prevention tools, such as measuring and mapping community viral load and enhancing HIV testing and linkage to care, making San Francisco's HIV prevention planning and service system a model for jurisdictions across the nation. When developing the city's most recent HIV prevention plan with diverse stakeholders, Dr. Colfax was mindful to ensure its consistency with the emerging National HIV/AIDS Strategy. Throughout his career, he has maintained his role as a physician at Ward 86 at San Francisco General Hospital, the nation's first HIV/AIDS-specialized clinic.

San Francisco AIDS Foundation stands ready to work with Dr. Colfax, the White House, and other community partners across the country to reduce new HIV infections, increase access to care for all people living with the disease, and reduce HIV-related health disparities.


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

Evaluation of PrEP Data and Decisions Taken in 2011

via Treatment Issues, by Deirdre Grant

More than a decade ago, “AIDS Drugs for Africa” was one of the rallying cries for a global activist movement.The meaning was simple: treat HIV-positive people with potent, life-saving medications regardless of where they live, how much money they have or who they love. These days, the phrase has more meanings than we could have ever imagined. The past two years have brought a range of data on the use of antiretrovirals for HIV prevention in HIV-negative people, as well as a preventive strategy in HIV-positive people. These developments are exciting, but the situation is far from simple. There are questions about feasibility and about levels of effectiveness observed in different trials. Today, many people want to know: Can antiretrovirals (ARVs) be used for HIV prevention in HIV-negative people? If so, which types of products, programs and for which populations is this prevention most effective?

The answers to these questions depend on several factors, including science, policy, funding, community demand, andthe future of treatment access for people with HIV. Not surprisingly, the possibility of using an ARV based prevention method in HIV-negative people generates strong opinions, both in favor of such a prevention tool and those opposed. In light of the potential, many questions have arisen including: Is it feasible? Will people actually use a pill or a gel once a day? Is it ethical, given the enduring need for ARVs for HIV-positive people worldwide? And, do we know enough from the trials to-date to describe levels of safety and effectiveness anticipated in a real world health care setting?

None of these questions have been completely answered. But over the past year, there has been a steady stream of developments that have both complicated and clarified the discussions. Mixed data on topical PrEP, such as the vaginal microbicide 1% tenofovir gel, and oral PrEP in women have left scientists and advocates perplexed. Many fear that the obstacles inherent in providing ARVs to HIVnegative people—repeated HIV testing, the need to ensure access for HIV-positive people, additional staffing requirements, and more—will overshadow the potential of these new tools. For advocates who want to see a full exploration of what ARV-based prevention can do in their communities, it’s as important as it has ever been to stay informed of developments as they emerge and maintain a firm pursuit of the ultimate goal: to curb the epidemic by preserving health in HIV-positive people and preventing as many new infections as possible.

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

The Influence of India's New Ruling on HIV/AIDS Pharmaceuticals

via Reuters.com, by Kaustubh Kulkarni and Henry Foy

"India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say."

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licenses for HIV/AIDS and heart disease treatments.

"This could well be the first of many compulsory rulings here," said Gopakumar G. Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.
"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."

The new wording is seen as a lower threshold for compulsory licenses, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licenses allow them to authorize the local manufacture or importation of much cheaper, generic versions.

Global drugmakers see emerging markets such as India as key growth opportunities, but remain concerned over intellectual property protection. Nair said HIV-related medicines were likely to be the most at risk by compulsory licenses in the future.

India has one of the world's fastest-growing rates of HIV and heart disease is also the country's biggest killer, but widespread poverty in Asia's third-largest economy makes many non-generic drugs unaffordable for millions.

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

NYT: PrEP Trial Results are Re-examined

via The New York Times, by Donald G. McNeil Jr.

The failure of a daily pill to protect healthy African women against AIDS may not have been the pill’s fault but the women’s reluctance to take it, scientists at an important AIDS conference in Seattle were told this week.

Last April, a promising trial of “pre-exposure prophylaxis” — giving small protective doses of antiretroviral drugs to uninfected people — was stopped early because women were getting infected anyway. It was a discouraging setback.

But scientists at this week’s Conference on Retroviruses and Opportunistic Infections who analyzed blood samples taken from the women reported that only a quarter of those who got infected had any of the drug, Truvada, in their blood. That suggested they had not taken their pills.

Papers presented at the four-day conference offered findings both optimistic and scary. There were hints at a possible way to flush the virus out of its hiding places in cells, and at ways to let some patients safely take “vacations” from triple therapy.

It is not known why so few African women took their Truvada, but there is still an enormous stigma about AIDS in Africa, and a bottle of AIDS drugs in the home implies that someone there is sick, said Mitchell Warren, executive director of AVAC, a prevention advocacy group. Mr. Warren pointed out that Truvada had protected women in a different study that enrolled established couples in which only one partner was infected.

In a different study, researchers from the University of North Carolina at Chapel Hill showed that they had used a cancer drug, vorinostat, to purge the virus hiding in the CD4 cells of six men who were already doing well on triple-therapy cocktails.

Although the cocktails can make the virus vanish from the blood, it hides in different types of cells, ready to roar back if the patient stops taking the cocktails.

Rooting some out with vorinostat “may not be the magic bullet,” said Dr. David Margolis, the study’s lead researcher, “but it suggests we can build a path that may lead to a cure.”

Another small trial, at the Wistar Institute in Philadelphia, gave patients synthetic interferon — a virus-blocker normally made by the human body — while they took “holidays” of up to six months from triple therapy. Nine of the 20 patients did not see their viruses rebound to dangerous levels. That result will not change clinical practice right away, said Dr. Luis J. Montaner, who led the study, but suggested an alternative to lifelong triple therapy, which can be debilitating.

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

Major Budget Cuts Hinder HIV/AIDS Treatment

via Nature News, by Erika Check Hayden

Preventing the spread of HIV used to mean testing people for infection and encouraging them to practise safe sex. Increasingly, it also means prescribing drugs, as studies show that giving infected people or their uninfected partners antiretroviral drugs as soon as an infection is diagnosed can help to check the spread of AIDS.

Yet at this week’s annual Conference on Retro­viruses and Opportunistic Infections in Seattle, Washington, there was growing concern that financial austerity in the United States and elsewhere is eating away at the funding needed for a worldwide prevention effort.

Many scientists and advocates agree that there is now an “awesome possibility to prevent the spread of HIV”, says Sharonann Lynch, HIV policy adviser for Médecins Sans Frontières (MSF, also known as Doctors Without Borders) in New York. “If we decrease the money invested in treatment now, we are squandering the best opportunity we’re going to have to get ahead of the wave of new infections.”

Last month, US President Barack Obama’s 2013 budget request proposed a 10.8% cut to direct international aid for HIV programmes under the President’s Emergency Plan for AIDS Relief (PEPFAR) which, together with previous cuts, would slice more than US$1 billion from the fund’s 2010 level. And last November, the Global Fund to Fight AIDS, Tuberculosis and Malaria said that it would not hand out any more funds for scaling up AIDS treatments until 2014 because of tightening budgets in donor countries.

The shortfalls come as a slew of results presented this week reinforce a growing consensus about the power of early treatment for HIV infections. The latest data are part of a trend that accelerated last May, when HPTN 052, a clinical trial run by the multinational HIV Prevention Trials Network, showed that giving antiretroviral drugs to people who are HIV-positive can stop them from passing the virus to their uninfected partners. In light of such results, the World Health Organization is expected to issue new guidelines for managing HIV in couples soon.

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

BHIVA Reports on the Need for Additional PrEP Studies

via AidsMap.com, by Gus Cairns

A position statement by the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH) has concluded that as yet the data on the efficacy of pre-exposure prophylaxis (PrEP) is not compelling enough for it to be offered to patients on demand, and that it should only be prescribed in the context of a clinical research study until more data on its efficacy is gathered.

The BHIVA/BASHH position contrasts with that of the US Centers for Disease Control, which issued guidance for doctors prescribing PrEP to patients last year.

The two UK organisations, which represent HIV and STI healthcare workers respectively, conducted a consultation on PrEP last year which included in-person and telephone conferences with a variety of UK treatment and prevention stakeholders in the UK (including NAM), and the creation of an ongoing PrEP Working eGroup.

The finalised position statement notes that in 2010 there was the highest-ever number of new HIV infections in gay men in the UK (over 3000, 81% acquired here) and adds that this “continued increase in infections...underscores the urgent need to...rethink our overall strategy for HIV prevention at a time when the NHS is undergoing change.”

It also however notes that the data on the efficacy of PrEP has so far been widely disparate (see Aidsmap reports on the iPrEx, PartnersPrEP, TDF2, FemPrEP and VOICE trials), in contrast to convincing evidence both for the efficacy of condoms when used consistently and correctly and of treatment as prevention.

It also notes that these are many unanswered questions in the case of PrEP: will it be affordable and cost-effective? Will it increase the likelihood of drug resistance? Are there long-term toxicity concerns for HIV-negative people taking it? And will it induce people to abandon condom use? It also notes there has never been a systematic evaluation of behaviour-change programmes in the UK, also in contrast to the US.

It concludes that “it is imperative to gather [more] evidence for the value of PrEP in the UK” and that therefore “We recommend that ad hoc prescribing is avoided, and that PrEP is only prescribed in the context of a clinical research study”. Until then, “regular HIV testing, the diagnosis and treatment of other STIs, and intensive health promotion activities...should be implemented in preference to PrEP.”

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

Researchers Explain the Role of Adherence in PrEP Trials at CROI 2012

via AidsMap.com, by Gus Cairns

Adherence makes all the difference to the efficacy of pre-exposure prophylaxis (PrEP), the 19th Conference on Retroviruses and Opportunistic Infections (CROI) heard today.

Further data were presented from two trials of PrEP (giving anti-HIV drugs to HIV-negative people to prevent infection), which announced dramatically different results last year.

In April 2011, the FEM-PrEP study found that giving HIV-negative women tenofovir/FTC (Truvada) pills to prevent their acquiring HIV was totally ineffective: there was no difference in HIV incidence between women taking Truvada and women taking placebo.

In July 2011, however, the Partners PrEP study found that Truvada was 73% effective in preventing HIV transmission between heterosexual partners of different HIV status.

How do we explain why giving HIV-negative women antiretroviral pills made no difference to the HIV infection rate in one trial, but prevented at least two in every three infections in the other? The difference, it appears, is that in the Partners PrEP trial, adherence to the study medication was very high, whereas in FEM-PrEP, despite counselling and support, less than half the women took their PrEP pills regularly.    

The Partners PrEP study

The Partners PrEP study enrolled 4758 serodiscordant couples in Kenya and Uganda; the HIV-negative partner was female in 38% of couples. This study had three arms: a daily tenofovir pill, a daily Truvada pill, or placebo.

There were 17 infections in participants on tenofovir, 13 on Truvada and 52 on placebo. Efficacy overall was 75% in those assigned Truvada and 67% in those assigned tenofovir, though confidence intervals (44% to 81% in tenofovir and 55% to 87% for Truvada) overlapped, so the efficacy of the two regimens was the same statistically. The same was true of efficacy observed in women (65%) and men (70.5%).     

Adherence according to pill counts of unused medication was 97%. A substudy (Donnell) compared tenofovir levels in the blood of 29 out of the 30 people who became infected in the two PrEP arms with levels in a random selection of 198 people who did not become infected.

Tenofovir was undetectable in the blood of 70% of the people who became infected but only 18% of the people who did not, indicating a ‘true’ adherence level of about 80% – and having a detectable level of tenofovir in the blood was associated with an 86% reduction in HIV risk in those taking tenofovir and a 90% reduction in those on Truvada.  

The FEM-PrEP study

In the FEM-PrEP study, 2056 HIV-negative women in South Africa, Kenya and Tanzania were randomised to take a daily Truvada pill or a placebo. The trial was stopped when an interim analysis found near-identical HIV infection rates in both trial arms. There were 33 HIV infections in women taking Truvada and 35 in women taking placebo; this translates into annual incidence rates of 4.7% and 5.0% respectively. This 0.3% difference is no difference at all, statistically speaking (hazard ratio 0.94, 95% confidence interval 0.59 to 1.52, p = 0.81). 

Participants in the study said they took their pills 95% of the time and adherence as measured by pill count was 85%. However when drug levels of tenofovir and FTC were measured in the blood of women assigned to Truvada, the investigators found that less than 50% of the women who should have been taking the drug had actually done so in the last 12 days, and less than 40% within the last 48 hours.

In infected participants, 26% had detectable levels of tenofovir in their blood in the last visit before they tested HIV positive, 21% at the visit they tested positive, and 15% at both visits; in non-infected participants whose samples were taken at the same visits they were 35%, 38% and 26% respectively.

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[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.]

CROI Reports First Trial Results on HIV Injectable Treatment

via AidsMap.com, by Gus Cairns

The first trial in humans of an injectable, once-a-month formulation of an HIV drug has found that drug levels were maintained at a level that should in theory be high enough to protect recipients against infection, and that the drug has so far produced very few side effects. The research was presented at the 19th Conference on Opportunistic Infections (CROI), in Seattle.

The small trial at the St Stephen’s AIDS Trust (SSAT) at London’s Chelsea and Westminster Hospital gave 27 women and six men a single injection of the long-acting formulation of the drug rilpivirine, which was licensed as an oral HIV treatment last year as Edurant and is also in the tenofovir/FTC/rilpivirine pill Complera. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) drug and is especially suitable to be turned into a long-lasting injectable form because the daily dose of it required to suppress HIV is very small.

No other HIV drugs are currently in a usable long-lasting injectable form, which will limit the use of long-acting rilpivirine (RPV-LA) in combination therapy, but it could conceivably make an ideal candidate as a prevention drug, as people would not need to remember to take it every day. Other preventative drugs already formulated as monthly injections include the injectable contraceptive Depo Provera and some anti-psychotic drugs.

SSAT recruited 27 HIV-negative women aged 18 to 50, more than 50% of them black African or Caribbean, for the trial and gave them one of three doses of RPV-LA as an intramuscular injection: 300, 600 or 1200mg (the oral dose of RPV is 25 mg/day). Drug levels were then measured over the course of the next twelve weeks in blood, vaginal fluid and in vaginal tissue samples. A substudy gave six men the 600mg dose and measured RPV-LA levels in blood, rectal fluid and rectal tissue samples.

Thirty days after injection, blood and vaginal fluid levels of rilpivirine were about 60 nanograms per millilitre (ng/ml) in both blood and vaginal fluid in women given the 600mg dose, and about 80 and 120ng/ml respectively in women given the 1200mg dose. Blood levels in men given the 600mg dose were about 70ng/ml at 30 days. For comparison, the trough levels of rilpivirine in people taking daily oral doses is about 140ng/ml; but the EC50 (the amount needed to reduce viral replication by 50%) in newly-infected T-cells is 27ng/ml. It is thought these levels should be adequate to prevent HIV infection. 

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[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.

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

CROI Researchers Share Partner PrEP Results

via MedPage Today, by Michael Smith

Giving anti-retroviral drugs to HIV-negative people can reduce their risk of acquiring the virus from an HIV-positive partner, a researcher said here.

In a large randomized controlled trial in Africa, this type of pre-exposure prophylaxis, or PrEP, cut the risk of infection by up to 75% compared with placebo, according to Jared Baeten, MD, of the University of Washington in Seattle.

The so-called Partners PrEP study is "clearly proof of concept" that treating the uninfected partner in a heterosexual couple can be a good approach to prevention, Baeten told reporters at the annual Conference on Retroviruses and Opportunistic Infections.

The trial is a mirror image of the major study reported last year – the HPTN 052 trial – that found that treating the infected member of such couples reduces the risk of transmission by more than 90%.
Given those findings – and the increasing desire of physicians to treat HIV-positive people as early as possible – the results of Baeten's study may fall on stony ground.

But Baeten told MedPage Today he thinks there will be a place for treatment of the negative partner.
Taken together, the two studies show "a high degree of protection with the use of anti-retrovirals," he said.

But in the heterosexual epidemics in much of the developing world, he said, people face "difficult choices about individual treatment, individual risk, and risk decision making, often related to the desire for pregnancy."

When, for one reason or another, the HIV-positive partner can't start treatment or doesn't want to start, offering therapy to the other partner makes sense, he said.

In a discordant partnership, it's already part of recommendations that the HIV-positive partner be treated, commented Wafaa El-Sadr, MD, of Columbia University in New York City, who was not part of the study but who chaired a press conference at which details were presented.

But she concurred with Baeten that there are likely to be cases where treating the negative partner is the right choice. For instance, she told MedPage Today, "they may not be confident the positive person is taking their medicine."

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