Once-A-Day Pill Shows Promise for People Living with HIV

via abcNEWS, by Mikaela Conley

Doctors told Thomas DeLorenzo he would have lived only two more days had he not come into the emergency room when he did in January 2001. He was dying of AIDS, they said, and his future was bleak because he had waited so long to get treated.

He was in denial for years after his partner died of AIDS in 1995. But after finally getting diagnosed six years later, he "did whatever the doctors said. Whatever it took," DeLorenzo, 49, of Los Angeles said.

"I remember the first day I took the medication," said DeLorenzo, who is now in law school. "It's this big moment that you say, 'Oh f---, here I am.' Reality just hits you in the face."

That was in 2001. After several trials and errors with drug cocktails, he has found a a stable treatment regimen that includes about 17 pills each day to combat and suppress the HIV, while also curbing side effects of the drugs.

And now, a new once-daily "Quad" pill might be added to the arsenal of effective HIV treatments in the near future, according to a new study published in the Lancet. The drug, which combines several medcations into one, could help patients like DeLornezo take fewer pills in the future.

For adults starting antiretroviral treatment, the U.S. Department Health and Human Services recommends the standard treatment for HIV-positive patients, four different drugs, which involved several pills multiple times a day.

Researchers from Harvard Medical School randomly assigned 700 North American patients on two different single-pill regiments, either the new Quad or Atripla, a drug that has become the standard treatment, approved by the FDA in 2006.

After nearly one year of treatment, 88 percent of patients on the Quad experienced a suppression of the virus, compared with 84 percent of the patients on Atripla, the study showed.

Both drugs were also proven to be safe, with only 3.7 percent of the study participants stopping the Quad and 5.1 percent stopping the Atripla.

Read the rest.


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SUPREME COURT RULING ON AFFORDABLE CARE ACT HUGE VICTORY FOR PEOPLE LIVING WITH HIV/AIDS

Press Release via San Francisco AIDS Foundation:

San Francisco, June 28, 2012 — Today the United States Supreme Court delivered a huge victory to nationwide efforts to establish a health care system that works for everyone, including the 1.2 million people living with HIV/AIDS in the United States. By upholding the Affordable Care Act (ACA), today’s decision delivers on the promise of health care for more than 30 million uninsured Americans. The historic ruling also upheld long-overdue protections for people with HIV and other chronic diseases, including safeguards against denial of coverage or exorbitant premiums for the especially sick, and annual and lifetime coverage limits for people with costly medical conditions.

“For the first time in the history of the epidemic, the ACA will dramatically expand health care access to people previously considered ‘uninsurable,’ including millions of Americans with HIV/AIDS and other serious illness,” said Neil Giuliano, CEO of San Francisco AIDS Foundation. “Today, we move one step closer to having a health care system that supports access to care and treatment that prevent illness and disease progression, rather than a ’sick care system‘ that promotes disability and illness by limiting coverage options.”

The Affordable Care Act will address the failings of the current health care system by expanding Medicaid to all low-income people, creating open, competitive, fair marketplaces for uninsured and under insured individuals and families to purchase private insurance, and providing subsidies to lower-income individuals to make insurance affordable. An estimated 1.2 million people are living with HIV in the United States and need access to high-quality, uninterrupted medical care to stay healthy, reduce new HIV infections, and cut long-term health care costs.

“While today’s ruling is a huge victory, there’s no time for rest. We must continue our efforts to educate people affected by HIV about the key components of the ACA and how it will affect access to quality HIV prevention, care, and treatment,“ said Courtney Mulhern-Pearson, director of state and local affairs at San Francisco AIDS Foundation. “It is critically important that all Americans have accurate information about the law, how it will benefit them, and what it means for their health and the health of their communities.”

With today’s historic decision, San Francisco AIDS Foundation will redouble its efforts to ensure that health care reform implementation proceeds full steam ahead. The foundation urges Congress to acknowledge that the Affordable Care Act is the law of the land by fully funding health care reform and ending efforts to repeal it. Progress must not be held hostage by politics.

“Today’s decision underscores the importance of continued funding of the Ryan White CARE Act during this time of transition to health care reform,” said Ernest Hopkins, director of legislative affairs at San Francisco AIDS Foundation. “In order to effectively transition clients and fully realize the promise of health care reform, we must continue our work with elected officials, policy makers, and peer organizations to secure the future of the Ryan White CARE Act.”



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From Revolution to Reality: How Will New Science Impact the US National HIV/AIDS Strategy?

via wiredforchange.com

AIDS 2012 Conference Satellite - Free and open to the public

RSVP requested

Sunday, July 22, 2012, 11:15 AM -1:15 PM

Mini Room 4, Walter E. Washington Convention Center, Washington, DC

Hosted by the Coalition for a National HIV/AIDS Strategy

Moderator: Gregorio Millett, Senior Scientist, CDC/HHS Liaison to White House Office of National AIDS Policy DONE

Presenters include (list still in formation):

- Carlos del Rio, MD, Hubert Professor and Chair, Hubert Department of Global Health, Emory University: Treatment Cascade
- Keith R. Green, MSW, Director of Federal Affairs, AIDS Foundation of Chicago: PrEP and the NHAS 
- David R. Holtgrave, PhD, Chair, Department of Health Behavior and Society, Johns Hopkins Bloomberg School of Public Health: Costs, Consequences and Feasibility of Achieving the NHAS Goals
- Molly Morgan Jones, PhD, Senior Analyst, RAND Europe: Mapping Pathways: Exploring strategies in the use of ARV-based prevention

Please register here.

The U.S. National HIV/AIDS Strategy (NHAS) has been in place for two years, and since its release, scientific breakthroughs and new research have transformed our thinking about the US HIV epidemic.  HPTN 052 and successful PrEP and microbicide trials demonstrate that biomedical interventions hold promise that were unthinkable just 2 years ago. 

At the same time, Gardner and his coauthors shine a spotlight on the human factors impacting the epidemic-half of people with HIV are not in medical care, and just 1 in 4 achieves treatment success.  Key researchers, including some who contributed to these breakthrough findings, will weigh in on the implications of new research on the US strategy.

Click here to register.

This session will be immediately followed by the satellite session, "Achieving the Goals of the United States National HIV/AIDS Strategy: Next steps", organized by the U.S. Department of Health and Human Services. 

This symposium is conducted in collaboration with and funded by Bristol-Myers Squibb with no editorial review of content. 


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Reasons to Use Biomedical Prevention to Fight HIV/AIDS

via thewarning.info

In France, the controversy between HIV organizations about PrEP appear in the media and social networks, from moral considerations disguised in ethical objections to classic behavioral speculations (as there was on the TasP or PEP) [4].

So, to clarify and defuse the situation, it should be noted some points :

The biomedical prevention is a revolution in terms of sexual and mental health for serodifferent couples (especially those who want to have children) and poz sex workers (under pressure from their customers to have condomless sex), removing the risk and visceral fear of contamination. It is essential for fighting the demonization of people living with HIV/Aids (PLWHA) in our poz-phobic society : they are no longer considered as « viral bombs ».

 The biomedical prevention is a need expressed by all PLWHAs and peoples concerned by HIV [5].

 The biomedical prevention is an additional argument for the battle for universal access to treatment in poor countries and in prisons.

 The biomedical prevention is an important argument against the criminalization of HIV transmission, which beyond our respective countries, is increasing in Africa (since women are the first victims).

 The biomedical prevention must be done within the strict framework of informed consent and needs (therapeutic, psychological, sexual and social) of the concerned person(s). In no circumstances it may force the initiation of treatment to anyone, even if early treatment appears to have benefits, and although some mathematical models abound for the establishment of a general strategy of Test&Treat. Warning has long been positioned on the subject [6].

These reasons alone are sufficient to promote biomedical prevention [7] in a responsible manner and combined [8] to other tools in the fight against AIDS : condoms, HIV testing [9], Counseling, and struggles against serophobia and criminalization of sexual transmission of HIV.

Read the rest.


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CDC Offers Free AIDS Tests at Drugstores

via washingtontimes.com, via Mike Stobbe

ATLANTA (AP) - Getting an AIDS test at the drugstore could become as common as a flu shot or blood pressure check, if a new pilot program takes off.

The $1.2 million program will offer the free rapid HIV tests at pharmacies and in-store clinics in 24 cities and rural communities, the Centers for Disease Control and Prevention announced Tuesday.

“We believe we can reach more people by making testing more accessible and reduce the stigma associated with HIV,” Dr. Kevin Fenton, who oversees the agency’s HIV prevention programs, said in a statement.

The tests are already available at seven places, including Washington, D.C., Oakland, Calif., and an Indian health service clinic in Montana. The CDC will soon pick 17 more locations.

The HIV test is a swab inside the mouth; it takes about 20 minutes for a preliminary result. The test maker says it’s correct 99 percent of the time. If the test is positive for the AIDS virus, pharmacy employees will refer customers to a local health department or other health care providers for a lab blood test to confirm the results, counseling and treatment. The workers are expected to deliver the news face-to-face and give customers privacy, the CDC said.

An estimated 1.1 million Americans are infected with HIV, but as many as 20 percent of them don’t know they carry the virus, according to the CDC. It can take a decade or more for an infection to cause symptoms and illness.

Since 2006, the CDC has recommended that all Americans ages 13 to 64 get tested at least once, not just those considered at highest risk: gay men and intravenous drug users. But fewer than half of adults younger than 65 have been tested, according to the agency’s most recent statistics.

It’s important to know about infection not only for treating the condition but also to take steps to prevent spreading it to others. An HIV diagnosis used to be a death sentence, but medications now allow those infected to live longer and healthier lives.

Read the rest.


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Inching Towards a Cure

via allafrica.com, by Ruby Leo

Almost a decade ago since the HIV/AIDS virus was discovered, no cure seems to be at the horizons, despite billions of dollars spent and pumped into research to stop the transmission of the disease which has claimed millions of lives across board.

It was nothing short of joy when scientists announced that a new drug, Truvada, can actually prevent the transmission of the virus.

It stipulates that once the person is taking the drug and has intercourse with an infected person, it would not jeopardize his immune system as he or she will be immune to the virus.

Gloria Funsho (Not real name) told Health Insight that there is hope for those of them that are living with the virus because their chances of marrying is now ascertained since the fear of infecting their partners has been eliminated.

The Director General of National Agency for the Control of AIDS (NACA), Professor John Idoko, speaking on the discovery said the drug which is just like the malaria drug, will prevent one from getting infected even if he or she has intercourse with a positive person.

Prof John Idoko, explaining the new prevention treatment drug, pre- exposure Prophylaxis, said "if we give the drugs to somebody who doesn't have HIV, and the person has sexual relationship with an HIV positive partner, it can prevent transmission from the positive person to the person. That is why it's called a pre- exposure prophylaxis because before exposure, the person has taken the drugs and because he has the drugs in him, the virus cannot infect him or her."

Also, Idoko says: "If you take this sero-discordant couples; one is positive and the other is negative, instead of giving the drug to the negative person before the sexual relationship, just put the positive one on drug as soon as you know. It doesn't matter what his CD-4 count is, even if it's 500, just give him the drugs. It has shown clearly one of the best study results that we have seen, as 96 per cent chance of the person transmitting HIV is blocked. So we call that treatment as prevention.

"So you can now imagine that if you go to a community, and they are using this method, your chances of blocking transmission are very high. We believe that these are the two things we need to put together as part of our combination prevention method."

Read the rest.


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The road to PrEP: trials, regulation and roll-out

via aidsmap.com, by Gus Cairns

Within the next three years, up to 33,000 people may take part in 22 different studies worldwide to demonstrate the feasibility, or otherwise, of pre-exposure prophylaxis (PrEP) to prevent HIV, the IAPAC evidence summit, Controlling the HIV epidemic with antiretrovirals, was told on 12 June.Some of these studies are underway but others are still in the design stage or in need of funding.

Dr Jim Rooney of Gilead Sciences, the manufacturer of tenofovir (Viread) and Truvada (tenofovir and FTC), the products being tested in the vast majority of these studies, told the meeting that up to 13,000 men who have sex with men (MSM) could end up being involved in 14 different studies and up to 19,500 heterosexual men and women in eight studies. These studies were particularly crucial in establishing whether PrEP might be less, or more, effective in open-label settings than in randomised placebo-controlled trials.

Some of these are ongoing or open-label extensions of studies such as Partners PrEP in 4758 sero-different couples in Kenya and Uganda, or iPrEx OLE (Open Label Extension) in 1500 MSM in six countries.  

Others are just beginning, such as the IPERGAY study of intermittent PrEP in gay men in France. While it is planned that this could eventually include 1900 men, researcher Bruno Spire told the IAPAC meeting that 300 participants had to be enrolled by February 2013 if the next phase of the study was to be funded, and that recruitment had been rather slow so far, partly because of "ideological obstacles" to there being a placebo arm.

Similarly, Dr Sheena McCormack of the UK's Medical Research Council told the meeting that, while the planned UK PROUD study of immediate versus delayed PrEP could eventually include 5000 MSM, only a pilot project in 300 MSM has so far been proposed, with a tentative start date (if the protocol is agreed) in October 2012. 

Read the rest.


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Uganda Dismisses Truvada as an HIV Vaccine

via observer.ug, by Shifa Mwesigye

Scientists in Uganda have dismissed reports that an HIV vaccine has been found.

The reports follow the US-based Food and Drug Administration’s approval of the anti-retroviral drug Truvada as a preventive measure against the transmission of HIV. Prof Pontiano Kaleebu, director of the Uganda Virus Research Institute in Entebbe, says Truvada is not an HIV vaccine but an anti-retroviral drug.

“No HIV vaccine has yet been discovered. There are, however, ongoing studies and efforts to discover a vaccine,” Kaleebu said.

Truvada has been shown to reduce risk of infection by up to 42% in gay and bisexual men and 75% in heterosexual couples according to the AIDS Research Alliance. Dr Patrick Ndase, the Ugandan HIV prevention research expert at the University of Washington, says Truvada is an anti-retroviral agent that has been in use for HIV treatment since 2004. It is one of the first line of drugs for HIV treatment in several countries in Africa.

“It most certainly is not a vaccine. The concept studied is the use of an anti-retroviral drug for HIV prevention similar to the approach used for prevention of mother-to-child transmission,” he said.

“There is no vaccine and clearly no clear timeframe can even be put to hopes of ever getting a vaccine against HIV, but the hope is alive.”

The scientists say that Truvada does not offer 100% protection against HIV and may encourage risky behaviour. For Truvada to give some measure of protection, an HIV negative person would have to take it daily, something that is difficult even for people who take part in vaccine and drug trials.

Read the rest.


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TAC Fights for Proper Treatment

via allafrica.com, by Ayanda Mkhwanazidoms

The Treatment Action Campaign (TAC) has vowed to mobilise more communities to fight for quality health should the Gauteng Health Department not deliver on their demands. This week, the TAC marched to the office of Gauteng Health MEC demanding the restoration of health services.

"This is violation of many rights in the Constitution... the right to equality... everybody has a right to free health care service, but because we are poor and do not have medical aid, I can't access health care. They are further violating our right to life because, for the love of God, these ARVs are our life and without them we are dead", Deputy Chairperson of the Treatment Action Campaign in the Ekurhuleni district of Gauteng, Portia Serote, did not mix her words as she reminded the hundreds of TAC members of their basic rights as enshrined in the Constitution.

Angry TAC members marched to the office of the Gauteng Health MEC, Ntombi Mekgwe, this week, demanding an end to the drug shortage in health facilities. Health services in Gauteng have been dealt a severe blow due to drug stock outs which have been ongoing for months. The TAC says the last straw was the lack of vital treatment, such as the Tenofovir drug, one of the Anti-Retroviral Drugs (ARVs) for HIV-positive people. Serote says it is unacceptable that essential drugs are unavailable to patients.

"For example, Tenofovir is a good drug that we, as the TAC, fought for, so everybody can access it for free. But what is happening in health facilities is that they do not stock enough. Others (patients) are switched with Stavudine", she says.

Some of the messages written on posters by prostestors were loud and clear: 'Provide treatment and do not gamble with our lives'.

Serote says patients have been constantly turned away from clinics and told to return on another date

Read the rest.


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ARM-ing Africa for Rectal Microbicides

Original content from the Mapping Pathways blog team

These are exciting times in the HIV-prevention landscape.  In an earlier Mapping Pathways post, we covered our colleague, Jim Pickett’s experiences at the Microbicides 2012 (M2012) conference in Sydney in April.  At M2012, advocates discussed a number of important issues, including the importance of adherence in clinical trials. 

A major development at M2012 was a report released by the International Rectal Microbicide Advocates (IRMA), a global network that Jim leads, as a cornerstone of their Project ARM (Africa for Rectal Microbicides). The report, titled “On the Map: Ensuring Africa’s place in Rectal Microbicide Research and Advocacy” outlines priority actions to ensure Africa is involved in rectal microbicide research and advocacy activities.

On The Map is the result of a two-day consultation that took place before the ICASA conference in Addis Ababa in December with African and international stakeholders. Says Pickett, “The central question of the consultation was ‘How can we be more strategic and proactive to make sure Africa is on the map when it comes to rectal microbicide research and advocacy?’”

The Project ARM report lays out seven key action areas specific to rectal microbicide research and advocacy in the African context:

Knowledge, Attitudes and Behaviors (KAB) studies on anal health and anal sex to generate data that can be analyzed across countries and populations

Rectal microbicide acceptability studies

Mapping of sex education curricula to determine what content on anal health is included

Advocacy for lubricant access through the “And Lube” campaign of the Global Lube Advocacy Mobilisation (GLAM)

Documentation of best practices for integrating anal health, anal intercourse and rectal microbicides into sexual health and HIV prevention education

Capacity-building activities for community leaders, advocates, and researchers

Awareness raising and education about anal health, anal intercourse, and rectal microbicides, including development of educational materials and other communications efforts specific to the African context

According to Pickett, members of the Project ARM working group further prioritized the key activities. While the members agreed that all the activities are important, the top three are the KAB studies, awareness raising and education on anal health and anal intercourse, and improving access to condom-compatible lubricants, which are in very short supply across most of Africa.

Pickett explained that the HIV epidemic in Africa is often wrongly considered as solely heterosexual, with sexual transmission driven entirely by unprotected vaginal sex between men and women. “There has been little to no official recognition of the fact that there are gay men and other men who have sex with men in Africa who are enduring high rates of HIV, and that plenty of heterosexuals also have anal sex. Unprotected anal intercourse is 10 to 20 times more likely to result in an HIV infection compared to unprotected vaginal intercourse,” says Pickett.

As mentioned, increasing access to condom-compatible lubricant is a key goal of Project ARM. Access to appropriate lubricants on the continent is quite abysmal. “In the absence of appropriate, safe lubricants, people use things like shampoo, cooking oil, hand lotion, antibiotic creams – even motor oil – that break down the latex in the condom, erasing the protective benefits.. People also use saliva, which dries out quickly – and can cause tears in the condom as well as harm the fragile rectal environment. For safer anal sex, lubrication that is condom-compatible is absolutely necessary,” says Pickett.

 “There is an immediate need for appropriate lubricants for people who have anal intercourse in Africa. If we can’t get lubricant to people now, how will we be able to deliver rectal microbicides to them when they become available? Increasing access to appropriate lube is absolutely critical, and paves the way for access to rectal microbicides down the line. We can’t have campaigns and programs that deliver condoms without also delivering condom-compatible lubes. Period.”

Stay tuned to the blog as we bring you more information on this exciting project. Until then, read a vivid snapshot of advocacy in Africa through the eyes of Brian Kanyemba here. Brian has been very involved with IRMA's Project ARM, and is an integral member of the Project ARM video working group, which is trying to produce an African-focused video on anal health and anal intercourse.

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

South African Clinicians Outline Best Treatment for Prevention Practices

via mg.co.za, by Mia Malan

South African guidelines for the preventative use of HIV medication by men who have sex with men who are not infected with the virus are to be published in the peer-reviewed academic publication, Southern African Journal of HIV Medicine, this month.

The treatment, pre-exposure prophylaxis (Prep), consists of an antiretroviral (ARV) pill that is taken daily by HIV-negative people to lower their chances of becoming infected with the virus.

The guidelines were developed by a panel of microbiologists, clinicians, virologists, pharmacists and community representatives affiliated to the South African HIV Clinicians’ Society. 

Several recent studies have revealed that, if Truvada pills, which contain the ARVs tenofovir and emtricitabine, are taken regularly, they can reduce the risk of men who have sex with men of acquiring HIV by up to 72.8%.

Prep is part of a movement based on the use of ARVs to protect vulnerable groups who are consistently exposed to HIV. In “discordant” couples, where one partner is HIV positive and the other negative, the uninfected person is at a high risk of contracting HIV if condoms are not always used, particularly if the ­positive partner has a large amount of the virus in his or her blood or sexual fluids because he or she is not yet on ARVs.

HIV-infected people’s chances of infecting their sexual partners with HIV are significantly lower if they are using ARVs, as the medication reduces the amount of virus in their bodies. Men who have sex with men are particularly vulnerable, and HIV infections are on the increase in this group, despite awareness of the effectiveness of condoms.

Read the rest.


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

PrEP: time to rethink prevention, effectiveness and ethics?

via Somatosphere, Marsha Rosengarten

One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc.  Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking to establish the efficacy of PrEP (see iPrEX versus Fem-PrEP), concerns have been raised about PrEP’s potential to undermine condom use, its cost implications in locales where treatment provision is still lacking and elsewhere, its potential to cause unwanted drug side-effects as well as possible drug resistance in those it fails to protect.

Nevertheless, continuing new infections and evidence that high adherence produces a strong protective effect are mobilising many public health authorities to devise feasible implementation models.

Most remarkable about the growing interest in PrEP is the exclusion of the social sciences from major forums where this work is taking place.  One such example is a two-day forum held in the UK by IAPAC on the dual topics of treatment as prevention (TasP) and PrEP.  The only non-biomedical speakers listed on the programme were a psychologist (speaking on adherence), a bioethicist, activists and public health officials linked to various national epidemics.

Indeed it won’t come as a surprise to many to know that despite the millions of dollars to support RCTs for PrEP, the Bill and Melinda Gates Foundation have so far declined to support a substantial programme of social research on PrEP.  In fact if we consider the bioethical requirements imposed on the conduct of RCTs for PrEP and other biomedical interventions, there is no ethical requirement for research on the social dimensions of the intervention during or post RCTs. This applies even when RCTs demonstrate candidate efficacy.

Read the Rest.


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

WHO Updates Treatment-As-Prevention Plan for HIV and TB

via iasociety.org, by Mark Mascolini

“It is certain that TasP [Treatment as Prevention] needs to be considered as a key element of combination HIV prevention and as a major part of the solution to ending the HIV epidemic.”

With that statement, the World Health Organization (WHO) issued its June 2012 Programmatic Update on Antiretroviral Treatment as Prevention (TasP) of HIV and TB, available at the link below.

As countries continue to expand antiretroviral therapy (ART) programs for HIV-positive children and adults, WHO says, “it is expected that they will concurrently identify opportunities to maximize the use of ART for prevention purposes.”

TasP should focus on specific populations—such as HIV-discordant couples and pregnant women—in whom prevention should have the greatest impact. UNAIDS issued updates and guidance for these populations “and is working with countries to address programmatic and operational challenges to inform the consolidated guidelines to be released in mid-2013.”

The Programmatic Update includes guiding principles, the evidence base for TasP, a review of the current status of national HIV treatment guidelines and implementation experience with TasP, programmatic and operational considerations, and WHO’s three priority areas:

• Develop norms and standards for treatment as prevention
• Inform programmatic and operational decisions
• Define metrics for monitoring and evaluating the impact of TasP

WHO’s Gottfried Hirnschall told attendees at a London meeting that the new TasP recommendations will almost double the number of people judged to need antiretroviral therapy, aidsmap.com reports.

Read the rest.

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

Mapping Pathways Community Perspectives on PrEP Webinar

Original content from the Mapping Pathways blog team

In response to recent news from the FDA regarding the use of the drug Truvada for prevention, Mapping Pathways U.S. partners AIDS United and AIDS Foundation of Chicago presented a webinar June 19 focusing on the ARV-based strategy PrEP (pre-exposure prophylaxis.)

During the webinar, key findings from the Mapping Pathways online survey and stakeholder interviews were presented to help illuminate the wide-ranging perspectives of advocates, clinicians, people living with HIV, policy makers and others regarding PrEP. While the U.S. context was highlighted, comparisons/contrasts were drawn with the opinions of individuals in South Africa and India.

Below are the slides from that webinar.

Mapping Pathways - Community Perspectives on PrEP

Click "slideshare" to download the slides if you wish.


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

Find Mapping Pathways at AIDS 2012

Original content from the Mapping Pathways blog team

The Mapping Pathways team will be participating in a number of sessions at the International AIDS Conference (AIDS 2012) in Washington, DC this July. Please check out our list of activities below, and join us!

We will be sharing data we collected in 2011 from India, South Africa and the United States - all related to the utilization of ARVs as HIV prevention. Community and stakeholder perspectives from the "grassroots" and the "grasstops" will be highlighted in each of our focus countries, and sharing an analysis of an extensive literature review conducted by RAND.

Mapping Pathways at AIDS 2012

Click on "View on slideshare" to download the PDF. We hope to see you in DC!

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

Tenofovir Shortage Exposes Problems in Health Management in South Africa

via allafrica.com, by Khopotso Bodibe

The recent shortage of a crucial antiretroviral drug, Tenofovir, is but just a symptom of an underlying general problem of health management in South Africa. Part of this is the lack of oversight on drug supplies and availability by the national Health Department.

At the heart of the seven months' long shortage of Tenofovir, which started running out in October last year is nothing else, but poor planning. For the whole of last year, the Health Department had a donated stock of the drug from the United States' government and retained two pharmaceutical companies, Aspen Pharmacare and Sonke Pharmaceuticals to produce a tiny fraction of the supply.

It was only when small quantities of the donated stock of Tenofovir were left that the Health Department urgently requested the two drug manufacturers in November to increase their production and supply 100 % of the stock, with Aspen Pharmacare responsible for producing 70% and Sonke Pharmaceuticals 30% of the required Tenofovir packs for an estimated 1.2 million patients. But the two failed to meet the demand at short notice, leaving patients in dire straits. Director of Section 27 and executive member of the Treatment Action Campaign, Mark Heywood, says this demonstrates a general lack of planning by the Health Department to address drug shortages in the country.

"Planning is absolutely crucial. If I was the Minister of Health, then I would instruct that the relevant official in the Department of Health has a monthly meeting with the pharmaceutical companies, with key people in some of the provinces just to assess on an on-going basis, not necessarily because there's a crisis, but just to make sure that they are looking at what are the drugs are the drugs in the system, are the drugs in the pipeline, are we getting to people, where is the weak point in the chain? If you put that type of system in place, then we wouldn't be facing what we are facing now", according to Heywood.

The recent shortages of Tenofovir, for example, occurred as a result of the Health Department not informing the contracted drug manufacturers in good time that a shortage was looming. Thus, they were not able to produce the required amounts. In addition, Aspen Pharmacare and Sonke Pharmaceuticals neglected to inform the Health Department that producing 1.2 million packs of Tenofovir within the required time would not be possible.

Read the rest.


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Hospital Fails to Make ARV Order for the Month of June

via allafrica.com, by Jennifer Dube

SCORES of people receiving anti-retroviral (ARV) drugs from Harare Central Hospital were early last week told to buy their own drugs as the hospital allegedly "forgot" to order the life-prolonging drugs.

A beneficiary of the government-free ARV programme showed The Standard his health card where "out of stock" had been written against the second line drug alluvia which is used together with tenolam.

"They said they do not have the drugs," the beneficiary said. "I was advised to buy the drugs but I currently do not have the money to do so. This will affect me as I may take long to get the money for the drugs."

Vice-president of Zimbabwe HIV and Aids Activists Union, Stanley Takaona said his organisation had been told the hospital did not make an order for the month of June.

"We have made a follow-up with the hospital together with the ministry and we were told the drugs are there at the national pharmacy but the hospital did not make an order for this month," Takaona said.

"Those are the most expensive ARV drugs, costing US$120 for a month's supply and most people who are on the government programme cannot afford them."

Takaona said such alleged negligence on the part of the hospital was disturbing as those on ARVs were supposed to take the tablets consistently, without skipping any days, for effectiveness.

Read the rest.


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

Clinical Trials Have Gone Global: Is This a Good Thing?

via plosmedicine.org, by Trudie Lang and Sisira Siribaddana

Why Do We Need Trials and What Makes a Trial a Trial?

Clinical trials are needed globally to reduce disease burdens by helping developing safe and effective new therapies and vaccines. These solutions may be for non-communicable diseases like cancer and diabetes, or, as is especially needed in the poorest regions of the world, infectious disease. Developing countries are under-represented in research due to lack of commercial viability and trained researchers, yet it is in these poorest regions where research-led solutions could bring the greatest impact to high rates of early mortality.

As a research tool clinical trials are fundamental in the effort to develop new products by gaining the data required by regulators, whether for product license extensions for existing therapies for common ailments or to bring cutting edge new therapies and vaccines into approved use. However, there is also a need for clinical trials to bring evidence to determine how to improve the management of health issues; these studies often do not involve a medicinal product but instead compare different options, such as different types of management of an illness in hospital with community-based care. Or, for example, a clinical trial might be used to assess different mechanisms to improve patient adherence to therapy. These pragmatic disease management trials can bring about significant improvements in public health and often require large yet simple trial designs.

The World Health Organization and journal editors define clinical trials as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes” [1]. Patients may be randomised to an intervention involving either an investigational new product or the standard-of-care treatment, or the patient might be randomised to be cared for by nurses who have been trained in one of two or more comparative ways.

Why Go Global?

Clinical trial data are often collected from varied populations to support a license application because geographically different trial sites are needed to ensure the product is safe and works in the same way in varying ethnic groups. This requirement is true whether it is a pharmaceutical company working on the next blockbuster drug or a non-for-profit partnership (which typically have a pharmaceutical partner involved in a non-for-profit capacity) developing a new drug or vaccine for a neglected disease. Here scientific and regulatory factors combine to encourage the globalisation of clinical trials.

Read the rest. 


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IAPAC Summit - If people who need HIV drugs aren’t getting them now, why should the prevention benefit of treatment be the reason that the drugs become available?

via Aidsmap, by Roger Pebody

The issue of ‘treatment as prevention’ raises a number of ethical issues, Richard Ashcroft, professor of bioethics at Queen Mary University of London told the IAPAC Controlling the HIV Pandemic with Antiretrovirals Evidence Summit in London this week.

He reminded the audience that it is rare for a doctor to give a patient a medicine that will primarily benefit a third party. He went on to highlight situations in which, at present, antiretroviral treatment is not universally available to all people who need it for their own health. In such circumstances, why should treatment’s prevention benefit be “the clincher” that convinces funders and policy makers to make the drugs more widely available?

At the same meeting, Kevin Fisher of AVAC noted that the ethical concerns tended to differ in different parts of the world. In settings where there is already good access to HIV treatment, the concerns are often related to individuals experiencing external pressure or compulsion to take treatment. In resource-limited settings, the concerns focused more on the cost of and access to treatment.

Read the rest.

And check out the Mapping Pathways slides that were presented at the same meeting, on the issue of PrEP.

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

Register today for the Mapping Pathways Community Perspectives on PrEP Webinar!

Tuesday, June 19 at 3:00pm EST

In response to recent news from the FDA regarding the use of the drug Truvada for prevention, Mapping Pathways U.S. partners AIDS United and AIDS Foundation of Chicago are presenting a webinar focusing on the ARV-based strategy PrEP (pre-exposure prophylaxis.)

Please join us Tuesday, June 19th at 3:00 pm EST for this webinar. Email zfellows1@aidsunited.org to register.

During the webinar, key findings from the Mapping Pathways online survey and stakeholder interviews will be presented to help illuminate the wide-ranging perspectives of advocates, clinicians, people living with HIV, policy makers and others regarding PrEP. While the U.S. context will be highlighted, comparisons/contrasts will be drawn with the opinions of individuals in South Africa and India.

Following the presentation, a moderated discussion will ask webinar participants to reflect on their particular jurisdictions and to share their own PrEP assessments.

We hope you will be able to join us for this timely conversation.


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

HIV Treatment as Prevention Biologically Plausible Using Ritonavir-Boosted Darunavir (Prezista) and Etravirine (Intelence)

via aidsmap.com, by Michael Carter

A pharmacokinetic study suggests that ritonavir-boosted darunavir (Prezista) and etravirine (Intelence) achieve high concentrations in semen and rectal tissue, and could therefore help avert HIV transmission and infection, especially in gay men. Concentrations of these antiretrovirals were monitored over an eight-day period in HIV-negative volunteers. The study is published in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The US investigators believe their findings “provide pharmacologic plausibility for the use of darunavir plus ritonavir and etravirine in secondary HIV prevention, in both infected and uninfected individuals”.

Antiretroviral therapy has a central role in combination HIV prevention efforts. Treatment that suppresses viral load has been shown to reduce the risk of transmission in heterosexual couples by 96%. Anti-HIV drugs can also reduce the risk of infection with HIV when used a pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP). Incidence of HIV remains high in gay men and they are therefore a priority for the use of HIV treatment as prevention.

It is currently unknown if specific combinations of antiretroviral drugs are more effective at preventing infection with HIV or onward transmission of the virus. “Defining the antiretroviral exposures in biological compartments that are vulnerable to acquisition and are sources of infection, such as rectal tissue and semen, could assist in selecting regimens for HIV prevention,” explain the authors.

They therefore designed a pharmacokinetic study lasting eight days involving twelve healthy HIV-negative men. Concentrations of darunavir/ritonavir and etravirine in blood, semen and rectal tissue were monitored intensively on day one and again on days seven/eight.

The participants had a median age of 27 years and were racially diverse. All tolerated the medications well.

After the first dose, all three drugs were detected in blood, semen and rectal tissue.

Read the rest.


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

Advisory Committee Recommends FDA Approval of In-Home HIV Test

via nature.com, by Cassandra Willyard

Last month, patient advocates hailed the unanimous vote by an advisory committee to the US Food and Drug Administration that recommended that the agency approve the OraQuick In-Home HIV test, an over-the-counter diagnostic that can be taken without medical supervision. If approved, the OraQuick test would be the first home test approved for an infectious disease. But concerns remain about whether the price will render it out of reach of those who need it most and what the test will mean for the handful of individuals participating in HIV vaccine trials.

The OraQuick test, from Pennsylvania-based OraSure Technologies, is a home version of a rapid HIV test already used in many medical centers. The kit includes an instructional booklet and a test stick, which the user swipes along his or her upper and lower gums and contains molecules that react against HIV-specific antibodies produced by the body. Results are ready just 20 minutes later. Two lines on the dipstick signify a positive result, which must be confirmed by a more sensitive test at a clinical laboratory. The company plans to provide a 24-hour hotline so that customers can ask questions or receive counseling, but the phone call is optional.

FDA approval of OraQuick would probably pave the way for other in-home HIV tests. Chembio Diagnostic Systems, based just outside New York City, already plans to seek approval for a home version of its rapid 'Sure Check HIV' test, which requires a drop of blood. Although over-the-counter tests for HIV and hepatitis C are already available from Illinois-based Home Access Health Corporation, both require the consumer to send a blood specimen to a laboratory for analysis and results.

No test is perfect, however, and one major concern is that people who test negative using the OraQuick kit might actually have HIV. In a recent phase 3 trial, OraSure gave the prototype to 5,662 individuals to use in their homes. The results, made public by the company in filing for approval, indicate that only 93% of the 114 individuals infected with HIV received a positive test result. In the clinical setting, the same test is 99% accurate. Why the home test missed so many infections isn't clear. Because the OraQuick test detects HIV-specific antibodies, recently infected individuals may test negative. False positives seemed to be less of a problem; only one uninfected study participant tested positive.

Read the rest.


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

Internation AIDS Official Conference Programme Available Online

Available online via aids2012.org

 

World’s Leading Scientists, President Bill Clinton, South African Health Minister Aaron Motsoaledi, philanthropist Bill Gates and humanitarian Sir Elton John to address the XIX International AIDS Conference in Washington, D.C. (AIDS 2012)

Daw Aung San Suu Kyi, General Secretary of the National League for Democracy, (Burma) to address the conference by video

Some 25,000 Scientists, People Living with HIV, and Other Stakeholders expected to attend AIDS 2012

Official Conference programme now online

Wednesday, 13 June 2012 (Washington, D.C., USA) – Organizers of the XIX International AIDS Conference (AIDS 2012) announced today that President Bill Clinton, founder of the William J. Clinton Foundation and 42nd President of the United States, South African Health Minister Aaron Motsoaledi, philanthropist Bill Gates, and humanitarian Sir Elton John, founder of the Elton John AIDS Foundation, will be among the high-level speakers who will join thousands of the world’s top AIDS researchers, community leaders, and other stakeholders in Washington, D.C. this summer. An estimated 25,000 attendees are expected to attend AIDS 2012, which will take place from 22 to 27 July under the theme Turning the Tide Together.

President Clinton will deliver keynote remarks at the closing session on Friday, 27 July. Sir Elton John will deliver a keynote address on Monday, 23 July.

In the last few years various research trials, including HPTN 052, TDF2, Partners PrEP, and iPrEx have demonstrated with solid evidence the efficacy of HIV treatment as prevention, while other studies are currently investigating the possibility of a cure for HIV. 

“Thanks to these scientific advances, for the first time we have a real opportunity to make a major dent in the epidemic,” said Elly Katabira, International Chair of AIDS 2012 and President of the International AIDS Society (IAS).

“We are delighted to welcome the world’s leading AIDS scientists to AIDS 2012, and to have secured these high-level keynote speakers at this crucial time in the global response to HIV.”

The theme of AIDS 2012, Turning the Tide Together, has been selected to emphasize how a global and decisive commitment is crucial to change the course of the epidemic now that science is presenting promising results in HIV treatment and biomedical prevention. This biennial event is the world’s largest meeting on AIDS, where leading scientists report on the latest AIDS research, and together with implementers, community leaders and policymakers, help to identify next steps in the global response to AIDS.

“AIDS 2012 represents a unique occasion to mobilize policy makers, governments, NGOs, scientists, people living with HIV and civil society to join forces,” said Dr. Diane Havlir, U.S. Co-Chair of AIDS 2012 and Professor of Medicine at the University of California. 

“Despite the global turbulent economic climate we cannot miss this historic moment, and it is vital to continue to attract funding to invest in AIDS research and promote programmes based on effectiveness and efficiency in order to optimize the use of resources,” concluded Havlir.

The full AIDS 2012 programme is now available through the conference website www.aids2012.org and significant parts of the programme – including webcasts of key sessions, speeches, slide presentations, abstracts, digital posters, session-specific and daily rapporteur reports, as well as workshop handouts and audio recordings, will also be online during the conference.

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

World Health Organization Encourages Antiretroviral Drug Use for HIV Prevention

via aidsmap.com, by Keith Alcorn

The number of people eligible for antiretroviral treatment will grow by around six million as a result of recent World Health Organization recommendations on the use of antiretroviral drugs to prevent HIV transmission, Dr Gottfried Hirnschall, head of the WHO’s HIV department told the IAPAC Controlling the HIV Pandemic with Antiretrovirals:Treatment as Prevention and Pre-Exposure Prophylaxis Evidence Summit in London.

The new recommendations almost double the number of people judged to be in need of antiretroviral therapy –  calculated at 7.4 million people with CD4 counts below 350 and therefore in need of treatment at the end of 2010. In 2010, antiretroviral coverage reached 47% of those eligible, he said.

His remarks coincided with the release by WHO of a Programmatic Update on Antiretroviral Treatment for Prevention of HIV and TB, which sets out the organisation’s plans to galvanise greater use of antiretroviral treatment in order to limit new infections.

The summit, organised by the International Association of Physicians in AIDS Care, is designed to review recent advances in the use of antiretroviral drugs as a means of preventing HIV transmission, and to discuss the practical implications of the new data for treatment and prevention programmes.

Speaking on the first day of the two-day summit, Dr Hirnschall pointed out that, for every person placed on treatment, 2.5 people are still becoming infected every year, amounting to approximately 2.7 million infections a year in 2010.

Scale-up of a combination of effective prevention interventions remains urgent, and antiretroviral treatment must play a central role in the prevention of new infections, he said, following last year’s release of the results of the HPTN 052 study, which showed that early antiretroviral therapy for the HIV-positive partner reduced the risk of HIV transmission by 96% in serodiscordant partnerships.

Similarly, evidence from the South African province of KwaZulu-Natal demonstrates that, at the population level, antiretroviral therapy is already having an impact on one of the most severe epidemics in sub-Saharan Africa. Every 1% increase in antiretroviral coverage among adults in rural communities between 2004 and 2011 was associated with a 1.7% reduction in the risk of HIV acquisition, suggesting the potential for large reductions in HIV incidence if greater progress towards universal access to antiretroviral treatment can be achieved.

However, Dr Hirnschall noted that current coverage in low- and middle-income countries – 47% in 2010 – “is not giving us the prevention gain we want to see”.

Read the rest.


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

HIV Drug Trial in South Africa Draws Concerns

via allafrica.com, by Anso Thom

AIDS activists and researchers are at loggerheads over the planned South African trial of a lower dose version of the controversial antiretroviral stavudine, which has in the past been responsible for debilitating side-effects in HIV patients.

The main adverse effect is peripheral neuropathy, which can be corrected by reducing dosage.

The symptoms of peripheral neuropathy include burning, stiffness, prickling, tingling, and numbness or a loss of feeling in the toes and soles of the feet. Sometimes the nerves in the fingers, hands, and wrists are also affected.

Stavudine is also one of the most likely ARVs to cause lipodystrophy, and for this reason it is no longer considered an appropriate treatment for most patients in developed countries and is no longer recommended by the World Health Organisation.

However, due to its low price, it is still widely used in the developing world.

Lipodystrophy is the redistribution of fat in the body, which manifests as excess, or lack of, fat in various regions of the body. People can have sunken cheeks and/or "humps" on the back or back of the neck (also referred to as buffalo hump).

In the one camp, the Treatment Action Campaign, Medecins Sans Frontieres (Doctors without borders) and the Treatment Action Group have serious concerns about the proposed trial.

They are concerned that stavudine is more toxic than tenofovir (the drug which replaced stavudine in the government treatment programme), making it an inferior treatment.

Patients' poor tolerance means that they are more likely to not adhere to treatment and will have to be switched to more expensive second-line treatment when they fail first line treatment.

Read the rest.


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

Mapping Pathways Presents on PrEP Community Perspectives at IAPAC Summit

Original content from the Mapping Pathways blog team

Click below for slides presented by Mapping Pathways' Jim Pickett (AIDS Foundation of Chicago) today in London at IAPAC's Evidence Summit on TasP and PrEP. Several members of the Mapping Pathways team have been participating in the Summit as well, helping to disseminate our findings from data collection activities we undertook in 2011.

The full program from the June 11 - 12 meeting in London, and all slides presented, are available on the IAPAC website now. They are a fantastic resource for individuals and organizations who are following these issues.

IAPAC Summit on TasP and PrEP Jim Pickett Mapping Pathways

View more PowerPoint from Jim Pickett

Click on "slideshare" to download the slides.

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