'Funding gap' imperils science exploits, AIDS forum hears

Via AFP, by Richard Ingham.

"Science is running much faster now than what we can implement and what we can pay for."

The four-day Rome conference, ending Wednesday, heard the outcome of several landmark trials.

The biggest found that giving early drug therapy to people with HIV reduced the risk of infecting others by a massive 96 percent.

Other trials found that giving antiretrovirals to a non-infected partner reduced the risk by around two-thirds.

These amount to two powerful new choices -- "treatment as prevention" and "pre-exposure prophylaxis" (PrEP) -- to brake transmission of the AIDS virus.

They join male circumcision, a proven measure to protect men, to which a vaginal microbicide, still under test, may one day be added for women.

In 2009, more than 33 million people were living with HIV and 2.6 million people became newly infected.

Making inroads into this tally means stumping up more money swiftly, said Julio Montaner, director of the BC Centre for Excellence in HIV/AIDS in British Columbia, Canada.

The higher early cost would lead to dividends, though. Eventually fewer people would ultimately become infected -- and people on treatment contribute to the economy because they are healthy rather than a burden to it through sickness.

"It could pay for itself in about a decade," calculated Jean-Paul Moatti, an economics professor at France's University of the Mediterranean in Marseille, southern France.

The financial outlook, though, is worrying.

Between 2001 and 2009, help for fighting AIDS in low- and middle-income countries rose nearly 10-fold, from $1.6 billion to $15.9 billion each year.

But in 2010, resources declined as Western countries, the mainstay of external funding, tightened the belt in response to their fiscal restraints.

Today, some 6.6 million people in poor countries have grasped the drug lifeline, but another nine million are still in need of treatment.

Reaching them by 2015, in line with the newly stated goal by UN members, will require between $22 billion and $24 billion annually.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

From 'What if' to 'What Now': Implementing the New Prevention Technologies

Via AIDSMap, by Gus Cairns.

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

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

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

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

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

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

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

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

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Investment in HIV Prevention Research

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

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

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

Source: HIV Vaccines and Microbicides Resource Tracking Working Group

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

IAS 2011: Day 2 Press Release

OFFICIAL PRESS RELEASE – DAY 2

16.30 (CET), MONDAY JULY 18

Antiretroviral Treatment is HIV Prevention: The proof is here

Leading researchers and international experts to discuss the policy and prevention implications of three groundbreaking trial results: the HPTN O52 study, the Centers for Disease Control and Prevention TDF2 study and the University of Washington Partners PrEP Study

Monday, 18 July, 2011 (Rome, Italy) -- A special press conference at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) will today feature a panel consisting of researchers from the CDC TDF2 study, the Partners PrEP Study and the HPTN 052 study. They will be joined by Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), Gottfried Hirnschall, Director of the HIV Department of the World Health Organization (WHO) and Elly Katabira, IAS 2011 International Chair and President of the International AIDS Society (IAS). The IAS 2011 conference opened yesterday, Sunday 17 July and runs until Wednesday 20 July and is being attended by over 5000 researchers, clinicians and community leaders.

In light of announcements this past week about new data on PrEP effectiveness, both the HPTN 052 abstract session (16.30, SR1) and press conference have been expanded to include presentations on the Partners PrEP Study and the CDC’s TDF2 study, both of which were released on 13 July in the US. The presentation on the CDC study was originally scheduled for a late breaker session at IAS 2011 on Wednesday 20 July.

“Treatment is prevention and these three studies provide the proof,” said Katabira.

“The XI International AIDS Conference in Vancouver in 1996 is remembered as the conference that heralded the arrival of combination antiretroviral treatment. The IAS 2011 Conference will be remembered as the beginning of the treatment as prevention revolution.”

“These studies mark a turning point in HIV science and in HIV prevention,” said Stefano Vella, IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS). “The urgent challenge now is to implement treatment as prevention in the developing world.”


Press conference line up:

Chair: Stefano Vella: IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS)


Myron Cohen: HPTN 052 Protocol Chair and Associate Vice Chancellor for Global Health and Director of the Institute of Global Health and Infectious Diseases at the University of North Carolina

About the HPTN 052 study:

The HIV Prevention Trials Network (HPTN) 052 study found that men and women, who were already infected with HIV, had a reduced risk of transmitting the virus to their uninfected sexual partners by 96% through early initiation of combination antiretroviral therapy (cART). HPTN 052 also found that early initiation of cART benefits the HIV-infected individual.

HPTN 052 was designed to evaluate whether early versus delayed use of cART by HIV-infected individuals would reduce transmission of HIV to their uninfected partners and benefit the HIV-infected individuals as well. During the course of the study, 39 participants who had been HIV-uninfected at the start of the study became infected with HIV. Of those, 29 were linked transmissions, where the virus from the originally-infected partner was confirmed by genetic analysis to be the source of infection in the newly infected sexual partner. Only one of the 29 infections occurred in the early cART arm. Based on the latest analyses, this one transmission most likely occurred close to the time the couple enrolled in the study and before HIV viral replication could have been suppressed by cART in the infected participant.

The new analyses also provide more insight as to how early initiation of cART benefits the HIV-infected person. Individuals who were put on early cART maintained higher absolute CD4 counts than those in the delayed arm, who received treatment when their CD4 counts fell below 250 cells/mm³ or an AIDS-related event occurred. Early cART was also associated with a 41% reduction in HIV-related illnesses or death, a direct benefit for the HIV-infected partner. The reliable suppression of HIV among HIV-infected people in the early treatment arm suggests potential impact on adherence when the infected individual is informed that their cART may also benefit their partner.


Michael C.Thigpen: Principal study investigator and epidemiologist at the Centers for Disease Control and Prevention (CDC), USA

About the TDF2 study:

The CDC TDF2 study was a randomized, placebo-controlled trial examining the safety and efficacy of a once-daily tablet containing tenofovir disoproxil fumarate and emtricitabine (TDF/FTC, known by the brand name Truvada) for reducing the risk of HIV acquisition among heterosexual men and women at two sites in Botswana. In addition to study medication, all participants received a comprehensive package of HIV prevention services. The study provides strong evidence that a daily oral dose of antiretroviral drugs used to treat HIV infection can reduce HIV acquisition among uninfected individuals exposed to the virus through heterosexual sex. The study, conducted in partnership with the Botswana Ministry of Health, found TDF/FTC reduced the risk of acquiring HIV infection by roughly 63 percent overall in the study population (95% CI, 21.5 to 83.4; p= 0.0133) ,and by 78 percent among trial participants believed to be taking study medications (95% CI 41.2 to 93.6, p=0.0053). Adherence (as measured by pill count) was high, both among those receiving TDF/FTC and those receiving placebo (84.1 percent and 83.7 percent, respectively). Reported sexual risk behavior was similar between the two study arms. Consistent with other PrEP studies, preliminary analyses did not identify any significant safety concerns associated with daily use of TDF/FTC.


Jared Baeten: Co-leader of the Partners PrEP Study and epidemiologist at the University of Washington, USA

About the Partners PrEP Study:

This is a phase III, randomized, double-blind, placebo-controlled trial of daily oral tenofovir and emtricitabine/tenofovir for the prevention of HIV-1 acquisition among HIV-1 seronegative partners in heterosexual HIV-1 serodiscordant partnerships. The study is funded by the Bill & Melinda Gates Foundation. The University of Washington coordinated the trial, in collaboration with investigators at nine sites in Kenya and Uganda. The study enrolled 4758 HIV-1 serodiscordant couples; HIV-1 uninfected partners were randomly assigned in equal numbers to one of three study groups: one group received tenofovir, one emtricitabine/tenofovir, and one matching placebo. All study participants received a comprehensive package of HIV-1 prevention services. On 10 July 2011, the Partners PrEP Study independent Data and Safety Monitoring Board (DSMB) recommended, after review of the study data, that the study results be publically reported and the placebo arm be discontinued, because of definitive demonstration of HIV-1 protection from pre-exposure prophylaxis (PrEP) in the study population. Tenofovir reduced HIV-1 risk by 62% (95% CI 34 to 78, p=0.0003), emtricitabine/tenofovir by 73% (95% CI 49 to 85, p<0.0001). Efficacy for tenofovir and emtricitabine/tenofovir were not statistically different. 62% of HIV negative participants were male, 38% were female: both PrEP medications reduced HIV-1 risk in men and women. Adherence to the daily PrEP medication was very high – more than 97% of dispensed doses of the study medications were taken. More than 95% of participants were retained in study follow-up. Safety parameters were comparable across the three study groups.


Anthony Fauci: Director, NIAID, USA

Fauci will remark on the implications for prevention research. He will talk about the collective importance of these studies in finding new HIV prevention methods and the optimism that these combinations when viewed in total will help to end the HIV/AIDS epidemic.


Gottfried Hirnschall: Head of the HIV Department at the WHO, Switzerland

Over the past year, WHO has been developing recommendations for couples HIV testing and counseling. More than half of all people living with HIV do not know their infection status, and therefore, may transmit HIV unknowingly. By partners testing together and mutually disclosing their test results, couples can learn about their options for HIV prevention and treatment.

The findings of the three cited studies above will be reflected in WHO guidelines for couples HIV testing and counseling and also to develop broader guidance on the strategic use of antiretrovirals for treatment and prevention of HIV.


Elly Katabira: International Chair IAS 2011 and IAS President

Katabira will talk about the implications of the three cited studies for HIV professionals


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Microbicide Trials Network Statement On The Partners PrEP Study And The CDC's TDF2 Study: VOICE Study Will Continue

Via Medical News Today.

Researchers from two major HIV prevention trials announced favorable results of an approach called oral pre-exposure prophylaxis, or PrEP. One of these trials, the Partners PrEP Study, has provided the strongest evidence yet of PrEP's effectiveness.

Information from both studies will need to be fully evaluated before it can be determined what impact they will have on another major trial that is ongoing. Investigators for VOICE - Vaginal and Oral Interventions to Control the Epidemic, and the study's sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), hope to complete their evaluation as soon as possible. In the meantime, the five-arm study involving more than 5,000 women in sub-Saharan Africa will continue as currently designed.

PrEP involves the use of antiretroviral (ARV) drugs commonly used in the treatment of HIV by individuals who are not infected. In the Partners PrEP Study, researchers from the University of Washington and their collaborators in Uganda and Kenya, evaluated the safety and effectiveness of daily use of two ARVs - tenofovir and Truvada®, the brand name for a tablet combining tenofovir and emtricitabine - among men and women in a discordant relationship with a partner who is HIV-positive. The study enrolled 4,758 serodiscordant couples.

There were 62 percent fewer HIV infections among participants assigned to take the ARV tenofovir daily compared to participants who took a placebo tablet, and 73 percent fewer infections among those who took Truvada. In statistical terms, the results leave little doubt they are not due to chance. However, the study was not able to say whether Truvada or tenofovir works better than the other in preventing HIV.

The results came to light during a review conducted by Partner PrEP's independent Data Safety and Monitoring Board (DSMB) just a few days ago, on July 10. The DSMB found the results so compelling that it recommended that it stop testing in the placebo group. The research team will be making arrangements so that participants who had been randomly assigned to take a placebo tablet can instead receive one of the study's active study products. Participants in the other two groups will continue to be followed.

In the second study, a smaller trial that involved 1,200 heterosexual men and women in Botswana, researchers from the U.S. Centers for Disease Control and Prevention (CDC) found that 62.6 percent fewer HIV infections had occurred in the group of participants assigned to take Truvada than in the placebo group. The CDC team will be reporting more details about the findings of the study, known as TDF2, at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome next week.
 
Both sets of results bolster the findings of iPrEx, which late last year provided the first evidence that oral PrEP can help prevent HIV. iPrEx found Truvada - together with a comprehensive HIV prevention package - was safe and 44 (43.8) percent more effective than a placebo tablet for protecting against HIV in men who have sex with men. The two studies' favorable results also raise more questions about what happened with FEM-PrEP. Two months ago, researchers announced the trial would be stopping earlier than planned because an interim review of the study's progress by its data monitoring committee determined that even if the study were to continue, it would not be able to conclude whether or not Truvada is effective in its population of women. The study team is still collecting data. A final report is not expected until late this year or early 2012.

Few conclusions can be drawn from the CDC study concerning the effectiveness of Truvada specifically in women. And although Partners PrEP found tenofovir and Truvada worked well for both men and women, the study provides more information about how these drugs can protect heterosexual men from getting infected than it does about how these drugs can protect women from getting infected from a partner with HIV. That's because in most of the 4,758 couples enrolled (62 percent) it was the male who was the uninfected partner.

VOICE involves 5,029 women from Uganda, South Africa and Zimbabwe. VOICE is testing not only daily use of an ARV tablet - Truvada or tenofovir, but also a vaginal microbicide containing tenofovir in gel form. VOICE is the only trial evaluating both a tablet and a gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women may prefer.
 
Read the rest here.
 
[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

IAS 2011 HIV Prevention Research Roadmap

Via our friends at AVAC.

Where: Rome, Italy

When: July 17 - July 20, 2011

The IAS Conference on HIV Pathogenesis, Treatment and Prevention is held every two years, and this year it will take place in Rome, July 17-20. The 2011 conference has a program that includes many sessions on a range of HIV-related topics. AVAC has compiled a roadmap that includes the range of HIV prevention research-related sessions planned for the conference. You can download a PDF of the current roadmap here (both detailed and abridged versions).

Or view the conference's Programme-at-a-Glance system, go to pag.ias2011.org and select the HIV Prevention from the roadmap drop-down menu.


AVAC is working with various partners on the following sessions that may be of interest:

Sunday, July 17


•10:15–13:15: Satellite, MR 1: Controlling the HIV Epidemic, the Promise of ARV-based Prevention (A flyer for this session is available.)

•12:30–14:30, Satellite, MR 2: GPP in Action: Introducing the 2nd Edition of Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials and Examples of its Implementation in Current Research

•14:45–16:45: Satellite, MR 2: HIV Vaccines and the Prevention Revolution: Shortening the Path to the End of the Epidemic


Monday, July 18

•18:30–20:30: Satellite, MR 3: Pre-Exposure Prophylaxis (PrEP): How Will the Future Pipeline Look Like?


Tuesday, July 19

•7:00–8:30, Satellite, MR 4: Zeroing out New Infections Through Prevention Tools and Technologies

•16:30–18:00, Bridging Session, SR 1: Use of Antivirals in Prevention—Current Challenges and Controversies
•18:30–20:30, Satellite, MR 3: Can We End the Epidemic?

And, for those of you who won't be attending in person, you can follow the conference proceedings from afar via regular reports from NAM, the official online partner for scientific reporting at IAS 2011, and post-conference coverage from Clinical Care Options (CCO), the official online partner for scientific analysis at IAS 2011. In addition, the Global Health Council will be blogging from the conference. Finally, you may follow IAS 2011 on Facebook and Twitter as well as AVAC on our own AVAC on our own Facebook and Twitter pages for updates.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Project Inform Reports: Financing Recommendations for PrEP

Project Inform recently released a report titled Financing and Delivery Mechanisms to Increase Pre-Exposure Prophylaxis (PrEP) Access in Populations at High-Risk of HIV Infection. Available here, the report discusses issues related to financing for PrEP to ensure that it becomes a viable, accessible prevention method for MSM. Here as an excerpt from the executive summary of the report:

One promising new HIV prevention strategy is the use of ARVs as pre-exposure prophylaxis (PrEP) among high-risk men who have sex with men (MSM). Several clinical and cost-effectiveness studies demonstrate that PrEP has the potential to reduce HIV infection rates for high-risk MSM in a cost-effective way. However, policymakers continue to face questions regarding how to improve drug adherence, offer services to the most high-risk individuals including African-American and Latino MSM and transgender women, and ensure that adequate financing mechanisms are in place to pay for the many biomedical and behavioral components of PrEP.

Policymakers seeking to increase PrEP access must further contend with the current political reality of constrained financial resources for public health assistance, including for state Medicaid programs and for HIV prevention programs that serve individuals at high-risk of HIV infection. Strategic opportunities for financing and delivery still exist, but numerous public and private sources will need to be mobilized for PrEP to reduce HIV infections in significant numbers.

Key financing and delivery opportunities include Gilead’s application for FDA approval of a prevention label for Truvada; National Institutes of Health (NIH) and Centers for Disease Control (CDC) funding for demonstration projects in San Francisco, Boston, and other U.S. cities; private and public health insurance coverage for PrEP; a Gilead-funded Patient Financing and Delivery Mechanisms to Increase PrEP Access 5 Assistance Program to help low-income patients pay for PrEP; and opening the PrEP drug market to non-Truvada PrEP formulations. Given that new clinical and cost evidence for PrEP is expected to arrive from a variety of studies and projects in the coming years, policymakers will need to adapt their implementation of PrEP accordingly.

Policy Recommendations:
The recommendations in this report are designed to help HIV policymakers and advocates like Project Inform improve PrEP access in a manner that is clinically effective, cost-appropriate, and politically feasible in line with existing research and evidence.

Consequently, this report recommends the following:
          1.) Support Gilead’s request for FDA approval of a prevention label for Truvada
          2.) Encourage the NIH and CDC to finance demonstration projects
          3.) Ensure public insurance coverage for PrEP through state Medicaid programs
          4.) Ensure private insurance coverage for PrEP
          5.) Advocate that Gilead develop a Patient Assistance Program (PAP) for PrEP
          6.) Encourage non-Truvada PrEP formulations and promote price breaks for Truvada
          7.) Promote PrEP in tandem with other combination approaches to HIV prevention

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

AIDS Summit at the UN: Not Enough Talk About Sex

Via the Huffington Post, by Evelyn Leopold.

World leaders gathered at the United Nations to mark the 30th anniversary of the HIV/AIDS epidemic and put out a 102-paragraph declaration. Adrienne Germain, the president of the International Women's Health Coalition (IWHC), has been working on women's issues all her adult life and was active in the 1994 Cairo conference on women, also known as the CPD (International Conference on Population and Development). In an interview with the Huffington Post, Germain and Alexandra Garita, an international policy program officer at IWHC, discuss the declaration and the controversies that arise whenever sex is on the agenda. The declaration, produced every five years, gives U.N. agencies a mandate for their programs and advises governments where best to spend monies.

Q: What about access to family planning, to birth control?

AG: We lost reproductive rights and reproductive health language from the 1994 Cairo document and from early drafts here. Reproductive rights, for example, also includes the right to freely and responsibly decide on the number and spacing of one's children. If you lose that and you have no reference to family planning services in the document, then you basically have no reference to contraception for women. You also don't have protection for women living with HIV who are sterilized without their consent and who are forced to have abortion. It is not a rare occurrence in southern Africa (including South Africa).

Q: And how about the new studies on early intervention of Antiretroviral drugs (ARV) to reduce transmission, which are welcomed as a major breakthrough?

An important development is using ARV treatment much earlier in a person's life in order to reduce the amount of virus in the body. Therefore the person will be less able to transmit the virus to someone else and you can use treatment as prevention. In this document, it is treated as a miracle breakthrough. We don't look at it that way. Probably about half the people in the world who are living with HIV don't know it. You are most infectious right after you have been infected. But at that time you have no symptoms at all so why would you go forward with testing? So to think that a medicine, a drug, is going to end this epidemic when we don't even know how to get more people to come forward for testing -- is really foolish. But debates on how best to end the epidemic go on all the time -- how we should all be giving much more time to prevention. Yet this document ends up with four paragraphs -FOUR!-on prevention. Does that make much sense? No. Not in our book.

Q: Homosexuals and prostitutes were a big issue five years ago, even among some delegates from the Bush administration. Has this changed?

They are in the document for the first time. There was one paragraph that names the community of drug users, men who have sex with men and sex workers. That is very good. But this listing is used once only and then there is UN mumbo-jumbo in other paragraphs where you should have specific references about the kinds of interventions needed to reach this population and what they face in their lives. And there is nothing on human rights for these people (despite the UN secretary-general's speech).

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

WHO Announces New HIV Strategy for 2011-2015

by Aldona Martinka

According to a news release from the United Nations’ website, the five year strategy that the World Health Organization announced yesterday could prevent as many as 4.2 million new HIV infections and save as many as 2 million lives.

The strategy for the coming years focuses on four strategic directions: “To optimize HIV prevention, diagnosis, treatment and care outcomes”, “to leverage broader health outcomes through HIV responses”, “to build strong and sustainable health systems “, and “to address inequalities and advance human rights.” Within these directions there are many exciting goals, such as reducing stigmatization of those with HIV/AIDS, promoting human rights where abuses are barriers to getting tested and/or treated, and driving the development of new preventative interventions.

The strategy specifically mentions PrEP, ARV therapy as prevention, and microbicides as potentially effective new interventions, and plans to guide countries in implementing these programs when the results of evaluations become widely available.

This strategy, unanimously adopted by the Sixty-Fourth World Health Assembly, will serve as a guide for the actions of the WHO and for governments worldwide in facing the AIDS crisis in the first half of the second decade of the new millennium.

Read the full strategy here, or get more information here.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

KENYA: Protest as government grapples with HIV funding shortages

via PlusNews

Hundreds of Kenyan AIDS activists held a protest on 18 May in the capital, Nairobi to demand that the government meet its commitment to increase annual health and HIV funding.

"The Minister of Finance promised an annual budgetary allocation increase of 10 percent to health and HIV - we demand that this promise be kept," Davis Njuguna, an AIDS activist with the National Empowerment of People living with HIV/AIDS in Kenya (NEPHAK), told IRIN/PlusNews during the rally. "We cannot pledge to end AIDS without increasing funding to it. Access to HIV treatment is a right and we are not accepting lip service any more."

Marching along Nairobi's busy Thika Road, protesters waved posters urging Finance Minister Uhuru Kenyatta and US President Barack Obama - who pledged during his presidential campaign to provide US$50 billion to fight HIV globally by 2013 - to keep their promises. Other placards read, "You Talk, You Talk, We Die!" and "Broken Promises Kill!"

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

NEWS ROUNDUP: Early HIV Treatment Can Reduce Transmission Risk By 96%, Study Results Show

via Kaiser Family Foundation


Results from a multicountry clinical trial, sponsored by the National Institute for Allergy and Infectious Diseases (NIAID), show that HIV-positive people who take combination antiretroviral therapy (ART) can reduce the risk of transmitting the virus to their HIV-negative partners by 96 percent, U.S. researchers announced on Thursday "[i]n what is being hailed as a breakthrough in HIV prevention," the Los Angeles Times reports (Maugh, 5/13).

The randomized controlled trial, run by the HIV Prevention Trials Network and named HPTN 052, was meant to run another four years, but an interim analysis by an independent monitoring group prompted NIAID to halt the trial and release the results, ScienceInsider writes. The study, conducted since 2005 at 13 sites in nine countries, recruited 1,763 couples, 97 percent of whom were heterosexual, in which one partner was HIV-positive at enrollment. None of the HIV-positive partners had taken ART, and their CD4 cell counts, a measure of the immune system's health, were between 350 to 550. "Half the participants received immediate treatment, and the other half did not start [therapy] until their CD4 count dropped to 250 or they developed an AIDS-related symptom, according to ScienceInsider (Cohen, 5/12).

Analysis "identified 39 new cases of HIV among the previously uninfected partners. In 28 of these cases, genetic analysis confirmed that one partner had infected the other. Of these 28 infections, 27 – or 96 percent – occurred among couples in which the HIV-infected partner did not start antiretroviral therapy immediately," HealthDay/U.S. News reports (Reinberg, 5/12). The couples were all counseled on safe sex practices, given free condoms and provided treatment for sexually transmitted infections, BBC News adds (Gallagher, 5/12).

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID Director Anthony Fauci said in a statement (5/12).

The New York Times notes that though the trial was "relatively large," there are limitations to interpreting the results for other populations, like men who have sex with men, because nearly all "of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual" (McNeil, 5/12).

Treating HIV-positive participants early also improved other health outcomes, the Los Angeles Times reports, noting that the results showed 17 cases of disseminated tuberculosis (TB) among those whose treatment was deferred compared with three cases among the treatment group (5/13). According to Bloomberg News, researchers will continue to monitor study participants to determine whether treatment benefits persist (Cortez/Bennett, 5/13).

Treatment As Prevention

"Until now, antiretroviral therapy was known to improve the health of people infected with human immunodeficiency virus, but this is the first study to show a solid impact on preventing transmission to an HIV-negative partner," Agence France-Presse reports (Sheridan, 5/12).

Though the preliminary results "are likely to end, or at least diminish, a bitter feud within the AIDS world over how much funding should go to treatment versus prevention," funding "will be a major obstacle," the Wall Street Journal writes. With more than five million HIV-positive people on treatment at the end of 2009, and another 10 million in need of the drugs based on international treatment guidelines, UNAIDS has estimated a treatment funding shortfall of more than $7.5 billion, the Wall Street Journal notes (Schoofs/McKay, 5/12).

Observational studies have shown a benefit to early HIV treatment, leading UNAIDS last year to adopt "as its goal" a "test and treat" policy that "encourages doctors to start people on treatment as soon as they test positive for HIV," the New York Times states. Still, "[f]or lack of money, clinics in Africa are turning away patients who are not just infected but close to death. And in some American states where money provided by the Ryan White Care Act has run out, poor uninsured people are on waiting lists," the newspaper adds (5/12).

UNAIDS Executive Director Michel Sidibe said, "This breakthrough is a serious game changer and will drive the prevention revolution forward. It makes HIV treatment a new priority prevention option," adding, "Now we need to make sure that couples have the option to choose treatment for prevention and have access to it," according to Reuters (Steenhuysen, 5/12). Sidibe said "he hopes the new results will compel pharmaceutical companies to lower the price of ARVs as the demand for the drugs expands," that "new partnerships will form to advocate for increased funding and that the findings will be prominently discussed next month at the United Nations High Level Meeting on AIDS in New York City," ScienceInsider reports (5/12).


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

ARVs Dramatically Reduce Risk of Passing HIV to Healthy Partners

via Health Behavior News Service, by Glenda Fauntleroy

When one partner in a couple is infected with HIV and the other is not, treatment with antiretroviral drugs can dramatically lower the chances of the infected partner passing along the disease to his or her mate, a new evidence review finds.

Patients with HIV receive a combination of drugs is given as part of antiretroviral therapy (ART) to stop progression of the disease. The new review discovered that when patients with HIV are on ART, their partners had more than a five-fold lower risk of getting the virus than in couples without treatment.

“We weren’t particularly surprised having followed this literature for awhile,” said reviewer George Rutherford of Global Health Sciences at the University of California, San Francisco. “The magnitude of the effect was somewhat surprising, though.”

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Starting HIV treatment when CD4 cell count dips below 500 improves AIDS-free survival

Via aidsmap, by Michael Carter

Patients who start antiretroviral therapy when their CD4 cell count dipped below 500 cells/mm3 are less likely to develop an AIDS-defining illness than individuals who start treatment with a CD4 cell count of 350 cells/mm3, an international team of investigators report in the Annals of Internal Medicine. However, initiating HIV treatment with a CD4 cell count of approximately 500 cells/mm3 did not reduce the risk of all-cause mortality.

“If the goal is to prevent AIDS-defining illness or death, our findings support cART [combination antiretroviral therapy] initiation once the CD4 cell count decreases below 500 cells/mm3,” comment the investigators.

Nevertheless, results of the study will undoubtedly inform the debate about the best time to start antiretroviral therapy.Treatment guidelines in Europe currently recommend that AIDS-free patients should start therapy when their CD4 cell count is in the region of 350 cells/mm3. However, US guidelines advocate treatment when an individual’s CD4 cell count falls under 500 cells/mm3.

Large randomised trials are currently underway to try and determine the optimum time to start HIV therapy. However, their results are not expected for several years. Because of this continuing uncertainty investigators from the HIV-CAUSAL Collaboration undertook a prospective observational study involving approximately 21,000 adult patients enrolled in cohorts in Europe and the US.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Is Africa ready for PrEP?

Via Incidence0.org, by Adebisi Ademola Alimi

One of the biggest breakthrough in HIV clinical research, since the outbreak of the epidemic 30 years ago, is the recent success in a clinical trial of a new HIV prevention approach based on the daily use of the antiretroviral drug Truvada by HIV negative person to prevent HIV transmission (Called PrEP, for Pre-Exposure Prophylaxis).

The results of the iPrEX trial raised hope but also many questions and concerns as showed by the ensuing debate about what the next step should be. Divergences culminated with the Aids Health Foundation (AHF) petitioning the FDA not to consider Gilead’s request for a licence to use Truvada for the prevention of HIV infection and a joint counter response by a number of HIV advocacy organisations.

But for me as an advocate and an African living in Europe, the most important thing on my mind is “Will Africa be able to access PrEP?” Providing ARV to HIV negative people in Africa needs to be considered in light of the challenge of accessing treatment in Africa, where more than 50% of HIV positive people in the world live (UNAIDS report).

Even if PrEP drugs become available, what are the mechanisms in place to ensure that it will not be tribalized in a continent where there are some indications that access to ARVs is based on political and ethnical loyalty and where there are evidences of bribery at the delivery point, misused of funds and a non-negligible ARVs black market leading to ARVs being dispensed to increasing numbers of patients at the periphery of the health system. One has to be skeptical about the PrEP implementation process in this context.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

AFRICA: Need for systematic HIV drug resistance testing

 via PlusNews

HIV is a tough enough diagnosis, but when one contracts a strain of HIV resistant to some life-prolonging medicines, treatment options are limited. A new study has found that transmitted HIV drug resistance may be on the rise in Africa, and the authors warn that unless resistance surveillance is increased, the continent's treatment programmes could suffer.

The study, led by the International AIDS Vaccine Initiative (IAVI) in five African countries, found that the prevalence of transmitted drug resistance in Rwanda, Uganda and Zambia was considerably higher than previously reported. Of 408 people studied in Kenya, Rwanda, South Africa, Uganda and Zambia, 19 had transmitted resistance mutations. Resistance prevalence rose considerably during the study in Zambia and remained high throughout the study in Entebbe (Uganda).

"The message to take away from this study is the urgent need for regular drug resistance surveillance, which we currently do not have," said Omu Anzala, head of the Kenya AIDS Vaccine Initiative. "If we can see transmitted resistance in such a small study then there could be much more going around."

"We saw what has happened with malaria over the years, with resistance developing against several drugs. We need to move quickly to ensure governments are aware and are implementing drug resistance surveillance to prevent the same thing happening with ARVs," he added.

In 2009 Kenya launched a five-year national plan on HIV drug resistance, prevention, monitoring and surveillance.

A separate study in 2010 by PharmAccess African Studies to Evaluate Resistance (PASER), a project of the PharmAccess Foundation, a Dutch health NGO, found that nearly 6 percent of patients about to start HIV treatment for the first time already had resistance to standard first-line ART.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HIV/AIDS: UNAIDS, activists urge countries to get clever with TRIPS

Via PlusNews

UNAIDS has released a new policy brief to help countries make intellectual property rights work for them, amid growing concern that an impending free trade agreement between the European Union (EU) and India could threaten the world's supply of generic antiretroviral (ARV) drugs.


The World Trade Organization's Trade Related Aspects of Intellectual Property Rights (TRIPS) allows countries to override patents - for public health purposes - by issuing "compulsory licenses" that enable the generic manufacture of drugs still under patent.

The UNAIDS brief, published on 15 March, noted that few developing countries had exercised this right and cited a lack of capacity to deal with the complicated legal paperwork required. Nevertheless, the flexibility afforded by TRIPS has brought increased competition, helping to lower the cost of first-line generic ARVs by as much as 99 percent in the last decade.

Recent changes in World Health Organization (WHO) HIV treatment guidelines substituted stavudine, a cheaper ARV, for tenofovir, a more expensive one, making it even more important for countries to take advantage of TRIPS to keep treatment costs low and extend coverage.

The UNAIDS paper - co-authored by UNAIDS, WHO and the United Nations Development Programme (UNDP) - aims to help countries improve their access to generic ARVs by using TRIPS. It also provides successful case studies from countries like Thailand, Brazil and Rwanda, which have used TRIPS to negotiate lower ARV prices, and recommends that governments adapt their national legislative frameworks and develop a domestic pharmaceutical production capability.

African activists speak out

According to UNITAID, an international facility for purchasing ARVs, India manufacturers most of the generic ARVs used in low-and middle-income countries, but African activists maintain that ongoing free trade talks between the EU and India will limit access to these drugs.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

CHAARM Program Newsletter - Issue Number 1, 2011

This newsletter contains information about the CHAARM project, main activities executed and results achieved in these 12 months activity as well as researchers’ interviews to give a deeper overview of single laboratories tasks.

CHAARM - Combined Highly Active Anti-Retroviral Microbicides project is large scale collaborative project co-funded by the European Commission under the 7th Framework Programme (FP7). The main objective of this project is to develop combinations of new and existing microbicides that will be designed to be specifically targeted agents, which can be applied topically to reduce transmission of HIV during sexual intercourse.

The content of the newsletter is the result of all CHAARM project partners’ efforts under the coordination of the communication partner together with the project coordinator. This newsletter is published once per year and is sent out via email to a number of interested stakeholders but it is also available on the website.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Straight talk with Ellen 't Hoen: Bringing down the price of ARVs

via Nature Medicine, by Asher Mullard


In July, the global health financing mechanism UNITAID established an intellectual property–sharing scheme focused on scaling up access to new and lower-priced antiretroviral drugs in the developing world. The initiative—called the Medicines Patent Pool (MPP)—aims to streamline licensing processes, drive the combination of multiple HIV medicines into one pill and foster the development of drug formulations for children. In September, the US National Institutes of Health (NIH) became the first contributor to the venture, licensing a suite of patents related to protease inhibitors that are used to treat HIV. The task of bringing drug firms and other key stakeholders into the fold now falls on Ellen 't Hoen, a lawyer who became MPP's executive director last month after previously heading up Médecins Sans Frontières' Campaign for Access to Essential Medicines. Asher Mullard spoke to Hoen about the challenges of encouraging companies to share their intellectual property in a normally guarded sector.


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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

'Whoonga' presents new challenge in South Africa's AIDS war

via The Washington Times

AIDS patients in South Africa are being robbed of their lifesaving drugs so that they can be mixed with marijuana and smoked, authorities and health experts say.

The concoction is called "whoonga" — less a word than an exclamation — and it adds a bizarre twist to the war on AIDS in the world's worst-affected country just as it embarks on a massive distribution of medications.

Whoonga's spread is so far limited to eastern KwaZulu-Natal, the country's most AIDS-stricken province, but AIDS and addiction specialists worry that it could reach other parts of the country.

There's no evidence that any ingredient of the AIDS drug cocktail is addictive or does anything to enhance the marijuana high. Whoonga smokers may be fooling themselves into believing the AIDS drugs are giving them a high, when it's really some other ingredient, says Dr. Njabulo Mabaso, an AIDS expert.

AIDS is already a source of damaging myths in South Africa, such as that the disease can be prevented by sleeping with a virgin or showering after sex with an HIV-positive partner.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HIV Meds for HIV Prevention.... Salvation?

via Positively Aware, by Jeff McConnell

Is ART prevention the second coming in this pandemic? 

The trials cannot tell us that. That is a question only communities threatened by HIV can answer.

Read the whole thing.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]