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Posts Tagged ‘antiretroviral drugs’

Daniel R. Kuritzkes, MD, Professor of Medicine at Harvard Medical School

The International AIDS Conference starts up in less than a week in Vienna, Austria.  ScienceSpeaks is gathering thoughts from leaders in the field HIV/AIDS treatment, research and advocacy in the question and answer series “Looking toward Vienna.”

Daniel R. Kuritzkes, MD, is a Professor of Medicine at Harvard Medical School. He is also the Head Director of the AIDS Research section of Retroviral Therapeutics at Brigham & Women’s Hospital in Boston.  Dr. Kuritzkes also serves as Vice Chair of the Executive Committee of the Adult AIDS Clinical Trials Group (ACTG) and is the Director and Principal Investigator of the Harvard Adult AIDS Clinical Trials Unit.

What are your expectations for the conference?

I hope that the conference will be another opportunity for networking and for inter-disciplinary discussion, particularly for people that have been developing therapeutics and those charged with rolling out ART in developing countries where there is high demand for these medicines.

I’m looking forward to dialogue about the intersection of therapeutics and prevention. The results of the first PrEP trials will be fostering much discussion, with the presentation of the CAPRISA trial results.

Any sessions you are particularly looking forward to?

President Clinton is going to be speaking again on Monday and that’s always interesting and exciting. Also, the sessions on therapeutics and drug resistance are a particular interest of mine. The discussions on the intersection of therapeutics and prevention, and discussions of the ongoing roll-out of HIV treatment in developing countries, are what this meeting especially helps to foster.

I do expect to hear news about novel antiretroviral regimens, HIV drug resistance, the role of immune activation in disease pathogenesis, HIV prevention, and of course HIV and TB.

The pivotal trial for rilpivirine (TMC278) will also be presented.  This drug potentially provides an alternative to efavirenz (EFV), lacking the CNS toxicity and the teratogenicity of EFV.  In addition, the AIDS Clinical Trials Group will be presenting data on bone effects of NNRTI- and PI-based regimens.  Lastly, before the actual conference gets underway there is an IAS-sponsored workshop dealing with viral persistence and eradication (Friday-Saturday) that I will be attending.

Are you aware of any new research in Vienna being released on HIV drugs?

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Here at the Microbicides 2010 conference in Pittsburgh I got a chance to talk with Dr. Gita Ramjee, one of the top researchers in the field, about the most exciting scientific challenges being discussed at the meeting.  Dr Ramjee is the Director of the HIV Prevention Research Unit at the South African Medical Research Council.  She also explains in the interview why development of an effective microbicide for rectal use is so crucial, for both men and women in Africa, in particular given higher than expected rates of reported anal sex in several countries, as well as in many other regions of the world including the United States.

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Can ARV treatment be used to prevent HIV infection?  What are the implications?  How far along is the science?

Mark your calendar to hear an online presentation and discussion on treatment as prevention, Thursday, April 1 at 10am EDT.

You can ask questions via the web as it is taking place, and you can also take part in the discussion by calling a toll-free number.  The online ‘webinar’ is sponsored by AVAC.

The talk will feature the co-chair of our Center’s Scientific Advisory Committee, Dr. Ken Mayer, who is at Brown University and Fenway Health.  Dr. Mayer will provide a short overview of his CROI presentation on antiretrovirals for HIV prevention, which will include updates on treatment as prevention, PrEP, PEP and ARV-based microbicides.

The rest of the hour will be devoted to discussion, which will be moderated by Chris Collins, Vice President and Director of Public Policy at amfAR and AVAC board member.

You can view the relevant webcast from CROI in advance of the webinar:

Please click to download and view the webcast of the presentation featured in this week’s presentation.

Webinar details:
Thursday, April 1, 10-11am US EDT
Participants, click to join the meeting: https://cc.readytalk.com/r/c2x5vi3ccc9b
Dial-in Number(s):
U.S. & Canada: 866.740.1260
Click here for a list of global toll-free numbers
Access Code: 3671021

(To check the time difference, visit www.timeanddate.com.)

If you need to be dialed out to, please email avac@avac.org and provide your full name, country and number at which you can be reached at the time of the webinar. Please send this information by the end of the day on Wednesday.

If you have not yet registered for the free webinar series, please email AVAC. You can also send AVAC any questions in advance.

Following each installment of the series, you will receive a link to the call recording and slides to download (where applicable) at your leisure. All sessions are also available on the AVAC website at www.avac.org/CROI2010. Visit the website to download the series, including webinars on male circumcision scale-up, treatment as prevention and the RV144 AIDS vaccine trial and the way forward in the vaccine research.

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The Center for Strategic and International Studies yesterday unveiled  a new “must-read” report for global health advocates, “Smart Global Health Policy.” While a panel at the Congressionally-chartered Institute of Medicine, made up primarily of scientists, issued recommendations on US global health policy last year, the CSIS panel is the first to involve high-level business leaders and sitting members of Congress.

The report drew on observations made during a study trip to Kenya, but it is unclear if consultation in developing countries went beyond that, for instance to include global representatives of affected communities and of developing country civil society, such as those on the boards of UNITAID and the Global Fund.

The report and the webcast of the launch event are available online.  Here are a few highlights:

The report makes a strong case that it is in the interest of the United States to continue and increase  our investment in global health and that the issue should matter to all Americans. It calls for keeping funding for AIDS, TB and malaria on a “consistent trajectory,” doubling spending on maternal and child health to $2 billion a year, forging a collaborative response to emerging heath threats, establishing strong coordination of global health policy across US agencies, and increasing support for multilateral efforts.

In 2009 there was a massive drop off in the expansion of treatment by US programs, and the report notes that AIDS advocates are “particularly anxious” at the slowing growth rate, a stalling that could also impact health systems.  The report suggests that funding is a concern for treatment advocates, yet, in fact, HIV prevention advocates have also been quite alarmed at the essentially flatline funding picture.

Despite World TB Day (March 24) being just a few days away, no mention is made in the report of immediate tuberculosis funding concerns, lowered TB targets in the 6-year Global Health Initiative or USAID’s role in responding to TB.  Instead, the report includes TB within a much longer timeframe, stating that “we can accomplish great things in the next 15 years:  We can cut the rate of new HIV infections by two thirds, end the threat of drug-resistant tuberculosis, and eliminate malaria deaths.”

In terms of overall funding, the report calls for less spending in the near term than either the IOM panel or the Global Health Initiative coalition did; instead, the CSIS document endorses the President’s proposed funding of $63 billion by 2014.  While the IOM called for specific increased funding levels on AIDS, TB and malaria consistent with Lantos-Hyde, the CSIS report does not delve into specific funding levels, with the exception of maternal and child health.  Instead, taking the long view, it calls for $25 billion in annual spending by 2025.

One exciting aspect of the CSIS report is that it endorses innovative financing as a means of raising funds for global health.  The report does not touch on the concept of innovative taxation for health, recently championed by maternal health advocates at Family Care International and many other groups. However, it identifies some specific mechanisms, such as borrowing the money needed through an international finance facility, and it urges the US National Security Council to review the most promising ideas on innovative financing and develop a US position.

Admiral William J. Fallon kicked off the launch event, stating that global health is a “bipartisan enterprise… which can unite US citizens in collective action.”  He stated the importance of maintaining forward momentum, noting that “we do not want to coast or slide backward.”  Helene Gayle said that global health efforts are showcasing the American spirit of generosity and said “we need forward momentum even in a period of constrained resources.”

Jack Lew, the top State Department official developing the US Global Health Initiative, spoke about the Administration’s goals in developing the new strategy. He said that the Administration’s aim was to “challenge a way of doing business by moving beyond a primary focus on disease treatment.”  He said the goal was “not to do harm to existing programs.”

Advocates for effective HIV prevention have felt stymied in recent weeks by the lack of specific HIV/AIDS guidances from the Administration to the field and have noted that Kenya’s Partnership Framework with the US even appears to rule out family planning integration.  Family planning came up at the event when Dr. Michael Merson, of Duke University, criticized the Canadian government’s rejection of the inclusion of family planning as a part of its maternal health initiative.

But Lew’s presentation did not delve into details — and there was no opportunity at the event for questions from the floor.  He stated that program integration was crucial to meet the needs of women, and he commented on the importance of having family planning and HIV/AIDS services in one location.

The report is particularly noteworthy for the very strong focus on measurement for accountability in delivering services. Business leaders at the event decried the reporting burden on health programs and, along with Dr. Merson, called for a common set of impact indicators.

Rajeev Venkayya, Director of Global Health Delivery at the Bill and Gates Melinda Foundation, said that measurement matters because it allows us to maximize efficiency and stretch dollars while identifying what works and what doesn’t.  In addition, measurement allows us to hold accountable institutions, organizations, and even individuals, which in turn allows for greater project improvement.  Exxon Mobil Chairman and CEO Rex Tillerson agreed, and cited a Lancet article which said that evaluation must be a top priority for global health.

Robert Rubin, former US Treasury Secretary and former head of Citigroup and Goldman Sachs, told the audience that global health leaders “face wrenching choices” as a result of US fiscal problems.  He asked two members of Congress, Rep. Keith Ellison and Senator Jeanne Shaheen, whether global health is an issue that can “break through the mire” on Capitol Hill.

Senator Shaheen said that the issue can succeed, but it is crucial to explain to Americans that international affairs spending is only a tiny fraction of the US budget, much less than people realize.   She said it was cheaper to spend on global health than on war, noting Bill Clinton’s recent statement about the appreciation of PEPFAR expressed by Muslim residents of Tanzania.  She also said the current committee structure in Congress is an impediment and endorsed the recommendation included in the report for a consultative body that would work across committees.

Congressman Ellison also voiced strong support for greater US action on global health, stating that “infectious diseases know no borders.”  He said that while in Kenya, he made good progress in persuading Kenyan leaders of the necessity of stepping up their own contributions.  He suggested that by reducing US spending on outmoded weapons systems the US could improve its budget outlook and make global health spending easier.

Gayle Smith, the NSC official leading the development of the US Global health Initiative, was the concluding speaker at the event. She said global health was a bipartisan issue and that in fact President Obama specifically directed that the achievements of the previous Republican Administration be recognized.  She praised the CSIS report, and said that its ideas were remarkably congruent with those of the Administration.

She said the Administration’s commitment to fighting global HIV/AIDS was “absolute” and, she added, “this will grow over the life of the initiative.” She said the Administration’s plans for the Global Health Initiative “include an ambitions set of targets in terms of outcomes.”

She did not respond to concerns submitted to the Administration by the Global Center, TAG, the Global Health Council, and the GHI Working Group that the Administration’s targets regarding tuberculosis contradict a directive from Congress approved in 2008 as a part of Lantos-Hyde.  In fact, it was surprising that the event unfolded without  reference  to the consultative process which numerous NGOs have engaged in regarding the US Global Health Initiative or to the detailed analyses these groups have submitted to the Administration.

There were a range of reactions from health NGOs to the event.  Eric Friedman at Physicians for Human Rights noted the “surprisingly little attention in the report to human resources for health and health systems, and no mention of including civil society in the development of country compacts.” He praised the report for “proposing that the Administration develop a long-term, 15-year framework for making progress in and committing the United States to improving global health, a good idea so long as it does not set the stage for underambition, and is flexible to respond to changes in the years ahead. ” He also would have liked to see “a recommendation that the United States should deliberately integrate a right to health approach throughout U.S. global health programs, including the consistent focus on equality, accountability, and participation that this entails.”

Matt Kavanagh at Health GAP praised what he heard from the report, which included an emphasis on keeping up the fight against HIV/AIDS, especially important for the health of African women. But he noted with concern that “some of the Administration comments that seemed to favor prioritizing ‘cheap’ interventions that do not work in the long term, such as single dose nevirapine instead of treatment for HIV positive mothers, an approach abandoned long ago as ineffective in wealthy nations.”

The American Medical Students Association’s Farheen A. Qurashi said that the report “takes a bold, but necessary, approach to U.S. global health planning by insisting upon a 15-year comprehensive plan.”  She said, “Unfortunately, the Commission’s report does not appear to specify the need for scaling-up of PEPFAR investments versus the dangers of flat-funding, and instead uses language that suggests that a continuation of current levels of funding without annual growth is sufficient.”

On health systems, she said that “though integration and health systems strengthening is mentioned in general terms, and the need for training and retention of health care workers is noted, there is no detailed analysis of the measures, funding, and support necessary to establish and retain adequate numbers of health professionals and other health care workers.”

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Physician-scientists working on the frontlines of the HIV/AIDS epidemic today urged the White House to set bold new HIV treatment targets for PEPFAR, the U.S. President’s Emergency Plan for AIDS Relief.

The Center for Global Health Policy joined with a coalition of other organizations—including HealthGAP, amfAR (the Foundation for AIDS Research), the Treatment Action Group, and The AIDS Institute—in calling for PEPFAR to reach 6 million people with antiretroviral drugs by 2013 and 7 million by 2014.

The Global Center and these other organizations, part of the Global AIDS Roundtable Treatment Working Group, detailed this HIV treatment imperative in a recent memo to US Global AIDS Coordinator Eric Goosby, MD.

The memo comes as the Administration crafts two related policy positions. First, the Administration is now preparing its Congressionally-mandated five-year global AIDS strategy, including treatment goals and funding levels for fiscal year 2011. And second, in the coming months, the White House is expected to release the details of its Global Health Initiative, which some fear will outline a shift away from AIDS toward other global health priorities.

HIV/AIDS experts say new attention to child and maternal health is welcome and necessary, but it cannot come at the expensive of continued scale up to combat the AIDS epidemic. For one thing, HIV/AIDS in inextricably linked to child and maternal health. In Sub‐Saharan Africa, antiretroviral drugs are critical to addressing maternal and child mortality, and robust scale-up of ARVs will mean millions of women’s lives saved from HIV and tuberculosis. It will mean fewer AIDS orphans and fewer HIV-positive babies.

“HIV remains the largest cause of maternal mortality in some countries and community‐wide coverage of ART is increasingly being shown to decrease non‐HIV infant mortality, poverty, and deaths from diseases like TB,” the memo to Dr. Goosby says. “It is also important to note that Lantos‐Hyde prioritizes scale‐up of PMTCT programs and expansion of ART treatment for HIV‐infected children—priorities that will not be realized in the absence of increased investment in ARV treatment and ambitious treatment targets.” (more…)

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The World Health Organization’s latest bulletin is a must-read for experts and advocates working on global AIDS, delving into the hot topic of preventing HIV transmission with antiretroviral drugs and noting upcoming WHO action on this issue in the coming months.

The bulletin, authored by Kevin M De Cock and others in the WHO’s Department of HIV/AIDS, is a great where-we-stand-on-AIDS report that synthesizes everything from the latest science to the current financial crisis, and how those developments may impact the ever-evolving approach to this global epidemic.

“By the end of 2007, approximately 3 million people were accessing ART in resource-constrained settings, an unimaginable achievement a few years previously, yet one whose expansion and sustainability are threatened by resource constraints and competing priorities,” the authors write. “Adding complexity are scientific uncertainties – where is the pandemic going, what is the best way to use ART for individual health and what role can ART play in HIV prevention?”

The bulletin takes note of recent research showing better survival rates among HIV-positive patients who started ART earlier and says that WHO will be “reviewing evidence and revising guidance on ART” later this year. The WHO will also be organizing “a consultation” at the end of 2009 to look at research priorities and a variety of other new questions triggered by the possible use of ART for HIV prevention.

“There is little doubt that ART has preventive effects; what is uncertain is how best to apply it and combine it with other evidence-based prevention interventions for maximal synergy and benefit,” De Cock and others write.  “At a time when other avenues of HIV prevention research, including vaccine evaluations, have given discouraging results, how to use ART for the greatest simultaneous therapeutic and prevention benefit is perhaps the most pressing question in HIV research.”

A link to the full WHO bulletin is above and again here.

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Editor’s Note: We will be blogging today about the House Appropriations subcommittee meeting, filing an update on funding levels for global health programs. So check back to see what happens!
Rep. Nita Lowey, center, held Neighborhood Office Hours to hear concerns of constituents. Dr. Germaine Jacquette, left, a member of IDSA and RESULTS from White Plains NY, and Inge Auerbacher, right, a TB advocate and Holocaust survivor, attended and shared concerns about global TB and HIV funding.

Rep. Nita Lowey, center, held Neighborhood Office Hours to hear concerns of constituents. Dr. Germaine Jacquette, left, a member of IDSA and RESULTS from White Plains NY, and Inge Auerbacher, right, a TB advocate and Holocaust survivor, attended and shared concerns about global TB and HIV funding.

At last week’s HIV/AIDS Implementers’ Meeting in Namibia, participants expressed deep concern about the commitment among donor nations to maintaining the momentum in the global fight against HIV/AIDS.

This week, attention will turn to the House of Representatives, where a key spending panel will divvy up the foreign aid spending pie—and the global health community will get the first real indication of how much Congress is willing to spend in FY 2010 on global AIDS as well as tuberculosis.

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