The following is an interview with Charles B. Holmes, MD, MPH, chief medical officer and Director of Research & Science at the Office of the U.S. Global AIDS Coordinator (OGAC). This is the last interview in a Science Speaks “motivator” series with staff members at OGAC, which oversees the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program. In his current role, Dr. Holmes is responsible for providing technical and programmatic leadership on issues related to HIV care, treatment and the prevention of mother-to-child transmission (PMTCT) of HIV to headquarters and field staff, and leading a group responsible for PEPFAR’s scientific work. He also serves as co-chair of the President’s PEPFAR Adult Treatment and PMTCT Technical Working Groups, and remains involved in several clinical and cost-effectiveness studies.
In this interview, Holmes discusses his various roles at OGAC, what steps have been taken so far in the campaign to end new pediatric HIV infections, and how the HPTN 052 trial results are changing priorities at PEPFAR.
How long have you been working at OGAC and in what capacity/ies?
I’ve been working here for three and a half years, starting out as a senior technical advisor for treatment and PMTCT, working with and leading both the antiretroviral therapy (ART) and the PMTCT interagency technical working groups, with counterparts at the U.S. Agency for International Development (USAID) and the Centers for Disease Control and Prevention (CDC) working as my co-chairs.
In my first three years I spent a lot of time in the field, visiting countries that had either particular issues that needed to be resolved – guidelines changes for treatment for example – and on public health consulting visits in which we helped our U.S. government (USG) teams better determine how they were going to assist host country governments and their programs. For example, I went on a trip to Uganda in 2009 with a group of seven or eight technical members of the working group with the intent of working with our team and Ugandan government to begin reshaping the way our program there was meeting the treatment needs of the people of Uganda. It was a really good and important trip in so far as we were able to build on the general consensus that we need to move from having very strong independent partners to more regional approaches that fit in much better with national and sub national government structures there. We came up with a number of recommendations and time frames about how best to nationalize and regionalize our partners in a way that was really in line with country ownership. We’ve seen the evolution of that in the past year and the real successes that the Uganda team is having in promoting a much more country-owned process and one that is really more efficient in terms of the USG support process.
My role now as chief medical officer has become broader – I have responsibility for not only treatment and PMTCT, but also our care and support and pre-ART programs as well as our TB programs working with our teams here at OGAC. That’s enabled me to search for ways that we can more effectively address the real continuum of care that our programs are contributing to, and it’s helped in terms of thinking across how these services assist the individual in a particular country and their health and well-being.
One of the other technical parts of what I do is finance and economics – building on my background in cost effectiveness analysis. It was a natural fit to work with economists at the CDC and USAID in developing new strategies to monitor how our expenditures were being translated into outcomes and results. I spearheaded, with others, our smart investment strategy and I work with economists and program experts to discover how we can have impactful programming here at PEPFAR.
Over the past month or so, I’ve also been involved in leadership of the research and science group at OGAC. Also, I’m focusing on the implementation science work being shaped and promoted by PEPFAR and funding academics and others to help us better understand what works and doesn’t work and feed that back into our programs. One of the nice things for me is that my roots are really in programming and making evidence-based program implementation decisions, being able to cross over and find where there are key gaps in that and make sure we are funding the kind of implementation science that will fill those gaps and improve our programs.
I’m also heading up the Science Advisory Board that Ambassador Goosby started up about a year ago and which will be meeting in Washington, DC September 14 and 15. With his leadership, I’m helping to frame some of the outcomes of their discussions and to shape the way they provide their scientific input for Ambassador Goosby’s consideration. A subgroup of this is considering what the HPTN 052 findings mean in terms of the science and how PEPFAR’s programming ought to change – that too has been a great role that I’ve enjoyed taking on.
On a personal note – I wanted to highlight that one of the real satisfactions of working at OGAC is the ability to see through and guide the enormous commitment of the U.S. government to these countries and the people we serve. I was in Malawi in 1999 working there as a medical student and literally was working in a hospital where people were three to a bed and deaths were an hourly occurrence and people were just being treated for their own comfort, not for their underlying disease. That was a tremendously important and troubling experience for me and when I come to work every day I feel like we’re actually making a difference. We’ve seen the transition away from that kind of devastation to a disease that can be managed, and in so doing building health systems that can be leveraged to benefit a whole range of other illnesses that will affect those very same people. It really is a pleasure to be in a position like this.
At the UN High Level Meeting on AIDS earlier this summer, PEPFAR announced a commitment to end pediatric AIDS, mostly through the scale up of the prevention of mother-to-child transmission services, by 2015. What is being done to increase our efforts in those areas since that commitment was made? Has there been a steady move to using FULL ART for PMTCT at least through breastfeeding or is the field still dominated by single drug prophylaxis?
The announcement of our commitment to work toward ending new pediatric HIV infections and to keep mothers alive was really the culmination of a lot of work by many people – our multilateral group and public affairs and our program group – to come to the conclusion that we could do this and do it with existing tools. But what was needed was greater commitment.
So Ambassador Goosby and UNAIDS Executive Director Michel Sidibe led a global process of identifying countries with the highest burdens of mother-to-child transmission (MTCT) and have brought together a coalition not only of very strong country leaders, but also strong private sector partners and implementers and other bilateral governments. And the plan is unprecedented in its very strong articulation of a goal that we think is doable. Since the announcement was made of our financial and programmatic commitment we have gone to 14 of our countries with the highest burdens of MTCT and solicited either new plans or updated plans that were meant to describe how PEPFAR would contribute to national goals for elimination of pediatric HIV infection.
We had a very detailed and technical review here with experts in PMTCT, pediatrics, family planning, maternal and child health, economics, and monitoring and evaluation. We’re sending those comments back and our field teams will be submitting these as part of the 2012 Country Operational Plans (COPs) and they will be receiving quite substantial additional funding. Our baseline funding for PMTCT at beginning of 2011 was $200 million. We supplemented that with an additional $100 million to support acceleration of PMTCT programs in 6 countries. In 2012, we are again committing that $300 million in and adding an additional $70 million to support acceleration of PMTCT programs in 8 new countries for a total commitment of $370 million for PMTCT. [The 14 countries include Cameroon, Lesotho, Swaziland, Ethiopia, Uganda, Democratic Republic of Congo, Burundi, Zimbabwe, South Africa, Zambia, Tanzania, Nigeria, Mozambique and Malawi.]
Our technical considerations strongly promote the 2010 World Health Organization (WHO) guidelines for PMTCT and our programs in their acceleration plans were requested to provide information on how they were transitioning to more effective treatment regimens. There is movement in almost all countries to get women with CD4 counts less than 350 on full ART, and we’ve asked each of our teams to get all eligible pregnant mothers on full ART. That means that the antenatal care clinics and systems need to work closely together to make that happen and we’re seeing exciting successes in ART in antenatal care settings. I can’t give you our latest numbers because they’re not currently available but our policy is to move in that direction quickly.
How are we doing this year in terms of treatment scale-up?
Our treatment programs are as strong as ever and I think they are beginning to really mature and take hold in a way that is very long term, sustainable and successful – meaning the programs like the one I highlighted in Uganda are really evolving to become regionally-based and in support of public sector clinics and systems of monitoring and evaluation and reporting up through regional to national programs. I am very pleased with the way in which our country teams are helping to facilitate that process. That’s allowing us to streamline our treatment programs in a way that creates more sustainability and more efficiency for our programs. That’s helping us in this global economic situation to continue to scale up our treatment programs very rapidly. As you know last year we added about 700,000 net patients to our PEPFAR patient program across all the countries that we support – and we are seeing additional scale up in 2011.
Section 4.3 of the 2012 COP guidance highlights Ambassador Goosby’s vision for how our teams can best support strong national treatment programs in every country we work in. That doesn’t look the same in every country. This year we tried to differentiate across countries that still had really high burdens of HIV disease but relatively low coverage rates and low resources, including low Global Fund investment.
There was a particular emphasis – stated very clearly in the guidance – that those countries that receive PEPFAR support need to make their own continued and increasing investments in treatment over time. In countries on the other side of the spectrum – for example middle income countries that we support like South Africa and Botswana – we are already seeing very favorable trends in much greater government investments not only in health but in HIV and treatment in particular. The vision for those countries in particular is that the treatment programs can be taken on and completely government owned over time, which will help PEPFAR to continue scaling up where the need is greatest and the resources are the least.
Do you think HPTN 052 should change the way we think about and address treatment in the PEPFAR portfolio?
This study really couldn’t have come at a better time for PEPFAR. We have been racking up some tremendous additions to our prevention armamentarium over the past one to two years and with medical male circumcision and improved PMTCT, a full recognition of the prevention benefits of ART from a randomized controlled trial really is extremely exciting for our program. That’s in large part because of the dual benefit that you’re able to achieve when you’re treating people for their own health and their partners are also able to experience the prevention benefits of treatment.
However there are lots of complexities and we do not yet have guidelines from the WHO on how best to interpret 052 at the country level. Right now we’re in a circumstance where national governments are looking for guidance, as are our programs, and we’re working with the WHO to help develop really sound guidance on how this study and others should influence guidelines at the national level. That said, the findings were so dramatic that we constituted a subgroup of 10 members of our PEPFAR Scientific Advisory Board (SAB), including the Principal Investigator for the 052 trial and some of our preeminent scientists and implementers, to help think through even in the absence of normative guidance what the science means for PEPFAR and how PEPFAR can respond to the data over time.
I’m very confident and pleased that this group has been able to weigh in – and those recommendations to PEPFAR will be provided at the board meeting on September 14 and 15.
Also, our prevention guidance has just been released which includes a lot of emphasis on doing what works and prioritizing investments in what works, and treatment coverage. There’s a figure in the guidance that describes how coverage rates for full ART are very much foundational to many of the other interventions that are being added on, recognizing that we don’t have full data yet on population level effects of treatment.
When we spoke with Bill Coggin, he mentioned treatment optimization as a potential source of further cost savings in PEPFAR. Can you define what you mean by treatment optimization? Is this in reference to treating people with D4T versus tenofovir? How is PEPFAR working to evaluate this? What kind of savings are you seeing/hoping to see?
Treatment optimization, as outlined in WHO and UNAIDS Treatment 2.0 Framework, requires attention to improving and streamlining the full spectrum of services, drugs and other commodities needed to support treatment for individuals living with HIV. I outlined PEPFAR’s engagement with the activities outlined in this framework in a recent talk at the World Health Assembly. While it does promote rapid movement to better antiretroviral regimens as you suggest, it also involves the adoption of fixed dose combinations, a key priority of PEPFAR over the next year. Additionally, it includes working with manufacturers to demonstrate our collective demand for better molecules and formulations to suit the people in our programs, who in many areas have high rates of HIV-related tuberculosis and malaria, and in whom antiretroviral treatment during pregnancy is a common issue.
On the downstream side, we’re also working with SCMS to ensure less expensive delivery of drugs via water and land freight instead of air. Additionally, there are a full spectrum of clinical and programmatic interventions that may allow for more streamlined and efficient care delivery, such as visit spacing for stable ART patients, more selective use of laboratory testing, nurse-initiated ART and decentralization to primary healthcare settings — as we’re supporting in South Africa and Zambia. We’re engaged in a number of critical evaluations of these strategies and anticipate continued efficiency gains that will allow our programs to work with national governments and other donors to serve greater numbers of people in need.