Ambassador Deborah Birx on viral load testing, young women, South Africa, and the T word

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DebBirxIn Part 2 of a Science Speaks interview with PEPFAR’s new leader, Ambassador Deborah Birx looked at impact, accountability and transparency in a sustainable response.

When Dr. Deborah Birx was sworn in as the fourth leader of the U.S. President’s Emergency Plan For AIDS Relief in April, she confronted a unprecedentedly complex, and some said, close to conflicting set of requirements and restrictions. There was, to begin with, the obligation to continue to provide care for the 6.2 million people living with HIV initiated on antiretroviral treatment through PEPFAR. There was the PEPFAR Blueprint, which established a plan of speeding expansion of evidence-based interventions to reach the goal of an AIDS-free generation. There was the need, raised during her confirmation hearing, to adhere to the congressionally mandated requirement to spend 50 percent of PEPFAR’s budget on treatment and care, while preparing to shift responsibilities for program management, funding and service provision to in country entities. And there was the need to do it all with diminished funding.

Welcome to PEPFAR’s third phase.

“If you thought about the first part of PEPFAR as being the emergency,” she said, in a recent interview with Science Speaks, “and you thought the second part as being really sustainability and working with countries in a new way which Ambassador Goosby did so incredibly well and really put us on a different dialogue with countries, I think the third phase will really be marked by measurement of impact and ensuring that every dollar is linked to impact. And we really need to expand the expenditure analysis, we need to expand our accountability at the site level and we’re just going to have to provide additional oversight. I think we’re in a position to do that from this office and support agencies to do that.”

Some cost saving will come with declines in incidence, she said. Some will come with shifts in what she calls the “financial partnership in bilateral relationships in countries able to take on a larger financial burden.” That will mean, she added “funding we can invest in countries with greater need.” Birx, who had already explained why she avoids using the term “country ownership,” (it implies “that they didn’t own the response to begin with”), also takes care with the word “transition.”

“That’s another word we’re trying to get away from because it implies we’re leaving,” she said.

She acknowledged problems, including overwhelmed clinics and patients lost to followup care, after transitions from direct service provision to technical guidance for  PEPFAR-supported programs in South Africa, that had been noted in a January report from Health GAP, and by Science Speaks, during a visit to Kwa Zulu Natal, in August.

It points to how comprehensive the planning needs to be, down to the last widget. There may have been broad-based planning and agreement in principles, when it came down to the precision of who is going to do what on what day for what person, it may have not been perfect, and I think we’ve learned a huge lesson from that about those financial transition countries and what needs to be in place and what kind of capacity,” she said. “We should have set up an early warning network to understand if patients were dropping out of care and treatment because in a country like South Africa when you have that level of prevalence the last thing you want is people not accessing their drugs and their viral loads going back up.”

Yes, expansion of viral load testing is important, she noted. “We have patients who have been on first line therapy for five, six, seven years. We owe it to monitor them in a way to really understand the drugs are still being effective for them.”

At the same time, unabated incidence and prevalence rates among young women remains high on her agenda.

“There’s a whole host of reasons, scientific reasons why young women are more vulnerable to HIV and why HIV is actually more infectious to them,” Birx said. “Is it just biology? I don’t think so. There has to be some behavioral factor involved or some societal norms involved or some cultural factors. I think everybody’s struggling to figure out how to change this number.”

It is a number, she adds on which strong data exists — a product of years of clinical trials for vaginal microbicide products to prevent HIV acquisition for women to use. Women in the trials are supplied with condoms, and counseled on the importance of using them in a clinical trial in which they don’t know if they are taking the product or placebo, or if the product is effective, Birx noted. But she added, “Year after year you look at those trials and the incidence is 8 percent, 9 percent, 10 percent. So I think that despite our best effort and the best messages that we have to date, there’s something still missing that young women need and we need to figure it out.

“Trying to separate environmental co-factors, biologic cofactors, really the social fabric cofactors will be really important,” she said. “I think the groups that look at the behavioral, the structural and the biomedical, I think that with many populations we have those brackets pretty well defined. I think that with young women we don’t have all the data that we need to understand how to stop this incidence.”

While the epidemic’s impact on young women has been relatively unyielding, she added, she believes it can be turned around. “This is not new, this is just a focus that we need to have,” she said. “I’m so impressed about what happens when people get into alignment and say can we address this problem. Because if you said to people we’re going to virtually eliminate pediatric AIDS in sub-Saharan Africa people would be like: I don’t think so.  But you know Michel Sidibe and Ambassador Goosby and certainly UNICEF and EGPAF got together and said yes we can, and look at the dramatic change that they’ve had. I think if we put our best minds at this we could have a dramatic impact.”

She plans to continue, and rely on the PEPFAR Scientific Advisory Board launched by her predecessor, Ambassador Eric Goosby.

“My background and my whole focus for how I judge the best ways to do things is all based on my scientific background,” she said, adding. “I don’t think you would find a physician that came out of a teaching hospital that wouldn’t tell you five heads are better than one.”

That, she says, is one of the reasons the new job, with its continued mission in a shifting landscape doesn’t overwhelm her.

“There’s a lot of worries,” she agreed.  “But you know it’s nice about having 35 years —  if I had to have learned this in the last five years I could never do this job. But I was fortunate to grow up in this epidemic and have a lot of mentors.

From the time she began to explore the HIV epidemic in the 1980s, she said, she has been guided by advocates and by experts working with the World Health Organization and UNAIDS.

“I have to say there’s still an amazing amount of good will in this field to help others,” she said. “Because I was helped all along the way. But I can’t imagine not having the breadth of experience and background I have with the level of complications that go on in this job every day. If I had to learn the science as well as the management piece at this point, I think that would be really difficult.”

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