amfAR TREAT Asia

Photo courtesy of Kevin Tachman/TREAT Asia

Photo courtesy of Kevin Tachman/TREAT Asia

My name is Annette Sohn and I am Vice President of amfAR, The Foundation for AIDS Research, and Director of TREAT Asia, a Bangkok-based programme of amfAR. Today, I am pleased to tell you about how our ground-breaking collaboration with ViiV Healthcare’s Paediatric Innovation Seed Fund is building on our regional paediatric programme to optimise treatment for infants, children and adolescents living with HIV in the Asia-Pacific region and to develop strategies for life-long care. 

Our regional paediatric programme, which began in 2005, invests in the future of people living with HIV in the Asia-Pacific region by supporting projects focused on children and adolescents, the paediatricians who care for them and the researchers working to improve their lives through evidence-based research. It is comprised of 20 sites in six countries, with Asia’s largest database of children and adolescents living with HIV.

Annette Sohn

M.D., Vice President, amfAR, and Director, TREAT Asia

Project: A multi-year partnership designed to optimise the quality of healthcare for infants, children and adolescents living with HIV across Asia. 

Run by: TREAT Asia/amfAR

Region: Asia-Pacific 

Population: Infants, children and adolescents living with HIV 

Challenges: High first-line antiretroviral therapy (ART) failure rates among children; Limited availability of ART regimens that can be dosed and delivered to newborns and young children, and that are safe to use during growth and development; Poor access to once-daily fixed-dose combination medicines and third-line options for adolescents; Gaps in research capacity and higher-level training for paediatric HIV providers. 

Activities: Conducting integrated and innovative programmes in research, provider education and global advocacy, with a focus on treatment failure, the emergence of drug-resistance and optimising antiretroviral sequencing for children living with HIV, among other important considerations for paediatric populations in the region and across the globe.

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Annette Sohn TREAT Asia Pt1 060513

by ViiV Healthcare Effect

"I think one of the things that we were seeing as a network of clinicians on the front lines caring for children growing up with HIV is that people were not planning for lifelong care for these children. There was a lot of attention placed on when they were born, when they were diagnosed, getting them on therapy. But then it was almost as if people forgot that children grow up and become teenagers and adolescents and young adults. And so paediatricians were having to wave their hands in the air and say, ‘We’re not sure how to best take care of these children as they’re growing up. Where is the data that’s helping to guide me both clinically and from a research standpoint? How do I know what are the best treatments to give these young people? And what are the side effects and complications of lifelong antiretroviral therapy?’ And so this collaboration was really to fill those gaps and try to identify and find answers for the clinicians who are asking the questions about how they could better care for their patients." - Annette Sohn, TREAT Asia

Children have consistently faced greater disadvantages with regard to the availability of antiretroviral therapy (ART) regimens that can be dosed and delivered to newborns and young children, and that are safe to use during growth and development. In the Asia-Pacific region in particular, access to appropriate ART and prevention of new HIV infections among children lag behind global averages. UNAIDS data found that 180,000 children and adolescents were living with HIV in the Asia-Pacific in 2010, but only 39% of children in need of ART actually receive it.[i]Underperformance of regional HIV programmes has dire consequences for future generations of HIV-affected and HIV-infected children.

When we set out on this initiative, we recognised that part of the problem stemmed from significant gaps in research, which meant that there was a lack of evidence to inform clinicians about the best treatments for children with HIV and to guide them on how to treat their paediatric patients over the long-term.

Another need related to data pertaining to drug-resistance and treatment failure. We knew from examining our database that 20% of children in the TREAT Asia network had failed their first ART regimen. Years of caring for children and adolescents had taught us that children fail because they are not getting the most potent medicines at the right doses, or they cannot adhere to their treatment because medicines are too hard to take, or come with serious side effects, or their social situations are too unstable. We knew that treatment failure was an issue, and we had a good sense of why, but we needed to assess the longer term consequences of treatment failure and to gather information to inform optimal ART regimen sequencing for these children over time.

Compounding these problems was that, while there was a need for more information, research capacity is not always strong within the region. We work with a network of clinical centres and paediatricians who are working very hard to take care of their patients, with little to no time set aside for research or reviewing data. So, we had to help build research capacity in order to address the issue holistically. Lastly, we found a vacuum in the region when it came to higher-level clinical and psychosocial training for paediatric HIV providers. Put all of this together and it left paediatricians in the region underprepared to care for their patients as they grew up with HIV.

In 2010 we set out on a multi-year collaboration with ViiV Healthcare’s Paediatric Innovation Seed Fund to address critical gaps in HIV/AIDS research, care and treatment programmes for infants, children and adolescents in the region. Through integrated programmes in research, provider education and global advocacy, we work to fill these gaps in order to optimise treatment for paediatric populations and develop effective long-term strategies for high-quality care.

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Anette Sohn TREAT Asia Pt2 060513

by ViiV Healthcare Effect

"We started looking at kids who were already on second-line therapy because we knew that at some point they were going to need third-line and we had almost no data within the region or even in the world in resource-limited settings about how to manage these children after they failed second-line therapy. So collaboration with ViiV Healthcare allowed us to set up a regional study in Indonesia, Vietnam and in Thailand for us to begin looking at a group of children who were already on second-line. I think one of the things that we found was that the age at which they had to switch treatment was at about eight years of age, which is pretty young. So for you to be eight years old and to be on second-line therapy in countries where there are only two lines of treatment meant that your chances of being able to get to adulthood were going to be small if we didn’t come up with strategies for getting you that third-line of treatment. I think the other thing that we saw was that the amount of time that they had been on first-line therapy was only about two-and-a-half years. So for them to go through their first-line regimen in less than three years was really sobering because it raised concerns about how we were going to sequence their antiretrovirals to be able to get them continuously treated and their HIV virus suppressed." - Annette Sohn, TREAT Asia

Our programme supports interventions and activities that include:

  • Monitoring for the emergence of advanced HIV drug-resistance in children who have failed first-line or are already on second-line ART to identify the antiretrovirals needed to optimise regimen sequencing – something that’s not been done in a structured way in other resource-limited settings.
  • Applying computer-assisted survey technology and utilising mobile phone text messaging to assess and encourage adherence in adolescents growing up with HIV.
  • Conducting pharmacokinetic studies of novel and second-line ARVs to evaluate dosing recommendations for Asian infants and children.
  • Studying ART toxicity and outcomes, including the use of protease inhibitors and switch practices among adolescents.
  • Examining reproductive health issues by studying use of oral contraceptives and drug interactions with ART, in order to inform a model of reproductive health services for adolescent females living with HIV in Asia. One hundred sexually active HIV-positive adolescent females and young women between 12 and 24 years of age will be enrolled in this project.
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Annette Sohn TREAT Asia Pt3 060513

by ViiV Healthcare Effect

"We took some time to completely think outside of the box. We tried to think about what would be the most innovative, cutting-edge type of work in our population that we could do in a relatively short period of time. And that’s where these studies on reproductive health and adherence and bone mineral density, that’s where these ideas came from. And it’s really such an opportunity to talk to researchers and clinicians and to tell them, ‘If you had a chance to do the research you really wanted to do, not because a donor told you what to do, but because this is what you believe is necessary today, what are the research questions you want to ask?’ And this is what ViiV Healthcare gave us the chance to do." - Annette Sohn, TREAT Asia

  • Studying prevention of bone demineralisation in children and adolescents in Asia. This 48-week study will be conducted at sites in Thailand and Indonesia among almost 250 adolescents.
  • Educating paediatricians on treatment failure, drug resistance, lipodystrophy management and optimisation of ART sequencing for children.
  • Research-capacity building and training for paediatric HIV providers.
  • Advocating for safe and effective HIV care and treatment for children in the region and across the globe.

Support from the Paediatric Innovation Seed Fund has opened up new and innovative research directions for studying the outcomes and co-morbidities of children and adolescents with HIV in Asia. This unique partnership has allowed TREAT Asia network investigators and clinicians to initiate research, receive training and promote optimal antiretroviral therapy regimens for their patients.

Though the initiative is still underway, progress has already been achieved in three core areas:

1. Research:

While much of our research is ongoing or just now getting underway, here’s a snapshot of some of the things we’ve accomplished thus far:

  • Approximately 300 patients have been enrolled at eight sites in Indonesia, Thailand and Vietnam in our study to monitor treatment failure and drug resistance.
  • Two initial pharmacokinetic studies in Thai children have been completed, providing new insights on optimal dosing of second-line ARVs for Asian infants and children.
  • We’ve completed a pilot study using computer-assisted technology to evaluate adherence and risk behaviours among adolescents with HIV. The pilot was conducted among 50 adolescents in Thailand and Malaysia. Although carried out among a small group of adolescents, investigators were able to use the pilot phase to learn how to best implement this type of study in TREAT Asia network sites, and we have expanded the study to 9 centres with a plan to enrol 300 HIV-positive and HIV-negative adolescents in Malaysia, Thailand, and Vietnam.
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Annette Sohn TREAT Asia Pt4 060513

by ViiV Healthcare Effect

"One of the major components of our collaboration with ViiV Healthcare has been on HIV education for paediatricians within the region. And this has been such an important focus for us because we can sometimes find support for individual projects, but for us to be able to find support for a series of trainings is pretty uncommon. And so we’ve been able to do training all around Southeast Asia on paediatric treatment failure and drug resistance. We’ve also been able to look at even basics of HIV treatment for primary care providers and long-term complications of HIV treatment such as lipodystrophy, one of the more disfiguring side effects of long-term treatment. So although the research has been very innovative, the reality is that those results will take time to come out as research results frequently do. But when you can start training paediatricians who are seeing patients today you can really change their approach to managing children with HIV. And so I think that by having the educational component, we’re able to have an immediate impact instead of waiting for the research investments to pay off." - Annette Sohn, TREAT Asia

2. Education:

Our research has been quite innovative, but the reality is that results from research take time – typically several years. One of the more gratifying aspects about this programme is that while we’re conducting research and waiting for findings, we’re also training clinicians about what we know now. As a result, we’re having an immediate impact and changing their approach to managing children with HIV for the better.

For example, following the training that we implemented on lipodystrophy (a side effect of long-term treatment where fat is abnormally lost or accumulated in certain parts of the body), we started to see our network members reducing use of a common medicine known to cause it. This wasn’t the case in all countries, particularly those where treatment options are limited, but this educational programme – combined with data coming out of Thailand showing that it was safe to switch children off of this medicine, and the World Health Organization’s interest in transitioning national programmes away from use of the drug – contributed to more children in the region being transitioned onto other medicines with fewer side effects.

To date we’ve conducted regional paediatric treatment failure and lipodystrophy management workshops, as well as country-level workshops on one or both of these topics in Cambodia, China, Indonesia, Malaysia, Thailand, and Vietnam. In total more than 400 physicians and nurses have participated in these educational workshops thus far.

This is not to suggest that the problem is solved. Although the situation with regards to both paediatric and adult HIV care in the region has improved, we still remain far behind where we want to be and this has consequences for the most vulnerable members of a family – the children. We remain committed to continuing to use education as a means to further improve HIV care in Asia-Pacific.

3. Advocacy:

We’ve also advocated for community-based treatment literacy on the occurrence of lipodystrophy and access to life-long care. For example, the programme is acting as a bridge between community groups across various countries in the region on treatment access issues, and between community members and providers to share about the challenges each other face in caring for children and adolescents.

By turning innovative research into best practices, this programme is shaping paediatric HIV care in the region, pushing the boundaries of paediatric HIV research and making a difference in the lives of children living with HIV across Asia.

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Annette Sohn TREAT Asia Pt5 060513

by ViiV Healthcare Effect

"I think that as a network – and I’m speaking not just as TREAT Asia but also our regional partners – we are really invested, and we all have a personal stake in the future of the children and adolescents with HIV living in this region. I think for us it’s beyond just looking at survival. Many times people look at, ‘Well, what are the survival outcomes?’ and the only thing that really matters is mortality. But for us that’s not enough. We want to see these children grow up and have functional lives. We want them to be able to be adults contributing to society and supporting themselves, to be independent, to essentially be like any other adolescent or teenager growing up in the world today. Why should HIV change that for them? And so I think that our network is composed of people who are stepping forward to say, ‘It shouldn’t be any different. A teenager with HIV should be the same as a teenager without HIV.’ And it’s up to us to provide these opportunities for them to grow up and to have functional adult lives. And through this collaboration we’ve been able to show the region that we care what happens to these children when they grow up." - Annette Sohn, TREAT Asia

For me, the main lesson gets back to the power of an integrated, multi-pronged approach. In this case, it’s using research to document problems and provide new insights, education to inform the community and advocacy to change policies and practices. Each component is integral to our ultimate goal of optimising treatment for paediatric populations in Asia and developing strategies for life-long care.

We’ve been able to learn and adjust to the challenges as we go. For example, we learned that some of the healthcare providers were not ready to study more complex issues like drug resistance, and needed basic and refresher trainings on paediatric care.

We’ve also evolved our programme over time to adapt to the shifting dynamics of the epidemic in the region. When we set out on our collaboration with the Seed Fund, we were dealing with a younger paediatric epidemic. Today, one-third of the children in the TREAT Asia network are 12 years of age or older. This collaboration has allowed us to increasingly expand our focus on this age group so that we now understand more about the long-term effects of HIV and its treatment on perinatally infected adolescents. We hope that the innovative questions we’ve started to explore and the pilot studies we’ve conducted thus far will lead to larger projects and greater interest both in and out of the region.

Something that we are continually reminded of at TREAT Asia is that networks and collaborations like the regional collaborations we’ve established here in the Asia-Pacific take time. We’re not here to run clinical trials and gather data and then leave; we are here to build capacity and a robust knowledge base in order to ensure a strong future for children with HIV in the region. That’s not something that can be done overnight.