Rapporteur reports
Science Track C: Epidemiology, Prevention and Prevention Research report by Heidi van Rooyen
- Julio Montaner (Canada): Case for expanding access to HAART. He spoke of HAART “to enhance prevention.” Treat symptomatic disease and everyone with CD4< 200 cells/mm3, and increasing interest in the 200-350 range, esp. if the CD4 is dropping and/or PVL is increasing rapidly. Start with fixed dose NRTI: TDF-FTC, ABC+FTC, or ZDV+3TC (alt. d4T+3TC, ddI+3TC), and EFV or NVP, or boosted PI. Now as few as one pill once a day, increased adherence. New formulations, health stable lopinavir, saquinavir 500 md/d, biojector for T20. Treatment interruption not currently recommended, but still some approaches deserve study, same with induction and maintenance. Rx: main goal is to aim for a fully suppressive regimen (<50 copies/ml). Need to understand residual antiviral potency of some of the drugs, which may be able to be recycled. New drugs: tipranavir and darunavir are second generation PI, increasingly potent. Need to switch with at least 2 active drugs. Treatment works everywhere in the world when access is guaranteed, and free drugs are associated with improved adherence. Lancet 2006; 368:531-536: Expanded access can decrease transmission of new infection, based on MTCT data; Rakai study showing that low PVL is associated with decreased transmission; some epidemiological data, e.g. Spanish discordant couples (Castilla) and national surveillance data in Taiwan. In British Columbia, declining HIV incidence, even while syphilis rates had increased. He estimates that treatment saves at least two dollars for every dollar spent because of the numbers of infections averted. He postulated that treating everyone infected could save billions of dollars over time.
2. Nduati (Kenya): Children are 14% of global infections. 14 million AIDS orphans by 2005. Lack of access to sanitation, clean water, food insecurity, exacerbate the immunodeficiency of HIV. Globally, AIDS is an increasing cause of death in children globally. ART prophylaxis limits MTCT substantially with HAART leading to the most optimal responses. Two year mortality in Subsaharan Africa is over 50% (compared to 15% in the pre-HAART era in the developed world). Children in Africa seem to have much higher PVL setpoint than adults. Risk of child’s death is ½ as great if the mother survives. Co-trimoxazole is necessary and still not widely available. 88% of children on HAART survived 2 years, with decreased diarrhea or wasting. 87% of African children were fully adherent on HAART and around only 5% have to change because of toxicity. Free HAART still has family costs,.e.g. transportation, time off from work. Family conflict and poor nutrition lead to suboptimal outcomes for HIV-infected children. Less than 10% of HIV-infected pregnant women get PMTCT; less than 10% of orphans receive systematic public support. More than 2 million children need co-trimoxazole treatment today! Need new diagnostic tools (simpler) to identify children for HIV infection, and to stage clinical decisions about HAART initiation. PCR testing to determine in utero infection is not widely available, but using dried blood spots and transporting the samples to reference labs, may allow for an efficient way to dx children in remote and resource-constrained environments (e.g. project funded by Clinton Foundation in Kenya). Need a comprehensive approach to pediatric HIV care. Need to train health care workers who are familiar with treating children. Crisis of health staff: global gap is 4.3 million HCS; need more than half a million nurses in Subsaharan Africa alone.
3. Bingawasho(Rwanda): Education, first, then consider ABC. 34% of the children 18 and below were orphaned in the genocide. Annual GDP: $300/year. HIV prevalence is 2.3% for women and 3.6% for men. They are trying to tie their response to AIDS with the Millenium Development Goals, e.g. if one family member is found to be HIV infected, then the whole family is offered testing and triage into care. Involved multiple sectors into their response against AIDS, and developed a national plan. 221 PMTCT sites. Now 22,000 persons on HAART. Developing a comprehensive approach, including primary health services, food support, working with multiple funders to develop a plan that is sustainable. Some of their challenges are finding support for some of the parts of the program, e.g. nutritional support.
4. DeKock (WHO): 6.8 million need rx, presently 1.6 accessing coverage=24%. Africans are 63% of people on ART in resource-constrained countries. Latin American countries have the highest coverage in the developing world. Women have increasingly accessed HAART, usually corresponds to % infected in most countries. Ten fold increase in ART coverage in the developing world since the end of 2003. Inequity of rx for IDU; only ¼ of HAART prescribed for IDU in EurAsia where up to 70% of those living with HIV are IDU. Increased resources for rx. Now as low as $130/year for first line, but costs of second line and diagnostics are significant barriers. CD4 and viral suppression similar in low and high income countries, but mortality remains around 4 times as high as resource rich environments, with most of the mortality being early in treatment, suggesting a need for earlier diagnosis and intervention. Need to get people tested before they end up with late stage disease. 75% lower mortality in programs offering free access. TB incidence is between 1.7% and 17.6% for HIV-infected persons. Need to ensure package of care, including TB screening, cotrimoxazole. Need to abolish user fees at point of care.
KC 5: Scaling up: Lessons from the field report by Fatima Hassan
PLENARY ASPECTS RELATING TO KC 5
Advancing treatment, reflecting on 25 years of treatment access and expansion. The road to universal access and the next 25 years.
Presentations:
The first speaker gave a historical overview of the development of ARVs in the last 25 years with particular attention to the development of simple treatment regimens for adults in the last few years and changes that have taken place over time to make treatment more easy to use.
Given these developments, he urged that in resource poor settings, ARVs should be available at no cost for all people.
Speakers pointed out that advances in drug development mean that treatment for infants and for pregnant mothers through MTCT programmes in both breast feeding and non beast feeding populations is now possible and should be scaled up. However it was pointed out that even though we have had terrific medical and evidence based advances in the last 25 years, only 10% of pregnant women who need PMTCT interventions have access to it globally. Despite this, in many parts of the world interventions to prevent new infections and treat HIV are being scaled up and showing good outcomes.
A Kenyan medical professional reported on a study that showed that in Kenya the risk of infant mortality is reduced to 50% if the mother is kept alive – even if she is HIV positive - by providing ARVs.
She stressed that cotrimoxizole must be made available to infants at risk as it has been shown to reduce infant mortality by 43% across all ages and all stages of HIV infection . She pointed out however that even though cotrimoxizole is on the WHO Essential Drug List (EDL) it’s use has not been scaled up widely enough in many settings.
She cited several studies from Africa that showed that ARVs have prolonged the life of children in Africa . A study from the Ivory Coast also showed that with ARVs, the overall survival rate of infants has increased and improved.
What is lacking and missing however is data on mortality and child survival in resource poor settings. Further, even though 600 000 children are globally infected annually, the majority are not able to access life saving treatment.
In Kenya, the early diagnosis of children has been improved by the use of dried blood testing for PCR testing. In many other settings this is not the case. According to her they 'have enough resources and knowledge to care for HIV positive children – but regardless of the setting (country) something must be done’.
A ministry of health official from Rwanda appealed for sustainability of government and donor treatment interventions. She stated that with ‘political leadership, commitment and donor resources’ it was possible to scale up treatment in Rwanda despite massive socio economic problems, a genocide, low literacy levels and poor public health infrastructure. She also reflected on good outcomes after introducing ARV treatment in Rwanda.
Kevin de Cock from the WHO reported that despite developments in the last quarter of a century, some 20 countries in the developing world have only managed to treat 50% of people in need of treatment. Sub Saharan Africa in particular, represents an astronomical 70% of the total unmet treatment need in the world.
He showed trends in scale up globally and in poor settings that indicate that women are accessing treatment in larger numbers than men. However children continue to be neglected with only 8% of infants who need access in Africa getting it. In Asia the figure is 5% and Latin America 8%. Marginalized groups such as IDUs are also being neglected by treatment programmes. For example, while at least 70% of HIV infections in Eastern Europe are with IDUs, only a quarter of those receiving treatment in Eastern Europe are IDUs themselves.
De Kock stressed that the priorities for governments and the international community should be to improve treatment access for children, IDUs and women through accessible PMTCT services.
In addition, he stated that the prices of ARVs in middle income countries pose a barrier to rapid scale up. Similarly the prices of 2nd line regimens, pediatric formulations and laboratory testing make it difficult to scale up.
He concluded by recommending that treatment and diagnosis must be prioritized and that the following is urgently needed to do so:
- Scale up testing for early diagnosis
- TB screening and the provision of an essential package of treatment to treat TB
- Provide ARVs to persons who meet WHO stage 3 and WHO stage 4 criteria
- Expand access to CD4 testing for earlier initiation on ARVs
- Abolish user fees in the public health sector
Finally he ended by warning that the prevalence of new HIV infections “will write the history of treatment ... we cannot simply treat our way out of epidemic".
And that " too often treatment delayed is treatment denied".
KC 1: Accelerating research to end the HIV/AIDS epidemic report by Sam Avrett
WEPL01: Antiretroviral therapy 2006
New IAS-USA guidelines for HIV treatment -- the seventh major revision -- recommend that even for heavily treatment-experienced patients, the goal of therapy should be to reduce HIV viral load to below 50 copies/mL. This reflects the availability of new combination treatment regimens and the consequent expectation that even in the case of individuals with multi-drug resistant virus and high degrees of treatment experience, regimens can be defined that can drive the virus to undetectable levels. (published by Scott Hammer, et al in JAMA)
The pipeline of new HIV treatments is healthy. Two new protease inhibitors have been approved (tipranavir and darunavir), and many new treatments are in on-going development , including two new integrase inhibitors, two non-nucleoside reverse transcriptase inhibitors, and three CCR5 antagonist inhibitors.
Providing free treatment access to all HIV positive people could also substantially reduce the rate of HIV transmission. The effectiveness of treatment-as-prevention has already been demonstrated in the use of HIV treatment to prevent mother-to-child transmission, and is being evaluated as PrEP. Now, new studies among sero-discordant couples and also at a population level indicate that universal treatment has an impact on HIV prevalence over time. (Julio Montaner, published in a special August 5, 2006 issue of The Lancet)
HIV treatment options are rapidly improving. Treatment and prevention are also ever more closely linked, since widespread access to HIV treatment is demonstrated to have an effect on HIV incidence and prevalence. HIV treatment access is therefore recommended as a component of a comprehensive HIV prevention effort.
Science Track B: Clinical Research, Treatment and Care report by Polly Clayden
“We cannot treat our way out of this epidemic” said Kevin De Cock in his plenary presentation but treatment access will also enhance prevention. Treatment success is “blind to race and continent”, but many challenges remain in improving coverage, especially for children who make up 14% of new global infections and 18% of HIV related deaths,
Treatment to enhance prevention.
Julio Montaner presented an overview of the evolution of HAART particularly expanding access to “curb the growth of the epidemic.” He explained: “This is not HAART instead of prevention, this is HAART to enhance prevention”
In a theoretical model re-examining the cost effectiveness of HAART, he concluded that “If we can treat everyone, HIV prevalence will decrease but if we continue to treat only 30% we will be paying this mortgage for the rest of our lives.”
Children are facing a very serious service delivery gap
Ruth Nduati gave a comprehensive outline of the global impact of HIV on children. She emphasised that a child’s risk of death is halved if his or her mother remains alive, and she stressed, “Care of the infected and uninfected child must include treatment of their mothers and families.” Dr Nduati outlined many of the obstacles to care and treatment, which have been recurrent themes throughout the conference, highlighting that the “WHO training package used in many countries does not include children, that is why many countries do not treat children.”
And despite a growing paediatric evidence base in both industrialised and resource limited countries, “There has been a failure to translate the most successful clinical trials to a public health success.” She finished by urging us to go forth and make a difference to the millions of HIV positive children across the globe.
Time for sustainability
In the third plenary talk, Agnes Binagwaho drawing on experience in Rwanda said, “It is beyond the time to deliver it is now time for sustainability”.She highlighted the multiple obstacles to sustained services in less resourced countries.
Time to deliver one world one hope
Kevin de Cock described experience with ART scale up from “3 by 5” to universal access. He showed that the scale of treatment of women has paralleled and sometimes exceeded the feminisation of the epidemic in high prevalence countries.
He called for the world to, “Define HIV treatment as a global public good by the abolition of fees at the point of care”. He urged us to listen to “science, epidemiology and those communities most affected”, in order to achieve rapid scale up everywhere as, “Treatment delayed is treatment denied” and people have, “the right not to die from HIV”
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