WHO at the 2009 HIV/AIDS implementers' meeting

Windhoek, Namibia | 10-14 June 2009

Rapporteur session - Evolving challenges in treatment, laboratory, care and support services

Presentation by Marco Vitoria, HIV/AIDS Department of the World Health Organization

Slide 1

Thank you Mrs. Chair and good morning everyone. I would like to thank the organizers for the honor to be the lead rappourteur of the care and treatment session at this successful meeting. I am sure that the intense debates and fruitful sharing of experiences that occurred here during the week will contribute to a better response to the challenges of the HIV/AIDS pandemic around the globe.

Slide 2

But before I start, I would like to express my sincere gratitude to the rapporteur team of this track that participated in the elaboration of this presentation. Without the valuable contribution of my colleagues Bill, Brad, Christian, Charles, Heidi, Helen, John, Kate, Linda, Nancy, Partima and Souleymane, it would not be possible. Thank you very much for the support and cordiality.

Slide 3

Regarding the numbers of this clinical track, these are the statistics: 14 sessions, 64 oral presentations and 24 posters.

Slide 4

These were the major topics discussed: Treatment costing, monitoring strategies, quality assurance for laboratory services, adherence monitoring, access to treatment, early mortality and treatment retention, drug resistance, pharmacovigilance, TB/HIV co-infection, opportunistic infections & cancer management, and experiences on linking ART services to community & other services. What I will try to do in the next 15 minutes is point out the most important aspects and extract some take home messages from these topics.

Slide 5

The global economic crisis has been viewed both a threat to the expansion and maintenance of ART programmes and an opportunity to improve their efficiency. Strategic choice of interventions with a focus on where they will have maximum benefits and better efficiency/efficacy has been suggested as the most suitable approach to face this situation, but it is important to bear in mind the we still have an emergency humanitarian crisis, with 18 million patients on an antiretroviral queue and 8,000 daily deaths caused by no access to treatment.

Slide 6

In the session on costing of ART, a substantial variation was observed in service delivery costs for treatment, both within and between countries. Improved data on the costs of delivering treatment services represent an opportunity to seek improved efficiencies in costs per patient, although quality of care delivery must also be considered. The current trend is to start ART earlier, use less toxic drugs and promote more lab monitoring. However, it is still not clear how early ART should be initiated, or the ideal way to use the different lab monitoring tools. The ART scale up process will cost more irrespective of the regimens or criteria adopted, but it is important to have in mind that the cost of the drugs are just part of the equation and the drug price reduction will not necessarily reduce the total ART cost. The scale up of HIV treatment will be accompanied by scale up of side effects that will need to be monitored. We have to look at opportunity costs and balance the continued treatment scale up with investments in prevention and systems strengthening. Therefore, when programming under a constrained budget, it is increasingly important that national programs, funders and other stakeholders have a sound understanding of the social policy choices and tradeoffs inherent in their decisions.

Slide 7

Clinical, immunological, and virological criteria have all been used to diagnose treatment failure among patients receiving first line ART. Multiple presenters report significant numbers of patients suspected of ART failure who exhibit immunological failure but have undetectable viral loads. These studies also suggested that viral loads predict true ART failure at a much better rate than simply CD4 cell count, and the identification of failure on immunologic criteria without complementary viral load data can lead to an unnecessary switch to second-line ARV drugs.

Slide 8

Furthermore, the strategic use of viral load testing to prevent unnecessary switching can lead to significant cost savings. In Vietnam, the result of avoiding unnecessary switching to second-line drugs was a cost savings of approximately 1,400 USD per client per year. The use of other variables such as adherence, body mass index and white cell count, if added to immunologic criteria, may improve the predictive power and is under evaluation.

Slide 9

To expand the use of viral load and CD4 tests, improvement in lab infrastructure and development of low cost, point of care viral load testing are encouraged, but partners must consider the available resources, the quality assurance and the needed frequency of testing, in order to promote a sustainable action.

Slide 10

High rates of false positive tests have been reported in some studies with rapid HIV tests, and concerns regarding reliability of CD4 and viral load tests were raised in some sessions. Accurate and reliable results are needed for HIV diagnosis and treatment monitoring, and development of a quality assurance policy is key to achieve ‘quality awareness’ in lab area. The use of dried specimens and private couriers can ease logistics challenges for lab quality assurance and quality control programmes.

Slide 11

Adherence is essential to limit virologic failure and drug resistance. The classic threshold of 95% as adherence success should be now reconsidered in light of differences among regimen and drug classes. A comprehensive approach to measuring adherence using multiple methodologies has proven to be most effective and an aggressive multi-faceted intervention seems to be effective with patients at high risk for non-adherence. New technologies for electronic monitoring, and the use of cell phones and other software offer promising new ways to measure adherence.

Slide 12

The reliance on WHO clinical staging of HIV disease only may result in significant missed opportunities for starting HAART. Incorporation of CD4 testing with WHO clinical staging improves access to ART for asymptomatic individuals, and studies presented in this meeting showed that empowerment in knowing one's CD4 status resulted in earlier identification of ART-eligible clients and improved retention.

Slide 13

As discussed in the previous slide, the enrollment of patients before advanced disease improves treatment retention. In a international multicentric study, patients provided with a 3-month period of intensive follow up demonstrated improved retention and decreased mortality nearly 1-year out in comparison to routine monthly follow up. Improved retention and survival was also observed in another study conducted in Vietnam, even in IDU patients followed in ART output clinics. Use of mobile staff servicing played a significant role in improving ART uptake, retention and adherence in rural areas of South Africa. The national programme of Mozambique also reported that addition of cotrimoxazol prophylaxis has an additive benefit to retention.

Slide 14

In the context of ART scale up, HIV drug resistance is inevitable and strategies have been developed by WHO and PEPFAR to minimize this phenomenon. The "early warning indicators" are key elements in the assessment of drug resistance strategy and use ART site factors that may be associated with preventable emergence of HIV drug resistance. They are easy to collect and also can be used, at the ART site or programme level, before or even in absence of genotyping and/or other complex lab tests, and therefore should be largely adopted to inform national decision-making on ART programme planning and other HIV drug resistance prevention measures. Country experiences presented in this meeting showed how valuable the early warning indicators are and how the implementation of this WHO strategy can improve programme quality.

Slide 15

Pharmacovigilance is a group of scientific activities related to detection, assessment, understanding and prevention of adverse effects. It is a necessity in resource constrained settings to safeguard the public’s health and to promote a culture of drug safety, and WHO is leading a global initiative in this area. However, significant gaps in drug safety among specific population groups still exist, and the harmonization of definitions, toxicity grading, management algorithm, simplified reporting, platform for gathering and sharing information are needed. Recently, the Therapeutic Information and Pharmacovigilance Centre, an official reference centre for monitoring medicine safety, was established in Namibia. Post marketing surveillance is also crucial to quantify adverse drug reactions and decrease morbidity and mortality associated with adverse events.

Slide 16

TB/HIV co-infection was an important topic in this meeting, with three full dedicated sessions. A significant increase in HIV testing for TB patients was observed, but ART uptake is still low. HIV testing among TB patients in Africa increased ten-fold in 4 years, but only one third of them started on ART. Further decentralization of ART services is crucial to improve this scenario. TB continues to be the major cause of death in patients living with HIV. According to WHO, approximately 23% of global HIV deaths were estimated to be TB related. In a study from Rwanda, 30% of those dying on ART have concomitant TB and 65% of national HIV deaths in the Ukraine are caused by tuberculosis. Therefore, a better monitoring to assess the impact, know the magnitude of the problem and plan accordingly is necessary, as well as the empiric treatment for TB in HIV-infected people deteriorating on ART. Implementation of the "3Is" concept is also crucial. TB screening is progressing but IPT and TB infection control are not moving forward at the same pace, with little implementation activity reported from countries. WHO is also planning to revise the guidelines on these topics in 2009.

Slide 17

In the context of HIV and AIDS, we should look beyond TB and consider other opportunistic infections. Cryptococcal meningitis and human papilomavirus leading to cervical dysplasia, for example, were specifically discussed in the last clinical session of this meeting. As a general recommendation in this area, the improvement of laboratory logistic systems for programme scale up in order to ensure availability of testing services should be promoted.

Slide 18

Involvement of people living with HIV (PLHIV) in programme planning, implementation and monitoring can lead to increased adherence rates, increased utilization of services and improved survival. In Tanzania, trained community volunteers have been used to provide home deliveries of ARVs and act as adherence assistants to clinically stable patients. Sensitization to their leadership at the local level improves integration with other services like TB.

Slide 19

Finally, some general messages related to this track: In treatment, we should be realistic and aligned to the context but continue to push for inspirational targets, continue to promote the strengthening of lab services, but not permit the absence of lab tests to be a barrier to access to treatment and care. We need to be simple, not simplistic, and promote efficient access to care and treatment with and for PLHIV, and prioritize people most in need.

Slide 20

And finally, some important acknowledgments: First to the Government and people of Namibia that kindly hosted more than 1500 delegates during our time here, and also to all presenters and participants, the organizers and sponsors, the team of rapporteurs and, very important, the HIV-infected patients worldwide who are the major reason to continue this fight.

Slide 21

Thank you.