Antiretroviral therapy in Kenya
Personal view
Overcoming challenges to the implementation of antiretroviral therapy in Kenya Miriam Taegtmeyer and Kenneth Chebet
Dramatic price reductions make antiretroviral drugs increasingly affordable in Africa. However, poor infrastructure, conflicting interests, and lack of commitment to a common strategy could keep them beyond the reach of most infected people. Recent experiences in Kenya, where the political will exists, show the complexity of turning this opportunity into safe and effective practice. Lancet Infectious Diseases 2002; 2: 51–53
It is estimated that in Kenya only 2000 of the 2·2 million infected with HIV are able to access western-style treatment through the private sector, a tiny minority of those who are currently in need of clinical care. As the number of people with advanced HIV disease increases rapidly and international pressure mounts it is hard for governments and donors alike to be seen to be doing nothing on this issue.1,2 Public access to antiretroviral therapy is thus a popular politically driven trend. Many countries, including Kenya, are now lobbying for cheaper antiretrovirals and for their implementation in the public sector. Many international organisations including the WHO have drafted policy statements on expanding access to antiretrovirals in resource-poor settings3 and limited pilot projects in countries such as Haiti have been a success.4 In Kenya donor organisations are starting to fund a selection of scattered projects with the sanction of the Kenyan government, which is unable to refuse research and funding that may provide antiretrovirals, even if on a limited basis, for its people. Commitments from donors in Kenya vary from provision of post-exposure prophylaxis only or prevention of mother-to-child transmission only, to limited access to antiretroviral drugs for a small number of individuals in various mission and district hospitals. Each project has selected its own drug regimen and its own system for selection of who is to benefit from treatment. Each has its own training, its own monitoring systems, and its own research agendas. Despite good intentions the result may well be the “antiretroviral anarchy” feared by Harries and colleagues in Malawi.5 A worst-case scenario is limited public access with expanding but unregulated private access, poor control of outlets, and, potentially, the rapid development and spread of resistant strains. THE LANCET Infectious Diseases Vol 2 January 2002
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Introduction
A physician-led approach to prescription and monitoring.
Consultative technical meeting in Kenya In September 2001, key players sat down together in Nairobi to consider in detail the realities of introduction of antiretroviral therapy in Kenya.6 These included the Ministry of Health and National AIDS Control Council, the donor community, non-governmental organisations (NGOs) from around the country, people living with HIV, and representatives from the private sector. We believe that this broad-based consultative technical meeting was among the first of its kind in this region and highlighted not only the challenges of putting theory into practice, but also fundamental differences in approach and attitude from the different players involved. From the meeting it became clear that the private sector and the academic establishment in Kenya (who mostly double up as private practioners) aim to maintain the highest standard with an individual physician-led approach to prescription and monitoring. A physician specialising in HIV care sees “clients” and can tailor-make a treatment regimen to their needs (figure). Regular monitoring of viral load and CD4 count is advocated. Recently published Ministry of Health guidelines7 detail the variety of options for treatment and monitoring and attempt to set a standard MT is at the Liverpool School of Tropical Medicine, Liverpool, UK, and based full time in Kenya; and KC is Director of the AIDS Control Programme, Kenya Contact: Dr Miriam Taegtmeyer. PO Box 43640, Nairobi, Kenya. email
[email protected]
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Personal view for the use of antiretrovirals in the private sector. However, even these guidelines state that “the lack of accessibility to antiretroviral therapy remains a major obstacle in the drug therapy of HIV/AIDS patients in Kenya”. Prices for highly active antiretroviral therapy regimes have dropped from $300 to $70 per month of treatment since March of this year. These current price reductions, the potential to manufacture or import generic drugs,8 and the encouraging of employers to expand private health insurance schemes are improving access in this sector, but essentially it will always remain inequitable, restricted largely to an urban elite. Then there were the “pragmatists” who acknowledged that antiretroviral therapies are already used in an ad hoc and unregulated manner in Kenya. Inappropriate prescription and dispensing of monotherapy, short courses of drugs, and poor adherence to treatment are already widely reported and as prices drop these poor practices may well become more widespread. Ignoring this process is ignoring the reality of Kenya today. The pragmatists advocate a form of damage limitation with recommended standardised regimens, a decision made on minimal monitoring requirements, and expanding access through government commitment and pilot projects. The “pessimists” held a more traditional view coloured by difficulties rather than needs. They voiced the opinion that public access to antiretroviral therapy is an unrealistic pipe dream in a country that is struggling to meet the basic nutrition and health needs of its people. If vertical programmes such as the tuberculosis-control programme are unable to cope with the ever-worsening situation with tuberculosis, how can vertical HIV programmes be run in conjunction with or in parallel? In addition, co-trimoxazole preventive therapy and preventive therapies for tuberculosis are rarely used in Kenya to date. There is widespread scepticism about the efficacy of both of these therapies, a lack of knowledge among health-care workers of their potential role in HIV/AIDS care, and a lack of Kenyan government policy on their use. The identification of HIVinfected individuals through counselling and testing is not yet fully integrated into the health system, the exclusion of
Recommendations under discussion in Kenya Vertical programme design separate from other programmes Start with a representative district then roll out Accredit sites according to agreed criteria Avoid pilot programmes that do not answer a specific and important question Standard regime to include two nucleoside reverse transcriptase inhibitors and one non-nucleoside reverse transcriptase inhibitor Decide on a minimum level of monitoring and support research into clinical monitoring Set up national reference laboratory Define training needs and curriculum Designate a cadre of HIV specialist clinicians Say no to donor funding and research that is not in line with or informing the process of government policy and regimens 52
Antiretroviral therapy in Kenya
active tuberculosis under routine conditions is unreliable in HIV, and even provision of drugs has been a challenge. In other words, interventions that have had numerous feasibility studies, pilots, and trails in Kenya and throughout Africa over the past decade have never been scaled-up. The pessimists are right to argue that antiretroviral therapy is even more complex and difficult to implement. The many potential challenges and complexity of expanding access to antiretrovirals are a constant reminder that HIV is a complex and expensive disease that is difficult to manage even in well-resourced, low prevalence settings. The opposing views and competing players mean that there is currently no agreement on programme infrastructure, a standardised regimen, drug procurement and distribution, and no agreed-upon monitoring levels. For any meaningful programme to be implemented on a larger scale these competing interests would need to be resolved into a common strategy and co-ordinated approach.
Challenges to implementation The current donor and political climate in Kenya is committed to attempting a limited public sector approach for antiretroviral therapy. However there are still significant challenges to co-ordinating the two communities to bring about an antiretroviral therapy programme in a meaningful and sustained way. First, there are limited resources in the public sector and a lack of donor commitment to sustain large-scale implementation.9,10 Hence the existence of donordriven pilot projects, which are time limited and designed to provide results of operational research and share the lessons learned for a scale-up that has no funding and may never happen. Second, linkages to other vertical programmes are unlikely to work in Kenya, currently overwhelmed by the tuberculosis epidemic, and so far no commitment has been made to a common programme design. On a national level key decisions still need to be made to integrate the interests of the Ministry of Health, NGOs, donors, and the private sector. The first steps are the choice of programme design and the commitment to a standard regimen. Choice of programme design (ie, vertical programme or horizontal) is dependent on capacity as much as commitment and will determine the methods of supervision, drug distribution, monitoring, and control of outlets. Choosing a regimen, however, puts any government caught between limited resources and the powerful lobbying of the pharmaceutical industry in an uncomfortable position. Most experts, in line with WHO thinking, are likely to recommend a standard first-line therapy with two nucleoside reverse transcriptase inhibitors (eg, zidovudine and lamivudine) and one non- nucleoside reverse transcriptase inhibitor. This regimen would then be followed by a standard salvage regimen for patients failing treatment. Interactions between the chosen antiretroviral regimen and antituberculosis treatment must also be taken into account. Once these decisions have been made, then training needs can be addressed effectively and efficiently. Standard regimens, side effects, and monitoring would be taught to the clinicians licensed to dispense the drugs. Furthermore, donors are moving away from THE LANCET Infectious Diseases Vol 2 January 2002
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Personal view
Antiretroviral therapy in Kenya
vertical programme designs in favour of more integrated implementation at the district level. Although there is much evidence that adherence to any particular regimen is as important as the choice of the regimen itself,11 many questions remain unanswered. What is the minimum required monitoring? What is the easiest regimen to adhere to? What is the easiest and cheapest regimen to procure, store, and deliver? Again, lack of evidence-based information in this setting has held back progress and commitment. Finally at a national level, a decision needs to be made about the role and regulation of the private sector. The private sector would have to comply with the national standards and they would therefore prescribe the national regimens. It is likely that they would have to apply for registration and accreditation before being licensed and a regulatory body would have to be set up. Once a facility is dispensing antiretrovirals the conflicting interests may not be immediately apparent, but still could affect the service. Although a large proportion of current medical workload is estimated to be due to HIV disease, there is widespread concern about the extra demand that antiretroviral therapies could generate. The designation of a specialist HIV clinician may be perceived as withdrawing scarce staff from other resources and duties. In addition the demand for counselling and testing (both voluntary and diagnostic) will increase many fold. Even for the individual with HIV there are likely to be conflicts. Should I buy drugs or should I spend money on the monitoring tests to see what the effects of the drugs were? How often should I be monitored? How can I be confident that my physician has received training and has basic competence in HIV medicine? Who can tell me whether I can start and stop taking drugs? Who can advise me on adherence? What if resistance develops? Individuals and advocacy groups have a key role in information sharing. Through regulation a unified agreed approach can be publicised and linked with community empowerment to bring together the individual’s with the public health interests.
Overcoming challenges to implementation in current donor and political climate in Kenya Following the publication of guidelines for private physicians and the consultative technical meeting in Nairobi, the National AIDS and STD Control Programme in Kenya has established a taskforce to inform government policy in the key areas of programme design, regimen choice, and training. A Department of Health standards and regulatory service has been established with the overall aim of assuring a quality of service in health care. This service would constitute the ideal forum for the legal accreditation and licensing of limited outlets for dispensing of antiretroviral therapy. The role of the task force would be in making key decisions on the tools that will be used to accredit or close down a site, including training needs, licensing of
THE LANCET Infectious Diseases Vol 2 January 2002
prescribers, uninterrupted supply of drugs from the standard regimen, ability to monitor adherence, and so on. Financially, a government cannot go it alone, it can merely take these first steps as Kenya has done. For any such programme to work it needs to pull together the private and public sectors under a common umbrella and to harness the inputs of NGOs, multinationals, and donor agencies. Recommendations currently under discussion for the structure of a Kenyan antiretroviral programme are shown in the panel.
Conclusion World AIDS day passed in December, and 2002 marks the 21st year since the first descriptions of AIDS. Effective treatments for HIV are now available, yet in most of the world people with AIDS are still unable to access them. Let us not talk of a world AIDS day without talking about empowering service users and resolving the conflicting interests of service providers. Let us also ask whether there is any longer a role for excellence without equity? If there is the will to do so and a strong leadership role is taken by governments such as Kenya, then it is possible to overcome challenges and start to introduce antiretrovirals safely and effectively in parts of the world where they are most needed. Acknowledgments
The Consultative Technical Meeting on Antiretrovirals held in Nairobi in September 2001 was supported by Family Health International’s IMPACT Project, funded by the United States Agency for International Development. We also thank Charles Gilks of the WHO and Eric van Praag of Family Health International for critically reading the manuscript. MT is part of the UK Department for International Development-funded HIV/AIDS Knowledge Programme of the Liverpool School of Tropical Medicine and a project manager for the IMPACT project in Kenya. However, the views expressed are those of the authors. No conflicts of interest were declared and the authors received no sources of funding other than those given above. References
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