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Africa: Too Little for Too Few

AfricaFocus Bulletin
Aug 18, 2006 (060818)
(Reposted from sources cited below)

Editor's Note

Ten times more people in Africa are getting life-saving HIV drugs than three years ago, reported Reuters this week from the XVI International AIDS Conference in Toronto, but most still get no treatment and the pandemic continues to spread worldwide. Fewer than ten percent of HIV-infected pregnant women in low- and middle-income countries get treatment to protect their newborn from infection.

The conference provided ample evidence both for recent progress in fighting AIDS and for the enormous gap still remaining on all fronts of the fight against the pandemic. Among the organizations detailing both success and obstacles was Médicins sans Frontières / Doctors without Border, that currently provides antiretroviral treatment to some 60,000 people in 22 countries.

This AfricaFocus Bulletin contains excerpts from a briefing and a press release by Médecins sans Frontières released at the International AIDS Conference in Toronto. The full briefing, with footnotes and graphs, is available on MSF websites, including http://www.accessmed-msf.org

For previous AfricaFocus Bulletins on health issues, visit http://www.africafocus.org/healthexp.php

Note: AfricaFocus Bulletin will be taking a break from publication over the next two weeks. Publication will resume early in September.

++++++++++++++++++++++end editor's note+++++++++++++++++++++++

Too Little for Too Few: Challenges for Effective and Accessible Antiretroviral Therapy

Campaign for Access to Essential Medicines
Tel. +41 (0) 22 849 8405
http://www.accessmed-msf.org
http://www.msf.ca/aids2006

Briefing Document

XVI International AIDS Conference, Toronto, August 2006

In the past 5 years, considerable progress has been made in scaling-up access to antiretroviral therapy. Today, 1.3 million people are receiving treatment. But a huge amount remains to be done. More than 40 million people are living with HIV/AIDS and an estimated 5 million of these are in urgent need of treatment. this means that 3.7 million are getting no treatment at all. Many of these people live in the world's poorest countries where the situation remains catastrophic.

Médecins sans Frontières (MSF) currently provides care for over 100,000 people living with HIV/AIDS (PLWHA) and antiretroviral therapy for more than 60,000 people across 65 projects in 32 countries. Although MSF programmes report very good outcomes, immense challenges remain.

Drawing on data and experiences being presented at the XVI International AIDS Conference in Toronto, this document highlights some of the strategies that have helped MSF to expand access to quality care, obstacles confronted along the way, and proposals for moving forward.

Analysis of Major Challenges to Providing Treatment

Even after more than 5 years of experience in providing antiretroviral therapy and substantial commitments of human and financial resources MSF continues to struggle to overcome day-to-day operational challenges in delivering HIV/AIDS treatment in resource-poor settings:

  • Treatment expansion is hampered by an acute shortage of health workers, especially in rural areas, and the high fees that are often charged to patients for medicines and services.
  • Too few children are receiving treatment, largely because the tools to diagnose and treat them are inadequate; meanwhile, the number of children born with HIV continues to grow because strategies and efforts to prevent mother-to-child transmission are insufficient.
  • Failures of coordination between TB and HIV control programmes and the lack of effective tools to diagnose and treat tuberculosis in HIV patients ensures that this curable disease continues to be the leading cause of death of PLWHA.
  • Newer formulations and combinations of antiretrovirals are often not registered or are unaffordable in developing countries. Successful long-term treatment will be unachievable due to lack of access to new drugs and to tools for assessing treatment efficacy, and limited action to ensure this happens.

The above list is not comprehensive, but focuses on barriers that require an urgent public policy response. These problems, encountered by MSF teams around the world, reflect a few of the challenges faced by other actors, governmental and nongovernmental, engaged in responding to the AIDS pandemic. They pose a serious threat to all efforts to expand quality treatment coverage and provide long-term care. ...

I. Strategies and Policies Needed To Ensure That Treatment Is Accessible to the Poorest

For successful coverage, governments and donors must commit funding to increase and retain health staff and allow patients to access free treatment and care.

Care must be decentralised and simplified

"If treatment is only available in cities and hospitals, the most vulnerable will suffer." - Dr Moses Massaquoi, MSF, Thyolo, Malawi

Ensuring that dedicated HIV services are available at the primary health care level is essential in enabling PLWHAs in rural areas to access HIV testing, care and treatment. Faced with severe human resource constraints, MSF has developed strategies to decentralise while maintaining the quality of treatment: specific clinical tasks are delegated from doctors to nurses and clinical officers, and community health workers and PLWHA are trained to assist with adherence counselling and other support activities. ...

Efforts needed to address the human resource crisis

"In Lesotho there are about 40 doctors in the entire country, and in the health district we are working in they have lost 18 nurses in 6 months, mainly to the UK and South Africa. We need an emergency response." - Rachel Cohen, MSF, Morija, Lesotho

Lack of skilled health staff is an overriding constraint to scaling up treatment, especially in rural areas. Health services are often understaffed and staff motivation suffers from isolation, difficult working conditions and lack of adequate remuneration and support. Recruitment freezes and salary restrictions render the public health sector unattractive. Meanwhile, donors are generally reluctant to provide funds to contribute to recurrent costs, in particular salaries.

It is encouraging that in some countries the human resource crisis is recognised as a crucial hurdle to expanding care and treatment. In Malawi, for example, the government and donor community are working to increase health staff training and deployment in rural areas, and measures have been taken to lift constraints on recruitment and remuneration of urgently-needed health staff.

Without immediate and fundamental changes to address the human resource crisis by governments and donors, decentralisation and scaling-up of AIDS care will be compromised.

Patients need free treatment: charging for treatment costs lives

... Providing free treatment is essential for optimal access and adherence. However, most countries still require a financial contribution towards AIDS care. Even in those places where antiretrovirals are free, other costs are often borne by patients such as consultation fees, medicines for opportunistic infections, lab tests and hospitalization.

MSF's experiences in Kenya and Nigeria, where the organisation provides free treatment, show that collecting fees for drugs or other treatment services can result in treatment interruptions, sharing of antiretrovirals and a higher risk of defaulting - all of which can contribute to treatment failure and the development of resistance. In Nairobi, Kenya, MSF runs a free treatment programme in the same hospital as a government programme that charges user fees. Data being presented at the XVI International AIDS Conference in Toronto, August 2006, demonstrate that among paying patients, the percentage lost to follow-up (13.6%) was twice as high as for nonpaying patients (6.9%).

II. New Tools must Be Developed

Diagnosing and treating HIV/AIDS in children

"Our results in treating children are very good, but it's an uphill battle. With better diagnostic tools, treatments that kids will swallow and that their bodies will respond to, many more young children could lead relatively normal lives." - Dr Rachel Thomas, MSF, Kibera, Kenya

Nearly 90% of the estimated 2.3 million children living with HIV live in poor countries, mostly in sub-Saharan Africa. Without treatment, half of all children born with HIV die before they are 2 years old. MSF's experience, among others', shows that children can be treated effectively, but without simple and appropriate tools for diagnosis and treatment, scaling-up will not be possible:

  • Diagnosing HIV in newborns is difficult in resource-poor settings because antibody-detection tests commonly used in adults do not work in children under 18 months.
  • Appropriate paediatric dosages of antiretroviral tablets are extremely limited, forcing caregivers to split adult tablets. Since these tablets are not designed for partial intake this approach is far from ideal. ....

While struggling to diagnose and treat children, it is essential that efforts to prevent new infections are not neglected. Preventing mother-to-child transmission of HIV - which is highly successful in wealthy countries - has proven to be a major challenge in resource-poor settings.

Urgent Need to Make PMTCT Work

The decline in paediatric HIV infections in wealthy countries is mainly due to the success of programmes to prevent mother-to-child transmission (PMTCT). There are, however, serious operational challenges to implementing PMTCT programmes in resource-poor settings, given the reality that women have little access to antenatal care that could provide the drugs and information women need to prevent mother-to-child transmission. Many institutions and organisations, including MSF, have failed to develop innovative strategies to overcome these constraints. Large-scale, efficient PMTCT programmes that are designed to work with weak health systems should be integrated into emerging antiretroviral treatment programmes at the primary care level....

Tuberculosis, the most common cause of death among PLWHA

"We must refuse to accept that millions of people will die of tuberculosis simply because we can't detect it. We need a simple, effective tool to diagnose active tuberculosis in HIV patients, and in the meantime, we need a less rigid approach to tuberculosis in high HIV prevalence settings to allow clinicians including nurses, to ensure early diagnosis and treatment of smear-negative tuberculosis." - Dr Martha Bedelu, MSF, Lusikisiki, South Africa

Tuberculosis is the most common cause of death in PLWHA. About one-third of the 40 million PLWHA worldwide are co-infected with tuberculosis. In some places where MSF works, such as Lesotho, the HIV prevalence among tuberculosis patients is more than 75%. In such settings, it is essential that these twin epidemics are treated simultaneously and that services for both diseases are integrated. Without proper treatment, approximately 90% of PLWHA die within months of developing tuberculosis.

The inadequacy of current tools makes it difficult to detect tuberculosis in HIV-positive patients. The standard detection method sputum smear microscopy detects about only one-third of active tuberculosis in HIV-positive patients. Clinical diagnosis is also difficult because many of the symptoms can also be caused by other infections. If severely immunocompromised tuberculosis patients go undetected, and therefore untreated, the disease progresses rapidly and leads to death.

Anti-tuberculosis drugs and antiretrovirals can interact, rendering some drugs toxic while others become less effective. Even the minor side-effects that both treatments can produce can become intolerable when combined. For this reason, most programmes recommend a shift from the simple standard first-line antiretrovirals to a more complicated and expensive regimen. Access to simple combinations of newer AIDS drugs that are compatible with tuberculosis drugs is needed.

The challenge of long-term management of HIV/AIDS

"You cannot effectively treat a chronic disease with a short-term perspective. We have an obligation to work with others to ensure treatment can be provided for life." - Dr David Wilson, MSF, Bangkok, Thailand.

Treatment strategies, drug regimens and monitoring procedures for antiretroviral therapy will need to evolve as treatment cohorts mature. The challenges of managing drug toxicity and resistance, inevitable after years on treatment, will be increasingly common. ...

Long-term management of HIV/AIDS calls for access to first-line and second-line combinations with minimal side-effects and tools for simplified virological monitoring to allow accurate detection of treatment failure and identification of the optimal time to switch to second-line. These and other challenges require a shift in research and development efforts to ensure that new tools are designed with specific concern for the problems of providing treatment in resource-poor settings.

III. Stronger Political Commitments Needed to Guarantee Long-term Treatment

"Affordable generic AIDS medicines have been one of the cornerstones of our ability to keep more people alive." - Dr Pehrolov Pehrson, MSF, Manipur, India

Since 2000, thanks to generic manufacture strongly supported by civil society pressure, in countries such as India, Thailand and Brazil the price of first-line regimens has been pushed down by 99% from an average of $10,000 US to the current price of just $132 US per patient per year. Today, 50% of people on antiretrovirals in the developing world rely on generic medicines from India. The cost of treatment can and should be pushed as low as possible if scaling up is to succeed. The most effective way to do this is through generic competition. However, this might become increasingly difficult in the future.

More potent and better-tolerated first-line antiretroviral regimens like those including tenofovir are essential to providing quality AIDS care and must be made affordable and available in developing countries. There is increasing evidence of serious, long-term sideeffects from some of the most commonly used first-line
antiretrovirals, especially stavudine. Access to first-line regimens containing tenofovir is an urgent priority. However, tenofovir still remains very costly and unavailable in the majority of developing countries, despite having been registered in the US since 2001.

Access to second-line medicines is also a growing concern. Latest data from Khayelitsha, South Africa, show that one in six patients (16.8%) who had been on treatment for 48 months had had to switch to second-line. But at current prices, treating 58 patients on second-line drugs costs the same as treating over 550 patients on first-line. Lack of affordable second-line treatment is the norm across the developing world. In addition, these drugs are difficult to access because pharmaceutical companies often make no serious attempt to register or market them in these countries. As resistance inevitably grows, it will become catastrophic if the situation is not addressed.

Conclusions

Just five years ago, many argued that providing antiretroviral therapy in resource-limited settings was far too costly and complex for the developing world. The 1.3 million people benefiting from life-prolonging treatment in developing countries today are testament to the dramatic impact it has on people's lives, and highlight the urgent imperative to further increase treatment coverage.

Ensuring treatment reaches those most in need can be achieved only by taking it from capital cities to rural health centres. In the face of the current human resource crisis, this means shifting away from a doctor-centred approach to treatment. At the same time, serious efforts are needed to retain health staff to work in these areas. In addition, treatment must be provided free of charge. Experience has shown that even charging a modest fee for treatment is associated with higher defaulting, poorer adherence and higher mortality. Treatment costs can be driven down by lowering the price of drugs and tests, and by adapting programme approaches. Patients should not be expected to pay.

The challenges of diagnosing and treating HIV in children and addressing tuberculosis as the major cause of death of PLWHA call for a massive innovation through research and development based firmly on the realities and constraints of tackling HIV in the less-developed world. ....

Affordable, effective fixed-dose combinations have been the key to scaling-up antiretroviral therapy. But the cost of treatment is rising rapidly as resistance and side-effects mean that patients need to shift to newer, more expensive treatments. Action to ensure sustainable access to second-line medicines is urgently needed. These drugs are priced out of the reach of, or inaccessible to, less-developed countries. ....


New MSF Data Shows Treatment of Children Works
in Resource-poor Settings

But scale-up is hampered by ill-adapted tools and exorbitant costs

Press Release

August 15, 2006

Toronto - Two new studies released by Doctors Without Borders/M‚decins Sans FrontiŠres (MSF) at the XVI International AIDS Conference in Toronto this week demonstrate good outcomes in antiretroviral treatment (ART) of children living with HIV/AIDS across a wide array of resource-poor settings, but also show that pediatric drug formulations are excessively overpriced, costing up to six times more than adult equivalents.

Globally, an estimated 2.3 million children are living with HIV, the vast majority in sub-Saharan Africa. Nine out of ten newly infected children acquire the virus through mother-to-child transmission, largely because efforts to prevent this are insufficient. Far too few children receive treatment - only 5% of the 660,000 in urgent need - and there are no appropriate tests for diagnosing infants and very few adapted tools to treat children. MSF stated that international organizations have been late to respond to the needs of an increasing number of children living with HIV/AIDS and warned that scaling-up treatment of children will be impossible without immediate action.

MSF presented clinical data in Toronto on outcomes of treating children in resource-poor settings. Data released on 3,754 children under 13 in MSF treatment programs in 14 countries showed that children can be treated effectively: 80% were alive and continuing therapy after 24 months on treatment, with few adverse side effects. Significant gains in CD4 count and weight were observed. In the absence of suitable pediatric medicine formulations, most children were treated with broken adult tablets.

"We know that treating children works, but with better tools we could be treating so many more," said Dr. Moses Masaquoi of MSF in Malawi. "And we see the number of children born with HIV constantly growing in Africa, because expecting mothers don't have access to antenatal care and children born to HIV positive mothers are largely lost to follow-up." This partly explains the worrying fact that infants under a year represented only 2% of children on ART in MSF projects. Without treatment, half of children who acquire HIV through mother-to-child transmission die before the age of two.

Diagnosing and treating children remains a major challenge. Diagnosis is difficult in resource-poor settings because antibody-detection tests commonly used in adults are not accurate for that age group. Treatment is difficult because there are very few appropriate pediatric dosages of antiretroviral drugs, forcing caregivers to split adult tablets that are not designed for partial intake - an option that is far from ideal. For children weighing less than 10 kilograms, even this strategy is impossible, as the only treatment options are syrups that are difficult to measure, bitter tasting, often need refrigeration, and are overpriced. Because the vast majority of infected children live in poor countries, most pharmaceutical companies are hardly investing in developing pediatric formulations.

MSF data presented on pricing showed that pharmaceutical companies are charging excessively marked up prices in resource-poor countries for pediatric formulations of ARVs. These prices are not justified by the amount of active pharmaceutical ingredient (API). API is the main driver of the cost of drug production and therefore of the final price - it typically accounts for more than half of what it costs to produce a drug.

As an example, the dose of zidovudine required to treat an adult costs US$175 per year. The amount of API in the adult dose is more than a third of that contained in a dose of zidovidune syrup for treating a child under 10 kilograms. Logically, the syrup should cost US$40. However, the drug is marketed for US$215, over 5 times more than that.

WHO and UNICEF need to issue a strong call for urgently needed formulations to serve as clear guidance to manufacturers. Because such guidance was lacking, two companies have started producing a long-awaited fixed-dose-combination, but in different dosages.

"Lack of guidance from WHO is making the treatment of children even more confusing, and some clear indications three years ago could have really helped avoid this," said Fernando Pascual, pharmacist with MSF's Campaign for Access to Essential Medicines.

MSF provides antiretroviral treatment to more than 60,000 patients spread across 65 projects in 32 countries, including to over 4,000 children. MSF has been caring for people living with HIV/AIDS in developing countries since the mid 1990s, and first began providing antiretroviral treatment in 2000.


AfricaFocus Bulletin is an independent electronic publication providing reposted commentary and analysis on African issues, with a particular focus on U.S. and international policies. AfricaFocus Bulletin is edited by William Minter.

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