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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 M�dicins sans Fronti�res
/ 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 M�decins sans Fronti�res 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.
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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.
M�decins sans Fronti�res (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 Fronti�res (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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