E-DRUG: HIV+ Africans can adhere to ART
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[Some time ago the New USAID Director Andrew Natsios made comments in the
Boston Globe and before the US House International Relations Committee that
"People in Africa don't know what Western Time is. Many people in Africa
have never seen a clock or a watch in their entire lives. And if you say one
o' clock in the afternoon, they do not know what you are talking about, they
know morning, they noon, they know evening, they know the dark
night.....Those who argue for AIDS in Africa...do not know the challenges we
have....We cannot get it (read AIDS Drugs) because of conflicts, because of
lack of infrastructure, lack of hospital, lack of roads, lack of
electricity" (end of quotes)
The TAC Newsletter (subscribe at www.tac.org.za) has this comprehensive
report on a compliance study at Somerset Hospital in Cape Town, confirming
the observation that compliance to ARV treatment regimens is no worse in an
African setting that in the developed world. Copied with thanks from
TAC-News c/o DRUGINFO. NN]
"WE TAKE OUR MEDICINES AND WE CONTROL OUR LIVES" - ADHERENCE TO
ANTIRETROVIRAL THERAPY IN SOUTH AFRICA
Study shows that Africans with HIV/AIDS take their medicines as prescribed.
"Before I had thrush, tuberculosis and pneumonia. I was very ill.
Then I took antiretrovirals. Now I cannot wait to take my
antiretroviral medicines every day. They have saved my life and made
me feel better and I know I have to take them every day, three times a
day, otherwise I will get ill again", says Nontsikilelo Zwelidala from
Nyanga in Cape Town. Zwelidala who has HIV/AIDS is on a clinical
trial based at Groote Schuur Hospital.
Her sentiments are echoed by Matthew Damane who says: "I have heard
people say that you need fridges to take these medicines - it is not
true. You have to change your routine and get used to the idea of
taking medicines. You have to be disciplined and you cannot party all
the time. These medicines have improved my health, they have given me
the opportunity to control my life again and that is why I will
continue taking them every day." Damane is on a Medicins sans
Frontieres primary care based ARV programme in Khayelitsha.
" I am not surprised that the Somerset Study shows that people with
HIV/AIDS in South Africa take their medicines properly. The health
care workers at that hospital support their patients and promote their
understanding of the medication" says Dr. Hermann Reuter who works on
the MSF programme. For him patients and their care-givers must work
together as equals: "Healthcare workers must assist patients. We must
build treatment literacy about HIV medicines and allow patients to
assert control over their lives including decisions about their health
and medicines. Many of our patients know that fluconazole is used for
cryptococcal meningitis and thrush. They know the difference between
the generic Biozole and the brand name Diflucan. They know the
difference between antifungals and antiretrovirals. None of them
studied medicine or pharmacy, they are poor people with HIV/AIDS who
are taking control over their lives."
Approximately 17 million Africans have died of AIDS, including 2.4
million who lost their lives in 2000. But for the estimated 25 million
people in sub-Saharan Africa living with HIV, it does not have to be a
death sentence. Antiretroviral medicines (ARVs) can significantly
lengthen and improve the lives of people with HIV/AIDS. Drugs such as
AZT, Nevirapine, Lamivudine, Stavudine, Nelfinavir, and Didanosine are
antiretroviral medicines. They should be used in combination with a
minimum of three drugs of different classes.
But, taking triple-drug antiretroviral therapy is not easy. People
with HIV/AIDS must stick to a strict and often complex schedule,
taking many tablets several times per day for life. In addition, these
drugs produce toxic side effects in a minority of patients. Despite
these real problems, there is overwhelming evidence that the benefits
of ARV treatment outweigh the risks. However, unlike in Europe,
America and Brazil most people in poor countries, particularly
sub-Saharan Africa, do not have access to ARVs. They are too expensive
to buy privately and, except for Botswana, African governments do not
supply them.
FALSE CLAIMS: POOR PEOPLE WILL NOT TAKE THEIR MEDICINES
Another obstacle to the provision of ARV therapy to people in South
Africa and other poor countries is the idea that "in settings of high
illiteracy patients would not take their antiretroviral drugs
correctly, thus promoting and spreading drug resistance". This
position was repeated by the South African Minister of Health, Dr.
Manto Tshablala-Msimang in the United States in June 2001. To explain
why the government will not make ARV therapy available to save the
lives of people with HIV/AIDS, Minister Tshabalala-Msimang used this
justification: "What we need is literacy so these people can
understand the importance of completing your course of TB therapy, of
antibiotics. People don't have watches. ....It's the whole issue of
poverty and underdevelopment, and if we don't address that we can't
get started."
This argument suggests that poor people who cannot read and write will
not be able to take their medicines. This theory had been disproved
in Brazil where the government makes ARV medicines available to people
with HIV/AIDS. It has been disproved in Haiti, Botswana, Ivory Coast,
Senegal and poor communities in the United States. Now, it has been
disproved in South Africa.
EVIDENCE - POOR PEOPLE TAKE THEIR MEDICINES
A study at Somerset Hospital performed by researchers Catherine
Orrell, Motasim Badri and Robin Wood of the HIV Research Unit at the
University of Cape Town provides evidence that poor people with
HIV/AIDS in urban Africa take their medicines as prescribed. The
Somerset Study analysed ARV therapy adherence and found that Minister
Tshabala-Msimang's prejudices are strongly contradicted.
The study cohort consisted of 287 HIV-positive patients from the Cape
Town area representing both genders and three home languages - Xhosa,
English, and Afrikaans. Patients used different antiretroviral
therapies that varied in complexity of the dosage.
After 12 weeks of taking ARV therapy, the average patient took
their ARV tablets as prescribed 95% of the time. For those that completed
the full 48 weeks of treatment, the average adherence was 92% (i.e. the
average person in the trial took their medicine correctly 92% of the time).
These numbers more than matched those found in many other countries,
showing that the overwhelming majority of patients adequately follow
their drug regimens and that concerns for potential adherence problems
in Africa, due to socio-economic, cultural and racial differences,
have no scientific basis.
Overall adherence was good irrespective of gender or language.
However, there was slightly lower, but statistically significant (only
just), adherence among Xhosa-speaking male patients. The researchers
hypothesize that this is because medical staff assisting the patients
at the site only speak English and Afrikaans. They conclude that it is
important for patients to have access to medical consultation,
education and counseling in their own language. This could also be a
result of the fact that many Xhosa-speaking people are less likely to
own cars and more likely to live further away from the hospital where
the trials were conducted. In the end, these minor differences in
adherence between language groups cease to be significant when looking
at the 82% of participants who completed the full 48 weeks of
treatment. Only six patients out of 287 who commenced therapy were
taken off the programme due to poor compliance.
COMBINING PILLS
An important factor that did have a statistically significant
influence on adherence was the complexity of the drug regimen. For
those patients whose regimen called for three times daily dosing,
adherence was reduced, though still high. This regimen format was more
complex than the others used in the study (twice daily dosing and
twice daily dosing with food restrictions). Treatments involving fewer
pills (e.g. AZT/lamivudine in combination, or AZT/lamivudine/abacavir
in combination) are easier to adhere to.
Therefore, pressure must be put on drug companies to manufacture
multiple combinations in one capsule and to register these medicines
in developing countries. Patents actually stand in the way of other
useful combination capsules being developed. For example, a useful
combination medicine would be ddI, d4T and nevirapine. BMS own the
patents on ddI and d4T and Boehringer Ingleheim own the patent on
nevirapine. Without voluntary or compulsory licenses, these three
medicines cannot be combined into one capsule and sold in a
TRIPs-compliant country. One generic manufacturer has announced its
intention to produce this combination therapy.
PATIENT AUTONOMY AND DIRECTLY OBSERVED THERAPY
The most important finding of the Somerset Study proves that all
people with HIV/AIDS irrespective of race, language or sex have the
potential to become and remain responsible patients who adhere to
their medicines. The Harvard Consensus Statement (2001) is one of the
most important interventions to support the provision of
antiretrovirals in all poor countries. However, it suggests directly
observed therapy (DOT) - the WHO recommended method for tuberculosis
treatment - as the model to ensure that people with HIV/AIDS adhere to
ARV therapy. In defence of personal freedom and dignity, many
activists have argued that the Harvard approach - the DOT model -
supports the idea that poor people in African countries are not
capable of taking their medicines.
Other pessimistic critics such as the study by Abt Associates that
argues against ARV treatment for people with HIV/AIDS in South Africa,
claim without any foundation that the DOT model will not work for
HIV/AIDS because of the differences between TB (short-term) and HIV
(long-term).
There may be a germ of truth in both criticisms but both lack
foundation in large-scale ARV programmes in poor countries. Given the
scale of the epidemic and its intersection with poverty, substance
abuse (widespread alcoholism), other epidemics (STDs, tuberculosis,
malaria), lack of transport, low levels of treatment literacy and
other social factors a DOT model in particular contexts may be appropriate.
The Treatment Action Campaign recommends that an integrated model
based on increased treatment literacy among people with HIV/AIDS,
their families, friends and communities combined with patient autonomy
and directly observed therapy where indicated be developed. In every
model including directly observed therapy, the dignity, individual
need and freedom of the person with HIV/AIDS must be promoted.
The results from the Somerset Study offer important evidence to
support the provision of ARV treatment for HIV-positive people in
sub-Saharan Africa. These crucial drugs can be administered in Africa
with similar success to that of the developed world. It is
indisputable that ARV therapy would result in a marked drop in deaths
of those infected with HIV while reducing the number of opportunistic
infections and hospitalisation. It is possible to live a productive,
healthy and fulfilling life with HIV. Life-prolonging antiretrovirals
can make it possible.
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