How is HIV/AIDS Transmitted
HIV/AIDS is a manageable disease
What are antiretroviral drugs and how do they work?
Types of Antiretroviral Drugs
The costs of providing treatment
The benefits of providing treatment
A clash between civil society and government
Initiatives on Access to drugs
is HIV Transmitted
Immune Deficiency Syndrome (AIDS) is caused by an
infection by a virus called the Human Immunodeficiency
is transmitted primarily through:
during pregnancy, childbirth and via breastfeeding,
transfusions (although this is rare as most blood
is screened or tested prior to being provided to patients)
care practices including transfusion of unscreened
contaminated needles, syringes, razor blades, and
other sharp instruments, and through the use of unsterilised
needles by injecting drug users.
infection can only be diagnosed through undertaking
HIV tests which detect antibodies produced by the
body as it tries to resist the virus. The antibodies
are produced within 3-8 weeks after infection. The
period following infection but before antibodies become
detectable is known as the widow period.
for HIV/AIDS is to be accompanied by pre – and post-test
A rapid test takes less than 10 minutes to provide
a result. These tests have an internal sample addition
control that validates each test run. In most instances
a positive result is indicated by the appearance of
a clearly visible dot or line.
assay (Elisa Tests):
Most commonly used type of test for screening is more
expensive than the rapid tests requiring skilled technical
staff, equipment maintenance, and a steady power supply.
positive results cannot be regarded as conclusive
and should be followed up with cofirmatory tests such
as the Western blot and Line immunoassays
which determine whether an initial positive result
correctly indicates an HIV infection.
Testing using whole
blood, dried bloodspots, saliva or urine: Are
particularly useful for research with hard to reach
populations such as sex workers and injecting drug
users and people opposed to giving blood on religious
grounds. Samples can be collected in situations such
as in a bar or on the street. These tests are sufficiently
sensitive for surveillance but should be followed
up with confirmatory tests.
HIV test may be undertaken through private doctors,
at public (i.e government) clinics and hospitals,
or at laboratories. In some urban areas tests can
be undertaken at the AIDS Training and Information
standard test used is the Rapid Test. If the test
is positive this is followed up by confirmatory test,
which utilises the Elisa Test.
is a manageable disease
is no cure for HIV/AIDS but it is increasingly a manageable
is possible for people living with HIV/AIDS to lead
a productive life by following a healthy high-protein
and high-kilojoule diet, managing stress levels, practicing
safer sex i.e. by using a condom and treating opportunistic
infections early. (see factsheet on Living Positively)
drugs do not cure
HIV/AIDS but they do prolong the lives of those
infected with HIV.
are antiretroviral drugs and how do they work?
(ARVs) are the primary method of treating HIV. These
drugs inhibit either of the two enzymes that are essential
for HIV replication, namely, reverse transcriptase
understand how antiretroviral drugs function, one
has to understand how the virus works. HIV enters
the blood stream and targets specific cells in the
immune system called T-helper cells. T-helper cells
have a protein called CD4 on its surface which the
virus attaches to in order to enter the cell.
inside the reverse transcriptase enzyme enables the
copying of viral RNA (ribonucleic acid) into viral
DNA (deoxyribonucleic acid) which then joins the human
DNA. The cells now produce viral RNA which assembles
and buds out of the host cell to form a new virus.
progression of HIV/AIDS is monitored by theCD4 test
and the Viral Load test.
CD4 test measures the amount of CD4 or T-helper cells
in the blood. The strength of your immune system is
a good predictor of how you will fight infections.
Viral load test measures the amount of HIV in the
blood in every milliliter of blood. The higher the
viral load the faster the progress to AIDS.
slow down the production of HIV and give the body
a chance to build up its CD4 cell count which, in
turn, helps the body fight against opportunistic infections.
has been found that taking one drug (monotherapy)
at a time may have short term effects, but HIV quickly
becomes resistant to it. This is because as said earlier
the virus replicates at different stages and so a
combination of drugs that work at these different
stages is more likely to work and therefore less likely
to cause resistance. Therefore, more than one antiretroviral
drug needs to be taken at a time for it to be effective
over a long term.
term Highly Active Antiretroviral Therapy (HAART)
is used to describe a combination of three or more
of Antiretroviral Drugs
drugs (ARVs) can be classified into 3 main classes.
Analogue Reverse Transcriptase Inhibitors (NRTI’s),
target the HIV protein reverse transcriptase preventing
the translation of viral RNA into viral DNA (e.g.
AZT, ddl, ddC & 3TC).
Reverse Transcriptase Inhibitors (NNRTI’s
slows the reproduction of HIV by interfering with
reverse transcriptase, an important viral enzyme.
This enzyme is essential for HIV to incorporate its
genetic material into cells. NNRTI drugs include:
Nevirapine, delavirdine (Rescripta), efavirenza (Sustiva).
Inhibitors (PI’s) that target the HIV protein Protease
and blocks it so that a new virus cannot assemble
in the host cell and be released.
HIV reproduces itself so rapidly, sometimes mistakes
are made. These are called mutations. This means that
the new virus differs slightly from the original one.
Because the antiretroviral drugs target certain strains
of HIV, other strains like the mutated ones, will
not be affected by these drugs and they become drug
resistant. They are also able to produce more strains
that are unaffected by drugs.
is therefore vital that the drugs be taken exactly
side effects to the drugs include anemia (a decrease
in red blood cells), diarrhoea, nerve problems and
hepatitis (inflammation of the liver). Only a minority
of people develop side effects and generally they
can usually be treated.
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costs of providing treatment
the past two years, much progress has been made to
reduce costs of ARVs and make drugs more affordable.
However ARVs remain unaffordable to the majority of
households in South
mean median income is less than R1 400.00 ($164.00)
and unemployment is estimated at 37%.
of January 2002, the cheapest triple-combination HAART
Regimen available in South
Didanosine, Stavudine and Efavirenz was R539.95 per
month. This regimen is often not an appropriate prescription
for patients. Another commonly prescribed regimen
Zidovudine, Lamivudine and Nevirapine costs R1 160
per month. The cost of both exclude VAT at 14% and
a R65.00 prescription fee.
that at some point in the epidemic two million people
would access a publicly available treatment programme,
the antiretroviral drug costs alone for the cheapest
regimen would amount to R16.8 billion or nearly 60%
of the 2001/2002 health budget. It is estimated that
to pay the full price for anti-retroviral therapy
would cost R70 billion a year by 2010, thus almost
tripling the public health care budget.
generic drugs could reduce the costs of providing
antiretroviral drugs by up to 30%. In Thailand
government is offering Stavudine, Lamivudine and Nevirapine
in one pill at US$ 27.66 approximately R235 per month.
MSF imports generic AZT, Lamivudine and Nevirapine
at R460 ($54.11) per month from Brazil
its pilot project in Khayelitsha. If South
to produce its own generic versions of the drugs this
could further reduce the costs of the drugs as it
may insulate drug prices against exchange rate volatility
and cover shortfalls that are likely to result from
massive demand if a public treatment programme is
benefits of providing treatment
complements prevention there is evidence to suggest
that counseling modifies sexual behaviour reducing
provision of treatment provides people with an incentive
to utilize voluntary counseling and testing.
will easen the burden on the hospital services. Research
commissioned by the Department of Health indicates
that an estimated 628 000 admissions to public hospitals
were for AIDS Related illnesses, amounting to 24%
of all hospital admissions. This places a huge strain
on hospital staff and services. The cost of hospitalizing
people living with HIV/AIDS in public facilities is
estimated to be have cost R3.6 billion in 2001 or
12.5% of total public health budget. Treatment also
alleviates the impact on HIV/AIDS on health workers
where it is estimated that 30% of student nurses were
HIV positive and 15% staff nurses and 10% of doctors.
treatment will reduce the number of orphans. In the
absence of treatment it has been estimated that approximately
5.7 million children will have lost at least one parent
by 2014. This may result in increased juvenile crime,
lower literacy levels, and an economic burden on the
state. It will also place a burden on the state to
provide foster child grants and care for an increasing
number of orphaned children.
most critical benefit of providing treatment and prevention
are the lives saved and the prevention of human misery.
clash between civil society and government
HIV cause AIDS Debate
debate on the causal link between HIV/AIDS is in many
ways intertwined with arguments concerning the use
of antiretrovirals. This debate was sparked when it
was learnt that President Thabo Mbeki, had contacted
David Rasnik, a known dissident to request his views
on the causal link between HIV/AIDS. It resulted in
the formation of the Presidential AIDS Panel which
brought together experts from both sides of the argument.
This Panel failed to reach any consensus on the causal
link between HIV/AIDS, the reliability of HIV testing
and the efficacy of treatment.
on reducing the prices of drugs
government and civil society have been at loggerheads
over the provision of anti-retroviral treatment, in
particular in relation to the prevention of mother
to child transmission and more recently regarding
universal access to antiretroviral drugs, they have
in the past collaborated to enforce access to cheaper
civil society efforts around access to treatment has
been largely led by the Treatment Action Campaign.
Launched on 10 December 1998 its objectives are to
campaign for greater access to treatment for all South
Africans living with HIV by raising public awareness
about issues surrounding the availability, affordability
and use of HIV treatments. TAC is chaired by Zackie
Achmat, who is HIV positive and has made an inspiring
stand with his decision not to take anti-retroviral
drugs until they are made freely available to all
to drugs needs to be understood in the context of
the World Trade Organisations (WTO) and the Agreement
on Trade-related Aspects of Intellectual Property
Rights (TRIPS). TRIPS obligates WTO members to offer
minimum standards for protection for patents, copyrights
and trademarkes. In the development of TRIPS it was
argued that it would result in research and development
but instead it resulted in considerably higher prices.
April 2001, the Pharmaceutical Manufacturers Association
(PMA) withdrew its case against the South African
government following international political and public
pressure. The PMA and its 39 companies sued the South
African Government in 1998 objecting to provisions
in the Act No 90.1997, Medicines and related Substances
Control Ammendment Act of 1997 centering around provisions
made in the act that would enable the Minister to
permit the use of generic drugs rather than brand
name drugs by authorizing parallel importing, compulsory
liscensing, or generic production.
Generic drugs are copies of brand-name drugs where
the patent has expired or are being made under compulsory
Means a brand name drug already sold iin South Africa
is simultaneously imported from another country where
it is sold cheaper. Parallel imported drgs are theoretically
the same as the brand product and may even come from
the same plant.
Allows a patent holder to be forced to allow others
to produce its product. Compulsory licensing is sanctioned
by the World Trade Organisation under certain conditions
such as patent abuse or in cases of national emergency.
means to provisions in the won the court action against
the pharmaceutical industry allowing the government
to issue compulsory licenses to local companies to
produce and import generics.
the court case government and civil society collaborated
with the Treatment Action Campaign being admitted
by the court as a friend of the court. However, since
the conclusion of this court case government has not
finalized regulations that will enable it to utilise
the cost-containment measures provided for in the
law. Furthermore there has been little action from
government to make treatment available. In addition
government continued to cite concerns relating to
toxicity and resistance as its reason for its reluctance
to provide ARV treatment. This despite the fact that
12 anti-retrovirals had been added to the WHOs Model
List of Essential Medicines which is an indication
to countries that these drugs should be considered
efficacious, safe, and cost effective.
Prevent Mother to Child Transmission
acrimonious legal battle has ensued between the TAC
and the South African Government, and 8 provincial
governments regarding the provision of Nevirapine
to pregnant women to prevent the transmission from
mother to child (PMTCT) ensued. The Western Cape Government
was not petitioned as it was already rolling out the
provision of Nevirapine for PMTCT. The Pretoria High
14 December 2001 ruled in favour of the TAC the
state "make Nevirapine available ... in public
health facilities" that are not part of the pilot
sites "where in the opinion of the attending
medical practitioner, acting in consultation with
the medical superintendant concerned, this is medically
indicated, which shall at least include that the woman
concerned has been appropriately tested and counselled."
This decision of the court was appealed by the Government
who requested for the matter to be placed before the
decide on whether the judiciary could issue orders
concerning matters of policy.
appeal was granted by the Pretoria High Court. In
April 2002, the Constitutional
an interim order compelling government to provide
Nevirapine in institutions where it had the capacity
to do so. This was followed by a ruling of the
Constitutional Court in
favour of the Treatment Action Campaign. The legal
campaign embarked upon by government was regarded
by many as a delaying tactic in providing Nevirapine
for PMTCT. In addition government has still not accepted
a 5 year offer of free Nevirapine from the manufacturers
Boehringer Ingelheim although the provinces of the
accepted this offer. The TAC is currently monitoring
the implementation of the ruling of the Constitutional
has already summonsed the Provincial MEC for Health
Ms Manana, for failing to comply with the order.
and Post Exposure Prophylaxis
the legal battle for the provision of treatment for
PMTCT ensued, the South African Law Commission in
December 2001 included in its review of the Sexual
Offences Act that government was compelled to provide
post-exposure prophylaxis (PEP) to rape survivors.
turn around but words not met by action
a statement issued on 17 April 2002
announced that it was intensifying the campaign to
prevent HIV infection. Government reiterated that
its programme was based on the premise that HIV causes
AIDS. It acknowledged that anti-retroviral treatments
can improve the condition of people living with AIDS
if administered at certain stages in the progression
of the condition and in accordance with international
standards. Government also announced that it would
provide PEP to rape survivors.
June 2002, a National Treatment Conference took place
organized by the TAC and COSATU. This Conference resulted
in the development and adoption of a National Treatment
Plan. The plan proposes
a "triangle" of interventions, with HIV
prevention and improved treatment of other sexually
transmitted diseases at the base and anti-retroviral
drugs and home-based care at the apex. The plan calls
for a strengthened SA National AIDS Council, with
a permanent secretariat and proper resources to monitor
the implementation of the plan.
plan was submitted to the National Economic and Development
Labour Council (NEDLAC) on 20 August 2002
established an AIDS Subcommittee to
oversee the negotiations on the plan.
reapproachment between government and the TAC seemed
imminent in October 2002 following a meeting between
the government, led by the Deputy President, Jacob
Zuma and the TAC. Zuma signalled
the importance of the National Economic, Development
and Labour Council (Nedlac) process under way to develop
a "framework agreement" for a national HIV/AIDS
treatment plan, and agreed that it should be presented
to Sanac. However, Zuma did express concern over the
TAC, World AIDS Day deadline for the adoption of a
prior to World AIDS Day 2002, indications were that
government would sign the National Prevention and
Treatment Plan following negotiations in NEDLAC. However,
government continues to refuse to sign the National
Prevention and Treatment Plan which has been developed
by the National Economic and Development Labour Council
TAC will undertake a protest march to Parliament on
14 February 2002,
to protest against governments refusal to sign the
Nedlac agreement. This march coincides with the opening
of Parliament by President Thabo Mbeki.
stalls while preassure is maintained on the pharmaceutical
has not indicated whether it will purchase locally
produced generic versions of ARVs for distribution
through the public health care system. Aspen Pharmacare,
a South African generic producer has been granted
voluntary liscences by the following pharmaceutical
Ingelheim to produce the drug Nevirapine this drug
is used to reduce the risk of mother-to-child transmission
and as part of HAART.
(GSK) for the provision of AZT and 3TC. In terms of
the license agreement with GSK,
obliged to pay 30% of the net sale price to non-governmental
organisations dealing with HIV/AIDS.
Myers Squibb (BMS) for the production Stavudine and
provision of these liscences places Aspen
in a position to provide a cocktail therapy for HIV/AIDS
at reduced prices. At present Aspen
made application to the Medicines Control Council
for the approval of some of its generics.
Treatment Action Campaign and National Association
of People living With HIV/AIDS (NAPWA) continue to
place pressure on the pharmaceutical industry to reduce
the cost of antiretrovirals in South Africa. Both
have focused their campaigns on the undertaking of
protests to protest against excessive pricing by the
pharmaceutical companies. The TAC has also recently
lodged an application with the Competitions Board
while in December NAPWA held a protest at the offices
of GlaxoSmithKline in South
on Access to drugs
number of national and international efforts are being
undertaken to make treatment more readily available
» WHO-UNAIDS Access to Care Initiative – Initiated in May 2001, this
initiative is a joint effort between the United Nations
and six pharmaceutical companies with products, research
and development portfolios in HIV/AIDS. This initiative
includes dialogue with the pharmaceutical companies
to make high quality medications (including generics)
more affordable in low- and middle-income countries;
and technical collaboration with countries to expand
their capacity to deliver care, treatment and support.
As of May 2002, 39 countries had completed, or were
close to completing, national care and treatment plans,
most with technical assistance from the UN. Nineteen
African, Caribbean and Latin
American countries had reached agreements with manufacturers
on significantly reduced drug prices. Individual companies
have have agreements with another four countries-
Botswana, Chad, the Democratic
Republic of the Congo and Malawi.
19 countries, as of May 2002, more than 27 000 people
had gained access to antiretrovirals. South
that it would only participate in this programme if
negotiations were conducted on a regional level through
the SADC, whose Health Committee is chaired by the
Minister of Health in South
Economic and Development Labour Council. (Nedlac)
government, AIDS activists, labour unions, religious
leaders and community organisations are currently
engaged in negotiations aimed at developing a national
HIV/AIDS prevention and treatment programme.
Sans Frontieres (MSF) and the Treatment Action Campaign
are operating a pilot project on the provision of
antiretrovirals in Khayelitsha. The objectives of
the pilot project are
to demonstrate the following:
Feasability: Standardised regimen, monitoring and
Adherence, Treatment Literacy, awareness
cost savings and cost effectiveness
on Health Services: Dedicated service, TB-HIV links,
impact on prevention
there are over 350 patients on ARVs being provided
with AZT, 3TC and Nevirapine, an additional 3 000
patients are being treated for opportunistic infections.
The objectives The programme is definitely having
an impact, as recent research by the Centre for AIDS
Development and Research (Cadre) found that Khayelitsha
was the township that had the highest percentage of
residents who had been for an HIV test.
Treatment Action Campaign (TAC)
is working through clinics, HIV support groups and
the private sector to prepare
people living with HIV for treatment, both of opportunistic
infections (such as TB and thrush) often associated
with HIV and ARV’s.
Several South African corporations have developed
programmes to provide anti-retroviral medicines to
HIV positive workers. These include AngloGold, AngloAmerican,
De Beers and Old Mutual, Vodacom, Multichoice, BP,
Daimler Chrysler,Abbott and Alexander Forbes have
been providing the drugs for some time already. Anti-retroviral
treatment programmes being undertaken by companies
vary with some companies providing drugs to workers
while employed by the company. Others provide the
drugs to employees and their dependents, and intend
to continue provision after the employee leaves the
company. See factsheet on HIV/AIDS in the World of
Work for more information.
‘to have hope’), is a joint initiative by The South
African Medical Association (SAMA) and the Nelson
Mandela Foundation. It is designed to provide free
antiretroviral treatment (ART) to 9 000 public sector
patients at 18 treatment sites countrywide. The estimated
cost of this programme is R80 million, which SAMA
hopes to raise from national and international sponsors.
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a number of initiatives are being undertaken to increase
access to treatment the amount of people receiving
treatment is very low. Why are so few people gaining
access to treatment? What have been the lessons learned
from programmes providing treatment?
debate on access to treatment has focused primarily
on the use of antiretroviral drugs with very little
attention paid to the costs of testing, especially
concerning CD4 cell count and viral load testing.
CD4 counts and viral load tests allow for more precise
health management. What are the costs of these tests
and what actions are being undertaken to make these
tests more affordable?
has often cited that their concerns regarding antiretrovirals
are that they are toxic and complicated to administer.
In Khayelitsha the MSF and TAC have been providing
drugs to people in resource poor settings. What is
the evidence from these projects relating to these
issues? Speak to people receiving treatment and also
to those who are not receiving treatment to find out
what their experiences have been?
companies are undertaking drug trials in South
What trials are being undertaken? What are the ethical
guidelines governing those trials? What benefit is
there for those participating in these trials especially
concerning continued provision of treatment at the
conclusion of the trial?
Pharmacare has been provided with voluntary licences
by some of the pharmaceutical companies to produce
local generics of their drugs? How far has
in the development and the approval of these drugs?
Has government indicated that it will procure these
drugs through Aspen?
are the social implications involved in allowing communities
to play a role in deciding who is allowed to take
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Department of Health
Name: Dr Nono Simelela
Tel: (012) 312 0121
Fax: (012) 326 2891
Action Campaign (TAC)
Nathan Geffen, Manager
Tel: (021) 788-3507
Sans Frontieres (MSF)
Marta Darder, Co-ordinator
Tel: (021) 364 5490
HIV Research Unit (PHRU)
Dr James McIntyre / Dr Glenda Grey / Dr Avye Violar
Tel: 11 989 9700
Fax: 11 938 397
African HIV Clinicians Society (See Medical Practitioners)
Name: Penny Penhall
Tel: (011) 453 5066
Fax: (011) 453 5059
African Medical Association
Dr Kgosi Letlape, Chairperson of SAMA
Tel: 012 481-2037
082 881 295
Health Organisation (WHO)
Tel: +41 22 791 4509
United Nations Programme on HIV/AIDS (UNAIDS)
Anne Winter/Dominique de Santis
Tel: +41 22 791 4509
United Nations Programme on HIV/AIDS (UNAIDS)
Dr Catherine Sozi
Tel: 012 338 5307
Trade Organisation (WTO)
Tel: +41 22 739 5286
Practitioners – Supplied by the SA HIV Clinicians
Dr Des Martin
Tel: (011) 453 5066
Fax: (011) 453 5059
Dr Steve Andrews
Tel: (021) 510 1569/81
Fax: (021) 510 1590
Prof Raziya Bobat
Tel: (031) 260 4355
Fax: (031) 260 4388
(021) 404 9111
ID Unit: 021) 406 4346 (IDUnit)
Fax: (021) 406 6896
Prof Robin Wood & Dr LG Bekker
Tel: (021) 402 6393
Fax: (021) 425 2021
Dr Koleka Mlisana
Tel: (031) 260 4562
Fax: (031) 260 4566
Tel: (011) 777 8000
Fax: (011) 787 0772
Manufacturers Association of South Africa
Mirryena Deeb, Chief Executive Officer
Maureen Kirkman, Head Scientific and Regulatory Affairs
Tel: 011 805 5100
Fax: 011 805 5105
Laboratories SA (PTY) LTD
Linda Pretorious, CEO
Tel: 011 239 6100
Fax: 011 239 6111
in HIV/AIDS: Generic Manufacturer. Been provided voluntary
lisences by Bristol Meyers Squibb, GlaxoSmithKline
and Boeheringer Ingelheim to produce generic versions
of their HIV/AIDS antiretrovirals.
Ingelheim (PTY) LTD
Tel: (011) 886 1075
Fax: (011) 886 3205
in HIV/AIDS: Producers VIRAMUNE
(active ingredient nevirapine). Has offered Viramune
for the management of MTCT free for the next five
years. Presently only the Provincial Governments of
the have accepted this offer. Aspen Pharmacare has
been given a license toproduce a generic version of
VIRAMUNE in South
The license is a royalty-free, voluntary, non-exclusive
license covering the public sector of all
countries of the SADC region.
Squibb (PTY) LTD
Vicky Baker,Simeka Communications
Tel: 011 712 9600
Mtshal, Programme Manager: Secure the Future
Tel: 011 456 6441
with HIV/AIDS: Producers of Stavudine and Didandanosine.
BMS also funds the Secure the Future Initiative a
five-year, $100 million commitment aimed at finding
sustainable and relevant solutions for the management
of HIV/AIDS in women and children, and provide resources
to improve community education and patient support.
BMS has also provided a voluntary license to Aspen
Michael Vogt, Strategic Brand Manager for HIV
TEL: 011 313 6000 (Tracey)
FAX: 011 313 6111
with HIV/AIDS: Producers of combivir, AZT, Lamivudine,
ziagen. Voluntary liscence provided to Aspen Pharmacare
for production of generic version of AZT and combivir.
(Merck Sharpe & Dohme)
TEL: 011 655
FAX: 011 655
in HIV/AIDS: Produce Crixivan and Stocrin. Also participates
in the WHO-UNAIDS Access to drugs initiative.
Laboratories (PTY) LTD
in HIV/AIDS: Has provided free Fluconazole indefinitely
to patients attending government hospitals and clinics.
Fluconazole is used in the treatment of opportunistic
infections such as Cryptococcal Meningitis a painful,
Products (PTY) LTD
FAX: 011-392 2338