HIV/AIDS Treatment

1. Introduction

Although there is no cure for HIV/AIDS, several treatments can be used to prolong the lives of those infected with HIV, reduce the chance of mother-to-child transmission, or prevent HIV infection after exposure to the virus.

The treatment of HIV/AIDS — or lack thereof — has remained a hot media topic in South Africa in particular, ever since the pandemic started to take hold in the late 1990s. The government has been routinely criticised by lobby groups such as the Treatment Action Campaign for not doing enough in this area. Their criticism has been echoed in court judgements such as the landmark 2001 Constitutional Court ruling (upheld on appeal in 2002) that the government provide nevirapine to HIV-positive pregnant women, and by other organisations, such as the South African Human Rights Commission.

President Thabo Mbeki's stance on treatment has also been widely covered in the press. As the timeline in this factsheet shows, he has moved from publicly associating himself with fringe scientific views on the causes and treatment of HIV/AIDS to distancing himself from AIDS dissidents and becoming generally quieter on the issue of treatment while his government has simultaneously changed tack, slowly rolling out a public antiretroviral programme.

2. HIV/AIDS Progression

2.1 Overview

To understand the treatment of HIV/AIDS it is important to understand how an HIV infection develops into AIDS. The treatment of HIV/AIDS and its related illnesses is largely informed by the stage at which the HIV infection is at.

2.2 HIV Progression

After infection, the HI virus enters the blood and attacks the body's immune system, specifically the important T-helper cell which co-ordinates the immune system's response to infections. The HI virus gains entry to the T-helper cell by attaching itself to the CD4 protein on the surface of the cell. Once the HIV has gained entry, it takes over the cell and replicates, seeking new T-helper cells to infect. The infected cell dies after a couple of days.

The body's natural response to an infection is to fight infected cells and replace the cells that have been lost. But gradually the HIV overwhelms the immune system, leaving the body vulnerable to infections and other diseases. The time it takes to do this varies from person to person, but averages at about nine years.

The normal range for CD4+T cells in a healthy person is 800-1200 cells per cubic millilitre of blood. When an HIV infected person's CD4+ T cell count falls below 200, he or she becomes increasingly vulnerable to opportunistic infections. In a person with a healthy immune system these infections would not normally be life-threatening but to an HIV-infected person they could be fatal.

Without treatment, the viral load, which refers to the relative amount of free virus in the blood, will increase to the point where the body can no longer fight it.

The progression of the virus can be measured by a CD4 test that measures the amount of CD4 or T-helper cells in your blood. The strength of your immune system is a good predictor of how you will fight infections.

The Viral Load test measures the amount of HIV in the blood in every millilitre of blood. A high viral load indicates that the patient is either in the first stage of infection or nearing AIDS.

HIV progression can be divided into 4 stages:

Stage	Description	Symptoms/Illnesses	Treatment
1. Primary HIV infection	During this stage most individuals will not be aware they are infected, and may even test HIV-negative because their body hasn't reacted to the virus and created antibodies. Symptoms normally occur within three months of infection and generally subside within two weeks.	A flu-like illness, swollen lymph nodes, diarrhoea, fever and fatigue.	Treat the infections and symptoms
2. Asymptomatic stage	No symptoms manifest but the virus remains active.
3. Symptomatic stage	Individual begins to feel unwell and experiences infections caused by bacteria and viruses that surround us all daily	Thrush, Herpes Zoster (shingles), Herpes Simplex, Oral Hairy Leukoplakia, Idiopathic Thrombocytopenic Purpura, Pneumococcal Pneumonia.	Prevent/treat opportunistic infections
4. Acquired Immune Deficiency Syndrome (AIDS)	Individual's CD4 count is less than 200.	Pneumocystis carinii Pneumonia (PCP), Kaposi's Sarcoma, Tuberculosis, HIV-Related Lymphoma, (more...)	Initiate antiretroviral treatment

3. Treating HIV/AIDS-Related Illnesses

3.1 Preventing Opportunistic and HIV-related Diseases

The best way of preventing opportunistic infections is by taking antiretroviral drugs. However, for people with CD4 counts higher than 200, antiretroviral therapy is not recommended (see antiretroviral treatment below).

People in other stages of HIV infection can prevent and treat opportunistic infections that may occur before they develop AIDS.

Most opportunistic infections are caused by common micro-organisms that may live in a person's body for years. The bacteria that causes tuberculosis, for instance, is carried by a third of the world's population, but only about 8-million people contract active tuberculosis every year (see Tuberculosis and HIV/AIDS below)

Because HIV makes the immune system weaker, these common micro-organisms have far greater "opportunities" to attack the body.

Common strategies for the prevention of opportunistic infections include:

The prevention of the micro-organisms that cause opportunistic infections

In some cases, people can prevent the micro-organisms from ever reaching their body by being careful while handling food and drink, handling pets and while having sex. However, these measures do not prevent the re-activation of micro-organisms already in the body.

Primary prophylaxis

HIV-infected people can prevent an opportunistic infection from first developing by taking special prophylactic treatment. There are common opportunistic infections that occur at predictable CD4 count levels, making it easier to predict and prevent these infections.

Secondary prophylaxis

Once a person has experienced and treated an opportunistic infection, they can prevent additional episodes of the infection by taking "maintenance therapy", usually consisting of smaller doses of drugs taken for the original infection.

Both these prevention techniques carry the risk of drug resistance and side effects associated with long-term prophylaxis.

Common preventative measures in South Africa include:

• offering symptomatic patients Co-trimoxazole (an antibiotic treatment that prevents bacteria from reproducing) to prevent infections such as Pneumocystis carinii pneumonia, toxoplasmosis, bacterial pneumonia and Diarrhoea
• administering a PAP smear to detect human papillomavirus-associated genital epithelial cancers that can be treated
• administering Hepatitis B and Influenza vaccines — SA National Department of Health (2000)

3.2 Treating Opportunistic and HIV-Related Diseases

The SA National Department of Health's Recommendations for the prevention and treatment of opportunistic and HIV-related diseases in Adults has guidelines on the management of opportunistic infections.

Some common opportunistic conditions associated with HIV/AIDS include:

Condition/Disease	Description
Tuberculosis	An illness caused by bacteria that infects the lungs, but can be found in other organs. Read more on AIDSmap.
Chronic Diarrhoea	Caused by many types of infection, diarrhoea usually results in frequent bowel movement, stomach pains and a liquid stool. Read more on AIDSmap.
Pneumocystis carinii Pneumonia (PCP)	A lung disease cause by a fairly common micro-organism that usually only infects the lungs when CD4 counts fall below 100 cells/mm3. Can also grow in other parts of the body. Read more on AIDSmap.
Kaposi's sarcoma (KS)	A cancer that causes lesions on skin but can spread all over the body. Read more on AIDSmap.

Most opportunistic infections are treatable, although some require special attention due to the interaction between antiretrovirals and other types of drugs. Once AIDS develops, opportunistic infection treatment is less likely to be successful and the infection can result in death if antiretroviral treatment is not taken.

3.3 Opportunistic Infections and Mortality

Deaths associated with opportunistic infections can give an indication of the progress of the HIV/AIDS epidemic.

4. Antiretroviral Treatment

4.1 Introduction

Antiretroviral drugs (ARVs) are currently the primary method for treating HIV. These drugs inhibit either of the two enzymes that are essential for HIV replication, namely, reverse transcriptase and protease.

Although antiretroviral treatment is not a cure for HIV/AIDS, it can significantly prolong and improve the lives of HIV-infected people. ARVs 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.

4.2 Types of Antiretrovirals

Antiretroviral treatment is usually prescribed as a combination of two or three different types of drugs to combat different processes during HIV replication. The three main types of drugs available are listed below:

Antiretroviral drug	Action	Generic examples (abbr)
Nucleoside Analogue Reverse Transcriptase Inhibitor (NRTI)	Prevents healthy T-cells from becoming infected with HIV by preventing the conversion of viral RNA into viral DNA.	zidovudine (AZT) lamivudine (3TC) stavudine (d4T)
Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI)	Prevents healthy T-cells from becoming infected with HIV by interfering with the reverse transcriptase enzyme which the HIV uses to convert viral RNA to viral DNA.	nevirapine (NVP) efavirenz (EFV) delavirdine (DLV)
Protease Inhibitor	Prevents infected T-cells from producing new copies of the virus by blocking the protease enzyme which helps produce new copies of the virus.	ritonavir (RTV) indinavir (IDV) lopinavir (LPV)

Also see: "Positively Aware" 2005 Drug Chart

4.3 When to Start Antiretroviral Treatment

There is still debate over when to start antiretroviral treatment (ART). Because ART has known side effects, including short and long-term toxic effects on the body, medical specialists disagree over when to start the treatment.

ART guidelines around the world generally recommend treatment begins when the patient has a CD4 count between 350 cells/mm3 and 200 cells/mm3 (depending on the individual) or if he/she is displaying an AIDS-defining illness, such as Kaposi's Sarcoma or wasting syndrome.

The SA National Antiretroviral Treatment Guidelines recommend that a patient begins ART when the patient's CD4 count is below 200, or s/he has displayed an AIDS-defining illness.

Some countries' guidelines provide for ART before the CD4 count has dropped to this level.

Current treatment guidelines in Europe and the United States for example, recommend that ART begins before the CD4 cell count falls below 200 cells/mm3 — the exact timing depending on the individual patient's condition. Because of known toxicities and resistance, and unknown long-term effects, most doctors see no benefit in beginning treatment in patients until their CD4 counts drop to a level between 350 cells/mm3 and 200 cells/mm3.

According to the South African guidelines, patients must also display a willingness and readiness to take antiretroviral treatment adherently. If patients don't take their treatment properly, their treatment will probably fail and the virus in their body will become resistant to the drugs. (See treatment adherence below.)

4.4 Recommended Treatment Regimens in South Africa

In South Africa, two standard regimens or treatment options for adults with CD4 counts lower than 200 are recommended in the National Antiretroviral Treatment Guidelines. Patients who fail both regimens are continued on treatment until there is no further clinical benefit. They are then referred to home-based and palliative care.

National Antiretroviral Treatment Guidelines: Treatment Regimens
1. First-line Therapy (Adults)
First-line Therapy (i.e. the first line of treatment) is given to all patients who haven't been exposed to antiretrovirals before. (Those who have had previous antiretroviral treatment are referred to specialists.) Women of child-bearing age take nevirapine instead of efavirenz if they cannot reliably prevent conception, due to the risk of birth defects.
1a	Stavudine (d4T) AND lamivudine (3TC) AND efavirenz (EFV)
1b	Stavudine (d4T) AND lamivudine (3TC) AND nevirapine (NVP)
2. Second-line Therapy (Adults)
Patients who do not respond to the treatment (e.g. their viral load remains high) should be changed to Second-line Therapy.
2a	Zidovudine (AZT) AND didanosine (ddI) AND lopinavir/ritonavir (LPV/r)
Source: National Antiretroviral Treatment Guidelines

4.5 Drug Resistance

Because HIV reproduces itself so rapidly, slight mistakes or mutations develop in the virus. Some of the mutations occur in parts of the virus targeted by the antiretroviral drugs. If a patient is only taking one drug (monotherapy), these mutations are likely to survive the treatment and spawn similar drug-resistant strains. If the patient is taking two or three different drugs, the mutation is less likely to survive as the other drugs will target different areas where there is no mutation and stop it from producing strains.

This is why combinations of antiretrovirals are prescribed in most AIDS treatment plans.

When a patient begins antiretroviral treatment, their viral load normally falls to undetectable levels. If drug-resistance begins, the viral load will rise as the new strain populates the body. When this happens, patients are usually prescribed a different regimen of drugs that will target other parts of the virus. When a second or third-line regimen becomes ineffective, a patient can run out of antiretroviral treatment options.

4.6 Treatment Adherence

Similarly, treatment adherence is an essential part of a treatment programme. If a patient does not take their treatment correctly, there is a major risk of drug resistance as mutations will be allowed to develop between their intermittent treatment.

The National Antiretroviral Treatment Guidelines define "ideal adherence" when a patient takes more than 95% of his or her doses. According to the guidelines:

• If a patient takes less than 95% of his/her doses, they are at risk at developing virological resistance to the treatment
• If a patient takes less than 80% of his/her doses, their treatment is unlikely to be successful

Drug-resistant strains of HIV can be transmitted by people. A person infected by a drug resistant strain will be as limited for treatment options as the person who infected them.

4.7 Side Effects

People taking antiretroviral drugs are likely to experience some side effects during their treatment. But most scientists and doctors agree that the benefits of antiretroviral treatment outweigh the side effects of the drugs. It is important that patients are made aware of known side effects so they maintain their treatment adherence whenever possible.

Possible major side effects to antiretroviral drugs include:

• Lipodystrophy and Wasting — changes in the amount and distribution of body fat and body muscle
• Facial Lipoatrophy — loss of body fat around the face (e.g. sunken cheeks)
• Hyperlipidemia — increases in blood lipids, notably cholesterol
• Fatigue and Anemia — lack of energy which can be caused by red blood cell count dropping
• Peripheral Neuropathy — nerve damage causes tingling or burning in hands or feet
• Nausea and Diarrhoea — upset stomach and liquid stool
• Hepatotoxicity — liver damage caused by medication

A patient may also experience short-term minor side effects.

A summary of reported antiretroviral drug side effects developed by Project Inform appears below:

Antiretroviral Drug Side Effects
	Side effect reported in > 15% of people in clinical studies
	Side effect reported in 5–15% of people in clinical studies
	Side effect reported in < 5% of people in clinical studies
(blank)	Side effect has not been reported
C	Reported only in children, or more commonly in children
‡	Potentially fatal side effect
LPV = lopinavir/ritonavir; EFV = efavirenz; NVP = nevirapine; 3TC = lamivudine; AZT = zidovudine; ddI = didanosine; d4T = Stavudine
	PI	NNRTI		NRTI
Drug Side Effect	LPV	EFV	NVP	3TC	AZT	ddI & ddI-EC	d4T
Abdominal pain
Altered taste
Anorexia (reduced appetite)
Arthralgia (joint pain)
Chills
Constipation
Depression
Diarrhea
Dizziness
Fatigue
Fevers
Headache
Insomnia (sleep problems)
Malaise
Myalgia (muscle pain)
Nausea
Neurological Symptoms
Neuropathy (pain/tingling in arms arms/legs/hands/feet)
Pancreatitis (inflammation of the pancreas)	‡	‡		‡	‡	‡	‡
Paresthesia (numbness, prickling, tingling)
Rash		‡	‡	‡		‡	‡
Seizures
Vomiting
Source: Project Inform. * This chart may not adequately reflect the percentages of side effects in women due to the limited number of women in many studies of these drugs.

4.8 Studies of Antiretroviral Drug Effectiveness

5. Access to Antiretroviral Drugs

5.1 Global Situation

The World Health Organisation estimates that of the 6.5-million people who required antiretroviral therapy in the developing and transitional world in June 2005, only 970,000 (15%) received it.

WHO: ARV therapy coverage in low and middle income countries, June 2005

Geographical Region	Number of people receiving ARV therapy	Estimated need	Coverage
Sub-Saharan Africa	500,000	4,700,000	11%
Latin America and the Caribbean	290,000	465,000	62%
East, South and South-East Asia	155,000	1,100,000	14%
Europe and Central Asia	20,000	160,000	13%
North Africa and the Middle East	4,000	75,000	5%
Total	970,000	6,500,000	15%
Source: ARV therapy coverage in low and middle income countries, June 2005. UNAIDS/WHO. Progress on Global Access to HIV Antiretroviral Therapy (1.5 Mb)

5.2 In South Africa

South Africa's controversial AIDS treatment history over the last decade has resulted in considerable media focus and attention. A timeline of the government treatment policy appears below in this factsheet.

After years of withholding general antiretroviral treatment in the public health sector, arguing that the drugs were unaffordable and inappropriate, the SA Cabinet announced its approval of the SA National Department of Health's Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB) in November 2003. The five-year plan provides for ARVs to be made available in the public health sector for the first time on a large scale. However, as detailed in the WHO report highlighted above, the implementation of this plan has been slow.

The Cabinet announcement cited "favourable conditions" including falling drug prices and growing experience in fighting HIV/AIDS as reasons for the implementation of the plan at this stage.

Planned number of patients on antiretroviral treatment vs no. of new AIDS patients per year
Years	ARVs	Total Cases on ARVs (planned)	Projected total new AIDS cases1
2003/2004	53,000	53,000	388,701
2004/2005	138,315	188,665	462,841
2005/2006	215,689	381,177	530,658
2006/2007	299,516	645,740	586,181
2007/2008	411,889	1,001,534	624,720
1. Data from Table 16.1. Represents new AIDS cases per year and not a culmative total. Source: SA National Department of Health, 2003. Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB)

However, the government was not able to meet its own projections as set out in the table above. By March 2005 about 104,600 people (44,600 public sector; 60,000 private sector) were being treated with ARVs in South Africa, out of a WHO-estimated 837, 000 who need the treatment (Dec 2004).

6. Treatment in South Africa: A Timeline

Abbreviations: = Important Event. ARV = antiretroviral event; PEP = Post-exposure prophylaxis event; PMTCT = prevention of mother-to-child transmission event; NUTR = nutrition-related event.
Date		KEY	Action
1997
		ARV	A group of AIDS researchers are invited to present the AIDS drug Virodene to the SA Cabinet. The government later fires top members of the Medical Control Council after they refuse to fast-track the drug (source), which is later found to contain industrial solvent and have no antiviral effects.
1998
December 10		ARV	The lobby group Treatment Action Campaign is launched. "Its main objective is to campaign for greater access to HIV treatment for all South Africans, by raising public awareness and understanding about issues surrounding the availability, affordability and use of HIV treatments." (About TAC)
1999
October 28		ARV	Mbeki questions the safety of AZT, widely regarded in the health profession an effective and relatively safe AIDS drug, in an address to the National Council of Provinces. "A large volume of scientific literature alleging, among other things, the toxicity of this drug is such that it is in fact a danger to health," said Mbeki. This was one of the first times he questioned in public conventional medical opinion on AIDS treatment and showing sympathy instead with a fringe group of AIDS dissidents.
2000
May 6		ARV	The Presidential Advisory Panel on AIDS, established by Mbeki to investigate the "way forward" in dealing with AIDS in Africa, meets for the first time. Just under half of panel members are AIDS dissidents, according to the respected scientific journal, Nature. The panel fails to reach consensus on a number of issues, including the link between HIV and AIDS (see full report).
August			The South African health ministry decides that the use of Nevirapine for PMTCT would first be tested for two years at 18 pilot sites (two for every province) around South Africa, "to determine whether or not the exercise would be feasible". (Health MinMEC Minutes cited by Heywood, 2003).
2001
October 24		ARV	Mbeki warns members of parliament over the toxicity of ARV drugs. "I would hope that if any members of parliament are taking those drugs, they need to have a look at that so as to advise their own medical practitioners as to how to proceed. Otherwise they are going to suffer negative consequences," Mbeki tells parliament.
August 21, 2001			The TAC, together with Save Our Babies (SOB) and the Children’s Rights Centre (CRC) in Durban files a constitutional claim against the government: seeking a declaration that their PMTCT policy was unconstitutional, asking that the government be ordered to make "Nevirapine available to pregnant women with HIV who give birth in the public health sector, and to their babies..."
December 14		PMTCT	The High Court orders the government to allow nevirapine to be prescribed to pregnant woman in South Africa where "medically indicated" and develop "an effective comprehensive national programme to prevent or reduce MTCT" by March 31, 2002, for further scrutiny by the Court." The government is later granted leave to appeal to the Constitutional Court. (see excerpt of judgement)
2002
January 21		PMTCT	The KwaZulu-Natal provincial government announces that HIV-positive pregnant women in state hospitals will receive nevirapine. In his state of the province address the following month, Premier Lionel Mtshali says: "As a Premier who heads a legitimate government, I must ask myself, as our posterity will undoubtedly do, what went wrong in South Africa for a judge to have to order us to have a plan and re-prioritise in order to save our children. Certainly, History will judge us harshly ..."
February 1		ARV	International humanitarian organisation, Medecins Sans Frontieres (MSF) and TAC announce they are importing generic drugs from Brazil for their pilot ARV programmes.
April 17		PEP ARV	In a Cabinet briefing, government announces that survivors of sexual assault and rape may receive ARVs from public health care providers and that government should investigate the provision of universal treatment for AIDS patients.
April 21			The Sunday Times reports that Mbeki and his Cabinet have distanced themselves from AIDS dissidents, demanding that dissidents on Mbeki's advisory council stop identifying themselves as members of the panel when writing documents or signing letters to newspapers. " Mbeki, who officials say has come round to accepting the negative impact that the pandemic is having on South African society and the country's image abroad, will refrain from expressing his personal views in public and will instead reiterate the official position when questioned on AIDS," said the article.
July 5		PMTCT	The Constitutional Court upholds the 2001 High Court decision and orders the government "without delay" to make nevirapine available for the prevention of mother-to-child transmission at public hospitals and clinics.
October		ARV	During the launch of its "Campaign of Hope" for AIDS, Cabinet issues a statement acknowledging that ARVs could "improve the condition of people living with HIV/AIDS" and says government is addressing challenges such as drug prices "to make it feasible and effective to use antiretrovirals in the public health sector".
2003
February 27		ARV	Finance Minister Trevor Manuel announces plans to almost double the amount spent on HIV/AIDS. Over the next three years, R3.3-billion (US $400-million) will go towards extending preventative programmes and finance "medically appropriate" treatment for HIV/AIDS.
February 28		ARV	Government misses the TAC deadline for signing the National Economic Development and Labour Council (NEDLAC) framework agreement for a national HIV/AIDS treatment and prevention plan.
March 18		ARV	Health Minister Manto Tshabalala-Msimang denies undermining the importance of ARVs but maintains the need for adequate infrastructure before rolling out a treatment plan.
March 20		ARV	TAC launches its civil disobedience "Dying for Treatment" campaign. Activists lay charges of culpable homicide against Tshabalala-Msimang, and Minister for Trade and Industry Alec Erwin, for failing to prevent an estimated 600 AIDS-related deaths in South Africa every day.
April 23		ARV	South Africa's AIDS policies are failing and the government urgently needs to make drugs freely available, a report by the South African Human Rights Commission (SAHRC) says. "Despite the creation of one of the most comprehensive policies and enabling legislation in the world, the country had not succeeded in implementing these plans sufficiently to make an impact on reducing the prevalence of HIV/AIDS," the SAHRC report warns. (news report)
August 7		ARV	The agreement between the government and the Global Fund is finally signed, with the Fund committing US $41-million to the country over two years. The grant aims to provide antiretroviral drugs and strengthen prevention and voluntary counselling and testing programs in South Africa.
August 8		ARV	Cabinet issues a statement instructing the health department to develop a "detailed operational plan" for an ARV rollout, "with urgency".
September 25			The Washington Post reports President Thabo Mbeki saying, "Personally, I don't know anybody who has died of AIDS." Asked whether he knew anyone with HIV, he reportedly said, "I really, honestly don't." At the time, the newspaper reported, one in 10 South Africans — nearly 5-million people — was infected with HIV, according to government statistics. (BBC story)
November 12		ARV	Minister of Finance Trevor Manuel allocates approximately US $2-billion towards HIV/AIDS over the next three years and clarifies that over $3-million of the total amount is earmarked for antiretroviral treatment. TAC says this is sufficient to rollout a comprehensive treatment programme with the potential to meet a target of at least 200,000 people by March 2005.
November 19		ARV	Cabinet finally approves the Operational Plan for Comprehensive Treatment and Care for HIV/AIDS (1.9MB). It aims to have 1.4-million people on treatment within five years.
2004
March 10		ARV	Tshabalala-Msimang is given until March 17 to respond to a TAC letter demanding the purchase of "an urgent interim supply of antiretrovirals pending the finalisation of the tender process" or face litigation.
April 1		ARV	South Africa's public HIV/AIDS treatment programme takes a step forward as patients in five hospitals in Gauteng begin receiving free antiretrovirals.
2005
January		ARV	Only 33,000 people received public sector AIDS treatment in January 2005, according to director for HIV and AIDS at the national health department, Nomonde Xundu. A WHO-estimated 837,000 people were in need of the treatment in South Africa in December 2004.
February		ARV	The TAC calls for government to treat at least 200,000 people with antiretrovirals by the beginning of 2006.
March		ARV	Doctor, pharmacist and dietician personnel shortages hamper the rollout of SA's antiretroviral treatment programme, reports the AFP. Out of 220 doctors required for the implementation programme, only 111 have been hired. Out of the 271 pharmacists needed only 90 were hired and out of 136 dieticians required, only 64 were hired.
April 13		NUTR	Tshabalala-Msimang defends controversial vitamin proponent Matthias Rath (see box below) saying nutrition is the foundation of fighting disease, including HIV/AIDS, and that the Rath Foundation, which advertises "natural" treatments for AIDS, is "not undermining government's position". "If you eat properly you can delay the onset of AIDS — in some cases indefinitely," she said, according to a Business Day report.
July 12		ARV	TAC march to Frontier Hospital, Queenstown to hand memorandum to management regarding the inadequate ARV roll out in the Chris Hani municipality, the hospital's ARV task team's relationship with the TAC and allegations of mismanagement in the hospital. The police use tear gas and rubber bullets to disperse the crowd. At least one person is taken to hospital. (see TAC statement)
July 26		ARV	TAC march to Queenstown police station to protest against police action on July 12 and then to Frontier Hospital to receive memorandum prepared by hospital management. The memorandum states that there are currently 415 people on their ARV programme, with 27 new patients per month. The national average is 35. Hospital management says the delay is due to staff shortages, but they are attempting to rectify the situation.
August		ARV	South African government estimates that about 78,000 people are on antiretroviral treatment by the end of August 2005. An additional 70,000 to 80,000 people were receiving antiretroviral treatment in the private sector. (source)
November		NUTR	The Treatment Action Campaign files an urgent application for an interdict against the activities of Matthias Rath in late November 2005. The TAC also asks the court to find that Tshabalala-Msimang has a duty to stop Rath (source). Tshabalala-Msimang earlier declined to distance herself from Rath despite mounting evidence that Rath's activities were illegal and harming patients. "I will only distance myself from Dr Rath if it can be demonstrated that the vitamin supplements that he is prescribing are poisonous for people infected with HIV," Tshabalala-Msimang said in a written reply to a parliamentary question by the Democratic Alliance. (source)
Sources: IRIN (C) — Chronology of HIV/AIDS treatment access row. Heywood, 2003: Preventing Mother-To-Child HIV Transmission In South Africa: Background, Strategies and Outcomes of the Treatment Action Campaign Case Against the Minister of Health. Anso Thom and Kerry Cullinan. Responses to HIV/AIDS. Health-e.

7. The Cost of Treatment in South Africa

7.1 Pharmaceutical Companies and Patent Rights

Court Case: PMA vs SA government

On February 18, 1998, the Pharmaceutical Manufacturers' Association (PMA) instituted legal action against the 1997 amendment and gained an interim interdict prohibiting the Minister of Health from using certain sections of the Act, including Section 15(C), which allowed for compulsory licensing and generic substitution. They based their argument on their constitutional "right to property". The Treatment Action Campaign entered the court case in 2001 as an amicus curae or "friend of the court" in an attempt to break what they termed was a "collusive paralysis" between the government and the PMA. The TAC's main argument against the PMA was that "access to health is a human right that trumps rights to private property — particularly when these rights are being abused". ( Heywood, 2001)The arguments were never fully interrogated in court. In April 2001, after three years of delays, the Pharmaceutical Manufacturers' Association (PMA) withdrew its case against the South African government following local and international political and public pressure.

South Africa is a founder member of the World Trade Organisation (WTO), an organisation established in 1995 to oversee the global agreements that define the "rules of trade" between member states.

One of these rules of trade is the Trade-related Aspects of Intellectual Property Rights (TRIPS), which protects patents, copyrights and trademarks.

When TRIPS was developed, proponents said the protection of rights would encourage pharmaceutical companies to research and develop new drugs. Critics have argued that instead it has resulted in higher prices.

To counter the general trend of higher prices for medicines, some countries have introduced pricing controls that prevent pharmaceutical companies from abusing their patent rights.

In South Africa, pricing controls are especially important because of the large inequalities that exist in the provision of health care and the large divide between rich and poor.

In 1997, Parliament passed the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 (Medicines Act) which contained provisions that made medicines more affordable.

The Act gives the government a legal framework to:

• compel pharmacists to prescribe cheaper generic substitutes of medicines no longer under patent (generic substitution)
• import cheaper brand-name medicines from countries where the product is sold for less (parallel importing)
• issue compulsory licenses, under certain conditions, to local companies to produce generics of patented medicines (compulsory licensing)
• introduce a transparent pricing mechanism to make pharmaceutical companies justify the prices they charge

The Medicines Act is an important piece of legislation for the provision of cheap antiretroviral drugs in South Africa.

7.2 The Economic Cost of Providing Treatment in South Africa

AIDS treatment has been traditionally expensive due to the:

• multiple drugs needed to suppress the virus, and,
• the health infrastructure needed to ensure treatments are effectively carried out (see Antiretroviral Treatment).

For a number of years in South Africa, the SA government refused to offer AIDS treatment due in part to the affordability of a treatment programme. (see above treatment timeline for more information)

However, AIDS treatment costs have fallen rapidly over the last 10 years (from about $10,000 to $300 per-year per-person by some estimates) due to the production of cheaper generic equivalents and price cuts by pharmaceutical companies.

In March 2005, the SA government awarded tenders to seven pharmaceutical companies worth R3.4-billion for the supply of ARV drugs for public health facilities. (see press release)

South African generics manufacturer Aspen Pharmacare received the greatest share of the tenders, while patent-holding international pharmaceutical companies were also included where no generic alternatives were available.

Cost of antiretroviral Regimens (Drugs Only) — 2005
Regimen	Cost per month*
First-line. Stavudine (d4T), lamivudine (3TC) and nevirapine	R97.26
First-line (b).Stavudine (d4T), lamivudine (3TC) and efavirenz	R269.00
Second-line. Zidovudine (AZT), didanosine and ritonavir-boosted lopinavir (Kaletra)	R534.98
*Prices for drugs only, not associated treatment costs. Prices modelled on 70kg adult. Some prices are structured to rise over the next few years as part of the tender agreement. Source: "Government circular" cited in: Delayed AIDS-drug tender awarded at last. Business Day, Mar 4, 2005.

Total Projected Costs

In the SA National Department of Health's Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB), the total budget is projected to rises from R296-million in 2003/04 to R4.47-billion in 2007/2008 for the treatment of people with HIV/AIDS. The cost of the antiretroviral drugs is the largest item in the budget, projected at R1.65-billion in 2007/08.

Total Programme Budget Estimate (Millions of Rands)
	2003/04	2004/05	2005/06	2006/07	2007/08
Service Staff	21	322	432	662	1,027
Laboratory Testing	20*	152	311	520	806
Antiretroviral Drugs	42	369	725	1,118	1,650
Nutrition	63	343	421	532	656
Health System Capability Upgrading	70	171	184	160	160
Programme Management	16	103	128	128	128
Capital Investment	30	75	100	100	0
Research	34	55	55	48	48
Total	296	1,590	2,358	3,268	4,474
* includes R20-million advance payment to the National Health Laboratory Service (NHLS)Source: Table 16.20. SA National Department of Health (2003). Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB).

7.3 The Economic Benefits of Providing Treatment

Providing treatment eases the burden on the hospital services.

In 2001, research commissioned by the SA National Department of Health found:

• 628,000 admissions to public hospitals were for AIDS-related illnesses
• the cost of hospitalising AIDS patients at public facilities was likely to be at least R3.6-billion, or 12.5% of the total public health budget (source)

A 2002 joint HSRC and Medical University of SA (Medunsa) study into the impact of HIV/AIDS on the health sector, found:

• An estimated 15.7% of health workers in public and private hospitals were found to be HIV positive. However, among those aged 18–35, the prevalence was 20.0%. Single African nurses were found to be most at risk
• A total of 28.0% of patients attending public and private health facilities, including clinics, tested positive for HIV antibodies
• Patients with HIV/AIDS stayed in hospital for an average of 13.7 days, in comparison to the 8.2-day average of HIV-negative patients. (source)

Providing treatment will reduce the number of orphans

In the absence of treatment it has been estimated that approximately 5.7-million children would have lost at least one parent by 2014 (source). 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.

Providing treatment reduces social and political costs

Treating working-age people in the public and private sectors will allow them to work longer and reduce the cost of training new staff if HIV is left untreated. The international political damage caused by South Africa's prior AIDS treatment policy could also be reduced.

8. Nutrition

8.1 Nutrition

Good nutrition is an essential part of HIV/AIDS treatment.

When a person is infected with HIV, their immune system is compromised (see stages of HIV infection) and becomes increasingly vulnerable to opportunistic infections. These infections cause conditions such as weight loss, fever and diarrhoea — conditions that reduce a person's appetite or block the body's ability to absorb nutrients (WHO).

The body also experiences increases in metabolic demands and uses more nutrients to fight opportunistic infections.

These factors cause the body to become malnourished — making the person more susceptible to further opportunistic infections and further malnourishment. This downward spiral can accelerate the development of AIDS.

Conversely, good nutrition can improve an HIV-infected person's quality of life by:

• "improving the function of the immune system and the body’s ability to fight infection;
• extending the period from infection to the development of the AIDS disease;
• improving response to treatment; reducing time and money spent on health care;
• keeping HIV-infected people active, allowing them to take care of themselves, their family and children; and
• keeping HIV-infected people productive, able to work, grow food and contribute to the income of their families." — ( FAO and WHO)

The dietary needs of HIV-positive people are similar to those of those without HIV: "A balanced and diverse diet consisting of starchy staples (e.g., rice, maize, potato, cassava, banana, yam) with cooked legumes (e.g., beans, peas), nuts and nut butters, animal foods, fat and oil, fruits, and vegetables", according to the US Food and Nutrition Technical Assistance (FANTA) HIV/AIDS: A Guide for Nutritional Care and Support 2004.

However, an HIV-infected person needs a larger energy intake than non-infected individuals:

• to fight the HIV infection and opportunistic infections
• to compensate for nutrients which are not absorbed properly
• for extra or different metabolic demands — FANTA

The amount of extra energy needed depends on the progression of the virus. At the asymptomatic stage, an HIV-infected person should increase their energy intake by 10% over the recommended energy intake for a similar, but non-infected individual. Once showing symptoms, this should increase to 20-30%, according to FANTA.

Nutrition is also an important component of antiretroviral therapy. The Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB) places a large emphasis on nutrition and acknowledges that adequate nutrition, appropriate micronutrient supplements and the treatment of malnutrition enhances the effect of antiretroviral treatment.

9. Traditional Medicine

9.1 Overview

Traditional healers are people recognised by their communities in the use of indigenous medications (aka traditional medicine) and therapies in health care.

Traditional medicine remains strong in developing countries such as South Africa due to its affordability, availability and role in predominant belief systems. It is also growing rapidly in developing countries in the form of complementary and alternative medicine (CAM), where patients use both biomedical and traditional forms of medicine.

The WHO estimates up to 80% of people in Africa make use of traditional medicine. ( WHO Traditional Medicine Strategy 2002–2005)

According to estimates referred to by the SA National Department of Health in the Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB), there are approximately 200,000 active traditional health practitioners in South Africa and 80% of South Africans consult traditional health practitioners. (Note: estimates range from 60%-80% in other literature)

In South Africa, traditional healing practices include "acupuncture, divination, herbalism, reflexology, shiatsu, and 'spiritual healing'", according to the American Journal of Nursing. African traditional medicine is most closely liked to herbal medicine.

Sangomas and iNyangas are popular traditional healers in South Africa.

• Sangomas believe that they build relationships with ancestral spirits that can assist them in the diagnosis and cure of physical and psychological illnesses
• iNyangas are essentially herbalists, working mainly with indigenous plants to provide medical treatments and cures

Both groups of healers are often consulted by people living with HIV/AIDS when they exhibit symptoms. Because healers are skilled at treating secondary or opportunistic infections, many South Africans and healers assume that they can treat and/or cure AIDS, though there is no known long-term cure for AIDS.

9.2 Tension Between Medical Disciplines

Most friction between biomedical and traditional arms of medicine stems from the conventional science notion of "material causation". Biomedical doctors generally look at the physical causes of an illness and treat them accordingly. Traditional healers generally look at other factors including spiritual causes.

The WHO has recommended that traditional healers and practitioners of Western medicine share their knowledge and collaborate where possible.

9.3 Legislation

In 2003, the South African Parliament passed the Traditional Health Practitioners' Bill, giving formal recognition to traditional health practitioners in South Africa. The Bill also provides for a "regulatory framework to ensure the efficacy, safety and quality of traditional health care services" and gives patients recourse in instances of malpractice.

The Bill allows traditional healers to issue prescriptions for medications and give sick leave.

The Bill prevents traditional healers who are not registered with the Traditional Health Practitioners' Council from offering treatment or cures for AIDS or other terminal diseases.

9.4 Research

The WHO states that "traditional medicines need to be evaluated for safety, efficacy and quality before they can either accepted or rejected from national health policies". (WHO Traditional Medicine Strategy 2002-2005)

10. Tuberculosis and HIV/AIDS

10.1 Overview

Approximately one-third of the world's population is infected with the bacteria — Mycobacterium tuberculosis — that causes tuberculosis.

Although the bacteria is easily spread from person to person, normally through droplet nuclei expelled into the air through coughing, only a small percentage of these people (about eight million each year) will develop active tuberculosis.

This is because most healthy immune systems are able to fight the bacteria that causes the disease. In fact, most people infected with the bacteria will never get sick and will remain unaware that they have latent (or inactive) tuberculosis throughout their lifetime.

People with HIV/AIDS have weakened immune systems and are up to 800 times more likely to contract active tuberculosis because their immune systems are weakened, according to the CDC.

The WHO estimates that the rate of progression to clinical TB is 10-30 times higher among HIV-infected people with TB.

TB is the most common opportunistic infection. In South Africa, a national survey estimated 55% of TB patients were living with HIV in 2002. The WHO estimated 61% in 2003.

In South Africa, recorded tuberculosis deaths increased from 22,021 to 50,872 between 1997 and 2001 according to a Statistics South Africa study (Mortality and causes of death in South Africa, 1997–2003).

Although tuberculosis usually infects the lungs, it can also be found in other organs such as the heart, brain and lymph nodes. HIV-positive people with compromised immune systems are more likely to have extra-pulmonary or non-pulmonary TB (i.e. TB outside of the lungs).

According to the NIH, out of the two billion people worldwide who have the bacteria in their body, about eight million people contract active TB per year. About three million people die from TB every year.

10.2 Treating Tuberculosis and HIV

Active tuberculosis is usually curable within six months using a combination of antibiotics. The therapy is more successful when the person takes their medication under supervision.

People who do not take their medication properly run the risk of developing Multi-Drug Resistant TB (MDR-TB), which is far more expensive and difficult to treat. Ordinary TB treatment costs about R310 (in 2002), whereas treatment for MDR-TB can cost over R20,000 per patient to treat, according to the health ministry.

People with both HIV/AIDS and TB require special treatment to combat both the conditions as some anti-HIV drugs and TB drugs interact poorly. The SA National Antiretroviral Treatment Guidelines require a regimen change if the patient is already on ART, or a delay before the commencement of antiretroviral therapy (ART) if the patient hasn't begun treatment.

National Treatment Guidelines for people with HIV and TB
If a patient develops TB while on ART*	Regimens altered while the patient undergoes TB treatment.
If a patient develops TB before commencing ART	CD4 count >200 cells/mm3. The need for ART should be reassessed on completion of TB treatment.CD4 count <200 cells/mm3. ART should commence after two months of TB therapy. CD4 count <50 cells/mm3. Ensure patient is tolerating TB treatment before initiating ART. The patient should complete at least two weeks of TB treatment before initiating ART.
* ART = antiretroviral therapy. Source: National Antiretroviral Treatment Guidelines.

11. Key References

General

• NIAID. 2003 (updated). Fact Sheet: The Evidence That HIV Causes AIDS
• SA National Department of Health. 2003. Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB).
• Statistics South Africa . 2005. Mortality and causes of death in South Africa, 1997–2003

Opportunistic Infections

• SA National Department of Health. Recommendations for the prevention and treatment of opportunistic and HIV-related diseases in Adults.

Antiretroviral Treatment

• SA National Department of Health. 2004. National Antiretroviral Treatment Guidelines
• World Health Organisation. Dec 2004. "3 by 5" Progress Report (3.38MB)
• SA National Department of Health. 2003. Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (1.9MB)

Treatment in South Africa

• Heywood, M. 2004.The Price of Denial

Pharmaceutical companies and patent rights

• Heywood, M. 2001.Debunking ‘Conglomo-talk': A Case Study of the Amicus Curiae as an Instrument for Advocacy, Investigation and Mobilisation

Nutrition

• Food and Nutrition Technical Assistance. 2004. HIV/AIDS: A Guide for Nutritional Care and Support

Traditional Medicine

• World Health Organisation. 2002. Traditional Medicine Strategy 2002–2005
• Richter, M. 2003. Traditional Medicines and Traditional Healers in South Africa. Discussion paper prepared for the Treatment Action Campaign and AIDS Law Project

HIV and Tuberculosis

• CDC, nd. TB and HIV Coinfection