Promoting rational drug use in the community

Promoting rational drug use in the community

South Africa, 5-17 September 2004

Fieldwork exercise

HIV/AIDS and opportunistic infections in South Africa – antiretroviral and other treatment

1. Introduction

The PRDUC field study focusses on the (mis)use of antiretrovirals in South Africa. In this background sheet, we first briefly introduce the current drug use policy and regulations in the country, and give insight into existing patterns of drug provision and drug (mis)use. In the second and third sections some background information is given about the incidence, terminology, community perceptions and health-seeking behaviour in case of HIV infection and opportunistic infections.

2. Incidence of HIV, drug policies and practices

2.1 Incidence¹ and prevalence² of HIV in South Africa

The prevalence of HIV in pregnant women attending antenatal care clinics in 2002 was 26.5%. Prevalence was highest in the 25-29 year age group (34.5%), followed by 30-34 years (29.5%), 20-24 years (29.1%), 40+ years (17.2%), and < 20 years (14.8%). KwaZulu/Natal had the highest prevalence (36.5%); Western Cape the lowest (12.4%)¹. Women with violent or controlling male partners were found to be at an increased risk of HIV infection².

Based on the Metropolitan/Doyle model, the overall prevalence of HIV infection in South Africa in 2002 in the age group 15-49 years was estimated at almost 30%, the prevalence for all age groups at 16%³. Of people living with HIV/AIDS, 55% were estimated to be in Stage 1, 20% in Stage 2, 18% in Stage 3 and 7% in Stage 4⁴.

In a household survey in 2002, prevalence rates for children were as follows: 2-9 years: 6.2%, 10-14 years: 4.7%, 15-18: 5%. The overall prevalence was 5.4 %⁵

The overall incidence rate in 2002 was estimated at 2.1%, the highest incidence rate was for infants at birth (6%)Error: Reference source not found.

In a study of patients presenting with STDs to a primary care clinic in KwaZulu/Natal in 1998, the prevalence of HIV infection was 42.5%⁶. UNAIDS statistics reveal that the percentage of hospital beds occupied due to AIDS in South Africa, ranges from 26% to 70% for adults and from 26% - 30% for children⁷.

2.1 Drug regulation

Public sector

The first governmental response to the AIDS epidemic came in 1992 with the formation of the National AIDS Convention of South Africa (NACOSA)⁸. The government’s National Drug Policy, published in 1996, mentions AIDS in one context: It envisages to encourage cooperation with traditional healers in the management of HIV/AIDS⁹. Public sector Standard Treatment Guidelines and Essential Drugs Lists introduced in 1996¹⁰ (PHC) and 1998 (Hospital level)¹¹ gave some indication of how to treat opportunistic infections and accidental exposure to the HI virus, but no antiretrovirals were provided in government facilities. Massive campaigning and legal action by activist groups brought about the roll-out of a public-sector programme for the prevention of mother-to-child transmission with nevirapine, starting at 18 pilot sites in 2002¹². An antiretroviral treatment plan was published in December 2003¹³, and treatment started in April 2004. In April 2004, 32 sites were accredited. The plan aims to provide ART to all South Africans needing it within five years (0.4 m by 2006, 1.4 m by 2009).

Private sector

More than 60% of health care resources in South Africa are consumed by the private health sector, which serves between 17%-18% of all South Africans. In the private sector, patients can access antiretroviral treatment either by out-of-pocket purchase, through health insurance or through an employer-sponsored programme (e.g. Anglo American, Daimler-Chrysler, Coca-Cola). Health funders use disease management programmes (DMPs) to manage benefits of HIV-infected patients. In 2002, 18 000 medical scheme members were registered with a DMP, representing less than 1% of all beneficiaries. This percentage is low relative to the estimate that about 5% of all medical scheme members were HIV-positive. The largest DMPs include Aid for AIDS and Discovery Health. The use of ARVs is accompanied by other services such as counselling, treatment of side effects, drug monitoring, diagnostic measures and support groups¹⁴.

HIV-related treatment contained in the Prescribed Minimum Benefits includes the following interventions¹⁵.

Medical and surgical management of opportunistic infections and localised malignancies

• 
  HIV voluntary counselling and testing
  
• 
  Co-trimoxazole as preventive therapy
  
• 
  Screening and preventive therapy for TB
  
• 
  Diagnosis and treatment of sexually transmitted infections
  
• 
  Pain management in palliative care
  
• 
  Prevention of mother-to-child transmission of HIV
  
• 
  Post-exposure prophylaxis following sexual assault
  

Other initiatives

In 2003, about 1500-2000 patients without access to medical aid were treated with HAART concurrently through approximately 25 different projects, mostly in the Western Cape, KwaZulu-Natal and Gauteng.¹⁶. Médecins sans Frontières (MSF) have provided antiretroviral treatment to patients in Khayelitsha since 2001; in September 2003 there were approximately 550 patients on treatment. The South African Catholic Bishop's Conference (SACBC), an NGO, provides antiretroviral treatment to just under 300 patients¹⁷. Other projects typically treat about 100-200 patients or less concurrently. Chris Hani Baragwanath Hospital has a perinatal HIV Clinic in operation since 1991, its research unit is a site for international HIV trials, and an adult HIV clinic. The University of KwaZulu-Natal has become the first tertiary institution in the country to provide antiretrovirals to HIV-positive students.¹⁸ Some of these projects ask patients to pay an affordable fee, while others provide treatment for free.

Availability of antiretrovirals

Twenty antiretroviral products (in varying dosage forms and strengths) are currently available in SA. The first generic antiretroviral to become available was Aspen stavudine in August 2003. Four generic products were listed in MIMS (April 2004), two containing stavudine, one lamivudine and one a combination of lamivudine and zidovudine.

2.3 ARV supply, use and resistance

In the public sector, antiretrovirals for the government programme will be procured by tender. The national tender process is expected to be finalised in August. Meanwhile, the roll-out is implemented by the Provinces. MSF projects have sourced generic medicines with the permission of the Medicines Control Council¹⁹. The Generic Anti-retroviral Procurement Project (GARPP), launched in August 2003, supplied 19 projects initially with generic antiretrovirals and anticipates extending its operations to 30 projects with a total of 4000 patients in 2004.

Current first line treatment is a twice-daily triple antiretroviral regimen including two NRTIs and either nevirapine or efavirenz. One study reported that in 23 of 288 patients the regimen was changed due to side effects²⁰. At least 95% adherence to antiretroviral therapy is required for antiretroviral therapy to be effective. Encouraging adherence rates have been reported from MSF sites²¹. Experience in the private sector showed that females were more adherent than males; adherence was lowest in adolescents, and highest in adults older than 30 years. Three year survival was strongly associated with the level of adherence²².

As failure to suppress virus replication has been shown to result in the development of resistance even at high levels of adherence, resistance to antiretrovirals remains a concern²³.

Knowledge of health care professionals about treatment of HIV is generally poor^{24, 25}. A national training plan is in preparation.

Public sector guidelines include an operational plan (2003)²⁶ and national antiretroviral treatment guidelines (2004)²⁷. Apart from antiretroviral treatment, nutritional support is also provided. To qualify for ART, a patient must have a CD4 count of 200 or below and/or have a WHO stage IV AIDS-defining illness and be committed to following the regimen strictly. Decision of enrolment is made by a multidisciplinary team.

Private sector guidelines are provided by disease management programmes and by the Treatment Action Campaign together with the Southern African HIV Clinicians Society. Various other training initiatives and courses are available.

3 HIV treatment in SA:

3.1 Community perceptions and responses

People do not generally refer to AIDS by name. They use euphemisms such as “amagama amathatu” (Zulu for “the three-letter word”)²⁸. Fear, stigma and discrimination continue to affect the readiness to be tested voluntarily for HIV/AIDS (30% among university students²⁹, 53% among township dwellers³⁰) and disclosure of HIV status³¹

Varying constructions of AIDS exist^32,33. Elders saw AIDS as traditional and curable, younger men and women as a modern, foreign disease. Witchcraft beliefs are popular in explaining why certain people die and not others. People who held traditional beliefs about the cause of AIDS, such as the belief that AIDS is caused by spirits, were more likely to stigmatise people living with HIV/AIDS. Health workers were also identified as a source of stigma; 50% of the health workers surveyed admitted that AIDS patients were sometimes denied services and certain rights. Concerns over confidentiality were a barrier to accessing free HIV/AIDS medical care for staff in a hospital in KZN.³⁴

Antiretroviral treatment is available from the private sector, at a number of public sector sites, and through other initiatives as outlined above. In 2001, only about 20,000 of South Africa's 5 million PLWHAs had access to antiretroviral medicines³⁵. This number represents less than 6% of the estimated 350 000 people living with Stage 4 HIV/AIDS (7% of 5 million). The government’s operational plan aims to provide antiretroviral treatment to 53 000 patients by the end of 2004Error: Reference source not found.

Traditional medicine is an important source of care in South Africa. There are about 200 000 traditional healers, and 80% of South Africans have consulted a traditional healer or taken traditional medicine³⁶. Efforts to train and integrate traditional healers into the health care system have had some success, but on the whole, traditional healers are still not playing the role they could in opinion-leading, providing information and support, and some individuals exploit patients’ anxiety by selling fake cures ^37,38.

Much research is still needed in South Africa to investigate long-term patterns and problems of antiretroviral use, specifically aimed at ensuring at least 95% adherence.

3.2 Measures used to reduce stigma and promote adherence

The stigma associated with HIV and discrimination against people with HIV is still very prevalent in South Africa. Project Ulwazi (Xhosa for ‘Knowledge’), sponsored by MSF, developed by the Treatment Action Campaign (TAC) and initiated in 2001, involves patients from the HIV/AIDS services and the PMTCT programme, in education and awareness campaigns in communities. Ulwazi is a treatment literacy project, which also aims to educate and promote awareness to endorse positive attitudes towards people living with HIV/AIDS. In 2002, Ulwazi set up a mobile exhibition called Yazinzulu-i-HIV (Xhosa for ‘Know more about HIV’), which was displayed in community halls and libraries in Khayelitsha and other townships in the country. Local schools, churches, leaders and NGOs were invited to participate in workshops, video sessions and discussions on human rights, prevention and treatment. In 2003, MSF and TAC designed a ‘Treatment Bus’ similar to the mobile community libraries accepted by communities.³⁹

Another example of education to improve adherence is the work of the Ithemba project in KwaZulu/Natal. The project is funded by the US, Britain and South Africa, and hopes to become an official rollout site of the South African government's programme. In a step-wise approach, clinical assessment of patients is followed by a three-day training education course over a period of three weeks. Only in the fifth week is the patient given ARVs. By then, s/he is expected to have enough background knowledge to be a responsible pill-taker. The Ithemba programme also insists that patients disclose their HIV status. Medication will then not have to be taken in secret, and patients’ emotional stress level are also much lower. Although some patients were initially offended by the programme's disclosure stipulation, almost all the project's ARV patients have had positive disclosure experiences. Ithemba's ARV treatment plan is supported by regular visits by health workers to monitor drug-intake and identify psychosociological challenges to adherence. The main obstacles identified by home-based carers were hunger, violence and poverty. To ensure that these concerns do not hamper adherence, carers help patients to access social grants. Ithemba has achieved a 95 percent success rate of patient compliance with its drug-taking rules since the ARV programme started. ⁴⁰

References

1 Incidence: The number of new cases of a disease in the population over a given time period.

2 Prevalence: The total number of cases of a given disease in a specified population at a designated time.

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