VIRUSMYTH HOMEPAGE

PRESIDENTIAL AIDS ADVISORY PANEL REPORT

RECOMMENDATIONS
Chapter 8

8.1 Introduction

The purpose of this chapter is merely to group together all the recommendations made in the different chapters of this report.

8.2 Recommendations on surveillance – what should be done about the South African epidemic?

8.2.1 Deliberations of the panel

The deliberations of the panel were at all times bedevilled by the absence of accurate and reliable data and statistics on the magnitude of the AIDS problem or even HIV prevalence in South Africa. Repeated requests for such data and statistics, particularly by panellists who refuted the causal link between HIV and AIDS, failed to result in the provision of such data by either South African panellists or the officials of the Department of Health.

Recommendation

It is therefore strongly recommended that appropriate measures be taken to establish the necessary infrastructure and provide the necessary expertise and resources to collect the data and develop reliable and up-to-date statistics on the magnitude of the AIDS problem and the prevalence of HIV in South Africa. All efforts must be made to ensure AIDS reporting in South Africa is up to the highest standards in the world.

8.2.2 Discussions on mortality data

The discussions around the mortality data presented by Dr Makgoba revealed the necessity for a study to unpack the numbers and gain deeper understanding as to whether the changing mortality profile resulted from AIDS only and/or from factors other than AIDS.

Recommendation

It is recommended that a trans-disciplinary team comprising members from all the relevant branches of science, including social sciences and humanities, other relevant professional spheres and representatives of relevant government departments be constituted to undertake an in-depth study of the mortality trends in South Africa and report on the results of the study to the South African government.

8.2.3 Recommendations from panellists who do not subscribe to the causal linkage between HIV and AIDS

It was recommended that the South African government commit to the following:

1. Suspend the dissemination of the psychologically destructive and false message that HIV infection is invariably fatal and assist in reducing the 'hysteria' around HIV and AIDS.
2. Suspend all HIV testing until its relevance is proved especially in the African context, given the evidence of false positive results in a tropical setting and the fact that most assumptions and predictions about AIDS in Africa are based on HIV tests.
3. Continue to improve social conditions in South Africa.
4. Continue to decrease poverty.
5. Continue to control infections and sexually transmitted diseases.
6. Continue to increase the nutritional status of the population.

8.2.4 Recommendations from panellists who subscribe to HIV as the cause of AIDS

Dr Gayle and Prof Abdool-Karim, representing panellists who endorse the causal link between HIV and AIDS, reinforced the importance of the following initiatives for the South African government:

1. Continue strengthening the surveillance of risk factors such as the behaviour of youth.
2. Surveillance of HIV prevalence in antenatal clinics, blood banks and among workers.
3. Conducting incidence surveys.
4. AIDS surveillance at health facilities.
5. Keeping death registers.
6. Standardisation and evaluation of diagnostic criteria and their completeness for reporting purposes.
7. Surveillance of antenatal syphilis.
8. Laboratory reporting
9. Health facility reporting.

8.2.4.1 Recommendations on surveillance as it pertains to reduction of blood-borne infection

The South African government needed guidance on the following issues:

1. The most appropriate policies on screening and quality assurance for blood safety.
2. The most appropriate policy to reduce or prevent needle-stick injury with specific reference to policies on single use needles.
3. Policies on the management of occupational HIV exposure, including post-exposure prophylaxis. Research on post-exposure prophylaxis needs to be pursued vigorously.
4. Policies on education and implementation of universal precautions.
5. Most appropriate education and training related to reduction of risk of HIV and transmission in nosocomial settings and related to surgical operations.
6. Policies on intravenous drug use.

8.2.4.2 Recommendations on surveillance as it pertains to reduction of HIV from Mother to Child

The South African government needed to pay attention to the following issues:

1. The most appropriate policy on voluntary HIV testing and counselling of pregnant women.
2. The best policy for contraception promotion, including targeting HIV-positive women.
3. The best policy on the use of anti-retroviral drugs to treat pregnant women. There were several research issues that were listed in this regard, including:
• Investigating the extent of Nevaripine resistance when used to prevent transmission of HIV from mother to child.
• The role of early weaning and non-exclusive breastfeeding.
• What other mechanisms can be devised to reduce transmission of HIV from mother to child.

8.2.4.3 Recommendations on surveillance as it pertains to sexual transmission of HIV

The following issues require attention:

1. The most appropriate policy on safe sex education
2. How best to promote the use of condoms
3. The best policy on the most appropriate and comprehensive treatment of sexually transmitted diseases
4. The most appropriate policy on post-exposure prophylaxis for rape
5. Regulation of commercial sex work and gender equity issues
6. Research into finding an efficacious and effective microbicide and into the development of a vaccine for therapy and prevention needs to be continued vigorously

8.2.5 General recommendation

There was general consensus on the need for the case definition of AIDS to be standardised for clinical practice in South Africa.

8.3 Recommendations on HIV Testing

8.3.1 Proposed studies and experiments

The key issue that came under focus was the reliability of the ELISA testing in terms of delivering time infection data. As a diagnosis of HIV infection has such a profound effect on a person’s life and future, it was considered of utmost importance that the tests are unimpeachably reliable. Since all epidemiological predictions concerning HIV/AIDS in South Africa are based on the results of such tests, their absolute reliability was declared to be of utmost importance.

A major recommendation arising from the two meetings was to apply a series of HIV tests of increasing stringency in order to establish the validity, veracity, rigour, reliability and concordance of ELISA, PCR and viral isolation. Details on some of these experiments are presented in Chapter 9 of this report.

The experiment will consist of the following series of steps:

1. ELISAs as they are currently employed.
2. The same tests using a pre-absorption protocol to remove cross-reacting antibodies such as those against mycobacteria that some panellists asserted frequently confound ELISA tests.
3. A variety of nucleic acid based protocols.
4. The application of the classical gold standard of virus isolation, including electron microscopy.

These tests will be performed on cohorts chosen to represent the full spectrum of the South African population.

8.3.2 Recommendation on future HIV testing

The panellists who refuted the causal linkage between HIV and AIDS recommended the suspension of all HIV testing until its relevance is proved, especially in the African context, given the evidence of false results in a tropical setting and the fact that most assumptions and predictions on AIDS in Africa are based on HIV testing.

8.3.3 General recommendations on testing

1. The case definition of AIDS to be standardised for clinical practice in South Africa.
2. Any positive HIV ELISA result to be repeated with at least two additional blood samples before an HIV diagnosis is confirmed in order to improve the reliability and validity of ELISA.
3. Apply a series of HIV tests of increasing stringency in order to establish the validity, veracity, rigour, reliability and concordance of ELISA, PCR and viral isolation.

8.4 Recommendations on treatment of AIDS with anti-retroviral drug

8.4.1 Recommendations on the use of anti-retroviral drugs for the treatment of AIDS from the panellists opposed the causal link between HIV and AIDS

The recommendations on the treatment of AIDS from panellists who refute that HIV has a causal link to AIDS were informed by their observation that the definition of AIDS in western countries was different from that used in Africa. These definitions have changed over time to the point where a person diagnosed with AIDS in Africa would not be considered an AIDS patient in the USA, Europe and Australia. There was also the critical question of whether Africans clinically diagnosed with AIDS were in fact HIV-positive. These considerations led to the following assertions:

• AIDS is not contagious, although many of the opportunistic infections are.
• AIDS is not sexually transmitted.
• AIDS is not caused by HIV.
• The admittedly toxic anti-HIV drugs are killing people.
• The drug-induced toxic effects cause AIDS-defining conditions that cannot be distinguished from AIDS.

These considerations led to the following recommendations on the treatment of AIDS:

1. The South African government should devote the bulk of national and international biomedical and other resources to the eradication of prominent AIDS-defining diseases such as malaria, TB and enteric infections and also to the improvement of nutrition and the provision of improved sanitation and clean water.
2. Anti-retroviral drugs and any other immune-suppressive drugs should under no circumstances be used to treat AIDS patients or any other patients that are immune-compromised. These drugs inevitably require significant amounts of compensatory medication and are claimed to produce, at best, only short-term benefits in seriously sick patients.

8.4.2 Recommendations on the treatment of AIDS from the proponents of anti-retroviral drug use

Given the demonstrated benefits of anti-retroviral drugs in the treatment of HIV/AIDS, the usage of that accumulated knowledge to the benefit of South Africans living with HIV infection was critical. However, the fact that there is relatively little relevance of the recommendations on the use of anti-retroviral drugs in the USA and Europe for a developing country like South Africa, there is a need for more locally derived evidence based on strategies derived from locally relevant research. This research will enable the identification of manifestations of HIV infection and of cofactors as well as the definition of local standards for the diagnosis of the conditions, the description of the local epidemiology. There is also a need for South Africa to collaborate with other countries and international organisations that are addressing the issue of how anti-retroviral drugs use is or should be different in a South African type setting. The development of these strategies would need to address the following specific issues:

1. By whom should these drugs be used. Secondary to this question are the following issues:

• How should these drugs be used.
• At what stage of infection should the drugs be used.
• How should the use of these drugs be affected by the different recipient populations such as adults, children, pregnant women, etc.
• How might the use of these drugs be influenced by the ongoing transmission that is likely in different populations.
• Issues related to use in post-exposure prophylaxis, whether in healthcare settings or after rape.

2. The choice of the anti-retroviral drug or drugs that might be used, their dosage and the scheduling of doses, as well as their cost and effectiveness

3. How might the effectiveness of the chosen drugs be affected by the concomitant use of traditional medicines

The issues listed above generated a number of considerations that informed the recommendations that were made on treatment. These considerations are as follows:

• Protocols need to be developed according to what is affordable and sustainable.
• Protocols will also be decided by the resistance profile in the community. This may necessitate expensive tests for resistance, which may not be cost-effective.
• Under the most ideal circumstances, a combination of drugs is best. This combination should comprise two protease inhibitors and a reverse transcriptase.
• Decisions on when to start anti-retroviral treatment may be difficult and must be based on the onset of symptoms. There is a move away from the early introduction of anti-retroviral medication.
• Starting treatment too early increases costs and may also undermine compliance. The development of resistance limits the number of combinations that may be effective.
• There is the possibility that patients may present late when they have opportunistic infections. The recommendation in this regard is to deal effectively with the opportunistic infections before instituting therapy with anti-retroviral drugs.
• Prior to commencing treatment, it is important to undertake a baseline assessment of CD4 and viral load.
• Finally, there seems to be a need to have guidelines on the use of anti-retroviral drugs, which must be updated regularly as new developments emerge.

These considerations led to the following recommendations:

1. A constantly evolving set of guidelines needs to be developed for the treatment, care and support of patients with HIV and AIDS. These guidelines need to address patients at all levels of care, including those in institutions and under community-based care, and include the following:

• Diagnosis, initial evaluation and long-term management.
• Prophylaxis and management of opportunistic infections.
• Psychological support and end-of-life care.
• Anti-retroviral therapy

2. Infrastructure needs to be developed for the purpose of:

• Provision of medication, monitoring of usage of anti-retroviral drugs and of clinical outcomes, including drug toxicity.
• Education and training of healthcare workers.
• Counselling and support of patients.
• Establishment of a panel for the development of guidelines and continuing review of new data, clinical outcomes and uses of medication. This panel should include local experts, health officials and persons with HIV and AIDS.

3. Ongoing programmes for the control of sexually transmitted diseases and tuberculosis should be linked to initiatives outlined above.

4. There remains a series of unanswered questions of relevance to the treatment of HIV and AIDS in South Africa which must be addressed through direct clinical research.

5. The Strategic Plan (2000–2005) developed by the South African government to combat HIV, AIDS and Sexually Transmitted Diseases was considered a good start to addressing some of the recommendations made here.

8.5 Recommendations on prevention of AIDS

8.5.1 Recommendations on prevention of AIDS from the point of view of panellists who do not support the causal link between HIV and AIDS

The recommendations listed below were proposed as necessary and sufficient to combat all the risk factors that are the real cause of AIDS:

1. Improving sanitation and public health measures to decrease water-borne diseases.
2. Strengthening health infrastructure.
3. Reduction of poverty and improving general nutrition and implementing nutritional education and supplements for the general population.
4. Improving screening for and treatment of sexually transmitted diseases.
5. Promoting sex education based on the premise that many sexually transmitted diseases and pregnancies could be avoided.
6. Implementing public education campaigns to destigmatise AIDS and reduce public hysteria surrounding the disease.
7. Investigating the use of immune-boosting medications, such as interferons, growth factors, B-complex vitamins and herbs (such as ginseng, Chinese cucumber, curcumin, aloe vera, garlic and echinacea).
8. Encouraging the detoxification of the body through several inexpensive interventions, such as massage therapy, music therapy, yoga, spiritual care, homeopathy, Indian ayurvedic medicine, light therapy and many other methods.
9. Treating infections vigorously and timeously.
10. Increased support for and promotion of research into the development of drugs against AIDS, its cofactors and risk factors.
11. Encouraging the involvement of complementary medical and health practitioners, including indigenous healers, in research and clinical fields.
12. Implementing aggressive programmes to empower women and change the power relations between men and women.
13. Reducing the vulnerability of communities by improving access to health care.
14. Improving literacy.

8.5.2 Recommendations on prevention of AIDS from the point of view of panellists who support the causal link of HIV to AIDS

Panellists who support the causal link of HIV to AIDS proposed that preventive strategies be linked more specifically to the different modes of transmission of HIV/AIDS. These panellists did, however, also support some of the more general medical and public health interventions listed in section 6.1.1 above as critical to ensuring a healthy society.

Three specific modes of transmission of HIV/AIDS were identified in Chapter 2 of this report as follows;

• Sexual transmission.
• Blood-borne/occupational transmission
• Mother-to-child transmission during pregnancy, at the time of delivery and during breastfeeding.

8.5.2.1 General recommendations

1. Other strategies need to be put in place to address the social environment, promote safer sexual practices and provide a supportive environment for people who are infected.
2. Establish and support programmes that minimise the spread of disease through the migrant labour system.

8.5.2.2 Recommendations on prevention of HIV/AIDS through sexual transmission

1. A stronger emphasis should be placed on sex education.
2. Improving public awareness and the use of safer sex practices, including condoms use, in order to interrupt the transmission of sexually transmitted diseases.
3. Improving blood screening for sexually transmitted diseases and other infectious diseases.
4. Improving screening for and treatment of sexually transmitted diseases.
5. Campaigns should be mounted to encourage the youth to delay their sexual debut.
6. Sexually transmitted infections should be treated comprehensively.
7. Regulation of commercial sex work.
8. Strategies should be devised and implemented to address gender inequality.
9. Reduction in the number of sexual partners.
10. There was a need to continue research on finding appropriate microbicides for prevention of sexual transmission.

Dr Fiala suggested that although he did not support the view of the sexual transmission of HIV, the above recommendations did make sense as long as the focus was on a broader approach to healthy sexual habits which encompass prevention of unwanted pregnancy, rather than a single focus on HIV.

8.5.2.3 Recommendations on prevention of blood-borne transmission of HIV/AIDS

1. Improving screening methods for infectious agents in blood.
2. Education campaigns for the community in order to identify potentially safe donors.
3. Training of medical practitioners on the rational use of blood and blood products.
4. Strict adherence to universal precautions by healthcare providers at all times.

8.5.2.4 Recommendations on prevention of mother-to-child transmission of HIV

Panellists who believe that infants can be infected during pregnancy and delivery and through breast-feeding provided several recommendations on preventing these forms of transmission from mother to infant.

I. General

• Supportive and effective reproductive health services must be provided to all women.

II. Education

1. Healthcare providers must inform women about the risks of being infected with HIV. They must educate women that infection occurs through sexual exposure, and that abstinence, mutual monogamy and consistent condom use are the only preventive methods known. (This, according to Dr Fiala, was futile, as 2000 years of such messages from the Catholic Church do not seem to have had much success.)
2. Healthcare providers must be trained in proper counselling skills so that they effectively counsel clients.
3. Women must be educated about dual protection, namely use of a condom and, in the event of failure, recourse to emergency contraception.
4. All women of child bearing age, and pregnant women in particular, must have access to voluntary counselling and HIV testing. Rapid tests must be used in this context so that women can make decisions about their health and access the care they need during their pregnancy. As far as possible, couple counselling must be encouraged in order to expand access to care to the family and to ensure psychological and emotional support for the woman.

III. Breastfeeding

1. Where feasible, HIV-positive mothers should not breastfeed their babies.
2. When breast milk is the only option for infant feeding, women should be encouraged to breastfeed exclusively and to wean the baby off early.

Dr Stein cautioned that the recommendations on breastfeeding had to be handled in such a way that the long- established benefits of breastfeeding for other women are not undermined.

IV. The use of anti-retroviral drugs

Evidence of the efficacy of anti-retroviral drugs is obtained from randomised-controlled trials as well as systemic reviews.

a) Zidovudine (AZT) - Efficacy and toxicity

The efficacy of AZT in preventing vertical transmission of HIV has been sufficiently demonstrated in several randomised-controlled trials. The reduction in the risk of transmission varies from 37% to 67% in the different studies.

No serious side effects in pregnancy were detected in the above studies and in the infants born to these mothers followed up to the age of four years. There is enough evidence to show that the benefits outweigh the risks, and it is recommended that this drug be provided to women in pregnancy where resources are available to do so.

b) Nevirapine – Efficacy and toxicity

The HIVNET 012 trial, a randomised-controlled trial comparing Nevirapine and AZT, was conducted in Uganda. Nevirapine use resulted in a decrease in vertical transmission of 48% (95% CI 17 to 60%). The regime is easy and cheap to administer.

Concerns have been raised over the development of resistance in women who have been exposed to a single dose of Nevirapine. Further research on the implications of this resistance is necessary.

There are concerns regarding the impact of breastfeeding on the transmission of HIV. Follow-up studies on mother–infant pairs where anti-retroviral drugs have been used show a reversal of efficacy when breastfeeding continues beyond six months. More research in this area is warranted. In the interim, the best feeding advice would be formula feeding for those who can afford it and exclusive breastfeeding with early weaning when women cannot afford to purchase formula.

c) Combination anti-retroviral use for MTCT prevention

Good evidence has been presented from the PETRA trial. This randomised trial assessed the combination of AZT and Lamivudine (3TC). This regimen resulted in a 48% risk reduction of HIV transmission.

V. Caesarean section in preventing HIV-1 vertical transmission

The role of caesarean section has been tested in a recent randomised controlled trail (RCT). This demonstrated an 87% reduction in vertical transmission in the group randomised to caesarean section. In a further analysis of this subgroup, which focused on women who had had prior exposure to AZT, the effect of caesarean section became less dramatic.

This intervention however, cannot be recommended as policy in South Africa for several reasons:

• There are staff constraints in terms of obstetrics anaesthesia, availability of blood products and antibiotics.
• The incidence of infectious morbidity may be higher in our population due to a higher rate of genital tract infections.
• In the absence of anti-retroviral drugs, 29 caesarean sections would have to be done to prevent one case of HIV-1 vertical transmission.

VI. Vaginal lavage during labour

The evidence from an RCT indicates that vaginal lavage is only of value if the labour is longer than four hours in duration. Reasonable guidelines would include not rupturing membranes in active labour unless there is an obstetric or foetal indication. Invasive monitoring techniques are not recommended. Routine performance of an episiotomy is also contraindicated.

8.6 Recommendations on socio-economic factors that impact on AIDS

As Dr Sonnabend put it: "It is not simply the cost of drugs. We need a whole lot more. We need the capacity to provide for people and to be able to monitor." Dr Coll-Seck strongly recommended an efficient system for monitoring and evaluating the following recommendations to ensure that they would be helpful, not only to South Africa but also to the countries and continents in the developing world:

1. Improving the social environment.
2. Reviewing laws (both customary and written) and their implementation to protect the safety of people living with HIV and AIDS and their families.
3. Initiating strategies to negotiate for reductions in the price of drugs, local production and generics.
4. Improving public awareness and use of safer sex practices in order to stop the transmission of HIV and sexually transmitted diseases.
5. Improving sanitation and public health measures.

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