nevirapine

There are no good reasons for delaying the gradual and phased expansion of prevention of mother-to-child transmission (PMTCT) services in all provinces, a research report commissioned by the health department has revealed. But the report also highlights that given the difference in capacity and infrastructure, it is reasonable for provinces to expand the provision of PMTCT services at different speeds What is important is that the expansion is done in a structured and properly planned manner, taking into account the many lessons that have been learned, the report states. The report, which is to be released this week, was written by the non-governmental organisation Health Systems Trust, and looks in great detail at the 18 pilot sites in the nine provinces. Currently, 21 hospitals (4 tertiary, 8 regional and 9 district), 12 day hospitals, maternity units, poly-clinics and community health centers and about 160 clinics are part of the national PMTCT programme. They cover about 6 090 ante-natal bookings per month. With additional political and senior management commitment at both the national and provincial level, it should be possible for all provinces to begin implementing PMTCT services in new sites by the mid-year, according to the researchers. They also point out that a phased and systematic expansion of comprehensive PMTCT services should be combined with the immediate provision of nevirapine to pregnant women already known to be HIV positive. The report praises the National Directorate of HIV/AIDS and their provincial counterparts who have worked hard and tirelessly to initiate the national PMTCT programme. Nonetheless, many constraints and difficulties have been experienced. These include -The fact that the health care system is still undergoing significant transformation, re-organisation and structural change; -The challenge of having to work with and through nine separate and different provincial departments of health; -Insufficient co-ordination and communication between different units and divisions of the public health care system; -A bureaucratic environment that hinders rapid implementation of new programmes; -Understaffing and poor infrastructrure of the health care system in many parts of the country; -Low morale and poor motivation among many front-line health care providers; -The continued denial and stigma about HIV/AIDS in the public as a whole. Sites that are struggling are generally operating within a poorly functioning health care system. Expanding and sustaining an effective PMTCT programme across the country will require the infrastructure of the health care system in the under-resourced parts of the country to be improved, the researchers find. There were several keys lessons and recommendations discussed in the lengthy report. Some of the human resources issues identified include inadequate staff to sustain the programme, no lay counsellors and a lack of participation from doctors, midwives and other specialist staff. Where senior managers have taken an active interest in the PMTCT programme, faster and more effective implementation has often followed. Inadequate physical space and privacy has hampered the ability to provide adequate counselling and HIV testing services in many facilities, the report revealed. The report also highlights the neglect of the serious issue of infant feeding and providing free formula milk. Although the long-term aim is to make it possible for all HIV positive women to provide safe and affordable exclusive formula feeding, under the current circumstances, the policy may lead to higher rates of mortality and morbidity due to other diseases, as well as higher rates of mixed feeding, the researchers warn. The report calls for a national commission of experts to be set up to review the current policy and guidelines on infant feeding and MTCT. An option that must receive serious and urgent attention is the post-natal administration of short-course anti-retroviral treatment to mothers and/or babies as a strategy to make breastfeeding safe, it adds. The researchers also noted that no significant side-effects had been recognised in either mothers or babies taking single-dose nevirapine as part of the PMTCT regimen. The report concludes by saying that the18 learning sites must continue with in-depth research and on-going evaluation for the next 18 months so that more lessons can be learnt.

The Government's AIDS policy appeared to be in tatters yesterday as Gauteng's African National Congress (ANC) premier, Mbhazima Shilowa, announced far-reaching plans to deal with the epidemic, and party bosses grappled with the issue until late last night. Former president Nelson Mandela attended a meeting of the ANC's national working committee yesterday afternoon, intending to raise his concern about government's AIDS policy, which has drawn international criticism. After the meeting, ANC spokesman Smuts Ngonyama acknowledged that AIDS had been discussed, but said Mandela agreed that government and the ANC were on the correct path. Shortly before the meeting, at the opening of the Gauteng legislature's session, Shilowa said that the antiretroviral drug Nevirapine would be supplied to HIV-positive pregnant women in all public hospitals. He committed R30m to the programme. Rape victims would also receive antiretrovirals at provincial facilities, he said. Gauteng's move seen as a shift in political commitment and policy within the ANC's ranks drew praise from AIDS activists and opposition parties. Shilowa's announcement makes Gauteng the third province to decide to provide the drugs, after Western Cape and KwaZulu-Natal, and the only one ruled outright by the ANC to do so. Gauteng had been supplying the drug at several sites assisted by the team at Chris Hani Baragwanath hospital, which supplies the drug to HIV-positive pregnant women throughout Soweto. Shilowa said that the plan was to ensure pregnant women throughout Gauteng accessed the full package of care within a reasonable distance from their homes. After consulting experts locally and internationally, Mandela stepped into the AIDS fray recently, believing government policy needed to be addressed. He told the Sunday Times at the weekend that he would meet the ANC yesterday, a meeting that lasted the afternoon. A second meeting, without him, was scheduled to take place later. According to Ngonyama, the meeting at Luthuli House did not specifically discuss Mandela's statements reported at the weekend. He said the issue was discussed more broadly. Mandela left before the meeting was over. (Source: Business Day, 19 February 2002)

Tacit agreement for the wider use of Nevirapine by SA's nine provinces appears to have been reached at a top-level meeting of provincial MECs for health and the national health minister. After the two-day meeting at the end of last week, insiders believe the door is now open to those provinces wishing to roll out further sites to provide the anti-AIDS drug to do so. Both the science and activist communities have expressed disappointment at the lack of clear policy directing health departments in all provinces to provide the drug Nevirapine to HIV-positive pregnant women wanting it. They have noted with alarm that there is nothing to compel those provinces that do not want to expand the provision of the drugs to do so. Health department insiders close to the meeting say there was little resistance from MECs wanting to provide an expanded programme and only two provisos were outlined. These were: programmes should be implemented taking cognisance of lessons learned from research sites and that sufficient resources to sustain a programme should be available when deciding to start dispensing the drug. A statement released at the end of the two-day meeting gave details of the number of women receiving counselling, testing and treatment and raised some of the known problems, like the adequacy of counselling. It did not specify whether or not the programmes should be expanded, but mentioned instead that a balance needed to be struck between the expansion in some areas, or rectifying problems where they occur. The largest problem encountered, according to the health department sources was in the area of counselling. (Source: Business Day, 4 February 2002)

Health Minister Dr Manto Tshabalala-Msimang and provincial health MECs will meet in Johannesburg this week to review government's programme against mother-to-child-transmission (MTCT) of HIV, at a time when two provinces and several state doctors have defied national policy. The meeting comes a week after the KwaZulu-Natal government announced it would provide the anti-retroviral drug Nevirapine to HIV-positive pregnant women in the province's state hospitals. The Western Cape government implemented a similar programme last year, which it has since extended. Recent news reports have also focused on how doctors and healthcare workers are defying the government's ban on the use of anti-retroviral drugs - such as Nevirapine - at state hospitals, resulting in some being censured and disciplined for doing so. The meeting in Johannesburg on January 31 and February 1, is a follow-up to December's Minmec (a national and provincial government health forum) meeting. That meeting followed a groundbreaking high court ruling which ordered the government to make Nevirapine available to HIV-positive pregnant women. The government decided to appeal the ruling. Health spokeswoman Jo-Ann Collinge said on Sunday it had been decided at the last Minmec meeting to conduct a further appraisal of the MTCT programme taking into account the latest date from current MTCT sites. According to a health ministry statement released after the December meeting, the January appraisal would be followed by a broader stakeholder consultation on the MTCT Programme to share the lessons of the pilot sites and to chart plans for the future of this programme on the basis of broad consensus. The consultation will be conducted in an inclusive and open manner. And we hope that this will reassure the public that we are committed to a successful, accessible MTCT programme, it said then. (Source: SAPA, 27 January 2002)

The Western Cape government is to receive free supplies of the antiretroviral drug Nevirapine, which is used to prevent HIV-positive women from infecting their unborn babies, from German pharmaceutical company Boehringer Ingelheim for the next five years. The application was made and approved yesterday and will result in a R750 000 saving for the provincial government. In the past, it bought the drug from the company. Premier Peter Marais' announcement follows a similar one by KwaZulu-Natal premier Lionel Mtshali earlier this week. In addition to the deal announced by Marais yesterday, the Western Cape has negotiated a 70% discount on AZT from GlaxoSmithKline for its pilot project in Khayelitsha. This programme, which started in January 1999 and has treated 3200 people, will be extended to other regions soon. Marais said the free Nevirapine would become available immediately at 38 maternity centres where the programme has been implemented, and at all other maternity service centres as the programme was rolled out. Marais has declared war on HIV/AIDS in the province and has committed his government to reducing the infection rate among pregnant women from its current 8,5% to 5% by 2004. Western Cape deputy health director-general Fareed Abdullah said the Western Cape programme, which started in January last year, was the largest in Africa in terms of the number of patients treated and facilities involved. By June, 95% of transmission cases would be treated and by March next year there would be 100% coverage. Abdullah said the cost of the drug (R25 per birth), was less than 5% of the total cost of the anti-transmission programme, the most expensive item being formula for the baby for six months (about R500 a child). Other costs were for counselling and testing, antenatal care and delivery and follow-up care. (Source: Business Day, 25 January 2002)

The Treatment Action Campaign (TAC) is to petition the Pretoria High Court to enforce its order that Nevirapine be made available immediately to HIV-positive mothers in public health facilities, regardless of the State's intention to appeal against the ruling. Usually a court order is suspended pending the outcome of an appeal, though it is not uncommon for the winning party to bring an application to lift this automatic suspension, especially in cases involving disputes over money. Late last year judge Chris Botha found in favour of the TAC's argument that it was unreasonable and unconstitutional for government not to have a plan to extend its HIV mother-to-child transmission (MTCT) programme beyond pilot sites. Section 27(2) of the Constitution obliges the State to take reasonable measures to achieve the progressive realisation of the right to healthcare. Judge Botha ordered government to devise such a plan and present it to the court by March this year. He also ordered that urgent action be taken in the interim, instructing government to make Nevirapine available as soon as possible in all public health facilities that have the capacity to run MTCT programmes. It is this latter part of the order that the TAC wishes to see implemented immediately. The application will be lodged before the end of the month. TAC attorney Geoff Budlender, of the Legal Resources Centre, says the court has the discretion to make this ruling based on a balance of prejudice. In other words, the TAC will argue that the inconvenience to the State of having to comply with the order is far outweighed by the unnecessary loss of life if the drug is not made available. He expects the matter to go to trial in February. (Source: Financial Mail, 18 January 2002)

The government is obliged to provide the anti-retroviral drug Nevirapine to all HIV-positive pregnant women, the Pretoria High Court ruled on Friday. Judge Chris Botha ruled in favour of the Treatment Action Campaign in its application to force the government to provide the drug to all such women in order to prevent the transmission of the virus to their unborn children. The judge said that the women should be suitable and they should be counselled. He also ordered that the government should, by the end of March, provide a programme of how they will extend their mother-to-child transmission prevention programme. Source: Sapa, 14 December 2001

The Pretoria High Court reserved judgment on Tuesday in the application by the Treatment Action Campaign (TAC) to force government into making Nevirapine available to HIV-positive pregnant woman. Judge Chris Botha said judgment would definitely be delivered before Christmas. Earlier, TAC attorney Gilbert Marcus told the court there was nothing that resembled a timetable for the expansion of the government's programme to distribute the drug. Marcus challenged argument presented on behalf of the Minister of Health and the provincial MECs, saying that the State had failed to address key elements of the TAC's case. Marumo Moerane, for health authorities, argued there were insufficient resources to expand its present programme, which was limited to certain pilot sites. He also said that the long-term efficacy of Nevirapine had yet to be proved. He said South Africans had a constitutional right to healthcare, not Nevirapine and the government's present cautious approach was responsible and reasonable. Marcus said the truth was that the government's current policy had nothing to do with the ideal of achieving 100 percent Nevirapine coverage. That was why doctors at the Johannesburg Hospital, who bought and dispensed Nevirapine at their own cost, were denigrated as being irresponsible when they took steps to achieve the ideal. He quoted from the affidavit of one Johannesburg paediatrician, who said withholding Nevirapine to HIV-positive pregnant mothers, was morally and ethically wrong. According to the affidavit Nevirapine was easy to administer with no side effects except extreme gratefulness. He said the State's understanding of equity seemed to be that all babies were equal, but some babies - such as those in the Western Cape and Gauteng where the Nevirapine programmes were being expanded - were more equal than others. He charged that health authorities had done nothing to explain why their present policy were forcing some doctors in the public health sector to act unethically by preventing them from prescribing Nevirapine, while they regarded it as in the best interest of a patient. (Source: SAPA, 27 November 2001)

Government affidavits filed in response to a court challenge by the Treatment Action Campaign say the slow introduction of nevirapine through 18 pilot sites is rational and responsible.

The government and the Treatment Action Campaign will meet in court next month to fight out their differences over the provision of anti-AIDS drugs to HIV-positive pregnant women. But the AIDS activists, disappointed at the Health Department's decision to contest the action, have appealed for an out-of-court settlement before November 26, when the hearing is due to start in the Pretoria High Court. In August, the campaign lodged papers in a bid to force the government to introduce a countrywide programme to reduce mother-to-child transmission of the HI virus. This was an attempt to pressure the government to set clear time frames for implementing a national mother-to-child transmission prevention programme, including voluntary counselling and testing, antiretroviral therapy, and the option of formula milk for feeding. The activists were demanding that the state make available the anti-AIDS drug Nevirapine, which substantially lessens a pregnant woman's chances of passing on the virus to her baby, to all HIV-positive women who planned to give birth in state hospitals if the attending doctor or nurse believed it necessary. The November court case will see a dramatic about-turn from earlier this year when the two parties were on the same side. The campaign was the government's key ally in a landmark court case against the world's biggest drug firms over the right of poor countries to import cheap anti-AIDS drugs to South Africa. Now that a court date has been set, however, the campaign has respectfully requested Health Minister Manto Tshabalala-Msimang to consider settling the action, particularly in light of the fact that 70 000 children contracted HIV this year from their mothers. Their conditions for settlement are: doctors in the public sector must be allowed to prescribe and dispense Nevirapine at the request of a pregnant woman with HIV/AIDS; and, the government must submit a plan within two months to the Human Rights Commission and the Public Protector to phase in a national mother-to-child transmission prevention programme over the following 18 months. Campaign publicists said that a few weeks ago the minister had asked for a two-week extension to file papers. Tshabalala-Msimang confirmed last month, the day after the state's deadline to respond to the TAC papers, that the government would fight the case. It would oppose the action along with only eight of the nine provinces, excluding the Western Cape. At that time, provincial health MEC Nick Koornhof said the Western Cape would contest the action, but would submit its own affidavit because of large-scale efforts already up and running in the region to prevent mother-to-child transmission of HIV. (Source: Cape Argus, 22 October 2001)