The Department of Health on Thursday released a revised policy and guidelines clearing the way for dual therapy in the prevention of mother-to-child transmission of HIV.
At the same time, Health Minister Manto Tshabalala-Msimang dismissed claims that her department was reluctant to implement the new regime.
”I was the first person to express concern about mono therapy… but we had to make sure that we had enough time to examine the implications of dual therapy,” she said.
Up to now, most state clinics have offered only the officially sanctioned single drug, nevirapine, to infants.
Dual therapy will mean the addition of a second drug, AZT, which will increase the effectiveness of the intervention.
Speaking during a media briefing at Parliament on Thursday morning, Tshabalala-Msimang said treatment guidelines and protocols had had to be drafted before the programme was rolled out.
”We had to make sure that sites were properly accredited and that there were proper facilities,” she said.
She said her department would meet the National Health Council at the end of February to finalise time frames for implementation.
Those provinces that were ready — such as Gauteng — would be allowed to immediately roll out.
Western Cape clinics already offer dual therapy.
Commenting on disciplinary action threatened against KwaZulu-Natal doctor Colin Pfaff for administering dual therapy at Manguzi Hospital, Tshabalala-Msimang implied that the provincial health department was correct in its decision to suspend him.
”We have particular protocols and guidelines on dual therapy. Anything done outside these guidelines is incorrect,” she said.
However, she would not be drawn into details of the case, saying it was an issue between Pfaff and the KZN provincial department.
In a foreword to the policy document, which is dated February 11, Tshabalala-Msimang said the PMTCT (prevention of mother-to-child transmission) programme was introduced in 2001.
At that time, the department had had concerns about monotherapy and the possibility of resistance to a single drug, as well as the lack of clarity on infant feeding options.
She said evaluation of the programme in 2005 suggested that resistance to monotherapy had indeed become a major issue, and that providing nevirapine alone was insufficient to ”improve outcomes” for mothers and babies.
”Recent research and advice from experts now suggests that dual therapy is indicated.
”After consultation between the Department of Health and experts it has been decided that the PMTCT guidelines should be revised and that dual therapy, using nevirapine and AZT, should be used instead of nevirapine only.”
She said this had not been an easy decision, given the lack of unequivocal scientific data and evidence on safety and effectiveness.
The document said PMTCT services were now offered in all public hospitals and in more than 90% of primary healthcare centres.
In the 2005/06 financial year 70% of all antenatal clinic attendees were tested for HIV, of whom 26% tested positive.
About 60% of those who tested positive received nevirapine.
”Various studies that have been conducted on the programme suggest that the transmission rates range from 10% to about 30% and are even lower in the Western Cape.” — Sapa