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Study helps revise ARV guidelines

Report Based On Clinical Trials Conducted At Two Pune Institutes And US University
arvHIV infection rates among babies are significantly cut when mothers are given prolonged ARV treatment during breastfeeding
A clinical trial conducted at the Pune’s B J Medical College and National AIDS Research Institute (Bhosari), as well as the Johns Hopkins University, USA, has led to a revision in the international guidelines for mothers taking antiretrovirals (ARVs). It has been found that HIV infection rates among babies are significantly cut when mothers are given prolonged ARV treatment during breastfeeding and the World Health Organisation (WHO) has amended its earlier guidelines following the new evidence.

“The revision in the existing guidelines is significant. Few researchers have an opportunity to change global practice,” said Arun Jamkar, dean, B J Medical College. Key recommendations of the guidelines were released on November 30 and the full guidelines are expected early next year, he added.

In the study, nevaripine (NVP) was administered to breast-feeding infants of HIVpositive mothers for a period of six weeks. It was found to be ‘highly successful’ in preventing transmission of HIV to infants via breastfeeding by almost half as compared with a single dose of NVP given to infants at birth, which is the current standard of care, said Jamkar.

“Moreover, at six months, the risk of post-natal HIV infection or death in babies who received NVP for six weeks was less than one-third the risk for infants given only a single dose,” said Jamkar.

The combined rates of HIV infection and death at both six weeks and six months were significantly lower in the SWEN (‘Six Week Extended Nevirapine’) group than in the group that received the standard, single-dose NVP regimen alone. “The risk of postnatal HIV infection or death at six weeks was 42 per cent lower in the SWEN group than in the single-dose group, and at six months, the risk was 27 per cent lower than in the singledose group. These findings contributed to the change of WHO guidelines,” said Jamkar.

B J Medical College Pune researchers in collaboration with Johns Hopkins University USA conducted the research from February 2002 to March 2007. NARI helped in laboratory aspects. From B J Medial college, a major role was played by the departments of obstetrics and gynaecology (medical researchers K E Bharucha and R A Bhosale), paediatrics (expert researchers M A Phadke, V Venkatramani ), microbiology (expert researchers A V Bhore and Renu Bhardwaj), biochemistry (expert researcher P M Bulakh) and pathology (expert researchers S D Deshmukh and Medha Khandekar).

“More than 1,10,000 pregnant women were screened counselled, educated for HIV and tested in Sassoon General Hospital, PMC centres and PCMC centres. A total of 370 were assigned by randomisation to single dose nevirapine (NACO policy) and 367 were assigned to extended dose nevirapine (SWEN).

“The mother and infants were followed for a year. After six months, 18 babies in SWEN and 28 babies who had been give a single dose became HIV positive. After six months, 4 babies in the SWEN group and 10 babies in the single dose group died,” said Jamkar.

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Source: Times of India

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