Concerned over the ill effects of Stavudine d4T, a first-line drug against HIV for long, the Centre plans to replace it with safer and better-tolerated Tenofovir and Zidovudine. Stavudine has been linked to high toxicity, adverse effects on cholesterol metabolism, painful neuropathy, pancreatitis, sunken cheeks and buffalo humps.

In a joint affidavit filed in the Supreme Court Monday, the Centre and the National Aids Control Organisation (NACO) said they have decided, in the wake of health concerns, to substitute Stavudine with Tenofovir and Zidovudine as the preferred first-line regimen for HIV and Hepatitis co-infection.

The NACO, the affidavit said, has decided to shift to the new regimen in two phases — adult patients on Stavudine for 6 to 24 months will be shifted to Tenofovir or Zidovudine in phase I, which will begin in January 2013, while those undergoing this treatment for longer will be shifted in Phase II, which will start in July 2013 — as suggested by a bunch of NGOs and patient groups that have petitioned the Supreme Court to direct the government to withdraw the drug from the anti-retro-viral treatment (ART) programme and substitute it with better-tolerated drugs like Tenofovir for adults and Abacavir for children.

Besides, “no new adult patient shall be initiated on Stavudine based regimen” — new anaemic patients will be started on Tenofovir-based regimen and those who are not anaemic will be started on Zidovudine — the affidavit said.

“Patients currently with significant toxicity to Stavudine, regardless of the length of time on Stavudine, are already being shifted to Tenofovir or Zidovudine, based on haemoglobin level,” added the affidavit, which was recorded by a bench of Justices Swatanter Kumar and S J Mukhopadhaya.

The bench later listed the case for hearing after two weeks, awaiting another affidavit from the Centre.

The WHO had advocated phasing out Stavudine in 2010 but the issue of pricing limited progress in this direction, particularly in India where the drug is widely used in the public-funded ART programme.

In fact, about half of the 5 lakh patients in the ART programme are on Stavudine, so the public health implications of its phasing out are bound to be huge, not least the 25 per cent increase in the cost of the ART programme.

“No new patients are started on Stavudine since July. We have decided to replace Rs 7 per day Stavudine with Tenofovir, which costs Rs 14. It will, like Stavudine, be administered as a triple drug combo. We have placed orders for new drugs which will come by November,” Dr B B Rewari, ART national programme officer in NACO, told The Indian Express.

Source: The Indian Express

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