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WHO issues guidance on what to do about delisted ARVs
The World Health Organization (WHO) this week issued a guidance note for doctors, patients, national regulatory authorities and national AIDS programmes on what to do following recent `delisting` of a number of WHO-prequalified antiretrovirals.
WHO recommends that in situations where prequalified substitutes are not available, patients should continue to take the delisted products rather than interrupt treatment, implying that so far, WHO has no evidence to suggest that the drugs are failing.
However, Daniela Bagozzi of the World Health Organization told HIV & AIDS Treatment in Practice: “We don’t want patients to take them unless there’s absolutely no alternative. At the moment we don’t know whether they are bioequivalent or not.”
The guidance note comes nearly one month after WHO announced that it had delisted three products manufactured by Ranbaxy from its list of `prequalified` antiretrovirals due to irregularities in the research procedure and three months after two Cipla antiretrovirals were delisted.
The products are:
A full report on the WHO guidance is available on this website in the September 3rd issue of HIV & AIDS Treatment in Practice.
WHO recommends that in situations where prequalified substitutes are not available, patients should continue to take the delisted products rather than interrupt treatment, implying that so far, WHO has no evidence to suggest that the drugs are failing.
However, Daniela Bagozzi of the World Health Organization told HIV & AIDS Treatment in Practice: “We don’t want patients to take them unless there’s absolutely no alternative. At the moment we don’t know whether they are bioequivalent or not.”
The guidance note comes nearly one month after WHO announced that it had delisted three products manufactured by Ranbaxy from its list of `prequalified` antiretrovirals due to irregularities in the research procedure and three months after two Cipla antiretrovirals were delisted.
The products are:
- 3TC (lamivudine) 150mg plus d4T (stavudine) 30mg and nevirapine 200mg tablet (Ranbaxy Laboratories Ltd., Dewas, India, Al strip of 10 or 60 in box, brand name Viro LNS).
- 3TC 150mg plus d4T 40mg and nevirapine 200mg tablet (Ranbaxy Laboratories Ltd., Dewas, India, Al strip of 10 or 60 in box, brand name Viro LNS).
- 3TC 150mg plus AZT (zidovudine) 300mg tablet (Ranbaxy Laboratories Ltd., Dewas, India, Blister pack of 60 or 100, brand name Virocomb).
- 3TC 150mg tablet (Cipla Ltd., Kurkumbh, India, blister pack of 10, brand name Lamivir).
- 3TC 150mg plus AZT 300mg tablet (Cipla Ltd., Vikhroli, India, blister pack of 10, brand name Duovir).
A full report on the WHO guidance is available on this website in the September 3rd issue of HIV & AIDS Treatment in Practice.
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