New & experimental HIV treatments

Second generic abacavir approved for PEPFAR

Keith Alcorn
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A generic version of the nucleoside analogue abacavir, manufactured by Cipla, has received tentative approval from the US Food and Drug Administration. The product can now be purchased by the President’s Emergency Plan for AIDS Relief (PEPFAR), which channels US money to treatment programmes in developing countries.

The FDA tentative approval also means that the product should receive rapid prequalification by the World Health Organization, since the two organisations have now agreed that the dossier used for FDA approval can be supplied to WHO to speed up prequalification.

Abacavir is likely to be used in developing countries as a second-line nucleoside analogue in combination with didanosine or tenofovir and one drug from another class.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

second-line treatment

The second preferred therapy for a particular condition, used after first-line treatment fails or if a person cannot tolerate first-line drugs.

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

Another generic version of abacavir, manufactured by Aurobindo, was approved by the US FDA in May 2006.

The Clinton HIV/AIDS Initiative announced in January 2006 that it had agreed with Cipla to offer abacavir to resource-limited countries at a maximum price of $440 a year, with discounts for high volumes of the drug ordered. Abacavir is likely to be one of the second-line drugs purchased by UNITAID, the international HIV drug purchase facility, which announced in September that second-line antiretrovirals would be one of its priorities.

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New & experimental HIV treatments
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