How cheaply can HIV drugs be made?

Keith Alcorn
Estimated reading time 2 minutes
This article is more than 24 years old.

Two important investigations on the cost of anti-HIV drugs were published today by the New York Times, highlighting some interesting facts about the true production costs of antiretroviral drugs, and the pitfalls of generic medicines.

Melody Peterson reports that bulk generic manufacture has brought down the price of the raw materials needed to produce d4T (stavudine) by more than 90% in the past year. Sufficient chemicals to produce a year's supply of d4T can now be had for as little as $23, yet Bristol Myers Squibb says that its new price for d4T in Africa - $55 - is below cost. Bulk purchase has chiefly been driven by the Brazilian government, which provides free antiretroviral treatment using generic drugs manufactured in Brazil.

Denise Grady reports that concerns persist among experts such as Mark Wainberg of the International AIDS Society regarding the wisdom of providing widespread treatment with generic antiretroviral drugs. Manufacturing processes may not be up to standard, and small deviations in the manufacturing process can lead to big differences in the performance of a drug. However, Cipla, the Indian manufacturer of antiretroviral drugs, has been inspected by the Food and Drug Administration, and the raw materials used in the manufacture of antiretroviral drugs for Brazil are supplied by the same US company which sources ingredients for the brand name versions produced in the United States.

Glossary

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. 

reverse transcriptase

A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). 

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.

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

Cipla have decided not to attempt the production of protease inhibitors because they are much more difficult to manufacture than nucleoside analogues and non-nucleoside reverse transcriptase inhibitors, and will concentrate instead on the formulation of combinations of several drugs into one tablet, in order to increase ease of administration.

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