Nearly 18 months after submission, an essential generic version of the anti-HIV drug tenofovir has finally been licensed in South Africa, along with a fixed dose tablet that combines tenofovir with emtricitabine, called Truvada.
Tenofovir (Viread) and Truvada will be manufactured and marketed in South Africa by Aspen Pharmacare, which holds a non-exclusive voluntary license for the products from Gilead Sciences.
Dr Francois Venter, president of the Southern African HIV Clinicians Society, said the approval was a "massive step forward", but told Business Day that the drugs remain "way too expensive for the public sector".
“The prices at which Aspen Pharmacare is selling these medicines is far too high,” said Nathan Geffen of the Treatment Action Campaign.
“They are selling tenofovir at R199.29 (incl. VAT) ($28.47) per patient per month and emtricitabine (i.e. the combination pill of tenofovir and FTC) at R329.89 (incl. VAT) ($47.12) per patient per month. This is higher than the price at which patients were previously accessing it under Section 21 Authorisation.”
Section 21 authorisation allows drugs to be imported into South Africa for individual use prior to licensing.
“Tenofovir is not patented in South Africa and we urge other companies to apply to register tenofovir so that competition drives the price down.”
However, competitors’ room for manoeuvre on price may be limited, because all generic producers holding voluntary licenses from Gilead are obliged to buy the specialised chemicals used in production of the drug from approved manufacturers who have also signed licensing deals with Gilead obliging them to sell these chemicals only to voluntary license holders.
This restriction, designed both to ensure the quality of tenofovir ingredients and to control who can sell generic versions of tenofovir in middle-income countries, means that the main route by which significant savings can be made will be through improvements in the manufacturing process.
The Clinton HIV/AIDS Initiative is working with Indian generic companies on identifying ways to streamline manufacturing processes for tenofovir and several other drugs needed in resource-limited settings, and is expected to announce a new round of price reductions for antiretrovirals available to developing countries through its price negotiation scheme within the next few weeks.
Access to tenofovir will remain difficult for patients receiving antiretroviral treatment through the public sector, because drugs have already been purchased through a tendering process. The Department of Health said this week that the drugs may be included in the next round of tendering in 2008.
Tenofovir is now widely used in place of d4T and AZT in Europe and North America because it has few side-effects. In particular it is associated with very low levels of fat loss, and does not cause peripheral neuropathy or lactic acidosis (unlike d4T), not anaemia (unlike AZT).
Revised World Health Organization guidelines on antiretroviral treatment in resource-limited settings now recommend tenofovir in preference to d4T or AZT wherever it is available and affordable.