Registration of critical ARV drug delayed

Tenofovir is an important drug for patients who suffer from lactic acidosis, a life-threatening side-effect of the first-line anti-retroviral d4T. Tenofovir is also needed as part of a new regimen for patients in Khayelitsha who have been on the first-line regimen for a very long time and have developed resistance to one or more of the first line drugs.

However, according to Medecins Sans Frontieres spokesperson Nathan Ford, the drug is virtually impossible to access because it is not registered in South Africa and so must be obtained through special authorization from the MCC for use on a six-month, named-patient basis ‘€“ and more problematically, shipped directly from California.

Ford revealed that it took MSF over two months to complete all the steps to access Tenofovir in South Africa ‘€“ about half that time was due to unexpected delivery delays. ‘€œThis left us with only two bottles of Tenofovir in our programme at the end of last year, whereas 13 patients were at the time receiving the drug.

There are currently 21 Khayelitsha patients on Tenofovir and increasing by around three every month.

‘€œWe are increasingly concerned that after two years of importing the drug we have not been able to establish a reliable importation system. This seriously limits our ability to start new patients on the drug who need it as a matter of life and death, since we can’€™t assure continuity of the supply,’€ Ford added.

The Treatment Action Campaign (TAC) recently sent a letter to the MCC requesting an update on the registration applications by manufacturers Gilead Sciences and generics company Aspen Pharmacare.

TAC National Manager Rukia Cornelius said that specialists had told them d4T-related toxicity was the main reason for stopping and/or changing the first-line regimen, with d4T accounting for almost all long-term side-effects.

‘€œTenofovir has shown to be safe, potent and well tolerated, having a significantly better side-effect profile that d4T,’€ Cornelius added.

Dr Francesca Conradie, a clinical consultant at Helen Joseph Hospital’€™s Thembalethu Clinic, the country’€™s biggest ARV treatment programme in the country, has said that she is on a mission to get d4T replaced with Tenofovir.

Thembalethu has over 3 000 patients on ARVs with about 10 percent experiencing side-effects while only one percent prove to be serious.

‘€œWe are swapping five to 10% of our patients on d4T because of side-effects,’€ Conradie said.

Ford expressed concern over the fact that since late October Gilead had applied for the registration of Tenofovir in only 11 African countries. This after the company announced preferential pricing for the developing world as far back at December 2002.

‘€œWith no interim measure being proposed, clinicians will have to continue to rely on a system which at best rations Tenofovir use and results in fragile stocks, but for the majority of physicians in the public sector Tenofovir is as good as non-existent,’€ said Ford. ‘€“ Health-e News Service

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