Joint Letter to Bill & Melinda Gates Foundation on Clinical Trial Comparing Stavudine and Tenofovir

Excerpt of letter:

"Dear Mr and Mrs Gates,

We write as people with HIV and community activists with serious and unresolved concerns about the proposed clinical trial comparing stavudine at 20 mg to tenofovir.

Although we are broadly very supportive of dose optimisation strategies, we do not support this trial; we do not think that the Bill and Melinda Gates Foundation should support it; nor do we think it should proceed. Several of us have discussed this with your representatives both formally and informally over the past months. Those of us who met with your representatives on 19 July 2011 at the International AIDS Society conference in Rome received no response to the concerns we raised.

We summarise our objections as follows:

1. Stavudine is more toxic than tenofovir, and for this reason, it is an inferior option.

The proposed trial aims to establish virological non-inferiority, which is a moot point, given the severe adverse events associated with stavudine. Considerable evidence supports the use of tenofovir over stavudine; regulatory bodies and the World Health Organization (WHO) have turned away from the drug. In 2004, stavudine was removed from the list of preferred first-line antiretroviral drugs recommended by the US Department of Health and Human Services (DHHS). Starting in 2006, the WHO recommended that countries start moving away from stavudine, and in 2009 recommended that the drug be phased out in first-line antiretroviral treatment (ART) programmes. Earlier this year, the European Medicines Agency (EMA) revised the indication for stavudine, noting, "…that the use of the medicine should be severely restricted in both adults and children... Prescribers are reminded of the severe side effects seen with Zerit [stavudine] and should only use the medicine when other appropriate treatments are not available. Patients being treated with Zerit should be assessed frequently and switched to appropriate alternatives as soon as possible."