Appendix 3: The Fortovase® Genotyping Surveillance Programme


To collect information which helps to define the best use of Fortovase® (FTV) based on virus genotype, including:

  • how often patients are not eligible to receive FTV due to resistance
  • clinical outcome of FTV when used optimally according to genotype
  • whether failure is associated with resistance to FTV or to RT inhibitors
  • best options for switching drug(s) if a patient develops resistance to FTV
  • clinical outcome of switch options after using FTV


  • Any prior therapy is allowed, and there are no restrictions on how FTV is prescribed.
  • Data are collected: at entry; at 24 and 48 wks.
  • If still on same therapy; in the event of failure; then 12 wks. after switch.
  • Roche affiliates nominate physicians and labs according to their expertise and resources.
  • Roche affiliates can choose the type of gene sequencing technology.
  • Physican signs up to the programme and receives RetroGram™ software.

Roche Pharma affiliates provide

  • Replacement genotype and viral load (state of the art, ultrasensitive) assays
  • Any investigator fees

Roche HQ provides

  • RetroGram™ decision support software
  • Overall program coordination; data management e.g. by Virology Networks