A new antiretroviral medication, FTC (emtricitabine, Emtriva) was listed on the PBS and became available for S100 prescription from 1 April. Manufactured by Gilead Sciences, FTC is a nucleoside analogue drug somewhat similar to 3TC, and is taken as a single capsule once daily with or without food.
Several clinical studies have demonstrated the drug’s effectiveness, notably study 934 which compared Gilead’s FTC and tenofovir with GlaxoSmithKline’s Combivir (AZT and 3TC). The study found that FTC/tenofovir was marginally more effective than Combivir, and was better tolerated.
Side effects of FTC are similar to other antivirals in the nucleoside analogue class, including headache, diarrhoea, nausea and rash, typically mild to moderate in severity. There have been occasional reports of excess pigmentation on the palms of the hands and soles of the feet in non-Caucasian people, and use of the drug should be careful monitored in people with kidney problems.
FTC has also been shown to be active against the hepatitis B virus, however the drug has not been approved in Australia for this purpose.
HIV drug manufacturer Roche has announced that it will withdraw from sale one of the first HIV drugs approved in Australia, ddC (zalcitabine, Hivid). First listed on the PBS in 1993, use of ddC has fallen dramatically as newer and better drugs have become available, leading to the decision to cease manufacture of the drug.
The number of people currently taking ddC in Australia is believed to be very small, however Roche will continue to make the drug available until the end of 2006 to provide adequate time for anyone who is taking ddC to make arrangements to change treatment.
Roche has also announced that it plans to withdraw the Fortovase ’soft-gel’ formulation of its protease inhibitor saquinavir. Use of soft-gel saquinavir has fallen due to a high pill count and tolerability issues, and Roche is seeking PBS listing for a new saquinavir formulation, Invirase 500mg tablets, which promise a dramatically reduced pill count. The company is hopeful that the new formulation of saquinavir will gain PBS listing in the second half of 2006, after which the Fortovase brand will be withdrawn.
Following a change to prescribing rules, Gilead’s nucleoside analogue drug tenofovir (Viread) is now available for prescription with no special restrictions. When first listed on the PBS in 2002, tenofovir was given a special restriction requiring that it only be used in people who had taken and failed other treatments, however increased evidence of the drug’s effectiveness in first-line therapy means that is now available under the same criteria as other HIV treatments.
