Tipranavir available in Scotland – almost one year after EU approval
A press release form Boehringer Ingelehiem on 11 September highlighted acceptance by the Scottish Medicines Consortium (SMC) for tipranavir/ritonavir in treatment experienced patients.
Tthe SMC statement included recommendations that:
- Tipranavir/r is accepted for restricted use within NHS Scotland for the treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
- At 48 weeks, tipranavir, in combination with low dose ritonavir, showed a significant improvement in the reduction of viral load compared with other protease inhibitor plus ritonavir regimens. Although the overall rate and type of adverse events were similar, tipranavir had a higher incidence of hepatotoxicity, hyperlipidaemia, bleeding events and rash.
- Tipranavir is more expensive than other protease inhibitors and it is restricted to patients with a tipranavir mutation score of less than 4.
The press release stated: The SMC reached their decision to approve tipranavir/r for these patients after a thorough analysis of the clinical data. The assessment considered the positive outcomes from 48 week analyses of two pivotal, open-label, randomized, phase III trials, RESIST 1 and RESIST 2. Patients enrolled in these trials had been treated previously with all three classes of antiretroviral drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors), had received at least two protease inhibitor-based regimens for at least 3 months, had a viral load of at least 1000 copies/mL and had documented multiple resistance to protease inhibitors. The 48-week data from the RESIST studies, which were presented this year at the 13th Conference on Retroviruses and Opportunistic Infections (CROI), and which were recently published in the medical journal The Lancet (Vol 368, August 5, 2006), showed that tipranavir demonstrated durable response that was superior to that of the comparator boosted protease inhibitor regimens.
It is disturbing that such a delay after approval occurs in any EU country, especially for treatments specifically developed as life-saving treatments for patients with resistance to existing drugs. Tipranavir was approved in the US in June 2005 and in Europe in October 2005, and was available on EAP in the UK for 6 months prior to approval.
Scottish patients, doctors and advocates hope that a similar delay does not occur for the next drugs likely to be given EU approval: darunavir, etravirine and MK-0518.
Source: Press release, Boehringer Ingelheim, 11 September 2006.