Scottish Medicines Consortium endorses use of Aptivus (tipranavir) in special HIV cases

HIV patients in Scotland with high levels of resistance to protease inhibitors could soon benefit from treatment with Boehringer Ingelheim's tipranavir boosted with ritonavir (tipranavir) following acceptance by the Scottish Medicines Consortium (SMC).

HIV patients with protease inhibitor-resistance and a treatment history of multiple antiretroviral agents are at high risk of progressing to AIDS. The acceptance of tipranavir for this difficult-to-treat population is therefore welcome news.

After assessment of clinical data, the SMC stated that: "tipranavir (Aptivus) in combination with low dose ritonavir 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.

However, the SMC said that tipranavir is more ex-pensive than other protease inhibitors and therefore is restricted to patients with a tipranavir mutation score of less than 4.

"It's good news that the SMC has accepted Aptivus and that patients in Scotland will now have easier access to it. This is a very effective drug for people living with HIV who have struggled to control their HIV," said Brian West, information and development officer at HIV Scotland. "Last month, the IAS stated that physicians should set a treatment goal of reaching undetectable levels of the viral load for all HIV patients, including treatment-experienced patients. When Aptivus is combined with some of the other new drugs available, it means that aims of treatment are becoming universal - controlling the virus, irrespective of which stage of the disease a person is at."

The decision to approve the drug for these patients comes after analysis of the clinical data from two pivotal, open-label, randomised, phase III trials, RESIST 1 and RESIST 2, presented this year at the 13th Conference on Retroviruses and Opportunistic Infections (CROI), and published in the medical journal The Lancet (Vol 368, August 5, 2006).

In addition to EU marketing approval, tipranavir has received US marketing authorisation by the FDA and was launched there in June 2005. Additional marketing authorisations from different countries have been received or are expected.