Boehringer Ingelheim trials highlight Aptivus-haemorrhage risk

New trials conducted by Boehringer Ingelheim have shown an increase in the incidence of intracranial haemorrhage events following the use of the HIV drug Aptivus.

In clinical trials surveying the use Aptivus capsules as an anti-HIV combination treatment, Boehringer Ingelheim reported 14 incidents of intracranial haemorrhage events with eight fatalities.

The trials were conducted with 6,840 HIV-1 infected patients, with a case-by-case analysis of each of the participants suffering from intracranial haemorrhage. Most patients had other complaints, such as central nervous system lesions, or were receiving medication that could have contributed to the illnesses.

Boehringer Ingelheim states that no relationship between the drug and intracranial haemorrhage events can be forged, though individuals suffering from HIV and AIDS and treated with Aptivus have previously shown an increased risk of intracranial haemorrhaging.

The company has consequently told regulators about the result of the trials and is in the process of informing health officials and investigators about the trials’ conclusions.

It has however urged patients taking Aptivus not to “discontinue or modify their treatment with Aptivus/ritonavir or any other medications without first speaking with their doctor to evaluate the appropriate course of therapy for their individual needs”.

Aptivus is a non-peptidic protease inhibitor that prevents HIV from spreading by inhibiting protease – an enzyme needed for HIV replication.

The drug can inhibit HIV replication for numerous strains of the disease that are immune to the action of other commercially available protease inhibitors and must be administered with ritonavir to be effective.

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