ABT-378 to be made available for salvage therapy in UK

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The new protease inhibitor ABT-378 (lopinavir) is to be made available in the UK to people who have run out of other protease inhibitor options.

Abbott Laboratories has established a study which will make ABT-378 available to anyone who has:

  • Experienced treatment failure or intolerance to at least two protease inhibitors, provided their viral load is greater than 10,000 copies.

Glossary

salvage therapy

Any treatment regimen used after a number of earlier regimens have failed. People with HIV who have experienced side-effects and/or developed resistance to many HIV drugs receive salvage therapy, sometimes consisting of a large number of medications.

drug interaction

A risky combination of drugs, when drug A interferes with the functioning of drug B. Blood levels of the drug may be lowered or raised, potentially interfering with effectiveness or making side-effects worse. Also known as a drug-drug interaction.

liver function test (LFT)

A test that measures the blood serum level of any of several enzymes (eg, AST and ALT) produced by the liver. An elevated liver function test result is a sign of possible liver damage.

AIDS defining condition

Any HIV-related illness included in the list of diagnostic criteria for AIDS, which in the presence of HIV infection result in an AIDS diagnosis. They include opportunistic infections and cancers that are life-threatening in a person with HIV.

treatment failure

Inability of a medical therapy to achieve the desired results. 

AND

  • A CD4 count below 200 in past 3 months and/or an AIDS defining illness that has occurred since commencing HAART

Individuals should not be taking any other drugs which interact negatively with ritonavir, since ABT-378 is taken with a very small dose of ritonavir in order to boost blood levels of the new drug. Pregnant women or those with liver function test values more than five times the upper limit of normal will not be permitted to receive ABT-378 for safety reasons.

The Royal Free Hospital, the Chelsea and Westminster Hospital and the Mortimer Market Centre in London are likely to take part in the study, along with the North Manchester Hospital. Abbott Laboratories is currently seeking permission from the Medicines Control Agency to expand the study to other hospitals in the UK. Clinicians interested in participating should contact the Clinical Research Department at Abbott.

More information about the potential use of ABT-378 in salvage therapy can be found in Drugs used by people with HIV.