NAPWA

Today’s PBS listing of a treatment for HIV-associated facial wasting will provide substantial improvements in quality of life for people living with HIV, the National Association of People Living with HIV/AIDS (NAPWA) has said.

Poly-l-lactic acid, powder for injection (Sculptra®) has been approved for the treatment of severe facial lipoatrophy caused by antiretroviralA medication or other substance which is active against retroviruses such as HIV. therapy in HIV-positive patients and will be listed on the Pharmaceutical Benefits Scheme[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs. (PBS) from 1 September 2009.

“This is welcome news for people with HIV, especially those with disfiguring facial wasting caused by their treatments,” said NAPWA spokesperson Peter Canavan. “For these people, facial lipoatrophy isn’t just a cosmetic issue – changes in appearance can cause significant loss of self-esteem as well as providing a very public indication of your HIV-positive status.”

Facial wasting, or lipoatrophy, is a common side effectAn unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time. of antiretroviral treatments. In severe cases it causes significant loss of subcutaneous fat tissue from the face, leading to a pronounced gaunt, hollow-cheeked appearance.

Poly-l-lactic acid injections have been shown to provide a long-lasting improvement in symptoms with a high degree of safety and tolerability. Today’s PBS listing makes the drug available to people with severe facial wasting through a limited number of doctors accredited by the drug manufacturer, Sanofi-Aventis Australia Pty Ltd. The PBS listing covers an initial course of treatment and follow-up treatments every two years.

“NAPWA has worked over many years to secure PBS approval for this essential medicine,” said Canavan. “We have been advocating for more than a decade about the social and psychological impacts from HIV-associated lipoatrophy and lipodystrophy and we acknowledge the cooperation of Sanofi-Aventis in making this product available over several years through clinical studyA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. and access programs.”

NAPWA also called on the Medical Services Advisory Committee (MSAC) to urgently approve an application for a Medicare item listing for the procedure needed to administer the treatment. “Getting PBS funding for the drug is only part of what is needed. Without Medicare funding for the necessary procedure, many people with HIV will still be unable to afford this treatment. We are very keen to ensure that Medicare funding is made available as soon as possible,” said Canavan.

“PBS listing for poly-l-lactic acid is a welcome development for people with HIV and we applaud the decision of the Pharmaceutical Benefits Advisory Committee (PBAC) which acknowledges the need for treatments for this condition. We also acknowledge the contribution of patient submissions and community statements in achieving this outcome.”

For more details or further comment contact:
Peter Canavan (Senior Coordinator, NAPWA Health Treatments & Research Unit) (02) 8568 0303 or mobile (0412) 274 208