Results of a patient-completed

1. Results of a patient-completed questionnaire about facial lipoatrophy and its repair procedures in France Poster P35 Emmanuel TRENADO, Thierry PRESTEL, Hind GAIGI, Jérôme SOLETTI AIDES, Tour Essor, 14 rue Scandicci, 93508 Pantin CEDEX, France Tél.: +33 1 41 83 46 13 Fax: +33 1 41 83 46 19 Email: etrenado@aides.org Web www.aides.org

2. Objectives To evaluate the need for and obstacles for repair procedures among HIV positive persons who experience facial lipoatrophy while on antiretroviral therapy. To collect patient satisfaction of the results of such procedures by people who have undergone them. The questionnaire The first part of the questionnaire was for people who had undergone repair procedures. The second part was for people with lipoatrophy who had not yet done so.

3. Methods A questionnaire was distributed to people experiencing facial lipoatrophy in hospitals, over the Internet, through AIDES chapters and the phone help line all over France and printed in the September 2001 issue of Remaides (community-based newsletter).

4. Results % 248 questionnaires were analyzed. The majority of responders are male. A majority of returned the questionnaires had been distributed with the newsletter REMAIDES (133 out of 248).

5. Age % The majority of responders were between 30 and 49 years old (71,8%). • 0,8% were below 30 • 31,5% were between 30 and 39 • 40,3% were between 40 to 49 • 26,2% were older than 49 1,2% of responders did not answer this intem

6. How long have you been HIV+? % 67,3% of responders had been HIV-positive for more than 10 years. • No answer 4% • For more than 15 years 27% • From 10 to 15 years 40,3% • From 5 to 10 years 22,6% • For less than 5 years 6%

7. Other Body Changes % The most frequent body changes that are reported, in addition to facial lipoatrophy, are: 1)prominent veins 2) lost of fat in the buttocks 3) belly fat accumulation 4) others 5) increase in breast size 6) buffalo neck

8. Significant differences in body shape changes according to gender • Males report more prominent veins • Females report more belly fat accumulation • Females report more increase in waist size % 1 2 3

9. Time to appearance of facial lipoatrophy % • responders report the appearance of facial lipoatrophy to have occured after 1996 • before 1996 • no answer

10. Exposure to ARVs % The chart shows that most responders have been exposed to NRTIs - retrovir (73,3%) videx (78,5%) epivir (85,8%) zerit (89,1%). % 62,2% of responders have been exposed to ARVs for more than 5 years.

11. Discussing facial lipoatrophywith the doctor % Most responders had discussed lipoatrophy with their doctors (77%). If yes, did your doctor explain the different repair procedures? % Overall only 49,6% of responders had discussed repair procedures with their doctors.

12. Have you had access to repair procedure? Type of repair procedure % % • Filling products • Autologous fat implant • Both 23,4% of responders had access to repair procedure (58 persons, 50 men and 8 women)

13. When were you treatedfor your facial lipoatrophy? Among the majority of responders, the first access to repair procedure happened starting year 2000. • 1997 1,8% • 1998 1,8% • 1999 5,4% • 2000 48,2% • 2001 42,9% % Last injection of filling product occurred in • 1999 2% • 2000 23,5% • 2001 74,5% %

14. Filling products % Two types of filling products are in use in France: Temporary filling products Most responders (72,5%) report having used acide polyactique (New Fill) as filling product. Acid Hyaluronique (Restilane and Perlane for example) is also reported as being used (12,5% of responders). • Permanent filling products « Other products » (15%) are mainly composed of permanent filling products such as Gore-Tex.

15. How filling products are used? It takes several injections to improve facial lipoatrophy. • Most responders have had between 3 and 5 injections (51%) • 39,2% of responders reported to have had less than 3 injections • 9,8% of responders have had more than 5 injections %

16. How responders who have had access to repair procedure report to have tolerated the procedure? The injection of filling products or the autologous fat implant surgery were well tolerated (86,8%). %

17. Were responders satisfied with the repair procedures? Overall, 75% of responders are satisfied or very satisfied with the results of the repair procedure. 25% of responders are not satisfied (mainly lack of filling effect or price issue). %

18. Will the results of the repair procedures be permanent? % Responders were well informed about the possible temporary effect of the repair procedure: 94,3% of responders were explained that the results will be temporary. • Surgery: 1 out of 9 responders was told the procedure to be permanent • Filling product: 1 out of 36 responders was told the procedure to be permanent % How often were you told that you will need repair procedures? • 57,7% were answered “less than once a year” • 34,6% were answered “every 6 to 11 months” • 7,7% were answered “more than once every 6 months”

19. Price and reimbursement of repair procedures % A majority of responders paid for the repair procedures (51%) but an important number of responders benefited from diverse forms of reimbursement: • facial surgery conducted in public hospitals • ongoing trials • compassionate access Did you pay for the repair procedure? % Surgery Both Filling products

20. Why did responders not accessrepair procedures? % Lack of information and financial reasons are stated as being the main obstacle for access to repair procedures. Among responders who answered “Other reasons” about one fourth state that facial lipoatrophy was mild and didn’t need repair procedure for the moment. Would you like to have access to repair procedures? % 1- My doctor does not want 2- I don’t know any doctor who could help me 3- I have some apprehension 4- Other reasons 5- Financial reasons 6- Lack of information A very large majority of responders would like to have access to repair procedures.

21. Do you know which repair procedure is available? % Only half of the responders report knowing about the available repair procedures. If yes, which one you would like to use? % A vast majority (77,9%) of responders who knew about available repair procedures, and had not yet undergone any, wishes to use filling products. The main reason reported to discard surgery is the existence of a long waiting list for such procedure.

22. Conclusions.1 • These results suggest that the vast majority of responders has not had access to repair procedures but wished to do so. • Filling products is the main repair procedure reported to have been used. • The responders who had undergone repair procedures are pleased with the results. • Lack of information and financial reasons are the main obstacles to access repair procedures.

23. Conclusions.2 • Repair procedures are understood to be of temporary result by the responders. • Only half of the doctors have been able to discuss with the responders the available repair procedures. • Women report different body changes to men.

24. Discussion • These results suggest that there might be a need: • To better inform people with facial lipoatrophy and the doctors about the available repair procedures. • To find ways to make those repair procedures available to people who need them. • Therefore to address the issue of reimbursement. • Furthermore: • To address the issue of safety? • To evaluate the different repair procedures?