Abstract
BackgroundMany HIV patients receiving antiretroviral treatment develop lipodystrophy. NEW-FILL® is a polylactic acid injected to treat facial lipoatrophy. The objectives of this study were to describe (1) change in quality of life (QoL) of HIV patients treated with NEW-FILL® in the management of facial lipoatrophy; (2) efficacy of NEW-FILL® using facial photographs and (3) a patient-reported “Overall Treatment Effect” (OTE) scale; and (4) safety of NEW-FILL®.MethodsDoctors from 13 treatment centres recruited 230 HIV patients to receive up to 5 sessions of NEW-FILL® injections. Patients self-reported QoL with the ABCD questionnaire before the first set of injections, at 2 months and at 12 to 18 months after the last session of injections. Efficacy was evaluated at each interval through photographs and OTE scale. Safety was evaluated via Case Report Form (CRF) data.Results64.4% of patients reported QoL improvements of >10% at 2 months, and 58.8% at 12–18 months. Lipoatrophy grades improved at each visit (“no lipoatrophy” or “limited lipoatrophy”: 20.3% at inclusion, 77.4% at 2 months, 58.4% at 12–18 months). Average OTE scores of 5.3 and 5.0 at 2 and 12–18 months indicated “moderate improvement”. Minimum Important Difference (MID) in QoL score was 7.1 points at 2 months; 7.4 points at 12–18 months. For 911 injection sessions performed, 3.4% resulted in “immediate” adverse events, 7% in “non-immediate” events, and 1.7% in “other” events.ConclusionsImprovements to quality of life and diminished lipoatrophy visibility were observed in the months immediately following NEW-FILL® treatment and were maintained 12–18 months post-treatment. Most adverse events were mild and transient. ABCD MID thresholds provide clinicians with means to assess the impact of lipoatrophy therapies on QoL.
Highlights
Many HIV patients receiving antiretroviral treatment develop lipodystrophy
The secondary objectives of this study were: [2] to describe the efficacy of NEW-FILLW based on photographs taken before the first injection, 2 months after the last injection session, and if applicable, 12 and 18 months after the last injection session; [3] to describe overall efficacy of treatment with an “Overall Treatment Effect” (OTE) scale [16]; [4] to contribute further data regarding the safety of NEW-FILLW in the short, medium and long term
Determination of the minimal important difference in quality of life was derived from calculation of the pre-treatment and post-treatment change in QoL score that corresponded with an OTE rating [2,3] of a condition ‘a little improved’ or ‘somewhat improved’
Summary
Many HIV patients receiving antiretroviral treatment develop lipodystrophy. NEW-FILLW is a polylactic acid injected to treat facial lipoatrophy. The objectives of this study were to describe (1) change in quality of life (QoL) of HIV patients treated with NEW-FILLW in the management of facial lipoatrophy; (2) efficacy of NEW-FILLW using facial photographs and (3) a patient-reported “Overall Treatment Effect” (OTE) scale; and (4) safety of NEWFILLW. The use of antiretroviral agents for treatment of HIV infection has made it possible to considerably improve morbidity and mortality associated with HIV infection. Their use exposes patients to adverse events in the medium and long term. It is important to improve the impact of therapies on quality of life and on compliance
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