BMC infectious diseases · 2013
A longitudinal evaluation of the impact of a polylactic acid injection therapy on health related quality of life amongst HIV patients treated with anti-retroviral agents under real conditions of use.
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Duracinsky Martin, Leclercq Pascale, Armstrong Andrew Richard, Dolivo Marc, Mouly Frédéric, Chassany Olivier
Аннотация
BACKGROUND: Many 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®.
METHODS: Doctors 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.
RESULTS: 64.4% 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.
CONCLUSIONS: Improvements 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.
METHODS: Doctors 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.
RESULTS: 64.4% 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.
CONCLUSIONS: Improvements 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.