Four-year safety with polyacrylamide hydrogel to correct antiretroviral-related facial lipoatrophy.

Infiltrations with synthetic substances are effective strategies for repairing facial lipoatrophy. However, few data are available on long-term safety. We describe the safety of polyacrylamide hydrogel in 145 patients who received facial infiltrations with Aquamid from September 2002 to April 2004. Epidemiological, clinical (mainly complications), and psychological data (patient satisfaction) were collected. We also recorded all patients who presented with a local infection at any time after receiving an infiltration. Sixty-two percent of patients presented with severe facial lipoatrophy before infiltration. The cumulative volume of Aquamid injected was 5.5 ml (4-18) per patient. During a mean (SD) of 50.2 (4.3) months after infiltration, only one patient presented with a local infection. Small palpable, nonvisible nodules or indurations were the most frequent complications (19.3% and 6.2%, respectively). If we include the remaining patients from our center (n = 294) who also received Aquamid (although less than 4 years ago), a further three patients presented with a local infection (incidence of 0.9%). Most patients (88.9%) were "satisfied" or "very satisfied" with the results; patients with mild to moderate baseline facial lipoatrophy were more satisfied than those with severe lipoatrophy ("very satisfied": 92.7% versus 86.5%, respectively). Only 17.4% reported mild impairment of lipoatrophy and only 9.2% required new infiltrations; however, 76% would have preferred more infiltrations. The high patient satisfaction and the low number of severe complications after at least 4 years of facial infiltrations with Aquamid reflect the long-term safety of this product for the repair of facial lipoatrophy. However, prolonged follow-up of these patients is recommended to detect unexpected long-term adverse reactions.

Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach.

OBJECTIVE: To assess the efficacy and safety of a once-daily antiretroviral regimen in HAART-experienced subjects with long-lasting viral suppression. METHODS: One-hundred-and-sixty-nine patients with chronically suppressed viral load (limit of detection <50 copies/ml) were recruited. Based on patient willingness to simplify treatment, 84 of them continued receiving their usual treatment (BID Group) and 85 switched to once-daily didanosine/tenofovir/nevirapine (QD Group) in a non-randomized fashion. RESULTS: At week 48, the proportion of patients with viral suppression in the QD and in the BID Group, respectively, was 97 vs 100% in the per-protocol analysis (P = 0.497), and 76 vs 86% for the intention-to-treat analysis (P = 0.176). Nevertheless, CD4 count decreased in the QD Group, with a mean decline of 95 cells/mm3 (95% CI: 45-145). Twelve subjects in the QD Group (14%) discontinued treatment due to adverse events, mainly nevirapine-related hepatitis (6%). No significant differences regarding the rate of acute pancreatitis or peripheral neuropathy were observed between both groups. A significant improvement in the lipid profile was only seen in the QD Group. High levels of adherence were observed in both groups during follow-up, as well as a good quality of life. At week 48, a reduction in effort to take medication (P < or = 0.001) and an increment in the satisfaction with the treatment (P < 0.001) was only seen in the QD group. No differences were observed in median nevirapine trough levels between patients on twice-daily nevirapine at baseline (4820 ng/ml) and subjects in the QD Group (6090 ng/ml, P = 0.30). CONCLUSION: Treatment simplification to a once-daily antiretroviral regimen based on didanosine, tenofovir and nevirapine may be a valid approach in HIV-infected subjects with long-lasting viral suppression. Combination of standard doses of didanosine and tenofovir may have contributed to the CD4 cell decline observed with this QD regimen.