Browsing by Author "Antinori, Andrea"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Discontinuation of maintenance therapy for cryptococcal meningitis in patients with AIDS treated with highly active antiretroviral therapy: an international observational study
    (2004-02-15) Mussini, Cristina; Pezzotti, Patrizio; Miró, José M; Martinez, Esteban; de Quiros, Juan Carlos Lopez Bernaldo; Cinque, Paola; Borghi, Vanni; Bedini, Andrea; Domingo, Pere; Cahn, Pedro; Bossi, Philippe; de Luca, Andrea; d'Arminio Monforte, Antonella; Nelson, Mark; Nwokolo, Nneka; Helou, Silvia; Negroni, Ricardo; Jacchetti, Gaia; Spinello, Antinori; Lazzarin, Adriano; Cossarizza, Andrea; Esposito, Roberto; Antinori, Andrea; Aberg, Judith A; International Working Group on Cryptococcosis
    We conducted a retrospective, multicenter study evaluating the safety of discontinuing maintenance therapy for cryptococcal meningitis after immune reconstitution. Inclusion criteria were a previous definitive diagnosis of cryptococcal meningitis, a CD4 cell count of >100 cells/µL while receiving highly active antiretroviral therapy (HAART), and the subsequent discontinuation of maintenance therapy for cryptococcal meningitis. The primary end point was relapse of cryptococcal disease. As of July 2002, 100 patients were enrolled. When maintenance therapy was discontinued, the median CD4 cell count was 259 cells/µL and the median plasma virus load was <2.30 log10 copies/mL, and serum cryptococcal antigen was undetectable in 56 patients. During a median follow-up period of 28.4 months (range, 6.7–64.5; 262 person-years), 4 events were observed (incidence, 1.53 events per 100 person-years; 95% confidence interval, 0.42–3.92). Three of these patients had a CD4 cell count of >100 cells/µL and a positive serum cryptococcal antigen test result during the recurrent episode. In conclusion, discontinuation of maintenance therapy for cryptococcal meningitis is safe if the CD4 cell count increases to >100 cells/µL while receiving HAART. Recurrent cryptococcal infection should be suspected in patients whose serum cryptococcal antigen test results revert back to positive after discontinuation of maintenance therapy.
  • Thumbnail Image
    Item
    Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy - naive adults with HIV-1 infection
    (2022-01-01) Cahn, Pedro; Sierra Madero, Juan; Arribas, Jose; Antinori, Andrea; Ortiz, Roberto; Clarke, Amanda E; Hung, Chien-Ching; Rockstroh, Jürgen K; Girard, Pierre-Marie; Sievers, Jörg; Man, Choy Y; Urbaityte, Rimgaile; Brandon, Daisy J; Underwood, Mark; Pappa, Keith A; Curtis, Lloyd; Smith, Kimberly Y; Gartland, Martin; Aboud, Michael; van Wyk, Jean; Wynne, Brian
    [ABSTRACTS]. OBJECTIVE: To assess efficacy and safety of dolutegravir (DTG) + lamivudine (3TC) vs. DTG + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naive adults with HIV-1 in the prespecified 144-week secondary analyses of GEMINI-1 and GEMINI-2. DESIGN: Identical, multicenter, phase III, randomized, non-inferiority studies (double-blind through 96 weeks). METHODS: Participants with HIV-1 RNA ≤500 000 copies/ml and no major viral resistance mutations to nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, or protease inhibitors were randomized 1:1 to once-daily DTG + 3TC or DTG + TDF/FTC. RESULTS: At week 144, DTG + 3TC (N = 716) was noninferior to DTG + TDF/FTC (N = 717) in proportion of participants achieving HIV-1 RNA <50 copies/ml (Snapshot algorithm) in the pooled analysis (82% vs. 84%, respectively; adjusted treatment difference [95% confidence interval (CI)], -1.8% [-5.8, 2.1]), GEMINI-1 (-3.6% [-9.4, 2.1]), and GEMINI-2 (0.0% [-5.3, 5.3]). Twelve DTG + 3TC participants and nine DTG + TDF/FTC participants met protocol-defined confirmed virologic withdrawal (CVW) criteria; none developed treatment-emergent resistance. One DTG + 3TC participant who did not meet CVW criteria developed M184V at week 132 and R263R/K at week 144, conferring a 1.8-fold change in susceptibility to DTG; non-adherence to therapy was reported. Significantly fewer drug-related adverse events occurred with DTG + 3TC vs. DTG + TDF/FTC (20% vs. 27%; relative risk [95% CI], 0.76 [0.63-0.92]). Renal and bone biomarker changes favored DTG + 3TC. CONCLUSIONS: Three-year durable efficacy, long-term tolerability, and high barrier to resistance support first-line use of DTG + 3TC for HIV-1 treatment (see Supplemental Digital Content 1, http://links.lww.com/QAD/C297; video abstract).