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  • SAGE Publications  (4)
  • Moreno, Ana  (4)
  • 1
    In: Antiviral Therapy, SAGE Publications, Vol. 5, No. 4 ( 2000-05), p. 243-248
    Abstract: To assess the long-term effectiveness of and factors associated with response to protease inhibitors (PIs) in a cohort of treatment-naive HIV-infected patients. Design and setting Prospective study in a tertiary care centre. Subjects A total of 207 treatment-naive patients starting PIs from March 1996 to May 1998. Main outcome measures: Clinical, virological and immunological outcomes, and adherence to therapy after 12 months. Results Baseline median CD4 cell count and viral load were 160 cells/mm 3 and 5 log 10 copies/ml, respectively. After 48 weeks, 168 patients (81%) reached plasma HIV-RNA levels below 400 copies/ml, and the mean increase in CD4 cell count was 196 cells/mm 3 . Clinical events were observed in 29 patients (14%) after a median time of 100 days on therapy, yet mortality was extremely low (0.9%). By multivariate analysis, adherence over 90% [relative risk (RR), 16.66; 95% confidence interval (CI), 5.26–50; P=0.00001] and AIDS diagnosis at baseline (RR 0.35; 95% CI, 0.14–0.90; P=0.02) were the strongest predictors for virological suppression. An immunological recovery over 100 cells/mm 3 was significantly associated with an initial virological response (RR 2.94; 95% CI, 1.31–6.66; P=0.009) and adherence over 90% (RR 3.44; 95% CI, 1.61–7.69; P=0.005). There were high rates of change with the first PI (40%), mostly due to adverse events (51%), but it did not compromise long-term effectiveness. Conclusions: Initial PI treatment in the clinical setting is able to reach equally good outcomes as those found in controlled trials. Changes in therapy due to toxicity do not compromise a successful outcome, which clearly depends on an adequate adherence to therapy.
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2000
    detail.hit.zdb_id: 2118396-X
    SSG: 15,3
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  • 2
    In: Antiviral Therapy, SAGE Publications, Vol. 9, No. 1 ( 2004-01), p. 133-138
    Abstract: Nucleoside analogues may induce mitochondrial toxicity, particularly didanosine. Ribavirin increases didanosine exposure, which might be clinically relevant when coadministered in HIV/HCV-coinfected patients. Objective To evaluate, among 89 patients receiving highly active antiretroviral therapy (HAART) and therapy for chronic hepatitis C, clinically relevant mitochondrial toxicity in those treated with concomitant ribavirin and didanosine ( n=35, 39%). Methods From January 2000 to July 2002 longitudinal analysis of the incidence and clinical course of didanosine-related hyperamylasaemia, pancreatitis, hyperlactataemia/lactic acidosis or neuropathy. Risk factors were evaluated using univariate and multivariate Cox's proportional hazards model. Results Among 35 patients who received concomitant didanosine (400 mg/day in 86%) and ribavirin (≥10 mg/kg/day in 91%), 20 (57%) developed one or more adverse events after a mean of 87 days. Most frequent laboratory abnormalities were hyperamylasaemia (18 patients, 51%) and hyperlactataemia (eight patients, 23%). Acute pancreatitis and symptomatic hyperlactataemia developed in 10 (28%) and six (17%) patients, respectively. Two patients (6%) with pancreatitis and severe lactic acidosis died; the other patients recovered uneventfully despite continuation of anti-HCV therapy in 83% after didanosine withdrawal in 40%. In the Cox's model higher baseline amylase levels (HR: 1.04, 95% CI: 1.02–1.06, P=0.001) and three nucleoside reverse transcriptase inhibitor-based HAART (HR: 5.3, 95% CI: 1.73–16.24, P=0.003) were significantly associated to toxicity. Conclusions The coadministration of didanosine and ribavirin should be avoided in HIV/HCV-coinfected patients, due to a high rate of clinically significant toxicity, particularly in triple nucleoside-based HAART. Amylase levels should be strictly monitored, especially if elevated at baseline.
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2004
    detail.hit.zdb_id: 2118396-X
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 3
    In: Journal of the International Association of Physicians in AIDS Care, SAGE Publications, Vol. 8, No. 5 ( 2009-09), p. 308-313
    Abstract: Purpose: To evaluate clinical, immunological, and virological outcomes after first-line highly active antiretroviral therapy (HAART) with a regimen including either efavirenz (EFV) or lopinavir/ritonavir (LPV/r) in treament-naive adult patients in routine clinical care. Method: An ongoing prospective, observational follow-up study included all patients starting their first antiretroviral therapy (ART) with any of the studied regimens from July 1998 to July 2004. The follow-up period was finalized in September 2006, when all patients completed an observation of at least 96 weeks. Mortality rates, CD4 counts, viral suppression (HIV RNA below 50 copies/mL), and discontinuation of any component of the regimen were compared at 48 and 96 weeks. Results: Despite the worst immunological status of the LPV/r group patients at baseline, this regimen was at least as effective as the one based on EFV not only in terms of treatment durability but also in terms of virological responses, nevertheless with an apparently quicker immune recovery. In general terms, both regimens present similar tolerability and safety outcomes except for the higher risk of increasing triglyceride (TG) levels in the LPV/r group. Low durability was observed in both regimens. Conclusion: In a routine clinical care setting, initial HAART containing LPV/r seems to present an effectiveness, tolerability, and toxicity similar to the one containing EFV.
    Type of Medium: Online Resource
    ISSN: 1545-1097
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2009
    detail.hit.zdb_id: 2709037-1
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  • 4
    In: Antiviral Therapy, SAGE Publications, Vol. 8, No. 6 ( 2003-08), p. 577-584
    Abstract: Resistance testing is useful in the management of virological failure patients, although the best method to be used in clinical practice has not been determined. Methods A prospective, randomized, double-blind, multicentre, controlled clinical trial was performed to compare the usefulness of drug resistance testing with a recombinant viral phenotype method or with a virtual phenotype, a genotyping interpretation system. Planned 300 HIV-infected adults failing their current antiretroviral therapy (HIV RNA 〉 1000 copies/ml) were centrally randomized 1:1 to resistance testing with a recombinant viral phenotype method or with a virtual phenotype, after stratifying according to previous drug exposure (one or two versus three drug classes). Percent of patients with HIV RNA suppression (% 〈 400 copies/ml) after 24 weeks was the primary outcome variable. Median HIV RNA concentration and change from baseline in HIV RNA concentration were also used to compare effectiveness. An extended analysis was performed at week 48. Results Of the 300 patients enrolled, a total of 276 patients could be analysed; 139 patients were randomized to the phenotype group and 137 patients were randomized to the virtual phenotype group. After 24 weeks of follow-up, 46.8 and 56.2% of patients had HIV RNA 〈 400 copies/ml ( P=0.1) in the phenotype and virtual phenotype, respectively. Mean decrease from baseline in viral load was 1.0 and 1.3 log copies/ml in the phenotype and virtual phenotype groups, respectively ( P=0.017). In a multivariate linear regression analysis, after adjusting for baseline HIV RNA and adherence to treatment, the virtual phenotype was associated with a greater mean decrease in plasma HIV RNA ( P=0.0063). The results observed at week 48 were similar. Conclusions Virtual phenotype is at least as effective as phenotype when used to select an optimized treatment for patients who have failed one or more antiretroviral regimens.
    Type of Medium: Online Resource
    ISSN: 1359-6535 , 2040-2058
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2003
    detail.hit.zdb_id: 2118396-X
    SSG: 15,3
    Location Call Number Limitation Availability
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