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1.
PLoS One ; 14(6): e0217052, 2019.
Article in English | MEDLINE | ID: mdl-31158237

ABSTRACT

BACKGROUND: Direct-acting antivirals (DAAs) are effective in patients aged ≥65 years. However, little is known about the effects of DAAs on survival, liver decompensation and development of hepatocellular carcinoma (HCC). OBJECTIVE: To compare the incidence of liver-related events and mortality between patients aged ≥65 and <65 years. METHODS: Prospective study comparing patients aged ≥65 and <65 years treated with DAAs. The incidence of liver-related events and mortality, and HCC was compared between age groups. RESULTS: Five hundred patients (120 aged ≥65 and 380 aged <65 years) were included. The incidence of liver-related events was 2.62 per 100 patient-years (py) in older and 1.41/100 py in younger patients. All-cause mortality was 3.89 and 1.27/100 py in older and younger patients, respectively. The respective liver-related mortality rates were 1.12 and 0.31/100 py. In patients with cirrhosis (stage F4), all-cause mortality (P = 0.283) and liver-related mortality (P = 0.254) did not differ between groups. All five liver-related deaths were related to multifocal HCC. The incidence of HCC was 1.91 and 1.43 per 100 py in the older and younger groups, respectively (P = 0.747). The diagnosis of HCC was 8 months after the end of treatment. CONCLUSIONS: The incidence of liver-related events and liver-related mortality was low in older people treated with DAAs and was similar to that in younger patients. The extra mortality in people aged ≥65 years treated with DAAs seems to be secondary to non-liver-related causes. These results support the utilization of DAAs in patients aged ≥65 years.


Subject(s)
Antiviral Agents/pharmacology , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/mortality , Liver/drug effects , Aged , Antiviral Agents/therapeutic use , Carcinogenesis , Carcinoma, Hepatocellular/complications , Carcinoma, Hepatocellular/pathology , Female , Hepatitis C, Chronic/complications , Humans , Liver/pathology , Liver Neoplasms/complications , Liver Neoplasms/pathology , Male , Middle Aged
2.
HIV Clin Trials ; 19(5): 197-201, 2018 10.
Article in English | MEDLINE | ID: mdl-30605006

ABSTRACT

OBJECTIVES: Darunavir/ritonavir (DRV/r) in mono or dual therapy has proven efficacy in selected patients. The aim of this study was to evaluate the efficacy of switching from DRV/r to DRV/cobicistat (DRV/c) in patients under mono or dual therapy. METHODS: This was a prospective multicenter cohort study of patients using DRV/r under mono or dual therapy plus lamivudine who changed to DRV/c maintaining the previous regimen. All patients had a controlled HIV viral load (<50 copies/ml) when switched and were examined every 12 weeks. The primary end-point was the percentage of participants without virological failure (VF) at week 48 in the intent-to-treat analysis. The CD4 cell count and concentrations of cholesterol, triglyceride, and creatinine were measured from baseline to week 48. RESULTS: A total of 162 patients were included: 68.5% were men, and their mean age was 46 ± 12 years. Seventy (43.2%) patients were treated with DRV/r monotherapy, and 92 (56.8%) were treated with DRV/r plus lamivudine. The efficacy at week 48 was 95.1% (95% CI: 90.6%-97.5%) in the intent-to-treat analysis and 98.7% (95.5-99.6%) in the on-treatment analysis. Two VFs were documented but without development of resistance mutations. No significant changes were found in the lipid profile. Creatinine concentration increased significantly by 0.07 mg/dl (0.04-0.10, P < 0.001). CONCLUSIONS: Switching from DRV/r to DRV/c in patients under mono or dual therapy is safe and effective.


Subject(s)
Cobicistat/therapeutic use , Darunavir/therapeutic use , HIV Infections/drug therapy , Ritonavir/therapeutic use , Adult , Cobicistat/administration & dosage , Cohort Studies , Darunavir/administration & dosage , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Prospective Studies , Ritonavir/administration & dosage , Viral Load
3.
J Clin Virol ; 88: 58-61, 2017 03.
Article in English | MEDLINE | ID: mdl-28183063

ABSTRACT

BACKGROUND: New direct-acting antivirals agents (DAAs) are very safe and well tolerated. OBJECTIVES: The purpose of this study is to analyse the efficacy and safety of DAAs in elderly patients, who have co-morbidities and are on chronic medications. STUDY DESIGN: All HCV-infected patients over 65 years old in clinical follow-up at two Hospitals in Spain who initiated anti-HCV therapy were included (August 2012-October 2015). RESULTS: A total of 120 HCV mono-infected patients were recorded. Mean age of patients was 72.6±7.4years. There were 53.3% women and GT1b was the most frequent (83.3%); 64.2% had cirrhosis and 42.5% were treatment experienced. Ombitasvir+Paritaprevir/r±Dasabuvir±Ribavirin (RBV) and sofosbuvir/ledipasvir±RBV were the most frequently used regimens. Weight-adjusted dosing of RBV was included in 61.7% and 43.6% of them required a dose reduction. Most of the patients (86.7%) had concomitant chronic medication and in 35.8% adjustment was necessary. Adverse events (AE) were seen in 65% of the patients; more frequent when a protease inhibitor (PI) was being used. The sustained virological response (SVR12) per ITT was 88.3%. Only 3 patients discontinued treatment and 2 patients died. CONCLUSIONS: High rates of SVR12 (88.3%) were observed among elderly patients with DAAs-based regimens. The presence of AE was frequent (65%). The majority of these patients (86.7%) had concomitant medication that required adjustment in 1/3 of them. These findings highlight the high rates of response to DAAs in the elderly HCV-population. However, special caution must be taken when using RBV and a PI.


Subject(s)
Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , Hepatitis C, Chronic/drug therapy , Aged , Aged, 80 and over , Drug Therapy, Combination/adverse effects , Drug Therapy, Combination/methods , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Male , Prospective Studies , Spain , Treatment Outcome
4.
J Med Virol ; 88(12): 2125-2131, 2016 12.
Article in English | MEDLINE | ID: mdl-27218208

ABSTRACT

The clinical experience with the protease inhibitor darunavir/ritonavir (DRV/r) was retrospectively evaluated in a cohort of 173 HIV+ patients who initiated antiretroviral treatment including DRV/r (period 2007-2015). The 43.2% had a CD4 nadir ≤100 cells/mm3 , 64.1% were treatment-experienced, and 36.5% had failed to >3 lines of antiretroviral therapy. Nonetheless, the rate of virological suppression (HIV-RNA <50 copies/ml) in naïve patients was 63%, 66.7%, and 63.6% at 48, 96, and 144 weeks, respectively. The rate of virological suppression in treatment-experienced patients was 62.7%, 78.7%, and 79.1% at 48, 96, and 144 weeks, respectively. No differences were observed according to the immunovirological status neither dosage of DRV/r. Most of them (82.6%) maintained DRV/r treatment. Causes for DRV/r discontinuation were mainly gastrointestinal and cutaneous adverse events (10.5%), switch to simplification treatment strategies (3.5%) and virological failure (1.7%). These findings demonstrate the prolonged efficacy and tolerability of DRV/r even in multi-treated HIV+ patients with an unfavorable immunovirological status. J. Med. Virol. 88:2125-2131, 2016. © 2016 Wiley Periodicals, Inc.


Subject(s)
Darunavir/therapeutic use , HIV Infections/drug therapy , HIV Protease Inhibitors/therapeutic use , HIV-1/drug effects , Viral Load/drug effects , Adult , Anti-HIV Agents/administration & dosage , Anti-HIV Agents/adverse effects , Anti-HIV Agents/therapeutic use , CD4 Lymphocyte Count , Darunavir/administration & dosage , Darunavir/adverse effects , Drug Administration Schedule , Drug Therapy, Combination , Female , HIV Infections/epidemiology , HIV Infections/virology , HIV Protease Inhibitors/administration & dosage , HIV Protease Inhibitors/adverse effects , HIV-1/genetics , Humans , Long Term Adverse Effects , Lopinavir/adverse effects , Lopinavir/therapeutic use , Male , RNA, Viral/blood , Retrospective Studies , Ritonavir/administration & dosage , Ritonavir/adverse effects , Ritonavir/therapeutic use , Spain , Sulfonamides/adverse effects , Sulfonamides/therapeutic use , Young Adult
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