REAL-LIFE SIDE EFFECTS OF INTERFERON-FREE THERAPY (OMBITASVIR / PARITAPREVIR / RITONAVIR + DASABUVIR +RIBAVIRIN) AND END OF TREATMENT RESULTS IN PATIENTS WITH COMPENSATED HCV CIRRHOSIS

Author(s):  
Alina Popescu
1994 ◽  
Vol 164 (5) ◽  
pp. 652-659 ◽  
Author(s):  
Metin Başoglu ◽  
Isaac M. Marks ◽  
Cengiz Kiliç ◽  
Richard P. Swinson ◽  
Homa Noshirvani ◽  
...  

Patients with panic disorder plus agoraphobia had 8 weeks of drug treatment (alprazolam or placebo) plus psychological treatment (exposure or relaxation). At the end of treatment at week 8, 40 patients who had become much/very much improved rated how much their gains were attributable to medication or to their own efforts. During the tapering-off to week 16, and treatment-free follow-up to week 43, patients who at week 8 had attributed their gains to medication and felt less confident in coping without tablets had more severe withdrawal symptoms and greater loss of gains than did patients who at week 8 had attributed their gains to their own efforts during treatment. Baseline illness severity, greater age, higher expectations from drug treatment, and more side-effects of drugs during treatment all predicted more external attributions (i.e. to the effect of drugs) but did not independently predict relapse. Patients on alprazolam compared with placebo had more drug attributions. Though drug attributions predicted relapse in both alprazolam and placebo groups, predictions were stronger in the alprazolam group.


2019 ◽  
Vol 76 (5) ◽  
pp. 531-536 ◽  
Author(s):  
Jasmina Simonovic-Babic ◽  
Ksenija Bojovic ◽  
Milotka Fabri ◽  
Tatjana Cvejic ◽  
Petar Svorcan ◽  
...  

Background/Aim. The era of direct-acting antiviral (DAA) regimen in the treatment of chronic hepatitis C virus (HCV) started in 2011. The aim of this study was to assess the antiviral efficacy and safety of DAA regimen, ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) + dasabuvir (DSV) + ribavirin (RBV), in patients with chronic HCV infection, genotype 1. Methods. The real-life data were collected. The study was multicentric and included seven infectious diseases and hepatology departments in Serbia. A total of 21 patients were enrolled in the OBV/PTV/r + DSV + RBV early access program, 20 of which were previously treated with pegylated interferon + RBV, while 1 was treatment-naive. All patients received the adequate doses of these antiviral drugs. RBV was not given to the patients with HCV genotype 1b infection according to the therapeutic protocol. For the majority of patient, the treatment duration lasted for 12 weeks. For the patients with liver cirrhosis, who were infected with HCV genotype 1a, the duration of treatment was 24 weeks. Viremia was assessed at four points in time: at baseline, 4 weeks after the treatment beginning (rapid viral response, RVR), 12 or 24 weeks after the treatment beginning (end of treatment response ? ETR) and 12 weeks after the end of treatment (sustained viral response ? SVR). SVR, as a confirmation of the absence of HCV was considered as endpoint of successful treatment. Results. Complete RVR, ETR and SVR were achieved in 64.71%, 85.71% and 95.24% of the patients, respectively. Only 3 patients had mild adverse effects which did not required dose reduction. Conclusion. The treatment of the patients with a chronic HCV infection with OBV/PTV/r + DSV + RBV resulted in excellent antiviral activity and tolerability.


CRANIO® ◽  
2020 ◽  
pp. 1-10 ◽  
Author(s):  
Aoben Chen ◽  
Maud S. Burger ◽  
Margriet A.W.J. Rietdijk-Smulders ◽  
Frank W.J.M. Smeenk

2013 ◽  
Vol 23 (9) ◽  
pp. 871-875 ◽  
Author(s):  
D. Rosenbaum ◽  
J. Dallongeville ◽  
P. Sabouret ◽  
E. Bruckert

2011 ◽  
Vol 26 (S2) ◽  
pp. 2178-2178
Author(s):  
G. Hajak

Agomelatine is a completely new approach to the treatment of depression thanks to its innovative mode of action. Acting as melatonergic agonist and 5-HT2C antagonist, it provides depressed patients with a distinctive antidepressant efficacy that perfectly suits patients’ needs and addresses all symptoms at each step of depression. Two years after the first launch in Europe, now is the time for an update from doctors and patients alike.The patient/doctor relation is key when initiating depression treatment, because patients are reluctant to start, fearing withdrawal symptoms, serious unwanted side effects, and “addiction”. It is important therefore that they understand that agomelatine has none of these effects.The benefits perceived by patients right from the first days of treatment are influential, because patients are reluctant to continue with classic antidepressants (delayed onset of perceived benefit, early side effects). The early improvement reported by patients on agomelatine supplements data on clinical benefits seen in clinical trials from the first week versus venlafaxine (CGI-I, rate of response, daytime alertness, feeling good) and after two weeks versus sertraline (twice as many HAM-D responders to agomelatine as to sertraline).Finally, patients are reluctant to maintain antidepressant treatment because of later side effects (weight gain, sexual dysfunction, emotional blunting). Patients on agomelatine confirm the absence of the classic side effects of antidepressants and are more likely to continue treatment than they are with other drugs. Both the antidepressant efficacy and the tolerability were confirmed in a large non-interventional study in a real-life setting in daily practice.


2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 608-608 ◽  
Author(s):  
Francoise Grude ◽  
Jean François Ramée ◽  
Laurent Guivarch ◽  
Jean-Yves Douillard ◽  
Sophie Rochard ◽  
...  

608 Background: Metastatic colorectal cancer (mCRC) management has been improved by targeted therapies. The evaluation of the use of panitumumab (PANI), after approval, in the real life is strategic to assess health politics. OMIT Bretagne - Pays de Loire is a network of private and public cancer centers. Methods: Data from patients treated with PANI in mCRC were collected. Previously published data are recited. Sex, age, primary tumor, Kras status, line of treatment, toxicity, reason of discontinuation, response, progression free survival (PFS) and overall survival (OS) have been studied. Results: Data of 322 patients treated between second half of 2008 and end of 2010 have been collected. PANI was used alone (85.5%) or with chemotherapy (14.5%) : mainly FOLFIRI, IRINOTECAN or FOLFOX). KRAS status was wild-type (WT 96.5%), mutated (0.5%), undetermined (2.5%) or not searched (0.5%). Only KRAS WT patients treated with monotherapy of PANI at 6 mg/kg every 2 weeks were analysed (n=263). Sexe : 177 men and 86 women. Median age : 67 years [36-90] (Van Custem JCO 2007: 62 years [27-83]). Primary tumor of patients was : colon (75%), rectum (22%) and others (3%). They received PANI mostly at line 2 (25%), 3 (46%) or 4 (19%). Discontinuation of treatment was mostly due to disease progression : 64%, death: 15% and toxicities : 7% (skin toxicities 3.7%). Clinical response was evaluated for the first 84 patients: partial response (PR): 30%, stable disease (SD): 14% and progression (P): 56%. In KRAS WT patients treated by PANI, Amado described 17% of PR, 34% of SD and 49% of P (Amado JCO 2008). Median duration of treatment was 69 days [0;360] (n=249). Median duration between end of treatment and death when death is the cause of end of treatment was 13 days [0;54] (n=35). Median of OS was 137 days [0;816] (n=143) which is lower than previously described (Van Cutsem JCO 2007 : 192 days regardless of KRAS status ; Amado JCO 2008 : 243 days in KRAS WT). Conclusions: The OMIT analysis of patients treated by PANI in Bretagne/Pays de Loire for a mCRC allows to assess the good use, according to its label, in the real life. Complete results about clinical response, PFS (cut-off 01/12/2011), OS and safety as well as previously published data will be shown at the meeting.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12507-e12507
Author(s):  
Giuseppe Buono ◽  
Alessandra Fabi ◽  
Lucia Del Mastro ◽  
Katia Cannita ◽  
Nicla Maria La Verde ◽  
...  

e12507 Background: T-DM1 is widely used in HER2 positive metastatic breast cancer (MBC) patients (pts), often for many cycles until progression. However, little is known about its long term toxicity. The aim of this study was to evaluate the safety profile of T-DM1 when delivered for ≥12 cycles. Methods: HER2 positive MBC pts who had received ≥12 cycles of T-DM1 across 18 Italian cancer centers were enrolled from January 2017 to September 2018. The 12 cycles cut-off was chosen based on the EMILIA trial median PFS (9.6 months), to identify a patient population treated with T-DM1 for longer time. Tumor and clinical characteristics were collected. Standard haematological tests, blood chemistries and side effects (nausea, vomiting, diarrhea, stomatitis, asthenia) were recorded cycle by cycle, according CTCAE criteria version 4. Haematological and laboratory toxicities were available for 86 patients, while other toxicities for all 115 patients. Results: Overall, 115 pts were enrolled. Median age was 54.5 (range 29.6–81.9); median time from diagnosis of metastatic disease to first T-DM1 cycle was 32.5 months. T-DM1 was administered as 2nd line and 3rd line of treatment in 45.2% and 27.8% of pts, respectively. Median number of cycles was 18 (range 12-59). Complete response, partial response and stable disease rates were 11.4%, 43% and 45.6%, respectively. Treatment related side effects are shown in table 1. Interestingly, no increased liver toxicity was observed in pts with liver metastases. Analysis of mean CTCAE grade by cycle showed that no relevant incremental toxicity was observed during long term T-DM1 therapy. Conclusions: T-DM1 is safe and well tolerated in these long responding pts. We found no relevant cumulative toxicity. Patients should be treated with T-DM1 as long as their tumor responds, as no safety issues are related to its long term use. [Table: see text]


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