Objectives: To comparatively ascertain possible ADR's on HIV patient's started/ substituted on Tenofovir/Lamivudine/Dolutegravir (TDF/3TC/DTG). Methods: A total of 50 ART Adherent patients newly started/substituted on Tenofovir/Lamivudine/ Dolutegravir were randomly selected from (St. Charles Borromeo Hospital and Holy Rosary Hospital). A total of 25 men of 30 years and above and 25 menopausal women of 50 years and above were sampled randomly from both hospitals with informed consent. Each of the 50 patients were placed on one month (TDF/3TC/DTG) with adequate counselling and monitoring. The daily dose of (TDF/3TC/DTG) were directed to be taken once in the morning after meal. Patient's were advised not to take the ART combination together with any drug or supplement. They were all accessed for adverse drug reactions on their next visit. Results: Statistical documentations of the different ADR's among patients, using the pharmacovigilance ADR's reporting form were recorded. 7 men representing 28% presented with CNS side-effects (Insomnia, headache, fatique and dizziness), 9 men representing 36% presented with GIT side-effects (Increased appetite, diarrhoea, nausea and vomiting). 2 men representing 8% presented with frequent urination, while 7 men representing 28% didn't come up with any significant ADR. 13 women representing 52% presented with GIT side-effects (Abdominal discomfort and pain, diarrhoea) while 6 women representing 24% presented with CNS side-effects (Fatique, headache, insomnia and dizziness), another 6 women representing 24% didn't come up with any significant ADR. A total of 13 patients of both men and women representing 26% of all presented with mild CNS ADR's, while a total of 22 patients representing 44% of all presented with moderate GIT ADR's. Finally, a total of 2 men only representing 4% of all presented with severe renal ADR's (Frequent urination). Conclusions: The general ADR observed in combination of (TDF/3TC/DTG) is minimal and well separated. ADR's in (TDF/3TC/DTG) is better manage with most positive outcomes.
Objectives: Currently, no specific rules to guide retreatment decisions exists for hepatitis C virus (HCV)-infected patients recidivants to previous treatments based on direct-acting antivirals (DAAs). Retreatment must be based on which drugs were previously administered and resistance-associated substitutions (RASs). The objective is to analyze the effectiveness of retreatment with DAAs in HCV-infected patients, non-responders to prior DAAs course and identify predictor variables of response. Methods: Prospective, observational study in recidivant HCV-infected patients, during 3 years. Exclusion criteria: patients from penitentiary centers and pediatrics. Effectiveness main variable: sustained virological response 12 weeks post-treatment (SVR12). Covariates: HCV genotype, HIV co-infection, liver transplantation, cirrhosis, RASs, antiviral retreatment, hepatocarcinoma. Statistical method: intention-to-treat analysis; statistical signification calculated with Fisher exact or Mann-Whitney tests. Study authorized by the Health System Investigation Committee. Results: 24 patients included: 88% males, 56.7613.4 years, 46%/33%/ 17%/4% genotype 1/3/4/2 infected respectively, 38% cirrhosis, 8% HIV-co-infected, 25% liver transplant, 13% hepatocarcinoma. 86%, 38% and 19% RASs to NS5A, NS3 and NS5B respectively. 88% (68%-97%, 95%CI) of patients reached SVR12. 75% genotype 3 vs 94% genotype non-3 had SVR12 (p=0.51). 89% cirrhotics vs 87% non-cirrhotics got SVR12 (p=0.63). 50% liver transplant recipients vs 100% non-transplant patients reached SVR12 (p=0.01). 33% vs 95% of patients with vs without hepatocarcinoma reaches SVR12 (p=0.04). No statistically significant differences were observed in SVR12 depending on the presence/absence of the different types of RASs (p. 0.65) or the presence of resistance to one of the rescue antivirals (p = 0.72). Conclusions: A high DAAs effectiveness is observed in recidivant HCV-infected patients. Being a liver transplant or having a hepatocarcinoma may condition the response to treatment. RASs presence does not seem to condition the effectiveness of the antiviral treatment, but given the limited population studied (derived from the high effectiveness of a first DAAs course), more studies are needed to confirm these data.
BackgroundChronic hepatitis C (CHC) treatment has radically changed with the commercialisation of direct-acting antivirals (DAAs) for the hepatitis C virus (HCV) with high levels of safety and effectiveness. Available data from clinical trials reveal that baseline factors at the beginning of treatment that can influence treatment results are basically viral genotype, baseline viral load, degree of fibrosis and previous treatments (naive or pretreated).PurposeTo identify patient, virus or treatment baseline factors which can influence antiviral treatment effectiveness obtained with DAAs in real clinical practice.Material and methodsProspective observational study of patients with CHC who initiated and completed antiviral treatment for 12 or 24 weeks, between 1 April 2015 and 1 January 2017. Exclusion criteria: patients from prisons. Main variable: sustained virological response (SVR). Covariates: sex, age, HIV coinfection, previous treatment, hepatic transplantation, cirrhosis, fibrosis, viral genotype, baseline viral load and antiviral treatment. Statistical method: descriptive analysis comparing patients with SVR and patients with relapse. Statistical significance was calculated with the Fisher exact test and Mann–Whitney U test. This study was authorised by the Health System Investigation Committee.ResultsSeven hundred and ninety-eight patients included, mean age: 58±12 years; 63.4% males; 66.8% naives; 30.6% cirrosis; 14% HIV coinfected; 4.7% hepatic transplantation; HCV genotypes: 4.4% G1; 23.6% G1A; 42.9% G1B; 5.3% G2; 13.5% G3; 10.3% G4. Median basal viral load: 1,475,595 UI/mL. Median adherence to DDAs: 100%. Fibrosis degree: 9.5% F0–1, 33.1% F2, 27.4% F3 and 30% F4. Treatments: 50.7% sofosbuvir/ledipasvir; 25.3% paritaprevir/ombitasvir/ribavirin/dasabuvir; 14.1% sofosbuvir/daclatasvir; 11.7% others (five). Eighty-three per cent DAAs treatment for 12 weeks. Only nine patients relapsed to treatment, so SRV was 98.7%. The lowest SVR were obtained for genotype 3 (96.9%) and for sofosbubir/daclatasvir (95.9%). None of the analysed basal covariates significantly influences SVR, except sexr (p=0.03), since all the relapsers were males.ConclusionThis prospective study in a large population of patients demonstrates the high effectiveness of treatment with DAAs against HCV in real clinical practice. Neither genotype, nor baseline viral load, nor degree of fibrosis, nor previous treatments nor any other variable except sex, had influence on SRV.References and/or Acknowledgements1. Jacobsen JC. Direct-acting antivirals for chronic hepatitis C. Cochrane Database Syst Rev2017Sep 18;9:CD012143.Conflict of interest: Corporate-sponsored research or other substantive relationships. Conference fees: Gilead, Bristol-Myers Squibb, Abbvie, Merck-Sharp-Dhome. Advisory Board: Gilead, Bristol-Myers Squibb.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.