Second-generation direct-acting-antiviral hepatitis C virus treatment: Efficacy, safety, and predictors of SVR12

Abstract

AIMTo gather data on the antiviral efficacy and safety of second generation direct acting antiviral (DAA) treatment with respect to sustained virological response (SVR) 12 wk after conclusion of treatment, and to determine predictors of SVR12 in this setting.METHODSTwo hundred and sixty patients treated with SOF combination partners PR (n = 51), R (n = 10), SMV (n = 30), DCV (n = 81), LDV (n = 73), or 3D (n = 15). 144/260 were pre-treated, 89/260 had liver cirrhosis, 56/260 had portal hypertension with platelets < 100/nL, 25/260 had a MELD score ≥ 10 and 17/260 were post-liver transplantation patients. 194/260 had HCV GT1, 44/260 HCV GT3.RESULTSTwo hundred and forty/256 (93.7%) patients achieved SVR12 (mITT); 4/260 were lost to follow-up. SVR12 rates for subgroups were: 92% for SOF/DCV, 93% for each SOF/SMV, SOF/PR, 94% for SOF/LDV, 100% for 3D, 94% for pretreated, 87% for liver cirrhosis, 82% for patients with platelets < 100/nL, 88% post-liver transplantation, 95% for GT1a, 93% for GT1b, 90% for GT3, 100% for GT2, 4, and 6. 12 patients suffered from relapse, 6 prematurely discontinued treatment, of which 4 died. Negative predictors of SVR12 were a platelet count < 100/nL, MELD score ≥ 10 (P < 0.0001), liver cirrhosis (P = 0.005) at baseline. In Interferon-free treatment GT3 had significantly lower SVR rates than GT1 (P = 0.016). Side effects were mild.CONCLUSIONExcellent SVR12 rates and the favorable side-effect profile of DAA-combination therapy can be well translated into “real-world”. Patients with advanced liver disease, signs of portal hypertension, especially with platelets < 100/nL and patients with GT3 are in special need for further research efforts to overcome comparatively higher rates of virological failure.

Treatment of Viral Hepatitis C by the Sofosbuvir and Ledipasvir With or Without Ribavirin Combination in Cameroon: Efficiency, Tolerance and Significant Predictors of SVR12

“…The median pre-therapeutic viral load was 1,183,000 IU/ mL and 58.2% of patients had a high viral load (≥ 800,000). This result was similar to that found by Werner et al which found an initial high viral load at 65% of cases [23]. This high mean viremia in this study population could be explained by the selection of severe patients in the indexed study.…”

“…However, the difference in SVR12 was not significant between genotypes. These results were close to those found by Werner et al in 2016 in Germany, which found a 98% SVR12 for genotype 4 [23]. Cirrhotic patients responded significantly less well with 71% SVR12.…”

“…Cirrhotic patients responded significantly less well with 71% SVR12. These results were close to those of Werner et al which found SVR12 to be significantly lower in cirrhotic patients at 87% compared to non-cirrhotic patients [23]. The low response of cirrhotic patients could be explained by the scarred fibrosis installed and the functional deficiency of the hepatocytes induced by cirrhosis.…”

Avaliação da efetividade e segurança dos novos fármacos de ação direta indicados no tratamento da hepatite C

“…Utilizou-se a média da taxa de RVS 12 semanas após o fim do tratamento, considerando seis artigos publicados previamente ao início deste trabalho (POL et al, 2017;SULKOWSKI et al, 2014;JI et al, 2016;WERNER et al, 2016;BECK;KIM;KHALILI, 2016;DAHARI et al, 2016). Estes artigos referem-se a estudos realizados com objetivos similares e em um contexto semelhante ao proposto por esta pesquisa.…”

“…). Um estudo de coorte alemão demonstrou que 92% dos pacientes que utilizaram SOF e DCV alcançaram RVS, enquanto 93% dos pacientes que utilizaram SOF e SMV alcançaram RVS(WERNER et al, 2016). Em estudo de vida real brasileiro realizado por Ferreira e colaboradores, o uso de tratamentos compostos por SOF e DCV proporcionou taxas de RVS de aproximadamente 95%, enquanto as taxas de RVS com o uso de SOF e SMV foram de aproximadamente 92%(FERREIRA et al, 2018).A tabela 6 descreve as taxas de RVS dentro de cada variável analisada, separadas por esquema de tratamento utilizado.…”