Comparative effectiveness of ledipasvir/sofosbuvir ± ribavirin vs. ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin in 6961 genotype 1 patients treated in routine medical practice

Backus, Lisa I.; Belperio, Pamela S.; Shahoumian, Troy A.; Loomis, Timothy P.; Molé, L

doi:10.1111/apt.13696

Cited by 69 publications

(77 citation statements)

References 27 publications

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“…These rates were similar to the 92.9% or 92% SVR rates derived from the first regimen presented in two US VA National Healthcare System studies[18,19] and the 94.9% or 95.1% SVR rates achieved with the second regimen in other studies in clinical practice[18,20]. …”

Section: Discussionsupporting

confidence: 84%

“…Most real-world studies reported results in genotype 1 HCV patients[14,19,20]. The SVR rate in our study, which included 362 genotype 1 patients, was 94.5% of the overall genotype 1 patients, which was somewhat higher than previously reported rates (SVRs over 91%), although limited differences were observed among the different DAA combinations, treatment durations and use of RBV.…”

Section: Discussioncontrasting

confidence: 68%

“…Discontinuation rates were low (< 1%), which is similar to that of CTs, and there were no deaths during treatment or follow up. In Backus et al[20] higher early discontinuation rates of 5.3% to 15.2% according to the treatment combination were found. In contrast, of the 802 patients in the genotype 1 group from the HCV-TARGET cohort treated with SMV and SOF, the rate of discontinuation for adverse events was only 2%[15].…”

Section: Discussionmentioning

confidence: 99%

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Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Ramos

Linares

Badía

et al. 2017

WJGPT

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AIMTo investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV).METHODSWe performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively).RESULTSThe most frequently prescribed treatment was simeprevir/sofosbuvir (36.4%), followed by sofosbuvir/ledipasvir (24.9%) and ombitasvir/paritaprevir/ritonavir (r)/dasabuvir (19.9%). Ribavirin (RBV) was administered in 198 patients (42.9%). SVRs occurred in 437/462 patients (94.6%). The SVRs ranged between 93.3% and 100% for genotypes 1-4. SVRs were achieved in 96.2% patients in the CT-met group vs 91.9% patients in the CT-unmet group (P = 0.049). Undetectable HCV RNA at week 4 occurred in 72.9% of the patients. In the univariate analysis, the factors associated with SVRs were lower liver stiffness, absence of cirrhosis, higher platelet count, higher albumin levels, no RBV dose reduction, undetectable HCV RNA at week 4 and CT-met group. In the multivariate analysis, only albumin was an independent predictor of treatment failure (P = 0.04). Eleven patients (2.4%) developed SAEs; 5.2% and 0.7% of the patients in the CT-unmet and CT-met groups, respectively (P = 0.003).CONCLUSIONA high proportion of patients with HCV infection achieved SVRs. For patients who did not meet the CT criteria, treatment regimens must be optimized.

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Section: Discussionsupporting

confidence: 84%

Section: Discussioncontrasting

confidence: 68%

Section: Discussionmentioning

confidence: 99%

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Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Ramos

Linares

Badía

et al. 2017

WJGPT

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“…The therapeutic success increased significantly to 95%-97% Sustained Viral Response (SVR) depending on the fibrosis stage and cirrhosis [5][6][7][8][9]. Therefore a necessity of earlier diagnosis became indubitable to prevent the future complications and deaths.…”

Section: Introductionmentioning

confidence: 99%

Screening and diagnosis of chronic HCV infection in Bulgaria: A review of the current practice

Dimitrova¹,

Kamusheva²,

Mitov³

et al. 2018

biomedicalresearch

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Background: Chronic HCV infection is one of the leading causes of chronic liver disease and places significant health and economic burden worldwide. In Bulgaria blood and blood products weren`t screened before 1992. Currently there is no official national screening program and diagnosis is usually accidental and in more advanced stages of the disease. Methods and materials: A synthetic, population-based decision tree with Markov chain model compares the current practice (No screening) with possible screening program among (Screening) the people aged 39-64 as a part of the routine prophylaxis program. A Markov chain model was built at the end every decision node of the patients without Sustained Viral Response (SVR) to find how they will progress for the observed period. Results: Possible national screening would lead to almost 4 times higher number of patients diagnosed at early stages of the infection, almost 2 to 4 times higher number of patients with access to treatment and decrease in the HCV-related expected mortality. Expected life years gained in the Screening alternative are almost 2 (10 417 LYGs) and 4 times (22 715 LYGs) higher compared to the current situation (4798 LYGs), respectively. Only 45% of the people however perform routine prophylaxis. Conclusion: National screening is considered as effective health care measure to fight chronic diseases because through active search we can find asymptomatic patients. Initiation of treatment in early stages of hepatitis C infection is more effective and decreases the mortality rates.

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“…While several observational studies [5, 6, 13–16] have studied DAA treatment effectiveness among cohorts with cirrhosis and human immunodeficiency virus (HIV) or through the United States Veterans Administration [13, 17], no study has evaluated the effectiveness among a diverse group of participants from a general population as large as that available in Clalit Health Services (CHS).…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir for hepatitis C virus in clinical practice: A population-based observational study

et al. 2017

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BackgroundDirect acting antivirals for hepatitis C virus have shown dramatic results in clinical trials. However, their effectiveness has yet to be demonstrated within observational cohorts which lack exclusion criteria found in randomized control trials.AimTo determine the effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir in achieving sustained virological response.MethodsRetrospective observational cohort study of all Clalit Health Services members with hepatitis C virus genotype 1 who were dispensed dasabuvir/ombitasvir/paritaprevir/ritonavir from January 1, 2015 to-November 31, 2015.ResultsThere were 564 participants during the study period. The average age was 61.9 years, 52.0% were male, and 61.5% were born Eastern/Central Europe or Central Asia. The prevalence of diabetes was 31.7% and 70.3% were overweight/obese. Cirrhosis was present in 41.0% of participants, of whom 52.8% had stage 4 fibrosis. Of the cohort, 416 (74.8%) had follow-up viral load testing at 10 or more weeks after the end of treatment. We report a sustained virological response of 98.8% among those tested.ConclusionsTreatment with dasabuvir/ombitasvir/paritaprevir/ritonavir demonstrated a near universal effectiveness in achieving a sustained virological response among HCV patients in a large cohort.

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Comparative effectiveness of ledipasvir/sofosbuvir ± ribavirin vs. ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin in 6961 genotype 1 patients treated in routine medical practice

Cited by 69 publications

References 27 publications

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Screening and diagnosis of chronic HCV infection in Bulgaria: A review of the current practice

Effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir for hepatitis C virus in clinical practice: A population-based observational study

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