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Frontiers in Public Health 2022This study aims to systematically review recent economic evaluations of elbasvir/grazoprevir (EBR/GZR) for chronic hepatitis C (CHC), to critically appraise the...
OBJECTIVE
This study aims to systematically review recent economic evaluations of elbasvir/grazoprevir (EBR/GZR) for chronic hepatitis C (CHC), to critically appraise the reporting quality and to summarize the results.
METHODS
A literature search was undertaken using Medline, Embase, the Cochrane Library, EconLit, China National Knowledge Infrastructure, Wanfang Data, and Chongqing VIP to identify original articles containing economic evaluations of EBR/GZR for CHC published between 1 January 2000 and 31 December 2020. The Consolidated Health Economic Evaluation Reporting Standards statement was used to assess the quality of reporting of the articles.
RESULTS
Of 93 articles identified, 13 studies fulfilled the inclusion criteria. These studies were conducted in 4 countries, and 8 active interventions were assessed. The target population was patients infected with CHC genotype 1 infection in all studies. Eight out of 13 studies that compared EBR/GZR vs. other direct antiviral agents suggested that EBR/GZR was generally more cost-effective or dominant than daclatasvir/asunaprevir (DCV/ASV), sofosbuvir/velpatasvir (SOF/VEL), ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir (3D) but not more cost-effective than glecaprevir/pibrentasvir (GLE/PIB). Two studies from China and one study from the USA that compared EBR/GZR vs. pegylated interferon and ribavirin (PegIFN/RBV) consistently indicated that EBR/GZR was generally more cost-effective than PegIFN/RBV. One study from Italy compared EBR/GZR with SOF + PegIFN/RBV and suggested that EBR/GZR had a lower cost and higher effectiveness. One study from France and one study from the USA confirmed that compared with non-therapy for patients with chronic kidney disease, EBR/GZR was cost-effective at commonly accepted current standards. All included studies were of good quality of reporting, with an average score of 21.9 (range 19-23).
CONCLUSION
EBR/GZR for CHC genotype 1 might be cost-effective or dominant compared with PegIFN/RBV and other direct antiviral agents (SOF/VEL, 3D, DCV/ASV, LDF/SOF) or non-therapy. However, under certain assumptions, EBR/GZR was not a cost-effective alternative for CHC patients vs. GLE/PIB.
Topics: Amides; Antiviral Agents; Benzofurans; Carbamates; Cost-Benefit Analysis; Cyclopropanes; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Quinoxalines; Ribavirin; Sofosbuvir; Sulfonamides
PubMed: 35646774
DOI: 10.3389/fpubh.2022.836986 -
Nutrition Reviews Oct 2022Nutritional interventions for newborns with brain injury are scarce, and there are gaps in the knowledge of their mechanisms of action in preventing the occurrence of... (Meta-Analysis)
Meta-Analysis
CONTEXT
Nutritional interventions for newborns with brain injury are scarce, and there are gaps in the knowledge of their mechanisms of action in preventing the occurrence of cerebral palsy (CP) or the incidence of other developmental disabilities.
OBJECTIVE
The objective of this review was to assess the effect of nutritional interventions in preventing nonprogressive congenital or perinatal brain injuries, or in improving outcomes related to neurological development.
DATA SOURCES
Randomized trials on any nutritional intervention for pregnant women at risk of preterm delivery, or for children with low birth weight, preterm, or with confirmed or suspected microcephaly, CP, or fetal alcohol syndrome disorders (FASDs) were retrieved from MEDLINE, Embase, Scopus, Web of Science, LILACS, and CENTRAL databases from inception to September 17, 2020.
DATA EXTRACTION
Data extraction, risk of bias (Cochrane Risk of Bias tool 2), and quality of evidence (GRADE approach) were assessed by 2 authors.
DATA ANALYSIS
Pooled risk ratios (RRs) with 95% confidence intervals were calculated using a random-effects meta-analysis. Seventeen studies were included on intravenous interventions (magnesium sulfate [n = 5], amino acids [n = 4], vitamin A [n = 1], and N-acetylcysteine [n = 1]); enteral interventions (vitamin D [n = 1], prebiotic [n = 1], nutrient-enriched formula [n = 1], and speed of increasing milk feeds [n = 1]); and oral interventions (choline [n = 1] and docosahexaenoic acid, choline, and uridine monophosphate [n = 1]). All studies assessed CP, except 1 on FASDs. Eight studies were judged as having high risk of bias. Five studies (7413 babies) with high-quality evidence demonstrated decreased risk of childhood CP (RR = 0.68, 95% CI: 0.52-0.88) with magnesium sulfate. Interventions with amino acids had no effect on CP prevention or other outcomes. Except for 1 study, no other intervention decreased the risk of CP or FASDs.
CONCLUSION
Although different types of nutritional interventions were found, only those with antenatal magnesium sulfate were effective in decreasing CP risk in preterm infants. Well-designed, adequately powered randomized clinical trials are required.
Topics: Acetylcysteine; Brain Injuries; Cerebral Palsy; Child; Choline; Docosahexaenoic Acids; Female; Fetal Alcohol Spectrum Disorders; Humans; Infant; Infant, Newborn; Infant, Premature; Magnesium Sulfate; Pregnancy; Randomized Controlled Trials as Topic; Uridine Monophosphate; Vitamin A; Vitamin D
PubMed: 35568996
DOI: 10.1093/nutrit/nuac028 -
PloS One 2022Contribution of UCP1 single nucleotide polymorphisms (SNPs) to susceptibility for cardiometabolic pathologies (CMP) and their involvement in specific risk factors for... (Meta-Analysis)
Meta-Analysis
Contribution of UCP1 single nucleotide polymorphisms (SNPs) to susceptibility for cardiometabolic pathologies (CMP) and their involvement in specific risk factors for these conditions varies across populations. We tested whether UCP1 SNPs A-3826G, A-1766G, Ala64Thr and A-112C are associated with common CMP and their risk factors across Armenia, Greece, Poland, Russia and United Kingdom. This case-control study included genotyping of these SNPs, from 2,283 Caucasians. Results were extended via systematic review and meta-analysis. In Armenia, GA genotype and A allele of Ala64Thr displayed ~2-fold higher risk for CMP compared to GG genotype and G allele, respectively (p<0.05). In Greece, A allele of Ala64Thr decreased risk of CMP by 39%. Healthy individuals with A-3826G GG genotype and carriers of mutant allele of A-112C and Ala64Thr had higher body mass index compared to those carrying other alleles. In healthy Polish, higher waist-to-hip ratio (WHR) was observed in heterozygotes A-3826G compared to AA homozygotes. Heterozygosity of A-112C and Ala64Thr SNPs was related to lower WHR in CMP individuals compared to wild type homozygotes (p<0.05). Meta-analysis showed no statistically significant odds-ratios across our SNPs (p>0.05). Concluding, the studied SNPs could be associated with the most common CMP and their risk factors in some populations.
Topics: Cardiovascular Diseases; Case-Control Studies; Cytidine Monophosphate; Genetic Predisposition to Disease; Humans; Metabolic Diseases; Polymorphism, Single Nucleotide; Prevalence; Uncoupling Protein 1
PubMed: 35482655
DOI: 10.1371/journal.pone.0266386 -
Journal of Clinical Anesthesia Aug 2022To investigate the association of unintentional dural puncture (UDP) and postdural puncture headache (PDPH) with the risk of chronic headache, backache, neckache and... (Meta-Analysis)
Meta-Analysis Review
STUDY OBJECTIVE
To investigate the association of unintentional dural puncture (UDP) and postdural puncture headache (PDPH) with the risk of chronic headache, backache, neckache and depression. We also investigated if epidural blood patch (EBP) is associated with reduced risk of these morbidities.
DESIGN
Systematic review and meta-analysis.
PATIENTS
Pregnant women who experienced UDP and/or PDPH versus those who had uneventful neuraxial procedures, and women who received EBP versus those who did not.
INTERVENTIONS
None.
MEASUREMENTS
Primary outcomes were headache, backache, and neckache lasting ≥12 months, and depression ≥1 month. Secondary outcomes included chronic headache, backache, and neckache persisting ≥1 and ≥ 6 months, and the effects of EBP on those outcomes at ≥1 and ≥ 12 months. Subgroup analyses of prospective studies and sensitivity analyses of primary outcomes excluding poor quality studies were performed.
MAIN RESULTS
Twelve studies compared 6541 women with UDP and/or PDPH versus 1,004,510 with uncomplicated neuraxial procedures. Eight studies compared EBP (n = 3610) with no EBP (n = 3154). UDP and/or PDPH were associated with increased risk of headache (RR 3.95; 95%CI 2.13 to 7.34; I 42%), backache (RR 2.72; 95%CI 2.04 to 3.62; I 1%), and neckache (RR 8.09; 95%CI 1.03 to 63.35) persisting ≥12 months, and depression (RR 3.12; 95%CI 1.44 to 6.77; I 90%) lasting ≥1 month. Results were consistent in analyses at ≥1 and ≥ 6 months, subgroup analyses of prospective studies, and after exclusion of one poor-quality study from our primary outcome. EBP was not associated with significant reduction in the risk of long-term morbidities.
CONCLUSIONS
UDP and/or PDPH were associated with increased risk of chronic headache, backache, neckache, and depression. EBP was not associated with a significant reduction in those risks, but this conclusion is limited by the heterogeneity of current data and lack of information on the success of EBP in relieving acute PDPH symptoms.
Topics: Female; Humans; Pregnancy; Back Pain; Blood Patch, Epidural; Headache; Headache Disorders; Morbidity; Neck Pain; Post-Dural Puncture Headache; Prospective Studies; Punctures; Spinal Puncture; Uridine Diphosphate
PubMed: 35358942
DOI: 10.1016/j.jclinane.2022.110787 -
International Journal of Antimicrobial... Mar 2022This systematic review and meta-analysis examined the efficacy of sofosbuvir-based antiviral treatment against COVID-19 (coronavirus disease 2019). PubMed, Embase,... (Meta-Analysis)
Meta-Analysis
This systematic review and meta-analysis examined the efficacy of sofosbuvir-based antiviral treatment against COVID-19 (coronavirus disease 2019). PubMed, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched from inception to 15 August 2021. Studies comparing the clinical efficacy and safety of sofosbuvir-based antiviral regimens (study group) with other antivirals or standard of care (control group) in patients with COVID-19 were included. Overall, 687 patients with COVID-19 were included, of which 377 patients received sofosbuvir-based treatment. Mortality was lower in the study group than in the control group [odds ratio (OR) = 0.49, 95% confidence interval (CI) 0.30-0.79; I = 0%]. The overall clinical recovery rate was higher in the study group than in the control group (OR = 1.82, 95% CI 1.20-2.76; I = 28%). The study group presented a lower requirement for mechanical ventilation (OR = 0.33, 95% CI 0.13-0.89; I = 0%) and intensive care unit admission (OR = 0.42, 95% CI 0.25-0.70; I = 0%) than the control group. Furthermore, the study group exhibited a shorter hospital length of stay [mean deviation (MD), -1.49, 95% CI -2.62 to -0.37; I = 56%] and recovery time (MD, -1.34, 95% CI -2.29 to -0.38; I = 46%) than the control group. Sofosbuvir-based treatment may help reduce mortality in patients with COVID-19 and improve associated clinical outcomes. Furthermore, sofosbuvir-based treatment was as safe as the comparator in patients with COVID-19. However, further large-scale studies are warranted to validate these findings.
Topics: Humans; Intensive Care Units; Randomized Controlled Trials as Topic; Respiration, Artificial; SARS-CoV-2; Sofosbuvir; Treatment Outcome; COVID-19 Drug Treatment
PubMed: 35134505
DOI: 10.1016/j.ijantimicag.2022.106545 -
Expert Review of Anti-infective Therapy Apr 2022Several randomized trials have evaluated the effects of sofosbuvir-based direct-acting antivirals on the clinical outcomes in patients with COVID-19. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Several randomized trials have evaluated the effects of sofosbuvir-based direct-acting antivirals on the clinical outcomes in patients with COVID-19.
METHODS
A systematic literature search with no language restrictions was performed on electronic databases and preprint repositories to identify eligible randomized trials published up to 8 July 2021. A random-effects model was used to estimate the pooled odds ratio (OR) for outcomes of interest with the use of sofosbuvir combined with direct-acting antiviral agents relative to the nonuse of sofosbuvir-based direct-acting antiviral agents at 95% confidence intervals (CI).
RESULTS
The meta-analysis of 11 trials (n = 2,161) revealed statistically significant reduction in the odds of mortality (pooled odds ratio = 0.59; 95% confidence interval 0.36 to 0.99) but no statistically significant difference in the odds of development of composite endpoint of severe illness (pooled odds ratio = 0.79; 95% confidence interval 0.43 to 1.44) with the administration of sofosbuvir-based direct-acting antiviral agents among patients with COVID-19, relative to non-administration of sofosbuvir-based direct-acting antiviral agents.Subgroup analysis with seven trials involving sofosbuvir-daclatasvir revealed no significant mortality benefit (pooled odds ratio = 0.77; 95% confidence interval 0.48 to 1.22).
CONCLUSION
Sofosbuvir-based direct-acting antiviral agents have no protective effects against the development of severe illness in patients with COVID-19 with the current dosing regimen. Whether sofosbuvir-based direct-acting antiviral agents could offer mortality benefits would require further investigations.
Topics: Antiviral Agents; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Randomized Controlled Trials as Topic; SARS-CoV-2; Sofosbuvir; COVID-19 Drug Treatment
PubMed: 34719324
DOI: 10.1080/14787210.2022.2000861 -
BMC Infectious Diseases Sep 2021Previous studies reported worsened lipid profiles in patients infected with hepatitis C virus (HCV) during direct-acting antivirals (DAAs) treatment. This study aimed to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Previous studies reported worsened lipid profiles in patients infected with hepatitis C virus (HCV) during direct-acting antivirals (DAAs) treatment. This study aimed to investigate the effect of sofosbuvir (SOF)-based DAAs on changes in low-density lipoprotein (LDL) in HCV patients.
METHODS
A systematic review of articles published before 31 May 2021 was conducted by searching MEDLINE, Cochrane Library, EMBASE, and CINAHL Plus. Eligible studies were those comparing SOF-based DAAs and non-SOF DAAs for HCV patients and providing numerical data for changes in LDL. Risk of Bias in Non-randomized Studies- of Interventions was used for assessing risk of bias, and meta-analysis was performed for changes in LDL.
RESULTS
Six studies comprising 1248 patients were included, 848 patients treated with SOF-based DAAs and 400 patients with non-SOF DAAs vs. SOF-based DAAs group had significantly greater increases in LDL from baseline to week 4 than non-SOF DAAs group (P = 0.001). However, changes in LDL from baseline to the end of treatment (P = 0.060), to post-treatment week 12 (P = 0.263), and to post-treatment week 24 (P = 0.319) did not significantly differ between the two groups. Further comparison of SOF/ledipasvir with asunaprevir/daclatasvir revealed a similar trend in changes in LDL.
CONCLUSIONS
For HCV patients, SOF-based DAA regimens were associated with rapid and significant increases in LDL during the initial 4 weeks of treatment, and the changes did not sustain after the end of treatment. Potential mechanism might be related to the phosphoramidate side chain of SOF.
Topics: Antiviral Agents; Drug Therapy, Combination; Genotype; Hepacivirus; Hepatitis C; Hepatitis C, Chronic; Humans; Lipoproteins, LDL; Ribavirin; Sofosbuvir; Sustained Virologic Response; Treatment Outcome
PubMed: 34548026
DOI: 10.1186/s12879-021-06657-9 -
Nephrology (Carlton, Vic.) Jan 2022Sofosbuvir (SOF) and velpatasvir (VEL) is a pan-genotypic regimen for the treatment of Hepatitis C virus (HCV) infection. The data on the efficacy and safety of this... (Meta-Analysis)
Meta-Analysis
Sofosbuvir plus velpatasvir combination for the treatment of chronic hepatitis C in patients with end stage renal disease on renal replacement therapy: A systematic review and meta-analysis.
INTRODUCTION
Sofosbuvir (SOF) and velpatasvir (VEL) is a pan-genotypic regimen for the treatment of Hepatitis C virus (HCV) infection. The data on the efficacy and safety of this regimen is end-stage renal disease (ESRD) is scanty. This systematic review and meta-analysis was done to ascertain the efficacy and safety of SOF and VEL in patients with chronic Hepatitis C (CHC) and ESRD on renal replacement therapy (RRT).
METHODS
Systematic search of Pubmed, Embase, Scopus, and Google Scholar was conducted using the search term (end-stage renal disease OR renal replacement therapy OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR haemodialysis OR dialysis OR peritoneal dialysis) AND (sofosbuvir OR velpatasvir OR NS5A inhibitors OR directly acting antivirals). Pooled sustained virologic response (SVR) and adverse event rates with 95% confidence intervals were estimated.
RESULTS
Seven studies (410 patients with CHC and ESRD on RRT) fulfilled our eligibility criteria. The overall pooled SVR rate of SOF and VEL in patients with HCV on RRT was 97.69% (95% CI: 95.71 to 98.92). There was no significant heterogeneity (I : 39.3%, p-value of Cochran's Q = 0.13) among the studies. The pooled estimate of efficacy of SOF-VEL combination among patients with cirrhosis was 91.94% (95% CI 77.03-98.52). Pooled SVR rates in genotype 3 infection [94.6%, (95%: CI 81.3-99.4)] was comparable to that in those with documented non-genotype 3 infection [94.63%, (95% CI 87.12-98.44)]. No serious adverse event attributable to SOF and VEL was reported in the included studies.
CONCLUSION
The fixed-dose combination of SOF and VEL is effective and safe in CHC patients with ESRD on RRT.
Topics: Antiviral Agents; Carbamates; Drug Combinations; Hepatitis C, Chronic; Heterocyclic Compounds, 4 or More Rings; Humans; Kidney Failure, Chronic; Renal Replacement Therapy; Sofosbuvir; Treatment Outcome
PubMed: 34453374
DOI: 10.1111/nep.13968 -
Virology Journal Jul 2021Limited data is available on the efficacy of direct acting anti-viral drugs on hepatitis C in drug users. The aim of this meta-analysis was to comprehensively analyze... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIMS
Limited data is available on the efficacy of direct acting anti-viral drugs on hepatitis C in drug users. The aim of this meta-analysis was to comprehensively analyze the efficacy and safety of LDV/SOF in drug users infected with the hepatitis C virus (HCV).
METHODS
The PubMed, Cochrane library, Embase and Web of Science databases were searched for articles published till April 2021 on HCV-positive drug users who were treated with ledipasvir/sofosbuvir (LDV/SOF). The primary endpoint was pooled sustained virological response at 12 weeks (SVR12) with 95% confidence interval (95% CI). Funnel plots and Egger's test were used to assess the publication bias.
RESULTS
A total of 12 studies and 711 subjects treated with LDV/SOF-based regimen for HCV were included, and the pooled SVR12 rate was 89.8% (95% CI 85.9-92.7). The pooled SVR12 rate of genotype 1 drug users was 92.4% (95% CI 88.6-95.0). Subgroup analysis showed that pooled SVR12 rates of patients treated with LDV/SOF and LDV/SOF ± RBV were 89.2% (95% CI 83.4-93.1), 90.4% (95% CI 83.6-94.5) respectively. In addition, the SVR12 rates were 88% (95% CI 70.7-95.7) for 8 weeks, 89.9% (95% CI 81.0-94.9) for 12 weeks and 82.2% (95% CI 24.9-98.5) for 24 weeks of treatment.
CONCLUSION
LDV/SOF is a safe and relatively effective treatment for hepatitis C in drug users.
Topics: Antiviral Agents; Benzimidazoles; Drug Users; Fluorenes; Hepatitis C; Humans; Sofosbuvir; Sustained Virologic Response
PubMed: 34315488
DOI: 10.1186/s12985-021-01625-w -
Pain Medicine (Malden, Mass.) Apr 2022Chronic musculoskeletal pain (CMP) outcomes are affected by numerous variables, including the clinical conversation. When good therapeutic/working alliances are formed,...
Patient and Provider Attitudes, Beliefs, and Biases That Contribute to a Marginalized Process of Care and Outcomes in Chronic Musculoskeletal Pain: A Systematic Review-Part I: Clinical Care.
OBJECTIVE
Chronic musculoskeletal pain (CMP) outcomes are affected by numerous variables, including the clinical conversation. When good therapeutic/working alliances are formed, congruent clinical conversations can lead to improved CMP outcomes. Identifying patient/provider attitudes, beliefs, and biases in CMP that can influence the clinical conversation, and thus clinical management decisions, is foundationally important.
DESIGN
The aims of this systematic review were to 1) summarize the evidence of the attitudes and beliefs of patients and health care providers (HCPs) involved in the clinical conversation about CMP, and 2) examine whether and how these perceptions impacted the process of care.
METHODS
A systematic search of CINAHL, PubMed, Scopus, Sociology Database in ProQuest, and Web of Science used the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Included studies were those investigating vulnerable adult populations with chronic pain. Study bias was examined with the Downs and Black tool.
RESULTS
Seven retrospective studies were included. When making pharmaceutical management decisions, HCPs demonstrated negative implicit biases toward minorities and women. When making referrals to multidisciplinary care, HCPs demonstrated negative implicit biases toward women with lower educational attainment. Unmet patient expectations resulted in higher dropout rates at multidisciplinary pain management programs. Patients' trust was influenced by the health care setting, and patients often had limited options secondary to health insurance type/status.
CONCLUSION
These findings suggest that patients with CMP may experience a marginalized process of care due to HCPs' negative implicit biases, unmet patient expectations, and the health care setting. Results suggest several factors may contribute to inequitable care and the recalcitrant nature of CMP, particularly in vulnerable populations with limited health care choices.
Topics: Adult; Attitude; Bias; Chronic Pain; Cytidine Monophosphate; Female; Humans; Musculoskeletal Pain; Retrospective Studies
PubMed: 34297104
DOI: 10.1093/pm/pnab195