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1.
Open Forum Infect Dis ; 4(1): ofw258, 2017.
Article in English | MEDLINE | ID: mdl-28480251

ABSTRACT

BACKGROUND: The Simeprevir ObservatioNal Effectiveness across practice seTtings (SONET) study evaluated the real-world effectiveness of simeprevir-based treatment for hepatitis C virus (HCV) infection. METHODS: The SONET study was a phase 4, prospective, observational, United States-based study enrolling patients ≥18 years of age with chronic genotype 1 HCV infection. The primary endpoint was the proportion of patients who achieved sustained virologic response 12 weeks after the end of treatment (SVR12), defined as HCV ribonucleic acid undetectable ≥12 weeks after the end of all HCV treatments. RESULTS: Of 315 patients (intent-to-treat [ITT] population), 275 (87.3%) completed the study. Overall, 291 were treated with simeprevir + sofosbuvir, 17 with simeprevir + sofosbuvir + ribavirin, and 7 with simeprevir + peginterferon + ribavirin. The majority of patients were male (63.2%) and white (60.6%); median age was 58 years, 71.7% had genotype/subtype 1a, and 39.4% had cirrhosis. The SVR12 was achieved by 81.2% (255 of 314) of ITT patients (analysis excluded 1 patient who completed the study but was missing SVR12 data); 2 had viral breakthrough and 18 had viral relapse. The SVR12 was achieved by 92.4% (255 of 276) of patients in the modified ITT (mITT) population, which excluded patients who discontinued treatment for nonvirologic reasons before the SVR12 time point or were missing SVR12 assessment data. Among mITT patients, higher SVR12 rates were associated with factors including age ≥65 years, non-Hispanic/Latino ethnicity, and employment status, but not genotype/subtype nor presence of cirrhosis. Simeprevir-based treatment was well tolerated; no serious adverse events were considered related to simeprevir. CONCLUSIONS: In the real-world setting, simeprevir + sofosbuvir treatment was common and 92% of mITT patients achieved SVR12. Simeprevir-based treatment was effective and well tolerated in this cohort, including patients with cirrhosis.

2.
Transpl Int ; 30(2): 196-208, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27896858

ABSTRACT

This prospective, randomized, phase 2 study in subjects with recurrent hepatitis C virus (HCV) genotype 1 postorthotopic liver transplant evaluated once-daily simeprevir 150 mg + sofosbuvir 400 mg, with and without ribavirin 1000 mg. Primary endpoint was proportion of subjects with week 12 sustained virologic response (SVR12). Thirty-three subjects without cirrhosis were randomized 1:1:1 into three arms (stratified by genotype/subtype and Q80K): Arm 1, simeprevir + sofosbuvir + ribavirin, 12 weeks; Arm 2, simeprevir + sofosbuvir, 12 weeks; Arm 3, simeprevir + sofosbuvir, 24 weeks; 13 additional subjects (two with cirrhosis, 11 without cirrhosis) entered Arm 3. All 46 subjects received at least one dose of study drug; median age, 60 years; 73.9% male; 80.4% White; 71.7% genotype/subtype 1a [12 (36.4%) of these had Q80K]; median 4.5 years post-transplant. Among randomized subjects, SVR12 was achieved by 81.8% in Arm 1, 100% in Arm 2, and 93.9% in Arm 3; two subjects did not achieve SVR12: one viral relapse (follow-up week 4; Arm 1) and one missing follow-up week 12 data. In total, five subjects had a serious adverse event, considered unrelated to treatment per investigator. Simeprevir exposure was increased relative to the nontransplant setting, but not considered clinically relevant. Simeprevir + sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials.gov Identifier: NCT02165189).


Subject(s)
Antiviral Agents/therapeutic use , Hepatitis C/drug therapy , Liver Transplantation/adverse effects , Postoperative Complications/drug therapy , Aged , Antiviral Agents/pharmacokinetics , Female , Hepacivirus/genetics , Hepatitis C/virology , Humans , Male , Middle Aged , Patient Reported Outcome Measures , Postoperative Complications/virology , Treatment Outcome
3.
Vaccine ; 34(50): 6236-6242, 2016 12 07.
Article in English | MEDLINE | ID: mdl-27836438

ABSTRACT

This study attempts to capture the opinions of stakeholders working in immunization programs in low- and middle-income countries to understand how vaccine products could be improved to better meet their needs and to obtain feedback on specific vaccine product attributes including the number of doses per container and ease of preparing a dose for administration. We also reviewed how procurement decisions are made within immunization programs. Semi-structured interviews were undertaken with 158 immunization stakeholders in Brazil, China, India, Peru, the Philippines, and Tanzania. Interviewees included national decision-makers and advisors involved in vaccine-purchasing decisions (n=30), national Expanded Programme on Immunization managers (n=6), and health and logistics personnel at national, subnational, and health-facility levels (n=122). Immunization stakeholders at all levels of the supply chain valued vaccine product attributes that prevent heat damage, decrease vaccine wastage, and simplify delivery. Minimizing the time required to prepare a dose is especially valued by those closest to the work of actually administering vaccines. Respondents appreciated the benefits of lower-multidose presentations on reducing wastage but seemed to prefer single-dose vials even more. They also expressed concern about the need for training and the potential for confusion and vial contamination if opened vials of liquid preservative-free vaccines are not handled properly. Procurement decision-making processes varied widely between countries, though most relied heavily on international agencies and vaccine manufacturers for information.


Subject(s)
Drug Stability , Immunization Programs , Vaccines/administration & dosage , Vaccines/supply & distribution , Developing Countries , Humans , Qualitative Research , Surveys and Questionnaires
4.
Vaccine ; 34(7): 899-904, 2016 Feb 10.
Article in English | MEDLINE | ID: mdl-26778422

ABSTRACT

INTRODUCTION: This study captures the perspectives of stakeholders at multiple levels of the vaccine supply chain regarding their assessment of challenges with storing vaccines within recommended temperature ranges and their perceptions on the benefits of having vaccines with improved stability, including the potential short-term storage and transport of vaccines in a controlled-temperature chain. METHODS: Semi-structured interviews were undertaken with 158 immunization stakeholders in six countries. Interviewees included national decision-makers and advisors involved in vaccine purchasing decisions, national Expanded Programme on Immunization managers, and health and logistics personnel at national, subnational, and health facility levels. RESULTS: Challenges with both heat and freeze-exposure of vaccines were recognized in all countries, with heat-exposure being a greater concern. Conditions leading to freeze-exposure including ice build-up due to poor refrigerator performance and improper icepack conditioning were reported by 53% and 28% of participants, respectively. Respondents were interested in vaccine products with improved heat/freeze-stability characteristics. The majority of those involved in vaccine purchasing indicated they would be willing to pay a US$0.05 premium per dose for a freeze-stable pentavalent vaccine (68%) or a heat-stable rotavirus vaccine (59%), although most (53%) preferred not to pay the premium for a heat-stable pentavalent vaccine if the increased stability required changing from a liquid to a lyophilized product. Most respondents (73%) were also interested in vaccines labeled for short-term use in a controlled-temperature chain. The majority (115/158) recognized the flexibility this would provide during outreach or should cold-chain breaks occur. Respondents were also aware that possible confusion might arise and additional training would be required if handling conditions were changed for some, but not all vaccines. CONCLUSION: Participating immunization stakeholders recognized the benefits of vaccine products with improved stability characteristics and of labeling vaccines for controlled-temperature chain use as a means to help address cold-chain issues in their immunization programs.


Subject(s)
Drug Stability , Refrigeration , Vaccines , Brazil , China , Drug Storage , Freezing , Health Personnel , Hot Temperature , India , Interviews as Topic , Peru , Philippines , Quality Control , Tanzania , Transportation , Vaccine Potency , Vaccines/economics
5.
Int J Gynaecol Obstet ; 127(1): 31-4, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25005056

ABSTRACT

OBJECTIVE: To assess the effect of a multifaceted intervention among skilled birth attendants on the use of oxytocin during the third stage of labor, the active management of the third stage of labor (AMTSL), and the rate of routine episiotomy during vaginal births in two health districts in Nicaragua. METHODS: An uncontrolled before-and-after study design was used. The rates of oxytocin use in the third stage of labor, AMTSL, and episiotomy were measured for vaginal births occurring in eight hospitals and health centers during 2011-2012, before and after implementation of a multifaceted facility-based intervention. The intervention involved the use of opinion leaders, interactive workshops to develop and implement evidence-based guidelines, academic detailing, the use of reminders, and feedback on the rates of oxytocin use and episiotomy. RESULTS: Oxytocin use during the third stage of labor increased significantly from 95.3% to 97.4% (P=0.003). The episiotomy rate dropped significantly from 31.2% to 21.2% overall, and from 59.6% to 40.5% in primiparous women (P<0.001 for both comparisons). CONCLUSION: The multifaceted intervention improved the targeted care practices during childbirth. However, a further decrease in the routine use of episiotomy would be desirable.


Subject(s)
Delivery of Health Care/statistics & numerical data , Episiotomy/statistics & numerical data , Oxytocics/therapeutic use , Oxytocin/therapeutic use , Postpartum Hemorrhage/prevention & control , Adolescent , Adult , Female , Humans , Labor Stage, Third , Male , Nicaragua , Pregnancy , Prospective Studies , Young Adult
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