Daily versus thrice-weekly interferon alfa-2b plus ribavirin for the treatment of chronic hepatitis C in HIV-infected persons: a multicenter randomized controlled trial

Among HIV-infected persons, chronic hepatitis C virus (HCV) infection causes substantial morbidity and mortality. However, few studies have evaluated the safety and efficacy of interferon alfa (IFN) and ribavirin (RBV) therapy in co-infected persons. Accordingly, a randomized, controlled, open-label, multicenter trial was conducted to establish the safety, tolerability, and efficacy of IFN alfa-2b 3 mIU daily plus RBV 800 mg/d compared with IFN alfa-2b 3 mIU thrice weekly (TIW) plus RBV 800 mg/d in HCV treatment-naive, HIV-infected subjects with compensated liver disease and stable HIV disease. The primary endpoint was sustained virologic response (SVR), defined as an undetectable HCV RNA level 24 weeks after discontinuation of HCV therapy. At study entry, subjects in both groups were similar with respect to age, gender, HCV genotype, and HIV disease status. Of 180 randomized subjects, 162 received at least 1 dose of study medication, constituting the modified intention-to-treat population. After 12 weeks of therapy, 122 (75%) had serum HCV RNA levels assessed; of these subjects, early virologic response (undetectable HCV RNA or >2 log10 decrease from baseline) was observed in 33 (42%) and 13 (16%) of subjects taking daily and TIW IFN, respectively (P < 0.001). SVR was observed in 15 (19.0%) and 7 (8.4%) of subjects taking daily and TIW IFN, respectively (P = 0.05). Adverse events were similar in both groups. However, while no deaths or opportunistic infections were observed, nearly 30% of subjects stopped treatment due to adverse events and 7 subjects experienced a serious adverse event. In conclusion, SVR was achieved in 19% of HIV/HCV coinfected subjects treated with daily IFN plus RBV, but the effectiveness of therapy was substantially diminished by relatively high rates of treatment-related toxicity.     

Correction to: Factor Structure and Equivalence of Maternal Resources for Care in Bangladesh,Vietnam, and Ethiopia

Maternal and Child Health Journal - The article “Factor Structure and Equivalence of Maternal Resources for Care in Bangladesh, Vietnam, and Ethiopia”, written by Sulochana Basnet,...     

Performance of Serum-Based Scores for Identification of Mild Hepatic Steatosis in HBV Mono-infected and HBV–HIV Co-infected Adults

Digestive Diseases and Sciences - There are limited data on noninvasive methods to identify hepatic steatosis in coexisting hepatitis B virus (HBV) infection. To evaluate the diagnostic performance...     

Readiness to change for interprofessional collaboration in healthcare: Development and validation of a theory-based instrument

This paper presents a study that aimed to develop and validate a theory-based instrument for the assessment of readiness to change for interprofessional collaboration in healthcare (IPC-TTM). The instrument was developed in the Persian language and tested in the Iranian context. Healthcare professionals from medical and nursing professions participated in the assessment of validity and reliability of the instrument. We conducted this psychometric study in two phases: First, the questionnaire was developed based on the transtheoretical model (TTM) through literature review and expert panel. Then, in the validation phase, we held three modified Delphi rounds to assess the content and face validity of the questionnaire. We used confirmatory factor analysis (CFA) to evaluate the fit of the questionnaire as applied to modified TTM. Reliability of the final instrument was tested by assessing the test-retest reliability of instrument items with Kappa coefficient. We also calculated the intraclass correlation coefficient (ICC) and Cronbach’s alpha to assess the test-retest reliability and internal consistency of the instrument sub-scales. The initial item pool consisted of 30 items and three sub-scales (Attitude, Intention, and Action). The content validity of the questionnaire was confirmed with 17 items. Based on the CFA results two additional items were deleted to increase the fit of the model. The final instrument was confirmed with 15 items and three sub-scales. Reliability assessment on the 15-item instrument showed an acceptable test-retest reliability of the instrument items. ICC values for the Attitude, Intention, and Action sub-scales of the instrument were calculated as 0.82, 0.73, and 0.71, respectively. Moreover, Cronbach’s alpha for the Attitude, Intention, and Action sub-scales were 0.85, 0.73, and 0.77, respectively. This study offers a new theory-based instrument to measure readiness to change for interprofessional collaboration in healthcare in the Iranian context. The questionnaire can be used for ‘needs assessment’ in developing tailored educational interventions and self-assessments in interprofessional education studies.     

Development of large-scale manufacturing of adipose-derived stromal cells for clinical applications using bioreactors and human platelet lysate

In vitro expanded adipose-derived stromal cells (ASCs) are a useful resource for tissue regeneration. Translation of small-scale autologous cell production into a large-scale, allogeneic production process for clinical applications necessitates well-chosen raw materials and cell culture platform. We compare the use of clinical-grade human platelet lysate (hPL) and fetal bovine serum (FBS) as growth supplements for ASC expansion in the automated, closed hollow fibre quantum cell expansion system (bioreactor). Stromal vascular fractions were isolated from human subcutaneous abdominal fat. In average, 95?×?10⁶ cells were suspended in 10% FBS or 5% hPL medium, and loaded into a bioreactor coated with cryoprecipitate. ASCs (P0) were harvested, and 30?×?10⁶ ASCs were reloaded for continued expansion (P1). Feeding rate and time of harvest was guided by metabolic monitoring. Viability, sterility, purity, differentiation capacity, and genomic stability of ASCs P1 were determined. Cultivation of SVF in hPL medium for in average nine days, yielded 546?×?10⁶ ASCs compared to 111?×?10⁶ ASCs, after 17?days in FBS medium. ASCs P1 yields were in average 605?×?10⁶ ASCs (PD [population doublings]: 4.65) after six days in hPL medium, compared to 119?×?10⁶ ASCs (PD: 2.45) in FBS medium, after 21?days. ASCs fulfilled ISCT criteria and demonstrated genomic stability and sterility. The use of hPL as a growth supplement for ASCs expansion in the quantum cell expansion system provides an efficient expansion process compared to the use of FBS, while maintaining cell quality appropriate for clinical use. The described process is an obvious choice for manufacturing of large-scale allogeneic ASC products.     

Methods for quantifying insulin resistance in human immunodeficiency virus-positive patients

Various indirect indices have been used in human immunodeficiency virus (HIV)-infected individuals to assess insulin resistance, but the validity of these measures has not been rigorously assessed by comparison with physiologic methods of quantifying insulin-mediated glucose uptake (IMGU). We directly measured IMGU in 50 nondiabetic HIV-positive subjects by determining the steady-state plasma glucose (SSPG) concentration in response to a 3-hour continuous infusion of insulin, glucose, and somatostatin. Because steady-state plasma insulin concentrations were similar (approximately 60 microU/mL) in all subjects, the SSPG concentrations provided direct assessments of insulin action. Relationships between SSPG levels and various surrogate measures of IMGU derived from the 75-g oral glucose tolerance test (OGTT) were determined. The indirect measure of IMGU most closely related to SSPG concentrations was the total integrated insulin response to a 75-g glucose load (r=0.78, P<.01), accounting for approximately two thirds of the variability in SSPG (r2=0.61). Other indirect measures of IMGU, including the homeostasis assessment for insulin resistance (HOMA-IR), were also significantly related to SSPG values, but had lower magnitudes of correlation (r=0.43 to 0.61), thereby possessing limited ability to predict SSPG variability (r2=0.18 to 0.37). In conclusion, indirect measures of IMGU need to be applied with caution when evaluating insulin action in HIV-infected patients.