Hep-CORE: a cross-sectional study of the viral hepatitis policy environment reported by patient groups in 25 European countries in 2016 and 2017.

INTRODUCTION: The first World Health Organization (WHO) global health sector strategy on hepatitis B and C viruses (HBV and HCV) has called for the elimination of viral hepatitis as a major public health threat by 2030. This study assesses policies and programmes in support of elimination efforts as reported by patient groups in Europe. METHODS: In 2016 and 2017, hepatitis patient groups in 25 European countries participated in a cross-sectional survey about their countries' policy responses to HBV and HCV. The English-language survey addressed overall national response; public awareness/engagement; disease monitoring; prevention; testing/diagnosis; clinical assessment; and treatment. We performed a descriptive analysis of data and compared 2016 and 2017 findings. RESULTS: In 2017, 72% and 52% of the 25 European study countries were reported to not have national HBV and HCV strategies respectively. The number of respondents indicating that their governments collaborated with civil society on viral hepatitis control increased from 13 in 2016 to 18 in 2017. In both 2016 and 2017, patient groups reported that 9 countries (36%) have disease registers for HBV and 11 (44%) have disease registers for HCV. The number of countries reported to have needle and syringe exchange programmes available in all parts of the country dropped from 10 (40%) in 2016 to 8 in 2017 (32%). In both 2016 and 2017, patient groups in 5 countries (20%) reported that HCV treatment is available in non-hospital settings. From 2016 to 2017, the reported number of countries with no restrictions on access to direct-acting antivirals for HCV increased from 3 (12%) to 7 (28%), and 5 fewer countries were reported to refuse treatment to people who are currently injecting drugs. CONCLUSIONS: The patient-led Hep-CORE study offers a unique perspective on the readiness of study countries to undertake comprehensive viral hepatitis elimination efforts. Viral hepatitis monitoring should be expanded to address policy issues more comprehensively and to incorporate civil society perspectives, as is the case with global HIV monitoring. Policy components should also be explicitly added to the WHO framework for monitoring country-level progress against viral hepatitis.

Health Outcomes for Clients of Needle and Syringe Programs in Prisons.

High levels of drug dependence have been observed in the prison population globally, and the sharing of injecting drug equipment in prisons has contributed to higher prevalence of bloodborne diseases in prisoners than in the general population. Few prison needle and syringe programs (PNSPs) exist. We conducted a systematic review to assess evidence regarding health outcomes of PNSPs. We searched peer-reviewed databases for data relating to needle and syringe programs in prisons. The search methodology was conducted in accordance with accepted guidelines. Five studies met review inclusion criteria, and all presented evidence associating PNSPs with one or more health benefits, but the strength of the evidence was low. The outcomes for which the studies collectively demonstrated the strongest evidence were prevention of human immunodeficiency virus and viral hepatitis. Few negative consequences from PNSPs were observed, consistent with previous evidence assessments. More research is needed on PNSP effectiveness, and innovative study designs are needed to overcome methodological limitations of previous research. Until stronger evidence becomes available, policymakers are urged to recognize that not implementing PNSPs has the potential to cause considerable harm, in light of what is currently known about the risks and benefits of needle and syringe programs and PNSPs and about the high prevalence of human immunodeficiency virus and viral hepatitis in prisons.

Policy responses to hepatitis C in the Nordic countries: Gaps and discrepant reporting in the Hep-Nordic study.

BACKGROUND AND AIMS: In the Nordic countries (Denmark, Finland, Iceland, Norway, Sweden), the prevalence of chronic hepatitis C virus (HCV) infection is relatively low in the general population, but is much higher among people who inject drugs (PWID). We conducted an exploratory study to investigate the extent to which these countries have policies supporting key elements of the public health response that is necessary to achieve the global goal of eliminating HCV as a public health threat. METHODS: Fourteen stakeholders representing government agencies, medical societies, and civil society organisations (CSOs) in the Nordic countries completed a cross-sectional online survey that included 21 policy questions related to national coordination, prevention, testing, linkage to care, and treatment. We summarised the findings in a descriptive analysis, and noted discrepant responses from stakeholders within the same country. RESULTS: Stakeholders reported that three of the five study countries have national viral hepatitis strategies, while only Iceland has a national HCV elimination goal. The availability of harm reduction services varies, with opioid substitution therapy provided for the general population throughout all countries, but not needle and syringe programmes. No country has access to anonymous HCV testing in all parts of the country. National HCV treatment guidelines are available in all countries except Finland, and all countries provide publicly funded direct-acting antiviral treatment. Disagreement regarding policies was observed across countries, and CSOs were the stakeholder group that most frequently answered survey questions incorrectly. CONCLUSION: The Nordic region as a whole has not consistently expressed its commitment to tackling HCV, despite the existence of large HCV epidemics among PWID in these countries. Stakeholder alignment and an established elimination goal with an accompanying strategy and implementation plan should be recognised as the basis for coordinated national public health efforts to achieve HCV elimination in the Nordic region and elsewhere.

Alkaline phosphatase variation during carfilzomib treatment is associated with best response in multiple myeloma patients.

The ubiquitin-proteasome pathway regulates bone formation through osteoblast differentiation. We analyzed variation alkaline phosphatase (ALP) during carfilzomib treatment. Data from 38 patients enrolled in the PX-171-003 and 29 patients in PX-171-004 studies, for patients with relapsed/refractory myeloma, were analyzed. All patients received 20 mg/m(2) of carfilzomib on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Sixty-seven patients from ALP data were evaluable. In PX-171-003, the ORR (>PR) was 18% and the clinical benefit response (CBR; >MR) was 26%, while in PX-171-004, the ORR was 35.5% overall and 57% in bortezomib-naive patients. ALP increment from baseline was statistically different in patients who achieved ≥ VGPR compared with all others on Days 1 (P = 0.0049) and 8 (P = 0.006) of Cycle 2. In patients achieving a VGPR or better, ALP increased more than 15 units per liter at Cycle 2 Day 1 over baseline. An ALP increase over the same period of time was seen in 26%, 13% and 11% of patients achieving PR, MR, and SD, respectively. This retrospective analysis of patients with relapsed or refractory myeloma treated with single-agent carfilzomib indicates that early elevation in ALP is associated with subsequent myeloma response.