DESIGN: In-depth interviews of adolescent health care providers, 2013-2014.
SETTING: Five countries where HPV vaccination is at various stages of implementation into national programs: Argentina, Malaysia, South Africa, South Korea, and Spain.
PARTICIPANTS: Adolescent health care providers (N = 151) who had administered or overseen provision of adolescent vaccinations (N = Argentina: 30, Malaysia: 30, South Africa: 31, South Korea: 30, Spain: 30).
MAIN OUTCOME MEASURES: Frequency of HPV vaccination recommendation, reasons providers do not always recommend the vaccine and facilitators to doing so, comfort level with recommending the vaccine, reasons for any discomfort, and positive and negative aspects of HPV vaccination.
RESULTS: Over half of providers 82/151 (54%) recommend HPV vaccination always or most of the time (range: 20% in Malaysia to 90% in Argentina). Most providers 112/151 (74%) said they were comfortable recommending HPV vaccination, although South Korea was an outlier 10/30 (33%). Providers cited protection against cervical cancer 124/151 (83%) and genital warts 56/151 (37%) as benefits of HPV vaccination. When asked about the problems with HPV vaccination, providers mentioned high cost 75/151 (50% overall; range: 26% in South Africa to 77% in South Korea) and vaccination safety 28/151 (19%; range: 7% in South Africa to 33% in Spain). Free, low-cost, or publicly available vaccination 59/151 (39%), and additional data on vaccination safety 52/151 (34%) and efficacy 43/151 (28%) were the most commonly cited facilitators of health provider vaccination recommendation.
CONCLUSION: Interventions to increase HPV vaccination should consider a country's specific provider concerns, such as reducing cost and providing information on vaccination safety and efficacy.
METHODS: Over a one or two-year period, children <5 years hospitalized with CAP were identified using ICD-10 discharge codes. Cases were matched to standardized definitions of suspected (S-CAP), confirmed (C-CAP), or bacterial CAP (B-CAP) used in a pneumococcal conjugate vaccine efficacy study (COMPAS). Median total direct medical costs of CAP-related hospitalizations were calculated.
RESULTS: Vietnam (three centers): 7591 CAP episodes were identified with 4.3% (95% confidence interval 4.2;4.4) S-CAP, 3.3% (3.2;3.4) C-CAP and 1.4% (1.3;1.4) B-CAP episodes of all-cause hospitalization in children aged <5 years. The B-CAP case fatality rate (CFR) was 1.3%. Malaysia (two centers): 1027 CAP episodes were identified with 2.7% (2.6;2.9); 2.6% (2.4;2.8); 0.04% (0.04;0.1) due to S-CAP, C-CAP, and B-CAP, respectively. One child with B-CAP died. Indonesia (one center): 960 CAP episodes identified with 18.0% (17.0;19.1); 16.8% (15.8;17.9); 0.3% (0.2;0.4) due to S-CAP, C-CAP, and B-CAP, respectively. The B-CAP CFR was 20%. Korea (three centers): 3151 CAP episodes were identified with 21.1% (20.4;21.7); 11.8% (11.2;12.3); 2.4% (2.1;2.7) due to S-CAP, C-CAP, and B-CAP, respectively. There were no deaths.
COSTS: CAP-related hospitalization costs were highest for B-CAP episodes: 145.00 (Vietnam) to 1013.3 USD (Korea) per episode.
CONCLUSION: CAP hospitalization causes an important health and cost burden in all four countries studied (NMRR-12-50-10793).
METHODS: In this open-label, multicentre phase 2 trial, we recruited patients aged 21 years or older with relapsed or refractory peripheral T-cell lymphoma who had received at least one previous line of systemic therapy from five tertiary hospitals in Singapore, Malaysia, and South Korea. Patients received 20 mg oral panobinostat three times a week and 1·3 mg/m(2) intravenous bortezomib two times a week, both for 2 of 3 weeks for up to eight cycles. The primary endpoint was the proportion of patients who achieved an objective response in accordance with the International Working Group revised response criteria; analyses were by intention to treat. The study is completed and is registered with ClinicalTrials.gov, number NCT00901147.
FINDINGS: Between Nov 9, 2009, and Nov 26, 2013, we enrolled 25 patients with various histological subtypes of peripheral T-cell lymphoma. Of 23 patients assessable for responses, ten (43%, 95% CI 23-63) patients had an objective response, of which five were complete responses. Serious adverse events were reported in ten (40%) of 25 patients. Common treatment-related grade 3-4 adverse events included thrombocytopenia (17 [68%]), neutropenia (ten [40%]), diarrhoea (five [20%]), and asthenia or fatigue (two [8%]). We recorded peripheral neuropathy of any grade in ten (40%) patients.
INTERPRETATION: Combined proteasome and histone deacetylase inhibition is safe and feasible and shows encouraging activity for patients with peripheral T-cell lymphoma. Our findings validate those of preclinical studies showing synergism in the combination and represent a rational way forward in harnessing the full potential of novel agents in peripheral T-cell lymphoma.
FUNDING: Novartis Pharmaceuticals, Janssen Pharmaceuticals, and Singhealth Foundation.
METHODS: A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries.
RESULTS: Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea.
CONCLUSION: We have identified substantial variations in the structures, processes, and outcomes of PV status among the countries of the APEC region. Therefore, efforts to reduce variations in the PV administration and regulation are warranted for harmonization of PV within the APEC region.