NFVIs, especially those due to V. vulnificus, demonstrate high morbidity and mortality. Persons with liver disease should be advised of the risks associated with seawater exposure if a wound is already present or is likely to occur. Clinicians should consider Vibrio species as an etiologic agent in infections occurring in persons with recent seawater exposure, even if the individual was only exposed during recreational marine activities. Immediate antibiotic treatment with aggressive monitoring is advised in suspected cases.
Summary Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Aim To report incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the tofacitinib UC programme. Methods DVT and PE were evaluated from one phase 2 and two phase 3 induction studies, one phase 3 maintenance study and an ongoing, open‐label, long‐term extension (OLE) study (September 2018 datacut). Data were analysed in induction, maintenance and overall (patients receiving ≥ 1 dose of tofacitinib 5 or 10 mg b.d. in any phase 2, 3 or OLE study) cohorts. Results 1157 patients (2404 patient‐years’ exposure; ≤ 6.1 years’ tofacitinib treatment) were evaluated in the overall cohort. In induction, one placebo‐treated patient had DVT and one had PE; no tofacitinib‐treated patients had DVT/PE. In maintenance, one placebo‐treated patient had DVT and one had PE; no tofacitinib‐treated patients had DVT/PE. In the overall cohort, one patient had DVT (incidence rate [patients with events/100 patient‐years; 95% CI]: 0.04 [0.00‐0.23]); four had PE (0.16 [0.04‐0.41]); all received predominant dose tofacitinib 10 mg b.d.; all had venous thromboembolism risk factors alongside UC. Conclusions In this post hoc analysis of patients with UC, during tofacitinib exposure, one patient had DVT and four had PE, all during the OLE study, on predominant dose 10 mg b.d. (83% of overall cohort patients received predominant dose 10 mg b.d.) with venous thromboembolism risk factors. This analysis is limited by small sample size and limited drug exposure; further studies are needed. ClinicalTrials.gov: NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612.
Validation studies of claims data published in the English language in the Asia-Pacific region are very limited. Given the increased reliance on administrative health care databases for pharmacoepidemiology and the need for ensuring the credibility of results from such data, additional support for the conduct of validation research of claims data in the Asia-Pacific region is needed.
Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We aimed to estimate the overall incidence of safety events in patients with UC in a real-life population cohort for comparison with the tofacitinib UC clinical trial program. Methods Clinical trial-like criteria were applied to an IBM MarketScan® claims database population-based cohort (n = 22,967) of patients with UC (October 2010 to September 2015) to identify a UC trial-like cohort treated with tumor necrosis factor inhibitors (TNFi; n = 6366) to compare with the tofacitinib UC clinical trial cohort (n = 1157). Results Incidence rates (events per 100 patient-years; [95% confidence interval]) in the UC trial-like cohort were as follows: serious infections, 3.33 (2.73–4.02); opportunistic infections (OIs; excluding herpes zoster [HZ]), 1.45 (1.06–1.93); HZ, 1.77 (1.34–2.29); malignancies (excluding nonmelanoma skin cancer [NMSC]), 0.63 (0.43–0.90); NMSC, 1.69 (1.35–2.10); major adverse cardiovascular events (MACE), 0.51 (0.31–0.79); pulmonary embolism (PE), 0.54 (0.30–0.89); deep vein thrombosis (DVT), 1.41 (1.00–1.93); and gastrointestinal perforations, 0.31 (0.16–0.54). Compared with the UC trial-like cohort, tofacitinib-treated patients had numerically lower incidence rates for serious infections (1.75 [1.27–2.36]), OIs (excluding HZ; 0.16 [0.04–0.42]), NMSC (0.78 [0.47–1.22]), PE (0.16 [0.04–0.41]), and DVT (0.04 [0.00–0.23]), and a higher rate for HZ (3.57 [2.84–4.43]); rates for malignancies (excluding NMSC), MACE, and gastrointestinal perforations were similar. Conclusions When acknowledging limitations of comparing claims data with controlled clinical trial data, incidence rates for HZ among TNFi-treated patients in the UC trial-like cohort were lower than in the tofacitinib UC clinical trial cohort; rates for serious infections, OIs, NMSC, PE, and DVT were numerically higher. ClinicalTrials.gov NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612.
Background Little research has investigated sexual transmissibility of HIV among young drug users in China. The objective of this study was to examine the role of sexual transmission on HIV infection among injection drug users (IDUs) and non-injection drug users (NIDUs). Methods Respondent-driven sampling (RDS) was used to recruit 426 young heroin/opium drug users in Yunnan, China. Logistic regression modeling was performed to examine interrelationships among risky sexual behaviors, drug-use modes, and drug-use practices. Results Substantial proportions of NIDUs and IDUs reported engagement in risky sexual behaviors including: (1) multiple sexual partners (42% of NIDUs vs. 37% of IDUs); (2) concurrent sexual partnerships (48% vs. 46%); (3) commercial sex partners (23% vs. 24%) and sex partners who were NIDUs (14% vs. 17 %). Both NIDUs and IDUs reported low levels of condom use with non-regular partners (48% vs. 42%) and regular partner (24% vs. 27%), and having a history of recent methamphetamine use (21% vs. 18%). Compared to IDUs, NIDUs reported having had fewer sex partners who were IDUs, fewer IDU network peers, more NIDU network peers, and having lower levels of HIV knowledge and self-perceived HIV risk. Conclusions Generalization of the HIV epidemic from high-risk groups to the general population may be driven by risky sexual behavior among drug users. Reducing sexual transmission of HIV among both IDUs and NIDUs is the next major challenge for HIV intervention among drug users in China.
The objective of this study was to examine the influences of social network factors, particularly social support and norms, in the transition from non-injection heroin and/or opiate use to heroin-injection, which is one of the leading causes of the spread of HIV/AIDS in China. Respondent-driven sampling was used to recruit young heroin and/or opiate users in an egocentric network study in Yunnan, China. Multivariate logistic regression using hierarchical combinations of candidate variables was used to analyze network factors for the injection transition. A total of 3,121 social network alters were reported by 403 egos with an average network size of eight. Fifty-eight percent of egos transitioned to heroin-injection from non-injection. This transition was associated with having a larger sex network size, a larger number of heroin injectors in one’s network, and a higher network density. The findings enhance our understanding of the influence of social network dimensions on the transition to injection drug use. Accordingly, the development of interventions for heroin and/or opiate users in China should consider social network characteristics.
Aims To investigate the patterns of concurrent sexual partnerships among young opiate users and sexual transmissibility of HIV in concurrent sexual partnerships in drug-use and sexual networks. Design Cross-sectional design. Participants 426 young opiate users in Yunnan, China. Measurement Respondent-driven sampling (RDS) was used to recruit participants. Multiple logistic regressions were performed to analyze the relationships of concurrent sexual partnerships with egocentric social network components, risky sexual behavior for HIV, and drug-use practices. Findings The RDS-adjusted prevalence of concurrent sexual partners was 42.9% among opiate users. Opiate users with concurrent sexual partnerships were more likely to engage in risky HIV-related sexual behavior, compared to those without. Specifically, they were more likely to report having had four or more sexual partners (26.3% vs. 2.0%), having had a spouse or boy/girl friends who also had concurrent sexual partnerships (28.1% vs. 8.2%), having exchanged drug for sex (12.4% vs. 3.8%), having had sexual partners who were non-injection drug users (22.6% vs. 10.1%), having had sexual partners who were injection drug users (25.3% vs. 13.5%), and having used club drugs (26.3% vs. 13.5%). There were no significant differences in consistent condom use between opiate users with sexual concurrency and those without. The same proportion (25.8%) of opiate users in the two groups reported having consistently used condoms when having sex with regular partners, and 46.3% of opiate users with sexual concurrency and 36.4% of those without such concurrency consistently used condoms with non-regular partners. Conclusion The expansion of the HIV epidemic from high risk populations to the general population in China may be driven by concurrent sexual partnerships. Behavioral interventions targeting safer sex should be integrated into harm reduction programmes.
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