AimsTo assess the long‐term safety of subcutaneous buprenorphine (CAM2038) weekly and monthly depots.DesignPhase 3, open‐label, observational, multi‐centre 48‐week trial (ClinicalTrials.gov NCT02672111).SettingTwenty‐six out‐patient sites (United States, United Kingdom, Hungary, Denmark, Sweden, Germany, Australia) between 14 December 2015 and 12 April 2017.ParticipantsTwo hundred and twenty‐eight adults with opioid use disorder; 227 received CAM2038 (37 initiated onto CAM2038 and 190 converted from sublingual buprenorphine).InterventionsCAM2038 weekly (8, 16, 24 or 32 mg) or monthly (64, 96, 128 or 160 mg) with flexible dosing and individualized titration utilizing multiple CAM2038 weekly and monthly doses.MeasurementsSafety variables, urine toxicology samples and self‐reported illicit opioid use were collected at each visit. Participants were administered a patient satisfaction survey at months 6 and 12, completed by 162 of 227 (71.4%) participants.FindingsThe study treatment period was completed by 167 of 227 (73.6%) participants. At least one treatment‐emergent adverse event (TEAE) was reported by 143 of 227 (63.0%) participants, of whom 60 of 227 (26.4%) reported as being drug‐related. Most of the TEAEs, reported by 128 of 227 (56.4%) of participants, were mild or moderate in intensity. Injection‐site reactions were reported by 46 of 227 (20.3%) participants, with most [45 of 46 (97.8%)] reported as mild to moderate. Five participants (2.2%) discontinued the study drug due to a TEAE, two cases (0.9%) of which were injection‐site‐related. No serious adverse events were attributed to the study drug. Among those remaining in the study, the percentage of opioid‐negative urine tests combined with self‐reports was 63.0% (17 of 27) in new‐to‐treatment participants and 82.8% (111 of 134) for those converted from sublingual buprenorphine. Participants reported high levels of satisfaction with CAM2038.ConclusionsSubcutaneous buprenorphine delivered weekly or monthly (CAM2038) was well tolerated, with a systemic safety profile consistent with the known profile of sublingual buprenorphine. CAM2038 weekly and monthly was associated with high retention rates and low levels of illicit opioid use throughout this study.
In Germany, direct-acting antiviral treatment of former or current drug users with or without opioid substitution therapy can achieve equally high sustained virological response rates as in patients with no history of drug use.
AVP was comparable to NE with respect to hemodynamics and blood gases, as well as brain metabolism in surviving animals throughout the study period. Our findings emphasize the importance of early resuscitation, as neuronal cell damage potentially starts immediately after onset of severe hemorrhage.
Objective: To evaluate the molecular typing system for Treponema pallidum using cerebrospinal fluid (CSF) specimens obtained from patients with neurosyphilis in Pretoria, South Africa. Methods: CSF specimens were collected from 32 men and 18 women with suspected late neurosyphilis. Typing of T pallidum involved PCR amplification and restriction analysis of the tpr E, G and J genes and determination of the number of 60 base pair tandem repeats within the arp gene by PCR amplification. Results: Of 13 typeable specimens, 4 strain types were identified: 2i, 3e, 14a and 17e. Subtype 14a was identified in 7 specimens (53.8%), subtype 3e in 4 specimens (30.7%) and subtypes 17e and 2i in 1 specimen (7.6%) each. Conclusions: This study shows that the typing system can be applied to specimens which may contain low numbers of spirochaetes such as CSF.A lthough effective treatment has been available for more than six decades, syphilis remains a significant public health problem, especially in developing countries. The World Health Organization estimates that 12 million new cases of syphilis occur annually worldwide, of which approximately 4 million are in sub-Saharan Africa.1 There has been a renewed interest in syphilis since ulcerative sexually transmitted infections (STIs) have been shown to be a risk factor for the transmission of HIV in HIV-infected individuals.2-4 Similarly, the presence of ulcerative STIs in HIV-negative individuals may increase susceptibility to HIV infection by either disrupting the epithelial barrier or the presence of macrophages and CD4 T lymphocytes in the ulcer, which are target cells for HIV. 6Syphilis is making a resurgence in many industrialised nations such as the US, Canada and the UK, where outbreaks either have occurred recently or are currently occurring.7-9 The rise in incidence of neurosyphilis cases may be linked, in part, to individuals who are immunocompromised as a result of infection with HIV. [10][11][12] Patients with ''early'' syphilis are defined as those with primary, secondary or early latent disease; patients with ''late'' syphilis are those with late latent disease, which includes late neurosyphilis.13 Central nervous system invasion by Treponema pallidum may occur in up to 70% of individuals during early syphilis or in 15-20% of individuals during late neurosyphilis, which occurs years to decades after initial infection.14 15Although the host immune response should be taken into account with respect to disease progression after neuroinvasion, the manifestation of late neurosyphilis in some individuals may be associated with neurotropic strains of T pallidum. The biological plausibility for this hypothesis is supported by recent studies on T pallidum and T pallidum-related spirochaetes. For example, the neuroinvasive capacity of six T pallidum strains was recently studied in a rabbit model. 16 Using reverse transcriptase-PCR, T pallidum was detected more frequently in the cerebrospinal fluid (CSF) of rabbits infected with the Bal 73-1 and UW085B strains and, to a lesser ...
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