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Up to now, immunisation regimens that have been assessed for development of HIV vaccines have included purified envelope (Env) protein among the boosting components of the regimen. We postulated that co-administration of Env protein with either a DNA or NYVAC vector during priming would result in early generation of antibody responses to the Env V1/V2 region, which are important markers for effective protection against infection. We aimed to assess the safety and immunogenicity of a multivalent HIV vaccine including either DNA or NYVAC vectors alone or in combination with Env glycoprotein (gp120) followed by a co-delivered NYVAC and Env protein boost.

Modest efficacy was reported for the HIV vaccine tested in the RV144 trial, which comprised a canarypox vector (ALVAC) and envelope (env) glycoprotein (gp120). These vaccine components were adapted to express HIV-1 antigens from strains circulating in South Africa, and the adjuvant was changed to increase immunogenicity. Furthermore, 12-month immunisation was added to improve durability. In the HIV Vaccine Trials Network (HVTN) 100 trial, we aimed to assess this new regionally adapted regimen for advancement to efficacy testing.

Introduction: Despite the availability of multiple effective therapies, discontinuation/switching of treatment is common for many patients with rheumatoid arthritis (RA). This study was designed to examine initiation of biologic disease-modifying anti-rheumatic drugs (bDMARDs) within the Consortium of Rheumatology Researchers of North America (Corrona) RA Registry, and characterize reasons for discontinuation. Methods: Inclusion criteria were: Corrona-registered adults (≥18 years) with RA (2002–2011); age of RA onset: ≥16 years; ≥6 months’ follow-up after initiation of first/subsequent bDMARD. Patients receiving both tumor necrosis factor antagonists and non-TNF antagonists were included. Treatment discontinuation was defined as first report of stopping initial therapy or initiation of new bDMARD at/between visits, using a follow-up physician questionnaire. Results: Overall, 6209 patients met inclusion criteria and 80.7% received TNF antagonists. Median time to discontinuation/change of therapy was 25.1 months (26.5 months with TNF antagonists vs. 20.5 months with non-TNF antagonists; log-rank p< 0.0001); 82.2, 67.3, and 51.1% of patients remained on therapy at 6, 12, and 24 months, respectively. Reasons for discontinuation were captured for 49.2% of patients, including: loss of efficacy (35.8%); physician preference (27.8%); safety (20.1%); patient preference (17.9%); and no access to treatment (9.0%). Baseline factors with greatest correlation to discontinuation were modified Health Assessment Questionnaire scores, patient-reported anxiety/depression, initiation of bDMARD treatment in 2007–2010 versus 2002–2003, and Clinical Disease Activity Index scores. Conclusions: Almost one-third of patients in the US discontinue currently available bDMARD therapies for RA by 12 months and almost half by 24 months, most commonly due to loss of efficacy. Funding: Corrona LLC and MedImmune.

In Atherothrombosis Intervention in Metabolic Syndrome with low HDLHigh Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial, addition of extended-release niacin (ERN) to simvastatin in participants with established cardiovascular disease, low high-density lipoprotein cholesterol, and high triglycerides had no incremental benefit, despite increases in high-density lipoprotein cholesterol. Preliminary analysis based on incomplete end point adjudication suggested increased ischemic stroke risk among participants randomized to ERN.

Objective.To measure adherence and persistence with methotrexate (MTX) and injectable tumor necrosis factor-α (iTNF-α) inhibitors (etanercept, adalimumab) among children prescribed these medications by a rheumatologist.Methods.Data were obtained from a US pharmacy benefits management firm. Children were included if they were < 18 years of age, had ≥ 1 prescription claim between January 2009 and December 2010 for MTX or an iTNF-α inhibitor that was prescribed by an adult or pediatric rheumatologist. The medication possession ratio (MPR) was calculated for each medication, with MPR ≥ 80% indicating good adherence. MPR were compared by route of administration, age, and by new users versus continuing users. Persistence was measured for new users of each medication from initiation until discontinuation, or for a maximum of 1 year.Results.A total of 1964 children were included. The majority of children had MPR < 80%. Children taking subcutaneous MTX had the lowest mean MPR [46.9%; median 44.9%; interquartile range (IQR) 23%–69.6%] and the lowest persistence, with 26% of children continuing the medication at 1 year. Mean MPR was highest for iTNF-α (65.7%; median 70.1%; IQR 46%–89.3%), as was persistence, with 52% of children continuing the medication at 1 year. Children age < 13 years tended to have higher MPR, but this was statistically significant only for oral MTX (61.1% vs 54.9% in children age ≥ 13 yrs; p = 0.02).Conclusion.Adherence and persistence in this cohort varied by medication and route of administration. Both outcomes are important considerations for physicians prescribing these medications in routine clinical care and for the assessment of treatment effectiveness in the research setting.