Jenna Payesko

Implementation of a syringe services program (SSP) resulted in rapid reduction in injection-related risk behaviors during a 2014 HIV outbreak among persons who inject drugs (PWID) in a nonurban setting in the United States, according to a recent study. The results 

emphasize the need for harm reduction interventions that include access to syringes and sterile injection equipment, in addition to comprehensive HIV prevention services.

Researchers investigated the late 2014 HIV outbreak in Scott County, Indiana, which happened to be the largest outbreak among PWID in a nonurban setting in the US with 181 HIV infections diagnosed between Nov. 18, 2018—Nov. 1, 2015. The SSP resulted in a rapid reduction in injection-related risk behaviors, including an 88% reduction in syringe sharing, a 79% reduction in syringe sharing to divide drugs and an 81% reduction in sharing of other injection equipment, findings that are consistent with SSPs implemented in nonoutbreak settings.

“In Scott County, this has been a really effective model for getting people who are ready for treatment into an effective treatment program, and more than 200 individuals have enrolled in treatment since it was initiated,” Joan Duwve, MD, MPH, Associate Dean for Practice, IU Fairbanks School of Public Health, told 

“When the community also participates by offering meals, clothing, support groups and other services needed, the added effect is considerable. People with substance use disorder are often stigmatized and living on the fringes of society. These programs send the message that their lives have value, and help lead them toward recovery.”

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The study emphasizes the need for harm reduction interventions that include access to syringes and sterile injection equipment, in addition to comprehensive HIV prevention services. 

Study: Syringe Services Program Reduced Injection-Related Risk Behaviors in HIV Outbreak

AbbVie announces positive top-line results from the SELECT-EARLY phase 3 study showing that both 15 mg and 30 mg doses of upadacitinib monotherapy met the primary endpoints of ACR50 at week 12, and clinical remission at week 24 versus methotrexate in adult patients with moderate to severe rheumatoid arthritis, methotrexate-naïve.

Additionally, all secondary endpoints were also achieved.

“SELECT-EARLY is the fifth pivotal trial that will support regulatory submissions for upadacitinib in rheumatoid arthritis later this year,” Michael Severino, MD, executive vice president, research and development, chief scientific officer, AbbVie, said in a 

. “Results from the SELECT-EARLY further support our belief that upadacitinib has the potential to be an important new treatment option for patients with rheumatoid arthritis.”

In the first phase of the SELECT-EARLY phase 3 study, patients were randomized 1:1:1 to receive upadacitinib 15 mg or 30 mg daily, or methotrexate. Additionally, it includes a Japan sub-study in which subjects were randomized 2:1:1:1 to receive upadacitinib 7.5 mg, 15 mg, 30 mg daily or methotrexate.

Primary endpoints included the percentage of patients achieving ACR50 after 12 weeks of treatment, and clinical remission after 24 weeks of treatment versus methotrexate, while secondary endpoints included the proportion of patients achieving ACR20, ACR70 and low disease activity in addition to changes in the modified total Sharp score in the Health Assessment Questionnaire-Disability-Index (HAQ-DI). Both endpoints were met.

Upadacitinib is currently being tested in phase 3 trials of rheumatoid arthritis, psoriatic arthritis and Crohnâ€™s disease, and is being investigated to treat ulcerative colitis, ankylosing spondylitis, atopic dermatitis and giant cell arteritis.

Upadacitinib Monotherapy Shows Positive Results in Rheumatoid Arthritis Trial

A first-of-its-kind study found that mortality in the first year after critical illness is higher among older adults with Medicaid insurance compared to those with Medicare and additional commercial insurance, especially among those discharged to skilled-care facilities.

The study, presented at the 2018 American Thoracic Society International Conference in San Diego, should prompt future investigations into care disparities at skilled-care facilities that may mediate higher mortality rates observed among the poor older survivors of critical illness.

“Our most significant finding was that poor older adults with Medicaid insurance who receive treatment for a critical illness in the ICU are more likely to die after hospital discharge when compared to those with commercial insurance,” lead author, Yoland Philpotts, MD, Columbia University College of Physicians and Surgeons, said. “This was true even after taking into account differences in pre-existing health conditions and the severity of critical illness.”

Mortality After Critical Illness Higher in Older Adults with Medicaid Insurance

Gilead Sciences, Inc. announced that the FDA approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada) in combination with safe sex practices, to reduce the risk of sexually acquired HIV-1 in at-risk adolescents.

The safety and efficacy profile of Truvada for HIV prevention in uninfected adults is well established. Truvada for pre-exposure prophylaxis (PrEP) was first approved for use in adults in 2012.

The addition of the adolescent indication is backed by a single-arm, open-label clinical trial, ATN113, conducted in HIV-negative individuals 15—17 years old by the Adolescent Medicine Trials Network for HIV/Aids.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” lead study investigator, Sybil Hosek, PhD, clinical psychologist, Cook County Health and Hospital System’s Stroger Hospital, said in a 

. “In addition to traditional risk-reduction strategies, health care providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.”

The FDA has approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada) in combination with safe sex practices, to reduce the risk of sexually acquired HIV-1 in at-risk adolescents..

FDA OKs Truvada to Reduce HIV Risk in Adolescents

Officials with the FDA announced the approval subcutaneous formulation of tocilizumab (Actemra) for treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.

The approval is backed by data from the JIGSAW-117 study, a 52-week phase 1b pharmacokinetic/pharmacodynamic bridging study that was designed to determine the appropriate dosing regimen of Actemra subcutaneous across an array of body weights in children with PJIA.

“Polyarticular juvenile idiopathic arthritis is a rare, often painful disease in children,” Sandra Horning, MD, chief medical officer, head of global product development, Genentech, said in a statement. 

“With this approval, we are pleased Actemra offers an alternative delivery option to physicians and parents of children aged 2 or older to treat this debilitating disease.”

The study enrolled 52 patients aged 1—17 years old with PJIA who experienced previous inadequate response or intolerance to methotrexate and were either Actemra naïve or received Actemra IV with adequate disease control.

The treatment was administered open label based on a body weight dosing regimen: PJIA patients weighing <30 kg received 162 mg of Actemra every 3 weeks and PJIA patients weighing ≥30 kg received 162 mg every 2 weeks for 52 weeks.

Officials with the FDA announced the approval subcutaneous formulation of tocilizumab (Actemra) for treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.


FDA Approves Treatment for Active Polyarticular Juvenile Idiopathic Arthritis

Data from a pooled analysis presented at the American Psychiatric Association’s Annual Meeting, concluded that lofexidine (LUCEMYRA) safely reduces opioid withdrawal symptoms at 3.2 mg/day and 2.4 mg/day to a clinically meaningful extent, facilitating opioid discontinuation treatment.

Investigators from US WorldMeds extracted data from 2 phase 3 placebo-controlled studies that evaluated withdrawal symptoms during the first 7 days of withdrawal from short-acting opioids (heroin or opioid analgesics).

“A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder,” co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, told MD Magazine. “The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment.

Lofexidine (LUCEMYRA) safely reduces opioid withdrawal symptoms at 3.2 mg/day and 2.4 mg/day to a clinically meaningful extent, facilitating opioid discontinuation treatment, according to data from a pooled analysis. 