Michaela Fleming

Certain populations, including men who have sex with men (MSM) and transgender women are disproportionately affected by HIV. For individuals who also belong to a minority group and/or have a lower socioeconomic status, the affect can be even more severe.

Based on this knowledge, a team of investigators from the University of Illinois at Chicago set out to compare virologic failure among MSM and transgender women receiving HIV care at a community-based model with those receiving care at a hospital-based model. The team found that the community-based model was just as effective as the hospital-based model in providing care to these patients.

The findings of the retrospective cohort study were presented in a poster at IDWeek 2019.

A version of this article was originally published by our sister publication Contagion. Visit 

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Community-Based HIV Care As Effective as Hospital-Based Care for Certain Populations

The 48-week results of the Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study indicate that the regimen of monthly injectable cabotegravir/rilpivirine is noninferior to continued 3-drug oral antiretroviral (ART) therapy in adults with virologically suppressed HIV-1 infections.

The findings of the study were presented in an oral abstract presentation at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019) in Seattle, Washington. 

Contagion® spoke exclusively to Susan Swindells, MBBS

, who presented the findings at the meeting. 

“The study was partnered by a study called FLAIR, which was a similar design in patients who were just starting anti-HIV therapy," said Dr Swindells, an investigator on the study. "They had very similar results: high levels of suppressions in both arms, patients liked it, and both studies went extremely well.”

ATLAS was a phase 3, open-label, multicenter study, which enrolled 616 participants who had HIV-1 RNA <50 c/mL for > 6 months without virologic failure on oral ART regimens of either 2 nucleoside reverse transcriptase inhibitors plus 1 integrase strand transfer inhibitor (NRTI + ISTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), or a protease inhibitor (PI).

A version of this article was originally published by Contagion. Visit 

The findings of the study were presented in an oral abstract presentation at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019) in Seattle, Washington.

Long-Acting Injectable Regimen Demonstrated Comparable Safety And Efficacy To Oral HIV Therapy

Regulatory filings for 2 antibacterial agents being developed by Merck have been accepted for review by the FDA.

A New Drug Application (NDA) was accepted for the Priority Review of the combination of relebactam with imipenem/cilastatin for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by susceptible gram-negative bacteria in adults with limited or no alternative therapies available.

A supplemental NDA (sNDA) was accepted for the Priority Review of ceftolozane/tazobactam (ZERBAXA) to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia caused by particular susceptible gram-negative microorganisms including E

nterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, 

“There is a major unmet need for new treatment options to address the growing danger of serious and potentially life-threatening infections caused by Gram-negative bacteria,” Nicholas Kartsonis, MD, senior vice president and head of clinical research for infectious diseases and vaccines with Merck Research Laboratories, said in a prepared statement.

In the United States, ceftolozane/tazobactam is currently approved for the treatment of adult patients with cUTI, including pyelonephritis, caused by particular gram-negative microorganisms, as well as in combination with metronidazole for the treatment of cIAI caused by susceptible gram-negative and gram-positive microorganisms in adult patients.

The NDA for imipenem/cilastatin/relebactam was based on the results of the phase 3 RESTORE-IMI1 trial. Relebactam is an investigational, intravenous, class A and C beta-lactamase inhibitor.

A New Drug Application (NDA) and a supplemental NDA (sNDA) were accepted for the Priority Review for products being developed by Merck.

Regulatory Review Filings for 2 Antibacterial Agents Accepted by FDA

People who inject drugs (PWID) are a critical population that are at a higher risk of being infected with HIV. According to the CDC, 

 can survive in a used needle for up to 42 days, depending on temperatures and other factors.

In a new study, which focused on the PWID population in multiple study sites, investigators used intervention programs where participants received referrals for HIV management and medication along with harm-reduction packages, HIV testing and counseling, referrals for antiretroviral therapy, and eduation about basic 

 in an effort to improve patient outcomes. The investigators concluded that the interventions actually increased use of antiretroviral (ART) medication use by 30%.

The investigators set out to create a low-cost effective program that could ramp up efforts to improve the worldwide health of people with HIV who inject drugs, including those living in areas that lack resources. The study sites included Kyiv, Ukraine (1 community site), Thai Nguyen, Vietnam (2 district health center sites), and Jakarta, Indonesia (1 hospital site). These areas were selected on the basis of ongoing HIV epidemics among PWID in regions with high HIV prevalence and/or incidence.

A new study examining HIV in people who inject drugs found interventions increased use of antiretroviral medication.

Study: Integrated Intervention Increases Use of HIV Therapy in Critical Population

Officials with the FDA have approved Grifols’ new formulation of immune globulin (GamaSTAN) for hepatitis A virus and measles post-exposure prophylaxis.

Currently, the new formulation is the only immune globulin available in the United States that is approved for post-exposure protection against hepatitis A and measles.

The immune globulin is a new formulation that uses a caprylate chromatography process which removes prions. The drug is contraindicated in patients who have anaphylaxis or severe sensitivity reactions to immune globulin and in IgA-deficient patients with antibodies against IgA.

, while a valuable option for hepatitis A and measles post-exposure prophylaxis, may take several weeks to take effect as your immune system works to build the antibodies it needs to fight these viruses," Stephen Scholand, MD, infectious disease specialist at MidState Medical Center, said in a recent statement. "Immune globulins such as GamaSTAN® have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection."

The CDC recommends immune globulin as hepatitis A post-exposure prophylaxis treatment for individuals who have weakened immune systems, infants <1 year, adults over 40, and individuals with cancer or chronic liver or kidney disease. When administered within 2 weeks after exposure to hepatitis A, immune globulin is 80% to 90% effective in preventing hepatitis A infection.

Officials with the FDA have approved Grifols’ new formulation of immune globulin (GamaSTAN) for hepatitis A virus and measles post-exposure prophylaxis.
 

New Immune Globulin Formulation for Hepatitis A, Measles Post-Exposure Prophylaxis Approved by FDA

The US Food and Drug Administration (FDA) has approved Grifols’ new formulation of immune globulin (GamaSTAN) for hepatitis A virus and measles post-exposure prophylaxis.

"Vaccination, while a valuable option for hepatitis A and measles post-exposure prophylaxis, may take several weeks to take effect as your immune system works to build the antibodies it needs to fight these viruses," Stephen Scholand, MD, infectious disease specialist at MidState Medical Center, said in a recent 

have been a valuable treatment option for many decades because they offer immediate and rapid protection with antibodies that fight infection."

The new formulation is the only immune globulin available in the United States that is approved for post-exposure protection against hepatitis A and measles.