Molnupiravir for the treatment of COVID-19 in immunocompromised participants: efficacy, safety, and virology results from the phase 3 randomized, placebo-controlled MOVe-OUT trial.

Purpose: Immunocompromised patients have a potentially increased risk for progression to severe COVID-19 and prolonged replication of SARS-CoV-2. This post hoc analysis examined outcomes among immunocompromised participants in the MOVe-OUT trial.

Methods: In phase 3 of MOVe-OUT, non-hospitalized at-risk adults with mild-to-moderate COVID-19 were randomized to receive molnupiravir 800 mg or placebo twice daily for 5 days.

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients.

Background: New treatments are needed to reduce the risk of progression of coronavirus disease 2019 (Covid-19). Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with molnupiravir started within 5 days after the onset of signs or symptoms in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed Covid-19 and at least one risk factor for severe Covid-19 illness.

Evaluation of Neural Tube Defects (NTDs) After Exposure to Raltegravir During Pregnancy.

Objective: To evaluate the risk of neural tube defects (NTDs) after exposure to raltegravir during pregnancy.

Methods: Exposures to raltegravir during pregnancy reported cumulatively through May 31, 2018, to the company safety database were reviewed to identify cases of NTDs. This database includes all reports of pregnancy from Merck-sponsored clinical trials, spontaneous postmarketing reports, and non-interventional data sources, including the Antiretroviral Pregnancy Registry (APR).

Use of an active surveillance system by the FDA to observe patterns of quinine sulfate use and adverse hematologic outcomes in CMS Medicare data.

Purpose: In 2005, the Food and Drug Administration approved Qualaquin (quinine) for treatment of malaria and later ordered unapproved quinine formulations off the market. In 2009, labeling for Qualaquin added a warning for use for leg cramps, as serious hematologic reactions could occur. We examined quinine use trends among Medicare beneficiaries focusing on indications for use and associations with adverse hematologic outcomes.

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

Importance: Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients.

Objective: To identify the reasons that FDA marketing approval for new drugs was delayed or denied.

Treatment approaches to prosthetic joint infections: results of an Emerging Infections Network survey.

We report the results of an Emerging Infections Network survey of 994 infectious disease consultants (IDCs) regarding their participation in the medical management of prosthetic joint infections and observations of adverse effects associated with antibiotic-impregnated materials (response rate, 54.8%). There was general agreement about when a prosthesis can be retained, but substantial variability in the duration of suppressive antibiotics was recommended, with 36% supporting life-long suppression.

Systemic blastomycosis with osseous involvement of the foot: case report.

We report a patient who presented with three months of foot pain, lytic bone lesions in the foot, and a painless ipsilateral leg skin ulcer. Bone and skin biopsies revealed organisms compatible with Blastomyces. Systemic blastomycosis is rare, especially with bone involvement in the foot.

Sternoclavicular septic arthritis: review of 180 cases.

We review 170 previously reported cases of sternoclavicular septic arthritis, and report 10 new cases. The mean age of patients was 45 years; 73% were male. Patients presented with chest pain (78%) and shoulder pain (24%) after a median duration of symptoms of 14 days.