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More data supporting the use of remdesivir

Due to the public health emergency, the FDA has issued an Emergency Use Authorization for the investigational antiviral drug remdesivir to treat hospitalized patients with severe COVID-19. Encouraging preliminary data from a trial involving more than 1,100 patients has been released by Gilead, the drug's manufacturer. The trial was a comparative analysis of 312 patients treated in the phase 3 SIMPLE-Severe study of remdesivir and 818 patients not in the study who received standard care. Treatment with remdesivir was associated with improved recovery and a 62% reduced risk for death compared with standard care. In addition, 74% of patients treated with remdesivir recovered by day 14 of treatment compared with 59% of patients receiving standard care. The drug was particularly beneficial for Black patients, those younger than age 65, and those who did not require ventilator support.


The results of this trial were presented at a virtual COVID-19 conference. The results have not yet been published in a peer-reviewed journal and require confirmation in prospective clinical trials.


Source: Gilead. Gilead presents additional data on investigational antiviral remdesivir for the treatment of COVID-19. News release. July 10, 2020.



Nitrous oxide safe, effective for pain relief

Neuraxial and opioid analgesia are the most common interventions used to manage labor pain in the US. Another option, inhaled nitrous oxide (N2O), is increasingly available in the US, yet few systematic analyses of outcomes from US-based cohorts are available. In a prospective chart review study, researchers investigated the demographic characteristics, safety, and satisfaction in a cohort of patients who used inhaled N2O analgesia during labor and also looked for predictors of conversion from N2O to neuraxial analgesia (such as spinal, epidural, and combined spinal/epidural analgesia). The 463 participants (age 18 or older) used self-administered inhaled N2O during the first or second stage of labor between March 1, 2016, and July 23, 2017. Their neonates were also assessed based on Apgar scores, advanced neonatal resuscitation, and neonatal ICU (NICU) admissions. Findings included the following:


* 31% of patients who chose N2O for analgesia did not convert to any other analgesic method.


* Maternal and neonatal adverse reactions were rare and not a significant factor for conversion to another pain relief modality. Neonatal resuscitations and NICU admissions were low.


* Patient satisfaction with N2O therapy was "moderately high."



The authors conclude that "N2O is a useful, safe option for labor analgesia in the United States."


Source: Nodine PM, Collins MR, Wood CL. Nitrous oxide use during labor: satisfaction, adverse effects, and predictors of conversion to neuraxial analgesia. J Midwifery Womens Health. [e-pub May 26, 2020]



PPIs may increase risk of COVID-19

Prior research has suggested that use of proton pump inhibitors (PPIs) may increase the risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. To investigate further, an online survey was conducted to examine whether community-dwelling Americans (age 18 and older) using PPIs face an increased risk for COVID-19. A nationwide representative sample of participants was recruited by an online search firm based on US census data. Responses were collected from May 3 to June 24, 2020.


All participants were asked about gastrointestinal (GI) symptoms they have ever experienced. Those who reported prior abdominal pain or discomfort, acid reflux, heartburn, or regurgitation were separately asked about use of any current PPI and/or histamine-2 receptor antagonist (H2RA). For those currently taking PPIs and/or H2RAs, researchers assessed duration and frequency of use.


Respondents were also asked if they had been tested for COVID-19. Those with a positive test were asked about new symptoms they experienced, if any, at the time of diagnosis, such as ageusia, anosmia, GI signs and symptoms, and respiratory or systemic symptoms.


About 6% of 53,130 participants reported a positive COVID-19 test. Compared with those not taking PPIs, those using PPIs once daily or twice daily had a significantly increased risk for reporting a positive COVID-19 test. However, taking H2RAs did not elevate the risk.


The authors write, "The highest risk is seen among individuals taking PPIs twice daily ... as they are nearly four times more likely to report COVID-19 positivity when compared to those not on PPIs. Since meta-analysis reveals that twice-daily PPIs do not offer clinically meaningful benefits over once daily dosing for gastroesophageal reflux disease, our findings further emphasize that PPIs should only be used when clinically indicated at the lowest effective dose."


Source: Almario CV, Chey WD, Speigel BMR. Increased risk of COVID-19 among users of proton pump inhibitors. J Gastroenterol. [e-pub July 7, 2020]



Combination drug approved for outpatient use

Administered by subcutaneous injection, Phesgo is a combination of pertuzumab, trastuzumab, and hyaluronidase. It is indicated in combination with chemotherapy to treat adult patients with HER2-positive metastatic breast cancer and in combination with docetaxel in certain adult patients with early HER2-positive breast cancer. Approximately one-fifth of patients with breast cancer are HER2-positive. Patients should be selected for treatment with Phesgo based on an FDA-approved companion diagnostic test.


Phesgo's therapeutic components are equivalent to those in I.V. pertuzumab and I.V. trastuzumab. Most patients with HER2-positive breast cancer currently receive trastuzumab and pertuzumab I.V. at infusion centers. But because Phesgo is administered subcutaneously, patients now have the option of receiving trastuzumab and pertuzumab as outpatients. Although used in combination with chemotherapy initially, Phesgo could be administered at home by a qualified healthcare professional once the patient completes her chemotherapy regimen.


Prescribing information for Phesgo includes a boxed warning about the risk of heart failure, fetal harm, and pulmonary toxicity. Healthcare professionals administering Phesgo should use monitoring parameters similar to those used when administering the I.V. formulations.


Source: US Food and Drug Administration. FDA approves breast cancer treatment that can be administered at home by health care professional. News release. June 29, 2020.