Tag: COVID-19

‘Eye of the storm’: Diverse east London grapples with virus

Post author By Michelle Dryden
Post date February 4, 2021
No Comments on ‘Eye of the storm’: Diverse east London grapples with virus

Road cleaners work in the town centre of Ilford in London, Friday, Jan. 29, 2021. In parts of east London, the pandemic is hitting much harder than most places in the U.K. The borough of Redbridge had the nation’s second worst infection rate in January, with an estimated 1 in 15 residents thought to be infected. (AP Photo/Frank Augstein)

LONDON (AP) — Taxicab driver Gary Nerden knows colleagues who got seriously ill from COVID-19. He knows the area of east London where he lives and works has among the highest infection rates in the whole of England. But since he can’t afford not to work, he drives around picking up strangers for up to 12 hours a day, relying on a flimsy plastic screen to keep him safe.

“I’ve got people telling me they won’t wear a mask, saying they’re exempt,” said Nerden, 57. “I’ve got diabetes, I have to look after myself. I wipe the handles, the seat belt, after every customer, but that’s all I can do, really.”

Nerden and his wife, a hospital administrative worker, live in the outer London borough of Redbridge, which in mid-January had the country’s second-highest rate of residents testing positive for the coronavirus: 1,571 cases per 100,000 people. Official figures estimated that at one point, 1 in 15 people there had COVID-19 — even after the government imposed a third national lockdown to control a fast-spreading, more contagious variant of the virus.

Redbridge and its surrounding areas, which lie on a commuter belt between the capital’s northeast and coastal Essex, have been dubbed the “COVID triangle” because they all topped England’s worst infection rates in recent weeks. While case rates have come down significantly, local leaders said the situation remained critical and the borough was still “in the eye of the storm.”

They say the area’s large number of essential workers in public-facing jobs, combined with dense housing and high levels of poverty, contribute to why the virus has hit it much harder than most places in the U.K. Those factors also make fighting the pandemic there particularly challenging.

“We have some of the most front-line workers here in the community: the taxi drivers, the NHS (National Health Service) workers, the train drivers going into central London, the commuter workers, the cleaners,” Redbridge Council leader Jas Athwal said.

“People are taking their chances — is it about feeding my children, or risking myself with COVID? And of course, they need to feed their children,” Athwal added. “All that accounts for the excess number of virus infections, the deaths, because people are having to go out to do their job.”

Many of those lower-income workers with high exposure to the virus are from ethnic minority backgrounds, who are among the most at-risk — as well as the hardest to persuade to get vaccinated. Redbridge’s population is among the most diverse in the country, with large Indian, Pakistani and Bangladeshi communities and fewer than 40% of residents identifying as white British.

Numerous studies have shown that the pandemic is causing disproportionate serious illness and deaths among ethnic minorities and those from poorer households. In the U.K., Public Health England found that after accounting for factors like age and sex, people of Bangladeshi heritage were dying from COVID-19 at twice the rate of white Britons. Black people and other Asian groups also had a 10% to 50% higher risk of death.

Experts say that is due to a combination of factors. People from minority groups are more likely to live in crowded housing and to take poorly ventilated public transport to go to work. They are also more likely to have long-term conditions like heart disease and diabetes that increase their risk of becoming seriously ill if they catch the virus.

Khayer Chowdhury, a Redbridge councilor of Bangladeshi descent, said many Asian households in the borough are multigenerational families living together under one roof, giving the virus greater opportunity to spread.

“Our diversity makes us unique, but it also makes us vulnerable,” he said.

Britain has lost more than 100,000 lives to the coronavirus, the worst death toll in Europe.

“Here in the community, everybody knows somebody who’s passed away,” Athwal said. “The fear is finally starting to hit home.”

Officials say a small but increasing number of people are breaking restrictions, partly because of fatigue with lockdown rules. Enforcement officers have broken up gatherings and “car meets,” shutting down and fining clubs and restaurants for hosting parties. On a recent weekday, a large team of police officers patrolled the main shopping street, which bustled with a steady stream of people despite the government’s “stay at home” message.

But the bigger challenge is on the vaccination front. Several U.K.-based studies have suggested that vaccine take-up rates for both the coronavirus and other jabs among Black people and minorities are significantly lower than that in the general population. Some researchers say that’s caused by longstanding distrust of authorities and disengagement from public health messages, and exacerbated by anti-vaccine posts on social media.

Full Coverage: Coronavirus pandemic

Local resident Salman Khan and his wife said they were not sure they would have the jab if offered, because the pandemic has made them question “whether the government and the news is telling the truth.”

Dr. Anil Mehta, a local doctor, said health officials are making every effort to reach the poorest and hardest to reach communities. This week he is offering vaccine shots out at homeless shelters, hoping to inoculate the area’s many refugees and those sleeping rough. He said he’s also taken up the role of “myth-buster,” trying to dispel misinformation and conspiracy theories.

“People believe in all sorts of things — this is affecting fertility, or against Black Lives Matter,” Mehta said. “There is a lot of hesitancy, whether they want it, whether they trust us. That’s our battle at the moment.”

___

Follow all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

— Associated Press

Tags #Diverse, #Virus, COVID-19, East London, England, Eye of the Storm, Infection Rates, Infection Rates#Diverse

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In 5 U.S. States, crushing numbers and hospitals at capacity

Post author By Michelle Dryden
Post date January 11, 2021
No Comments on In 5 U.S. States, crushing numbers and hospitals at capacity

Arizona, California, Oklahoma, Rhode Island and South Carolina are now averaging the most daily new cases per person.

— NYT: Top Stories

Tags Arizona, California, COVID-19, Hospitals, Oklahoma, Rhode Island, South Carolina, South CarolinaArizona

Healthcare

Merck to present new data from its extensive infectious diseases and vaccines pipeline and portfolio during IDWeek 2020

Data from More Than 50 Clinical and Epidemiological Abstracts Across Vaccines, HIV, Antibiotics and Antimicrobials Show the Breadth of the Company’s Commitment to Addressing the Threat of Infectious Diseases

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that new clinical and epidemiological data from its broad infectious diseases and vaccines program will be presented at IDWeek 2020 from Oct. 21 – 25, 2020. Clinical data to be presented include new subgroup analyses from the Phase 3 RESTORE-IMI 2 trial evaluating the safety and efficacy of RECARBRIO™ (imipenem, cilastatin, and relebactam) in adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), and a new pooled analysis of the safety and efficacy of PIFELTRO™ (doravirine) or DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) in adults 50 years of age and older living with HIV-1 who are treatment-naïve. As part of Merck’s commitment to greater understanding of infectious diseases, Merck researchers will present epidemiological data including two multicenter evaluations of bacterial infections and antimicrobial use among COVID-19 tested patients, and 12 studies evaluating disease burden and vaccination strategies. Merck will also be sharing updates from SMART (Study for Monitoring Antimicrobial Resistance Trends) surveillance program-related abstracts accepted by the congress.

“This year, we’ve all witnessed the devastating impact infectious diseases can have on patients and society. The pandemic reinforces the compelling need for Merck to continue our unwavering, decades-long commitment to addressing the threat of infectious diseases through research,” said Dr. Nicholas Kartsonis, senior vice president, infectious diseases and vaccines, Merck Research Laboratories. “The breadth of our portfolio in infectious diseases will be on display at IDWeek as we share new research in vaccines, HIV and antibacterials.”

Select abstracts in the IDWeek program include:

Pediatric Infectious Diseases

Evaluation of the Impact of a Single-dose Hepatitis A Vaccination in Brazil: a time-series analysis. Poster: 1392. Bierrenbach AL, et al.
Current practices in the diagnosis and treatment of varicella infections in the United States. Poster: 1387. Fergie J, et al.
Effectiveness of M-M-R^® II in outbreaks – a systematic literature review of real-world observational studies. Poster: 1390. Li S, et al.
Factors Associated with Co-administration of Pentavalent DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United States (US). Poster: 1393. Petigara T, et al.
Caregiver Burden related to Rotavirus Gastroenteritis: a systematic literature review. Poster: 1379. Carias C, et al.
Current status of the legal landscape regarding Rotavirus Vaccination in the United States. Poster: 1380. Bhatti A, et al.
Rotavirus Gastroenteritis among older adults: discussion based on a systematic literature review. Poster: 1381. Carias C, et al.

Pneumococcal Disease

Incidence of Acute Otitis Media in Children in the United States before and after the introduction of Pneumococcal Conjugate Vaccines (PCV7 and PCV13) during 1998-2018. Poster: 1479. Hu T, et al.
Incidence of Non-Invasive Pneumococcal Pneumonia in Children in the United States before and after Introduction Pneumococcal Conjugate Vaccines (PCV7 and PCV13) during 1998-2018. Poster: 1480. Hu T, et al.

Certain HPV-Related Cancers and Disease

Observational Study of Routine Use of 9-Valent Human Papillomavirus Vaccine: Safe in More Than 140,000 Individuals. Poster: 5. Hansen J, et al.

HABP/VABP & Antibiotics

Imipenem/Cilastatin (IMI)/Relebactam (REL) in Hospital Acquired/Ventilator-Associated Bacterial Pneumonia (HABP/VABP): Subgroup Analyses of Critically Ill Patients in the RESTORE-IMI 2 Trial. Poster: 1460. Chen L, et al.
Clinical and Microbiologic Outcomes by Causative Pathogen in Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Treated with Imipenem/Cilastatin (IMI)/Relebactam (REL) Versus Piperacillin/Tazobactam (PIP/TAZ). Poster: 1230. Losada M, et al.
Multivariate Regression Analysis to Determine Independent Predictors of Treatment Outcomes in the RESTORE-IMI 2 Trial. Poster: 1574. Tipping R, et al.

Antimicrobial Epidemiology/Surveillance

Comparison of the Epidemiology and Pathogens Cultured from Patients Hospitalized with SARS-CoV-2 Positive versus SARS-CoV-2 Negative in the US: A Multicenter Evaluation. Poster: 373. Puzniak L, et al.
Epidemiology of Antimicrobial Use Among SARS-CoV-2 Positive and Negative Admissions in the US: A Multicenter Evaluation. Poster: 379. Puzniak L, et al.
Comparison of Ceftolozane/Tazobactam, Ceftazidime/Avibactam, and Meropenem/Vaborbactam Activity Against P. aeruginosa: A Multicenter Evaluation. Poster: 1603. Moise P, et al.
Frequency of Carbapenem-resistant Pseudomonas aeruginosa Among Respiratory Pathogens Impacts First-Line Beta-Lactam Susceptibility: Potential Role for Ceftolozane/Tazobactam (C/T) and/or Imipenem/Relebactam (I/R). Poster: 1450. Klinker K, et al.
Activity of Ceftolozane/Tazobactam Against Gram-Negative Isolates From Lower Respiratory Tract Infections – SMART United States 2018. Poster: 1587. Lob S, et al.
Epidemiology and Susceptibility to Imipenem/Relebactam of Gram-Negative Pathogens From Patients With Lower Respiratory Tract Infections – SMART United States 2017-2018. Poster: 1609. Lob S, et al.

HIV

Efficacy and Safety of Doravirine in Treatment-Naïve Adults ≥50 Years Old With HIV-1. Poster: 1011. Mills A, et al.

For more information and access to IDWeek’s virtual program, please visit the IDWeek 2020 website.

About RECARBRIO^TM (imipenem, cilastatin, and relebactam) for injection 1.25 g

RECARBRIO is indicated for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.

RECARBRIO is also indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae and Pseudomonas aeruginosa.

RECARBRIO is also indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis and Pseudomonas aeruginosa.

Approval of the cUTI and cIAI indications is based on limited clinical safety and efficacy data for RECARBRIO.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Safety Information for RECARBRIO

Hypersensitivity Reactions: RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with RECARBRIO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta-lactams, and other allergens. If a hypersensitivity reaction to RECARBRIO occurs, discontinue the therapy immediately.

Seizures and Other Central Nervous System (CNS) Adverse Reactions: CNS adverse reactions, such as seizures, confusional states, and myoclonic activity, have been reported during treatment with imipenem/cilastatin, a component of RECARBRIO, especially when recommended dosages of imipenem were exceeded. These have been reported most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) and/or compromised renal function. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether RECARBRIO should be discontinued.

Increased Seizure Potential Due to Interaction with Valproic Acid: Concomitant use of RECARBRIO, with valproic acid or divalproex sodium may increase the risk of breakthrough seizures. Avoid concomitant use of RECARBRIO with valproic acid or divalproex sodium or consider alternative antibacterial drugs other than carbapenems.

Clostridioides difficile-Associated Diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including RECARBRIO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C difficile may need to be discontinued.

Development of Drug-Resistant Bacteria: Prescribing RECARBRIO in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions: The most frequently reported adverse reactions occurring in ≥2% of cUTI and cIAI patients treated with RECARBRIO were diarrhea (6%), nausea (6%), headache (4%), vomiting (3%), alanine aminotransferase increased (3%), aspartate aminotransferase increased (3%), phlebitis/infusion site reactions (2%), pyrexia (2%), and hypertension (2%). The most frequently reported adverse reactions occurring in ≥5% of HABP/VABP patients treated with RECARBRIO were aspartate aminotransferase increased (11.7%), anemia (10.5%), alanine aminotransferase increased (9.8%), diarrhea (7.9%), hypokalemia (7.9%), and hyponatremia (6.4%).

About ZERBAXA^® (ceftolozane and tazobactam) for injection (1.5g)

ZERBAXA is indicated for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.

ZERBAXA is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.

ZERBAXA used in combination with metronidazole is indicated for the treatment of patients 18 years and older with complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Safety Information for ZERBAXA

Patients with renal impairment: Decreased efficacy of ZERBAXA has been observed in patients with baseline CrCl of 30 to <50 mL/min. In a clinical trial, patients with cIAIs with CrCl >50 mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9% when treated with meropenem. In the same trial, patients with CrCl 30 to <50 mL/min had a clinical cure rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2% when treated with meropenem. A similar trend was also seen in the cUTI trial. Dose adjustment is required for patients with CrCl 50 mL/min or less. All doses of ZERBAXA are administered over 1 hour. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly.

Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane/tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.

Clostridioides difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.

Development of drug-resistant bacteria: Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.

Adverse reactions: The most common adverse reactions occurring in ≥5% of patients in the HABP/VABP trial were hepatic transaminase increased (11.9%), renal impairment/renal failure (8.9%), and diarrhea (6.4%). The most common adverse reactions occurring in ≥5% of patients in the cUTI and cIAI trials were headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea (6.2%), and pyrexia (5.6%) in the cIAI trial.

About PIFELTRO^TM (doravirine, 100 mg) and DELSTRIGO^TM (doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg)

PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. DELSTRIGO contains a boxed warning regarding posttreatment acute exacerbations of hepatitis B (HBV) infection. See Selected Safety Information below.

Selected Safety Information for PIFELTRO and DELSTRIGO

Warning: Posttreatment Acute Exacerbation of Hepatitis B (HBV)

All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted.

PIFELTRO and DELSTRIGO are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO.

DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min.

In clinical trials in HIV-1 infected adults, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF.

Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

Co-administration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended.

If DELSTRIGO is co-administered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.

If PIFELTRO is co-administered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).

Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions.

Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min.

The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%).

By Week 96 in DRIVE-FORWARD, 2% of adult subjects in the PIFELTRO group and 3% in the DRV+r group had adverse events leading to discontinuation of study medication.

By Week 96 in DRIVE-AHEAD, 3% of adult subjects in the DELSTRIGO (doravirine/3TC/TDF) group and 7% in the EFV/FTC/TDF group had adverse events leading to discontinuation of study medication.

In DRIVE-FORWARD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, mean changes from baseline at Week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-SHIFT, mean changes from baseline at Week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult subjects in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium.

The safety of DELSTRIGO in virologically-suppressed adults was based on Week 48 data from subjects in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult subjects was similar to that in subjects with no ARV treatment history.

Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of subjects in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of subjects had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of subjects in the delayed switch group experienced ALT and AST elevations of greater than 1.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Sarra S. Herzog

(201) 669-6570

Investors:

Peter Dannenbaum

(908) 740-1037

Raychel Kruper

(908) 740-2107

Read full story here

Tags #Diseases, #IDWeek, COVID-19, Infectious, Merck, Pipeline, Portfolio, Vaccines, Vaccines#Diseases

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Chris Christie released from hospital after COVID-19 diagnosis

Post author By Michelle Dryden
Post date October 10, 2020
No Comments on Chris Christie released from hospital after COVID-19 diagnosis

Former New Jersey governor and ABC News contributor Chris Christie said he was released from the hospital on Saturday, one week after his COVID-19 diagnoses.

— ABC News: Top Stories

Tags #Hospital, #Released, Chris Christie, COVID-19, Diagnosis, Diagnosis#Hospital

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No positive tests allow Patriots, Titans to work in person

Post author By Michelle Dryden
Post date October 10, 2020
No Comments on No positive tests allow Patriots, Titans to work in person

The Tennessee Titans and the New England Patriots had no positive COVID-19 tests Saturday, and both teams are getting back into their facilities.

— FOX News

Tags #Patriots, #Titans, COVID-19, New England, Tennessee, Tennessee#Patriots

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Dozens of COVID-19 cases reported at 2 veterans care centers

Post author By Michelle Dryden
Post date October 10, 2020
No Comments on Dozens of COVID-19 cases reported at 2 veterans care centers

Dozens of COVID-19 cases have been reported at two veterans care centers in Virginia.

— ABC News: Top Stories

Tags #Virginia, COVID-19, Veterans, Veterans#Virginia

Local News

Why independent bloggers need DEI from funders

Post author By Michelle Dryden
Post date September 20, 2020
No Comments on Why independent bloggers need DEI from funders

The news media landscape has been evolving, where independent bloggers and freelancers are an essential part of the news ecosystem, which supports our democracy.

Nevertheless, due to the new digital era and the independent roles that have been established, some bloggers and journalists are experiencing revenue disadvantages in funding for small blog businesses, and from advertisement networks such as Google AdSense.

They lack diversity, equity and inclusion (DEI).

An example of the changes in the journalism industry exists even with the New York Times that has transitioned from a traditional newsroom with a large daily newspaper circulation, to include a robust digital online presence nowadays. Many other publications these days do not even have print copies but are now only online.

With emerging online news options, the entire business at large continues to change. Headlines and news leads no longer strictly adhere to traditional Associated Press (AP) rules, in terms of length and forbidden English articles such as “the,” “a” and “an.” The game is so different now because the Internet provides unlimited space for content.

But with so much in and a lot more gone from our newsrooms, who will be paying for the new technology and those using it for freelance and independent work?

Is the answer the collaboratives such as The Lenfest Institute and Facebook Journalism Project?

“The Lenfest Institute team was hired in Sept. 2016, and our first major grant program was 2017,’’ stated Jim Friedlich, who is part of the Lenfest-FJP team.

Many other organizations such as grant funders for Journalism projects and initiatives are on the rise to endeavor in assisting with business costs and revenues. But who gets these funds? Do all eligible and qualified journalists get their fair share? The answer is, NO!

The Google News Initiative, for example, tries to be inclusive with each of their different funding projects.

“We try to fund for a diversity of applicants, so we change the themes, too: From local and technology to diversity equity and inclusion,” explained Madhav Chinnappa, director of News Ecosystem Development at GNI.

The GNI has been funding innovative Journalism projects for a few years now, and since the COVID-19 Pandemic, it even funded journalists just to help with emergency revenues. But still, the DEI efforts to fund all eligible applicants have not been fully successful.

This is where we experience the adverse effects of traditional journalism out, and digital in. With all the newspaper industry changes and the issues of downsizing, the Internet has replaced a lot of manpower, or people needed for newsroom jobs.

So, now we have social media, bloggers, and independent Journalists doing the traditional newsroom jobs that must go on in a digital era. This is a big deal. Everyone now has a stronger voice. Democracy is very much alive. But not everyone is getting paid.

Journalist are still carrying on the voice of their local newspapers in a digital way. The problem is, who pays the digital journalists now? How do bloggers and Independent Journalist get paid for helping to keep our democracy functioning?

There are a few true and tried methods for revenue: Of course, the grant funders make an effort; also do the advertisement networks such as Google AdSense and others, and thanks to readers’ contributions.

But all that is not enough when some independent journalists are constantly working and posting their stories but are not making a living wage. It seems this disparity affects minorities because of the built-in systematic injustices that are tied into the new journalism revenue systems.

Grant funding is never guaranteed even though minority applicants are very eligible and over-qualified. Neither are the payments from Google AdSense diverse, equitable or inclusive. Minority journalists always have to compete for a paycheck. This is a huge discrepancy in the revenue system and for our shared democracy.

Although Chinnappa states that Google Adsense does not intentionally lack DEI, and “that it is definitely not the intent in any of (Google) products,” to show disparity, some Journalist are just not happy with the current revenue system that significantly limits payments for those who work, but are not as accepted or as popular.

Our democracy needs all our voices, not just some. That’s why voting matters for all, and so does journalism.

Now, with everyone having a place online to speak up and help to contribute to a variety of discourses, communities have a greater sense of our common humanity, and a better understanding of who we all are, and our place and purpose in society.

All people matter. All of our voices and our purposes matter.

Tags #DigitalJournalism, #FJP, #GNI, #Grants, #Newsrooms, COVID-19, Facebook Journalism Project, Funders, Google News Initiative, Grant Funding, journalism, Revenue, The Lenfest Institute, traditional, traditional#DigitalJournalism

Regulations & Security

Georgia jail housing ICE, other detainees performed questionable hysterectomies, shredded records, nurse says

Post author By Michelle Dryden
Post date September 15, 2020
No Comments on Georgia jail housing ICE, other detainees performed questionable hysterectomies, shredded records, nurse says

An immigration detention center in Georgia performed questionable hysterectomies, refused to test detainees for COVID-19 and shredded medical records, according to a nurse quoted in a complaint filed Monday.

— FOX News

Tags #Georgia, #Nurse, #Shredded, COVID-19, Detention Center, Hysterectomies, Ice, Immigration, Medical Records, Medical Records#Georgia

For Edit

Steve Martin shares the hilarious way he’s coping with wearing a mask amid the COVID-19 pandemic

Post author By Michelle Dryden
Post date September 13, 2020
No Comments on Steve Martin shares the hilarious way he’s coping with wearing a mask amid the COVID-19 pandemic

Steve Martin shared the hilarious way he’s coping with having to wear a mask as a celebrity amid the COVID-19 pandemic.

Actually, the comedian, actor, and avid banjo player, has come up with a solution to remain recognizable for his celebrity while wearing a mask in public.

“I always wear a mask when I go outside,” tweeted Martin.

“But something about it was leaving me anxious and unsettled. I thought about the problem, addressed it, and here is the solution.”

Martin tweeted a photo of of him wearing the classic medical mask, a pair of shades, and a hastily written sign that says, “Steve Martin” with an arrow pointing down to his face.

So, thanks to his ingenuity, we can be sure the masked grey-haired man we just passed walking down the street was indeed Steve Martin.