, coronavirus and other infectious diseases.

Rachel Lutz

GSK's Priorix, a new measles, mumps, and rubella (MMR) combination vaccine, can be used as an additional option to prevent MMR, according to a paper published in the U.S. Centers for Disease Control and Prevention’s 

Investigators from the CDC’s Advisory Committee on Immunization Practices (ACIP): Measles, Mumps, and Rubella Vaccine Work Group met in order to discuss issues with Priorix implementation, including prevention of MMR, short-term humoral immunity, persistence of the humoral immune response, and adverse and serious adverse events. They collected studies to analyze from the PubMed, Medline, Embase, Scopus, and Cochrane databases, plus clinicaltrials.gov.

The study authors explained that M-M-R II (Merck and Co.) was previously the only available MMR vaccine in use in the United States. The vaccine has worked to eliminate the diseases in the United States, but infections are endemic worldwide and can lead to local transmissions within the US.

In 4 randomized controlled trials that the work group examined, safety profiles of 1960 subjects who received 1 or 2 doses of Priorix were compared with 933 subjects who received 1 or 2 doses of M-M-R II. A majority (90 percent) of the patients were aged 12 to 15 months. The study authors observed a similar frequency of vaccine-related adverse events between the groups: 0.0 to 0.2 percent among Priorix subjects and 0.0 to 0.3 percent among M-M-R II subjects.

The study authors also noted that the highest rate of febrile seizures is 6 to 11 days after vaccination for all MMR vaccines, and is typically found among 3.3 to 8.7 per 10,000 doses (according to 2 studies from the United Kingdom). The time course of fever was comparable for both vaccines, too, the study authors said, with instances noted on days 5 to 12 of the post-vaccination period.

Among 4 randomized controlled trials in the U.S. assessing the potency of Priorix, 1 case of ITP was found among 1960 Priorix recipients and 1 case was found among M-M-R II recipients, the study authors wrote.

The study authors used 13 randomized controlled trials to assess serologic response thresholds, which were achieved for all 3 antigens in all 13 studies, they said. The 4 studies that focused on Priorix potency found no significant difference among anti-measles, anti-mumps, or anti-rubella geometric mean concentrations after the first dose between Priorix and M-M-R II recipients, the study authors wrote. Plus, they added, none of those studies reported any potency differences between the 2 vaccines after the second dose.

ACIP recommended Priorix in June as an option to prevent MMR, adding that it was interchangeable for all indications for which MMR vaccination is recommended. Priorix can be administered concomitantly alongside other routine childhood vaccines, the study authors added, with the same contraindications for Priorix as with M-M-R II. The Work Group additionally recommended that doses of the vaccine come from the same manufacturer, but noted that should not come at the cost of delaying a subsequent dose.

“Given the similarities in potency and vaccine components, and evidence for similar safety and immunogenicity, as well as stakeholder support, Priorix and M-M-R II are considered fully interchangeable, including for all off-label recommended uses,” the study authors concluded. “Either vaccine may be administered in any situation in which an MMR virus-containing vaccine is indicated. Two interchangeable vaccines from different manufacturers will help safeguard vaccine supply in the United States to maintain measles and rubella elimination and mitigate mumps cases and outbreaks.”

Articles

Priorix and M-M-R II are fully interchangeable vaccines to protect against measles, mumps, and rubella, the CDC’s Advisory Committee on Immunization Practices said.   

CDC Outlines Best Practices for Priorix for MMR Vaccination  


Bulevirtide is a potential treatment option for people living with chronic hepatitis delta virus (HDV), according to a key presentation from The Liver Meeting, which took place earlier this month. The research was selected to be part of the “Best of the Liver Meeting” highlights.

Investigators from Gilead conducted phase 2 and Phase 3 studies of bulevirtide in order to evaluate its 48-week integrated safety and efficacy among those living with chronic HDV. Bulevirtide (Hepcludex in the European Economic Area and United Kingdom) is Gilead’s first-in-class investigational treatment for chronic HDV. The drug was granted Breakthrough Therapy and Orphan Drug designations by the FDA, according to a 

In the first study, 269 patients were either treated with bulevirtide alone at 2 mg daily (64 patients) or 10 mg daily (115 patients), while 39 patients received Peg-IFNα, and 51 patients served as controls. After 48 weeks, overall incidence of participants who experienced adverse events was similar between the 2 groups that received bulevirtide (85 and 86 percent) compared to 89 percent in the Peg-IFNα group and 76 percent in the control group. However, the study authors wrote that most adverse events were mild or moderate in their severity. They ultimately concluded that bulevirtide 2 mg daily was safe and well-tolerated, including in patients with compensated cirrhosis as well as among patients who were not naïve to interferon.

A second study explored the effects of bulevirtide 2 mg daily or bulevirtide 10 mg daily on 64 and 65 patients, respectively, compared to 51 control patients receiving no active anti-HDV treatment during a 48-week analysis period. The study authors determined that treatment with bulevirtide had similar endpoints between the 2 mg and 10 mg groups; additionally, treatment with bulevirtide offered better results than the control group, which received no treatment.

Finally, the investigators examined quality of life among patients with HDV. A total of 150 patients were randomized into equal groups to receive either bulevirtide 2 mg daily, bulevirtide 10 mg daily, or no treatment until week 48 followed by bulevirtide 10 mg afterwards until 3 years.

The patients self-rated their quality of life at baseline and at week 48. Those who received bulevirtide 2 mg daily reported statistically significant quality of life improvements through week 48, the study authors observed, and these improvements were significantly better in terms of a change from baseline compared to control. Quality of life improvements among patients who received bulevirtide 10 mg daily did not reach statistical significance, the study authors reported.

Taken together, this body of research underscores “the clinical utility of bulevirtide as a potential treatment option for people living with chronic HDV,” the company statement said.

“Our latest research helps to address some of the most significant needs of people living with liver diseases globally,” Anu Osinusi, vice president, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead, said in the press release. “It includes analyses from our clinical program on bulevirtide for the treatment of chronic hepatitis delta virus and preclinical data demonstrating the progress Gilead is making on the journey towards a potential cure for hepatitis B. Through our ongoing research programs, we continue our longstanding commitment to address the unmet needs of people impacted by liver diseases.”

Three posters on the subject were presented at The Liver Meeting and were among the meeting’s key presentation highlights called “Best of the Liver Meeting.” 

Breakthrough Therapy Bulevirtide was Safe, Effective, and Improved Quality of Life for Hepatitis Patients 


Automated letters implemented as part of a hepatitis C virus screening program lead to about a third of recipients getting screened for the virus, according to investigators from the Veterans Affairs Greater Los Angeles Healthcare System. Their study was developed into a 

, “Analysis of an Automated Letter HCV Screening Program within a Veterans Affairs Health System: Implications for Universal HCV Screening” which was presented at the recent ID Week 2022.

The investigators mailed letters to veterans in order to characterize the efficiency of an automated letter HCV screening program at the VA and its associations with care. Veterans received these letters between January 2017 to May 2020 if they were born between 1945 and 1965 and did not have a hepatitis C antibody test result on file within the last 10 years. The study authors said that despite a US recommendation for universal hepatitis C screening, the optimal delivery method is unknown.

Once veterans received the letter, they used it to present to a VA laboratory for hepatitis C Ab testing, including reflect hepatitis C viral load, the study authors explained. Those who had hepatitis C had some baseline characteristics collected and were referred to hepatology or infectious disease clinics to initiate treatment.

The study authors identified 12,875 veterans, of which 4,011 presented for hepatitis C Ab testing (about a third), they said. Of those who were tested, 4.2 percent were hepatitis C Ab + and 41.3 percent had hepatitis C viremia (69 patients).

Almost all of the viremic patients were male (94 percent), about a quarter were African-American (26 percent), most had stable housing (62 percent), a quarter lived more than 90 miles from the nearest VA clinic (24 percent), and 17 percent had cirrhosis, the study authors observed. The median page was 63 years. The study authors also noted 10 percent of the viremic patients had an opioid use disorder and 29 percent had an alcohol use disorder.

Nearly all of the viremic patients–94 percent–were treatment naïve, the study authors added.

When characterizing the efficiency of the letters, the study authors defined the first hepatitis C visit as the first clinical visit to a hepatology or infectious disease specialty clinic for evaluation or treatment. With that said, 55 veterans were evaluated in a viral hepatitis clinic and 84 percent of those patients initiated hepatitis C treatment.

From there, the study authors learned that almost all of the patients who initiated treatment completed hepatitis C direct-acting antivirals and a majority of those patients made it to sustained virologic response.

Reasons for not creating an initial appointment included patients’ housing status, cirrhosis, and distance to the clinic, the investigators determined.

“Automated letter screening is a promising approach to HCV screening, including universal screening,” the study authors concluded. “Future research should include investigations of telehealth and e-consultsfor linkage to care, especially for those who have marginalized housing status and live far from clinic.”

About a third of veterans who received a letter to get tested for hepatitis C did so, according to a study by the Veterans Affairs Greater Los Angeles Healthcare System. 

Automatic Letters Help Boost Screenings for Hepatitis C 


Hispanic or Latino (Hispanic) patients with HIV experience more health care disparities and discrimination events compared to other racial groups, according to the US Centers for Disease Control and Prevention’s 

Investigators from the CDC used data from the Medical Monitoring Project between 2018 and 2020 in order to understand and eliminate the barriers to HIV care and treatment. The data included self-reported stigma and health care discrimination reports from 2690 adult Hispanic participants.

A previous report, the study authors noted, found that Hispanic patients who received HIV care, were retained in care, and were virally suppressed at levels lower than their non-Hispanic counterparts.

The participants were made up of a group that was 81 percent male, the study authors noted, including 66 percent who identified as white, 13 percent who identified as Black, and 4 percent who identified as American Indian or Alaska Native. The study authors also were able to trace Hispanic heritage, with 36 percent reporting Mexican, Mexican American or Chicano heritage, 34 percent identified their heritage as Puerto Rican; additionally, about two-thirds (62 percent) were born outside the continental US, 22 percent were born in Puerto Rico, and 19 percent in Mexico. The study authors added that 42 percent of participants reported limited English proficiency.

The highest reported median HIV stigma scores on a scale of zero to 100 was 31.7, with women and American Indian or Alaska Native patients reporting the highest scores among Hispanic persons with HIV, the study authors reported, at 35.6 and 38.9, respectively. The study authors also found that HIV stigma was primarily attributed to disclosure concerns (between 48 and 78 percent of participants), which include fearing others will reveal someone’s HIV status and being careful about who knows someone’s HIV status. Between 20 and 28 percent of participants agreed with the items about perceived public attitudes – including feelings of disgust and rejection related to a positive HIV status – the study authors determined.

Almost a quarter of Hispanic persons with HIV (23 percent) reported health care discrimination, the study authors observed. It was more frequently experienced by Hispanic men (23 percent) compared to Hispanic women (18 percent), they found, as well as by Black or African American Hispanic persons (28 percent) compared to White Hispanic persons (21 percent).

“Understanding disparities in experiences of stigma and discrimination is important when designing culturally appropriate interventions to reduce stigma and discrimination,” the study authors wrote.

Examining health care discrimination events, 22.6 percent of Hispanic persons with HIV reported experiencing any discrimination in the prior 12 months, the study authors found: 8 percent reported 1 event, 4 percent reported 2 events, and 11 percent reported 3 or more events. These events were categorized by the following types of experiences, as explained by the study authors:

62 percent felt that a doctor or nurse was not listening to what they were saying

48 percent felt they were treated with less respect than others

48 percent perceived they were treated with less courtesy than others

The participants were also asked to attribute their discrimination to certain qualities:

30 percent attributed health care discrimination to their HIV infection

23 percent to their sexual orientation or sexual practices

Hispanic men were more likely than Hispanic women to experience health care discrimination, as were multiracial Hispanic patients compared to white Hispanic counterparts, the study authors found. They also noted that those born inside compared to outside the U.S. experienced more discrimination, specifically those born in Mexico, Central America, and South America compared to a U.S.-born person.

“Data disaggregation among Hispanic persons with HIV revealed disparities in stigma and discrimination experiences,” the study authors concluded. “Designing multilevel, culturally, and linguistically appropriate approaches that address stigma and discrimination, particularly among priority populations such as Hispanic persons with HIV, is key to improving care and treatment outcomes and ending the HIV epidemic.”

The study authors called eliminating barriers to HIV care and treatment a national priority.

Quantifying HIV Stigma Among Hispanic and Latino Populations


Prevymis (letermovir) was more effective in preventing CMV in adult kidney transplant patients than the standard treatment, valganciclovir, in a Phase 3 trial, according to results of a study presented at 

Investigators from Merck conducted a phase 3, randomized, double-blind non-inferiority trial in order to compare Prevymis to valganciclovir and their abilities to prevent CMV disease among 601 high-risk adult kidney transplant recipients. The patients were randomized to either receive 480 mg of Prevymis once per day or 900 mg of valganciclovir once per day for 7 days post-transplant for 28 weeks with follow-up through 52 weeks, the study authors explained. The median age for the patients was 52 years in the Prevymis group and 51 years in the valganciclovir group, they added.

Prevymis was approved by the FDA in 2017 for the prophylaxis of CMV infection among adult CMV-seropositive recipients of an allogenic hematopoietic stem cell transplant (HSCT), according to a Merck press release. Valganciclovir is the current standard treatment, the statement continued, though leukopenia (the decrease in white blood cells) and neutropenia (the decrease of the most common white blood cell) can be common hindrances.

The statement also added that CMV can infect anyone of any age, but transplanted organs can carry the disease and infect the recipient. This can lead to end-organ damage and transplant recipients with CMV are at risk for transplant failure and death, the statement said.

At 52 weeks post-transplant, 10.4 percent of the Prevymis group had CMV disease, compared to 11.8 percent of the valganciclovir group, the study authors reported. They said this finding was consistent across all subgroups such as age, gender, race, and geography.

The study authors also observed that after 52 weeks post-transplant, none of the Prevymis participants had adjudicated CMV disease compared to 5 patients (1.7 percent) of the valganciclovir group.

Leukopenia and neutropenia were found to be lower among patients randomized to receive Prevymis compared to valganciclovir, the study authors learned, with leukopenia and neutropenia being 38 percent lower in the Prevymis group compared to valganciclovir.

“There is a need for additional CMV prophylactic options for kidney transplant recipients to help patients reduce risk of opportunistic infections,” Nicholas Kartsonis, MD, senior vice president, vaccines and infectious diseases, Global Clinical Development, Merck Research Laboratories, said in the statement. “These new study results in adult kidney transplant patients are encouraging and demonstrate the potential of PREVYMIS to prevent CMV disease with a therapy that showed lower rates of neutropenia and leukopenia versus the comparator.”

Among the Prevymis group, there were drug-related adverse events reported about 20 percent of patients through week 28 post-transplant, and serious adverse events reported in 1.4 percent of patients, the study authors wrote. In the valganciclovir group, these numbers were higher with 35 percent of patients reporting adverse events and 5.1 percent reporting serious adverse events.

“I was excited to see these trial results that showed that the efficacy of PREVYMIS for prevention of CMV disease in kidney transplant patients was similar to the current standard of care treatment, but with significantly less toxicity,” added Ajit P. Limaye, MD, director, Solid Organ Transplant Infectious Disease Program at University of Washington School of Medicine.

Prevymis showed less leukopenia and neutropenia compared to valganciclovir during the trial.

Prevymis Effective in Preventing CMV in Adults Post-Transplant


Vaccination efforts have lead to a reduction in hepatitis A outbreak-affected states, and this progress should be encouraged to continue, according to the US Centers for Disease Control and Prevention’s 

Investigators from the CDC analyzed data around 33 eligible hepatitis A outbreak-affected states in order to characterize the demographic, risk factor, and clinical outcome data between 2016 and 2020. Since the introduction of the hepatitis A vaccine in 1996, rates of infection in the US have declined about 97 percent through 2015, the study authors said. However, they noted outbreaks reported in 37 states, accounting for about 44,650 cases, 27,250 hospitalizations, and 415 deaths. Many of these infections occurred among persons who reported injection or non-injection drug use or who were experiencing homelessness, according to a 2017, the study authors also noted.

Of the infected individuals, 56 percent reported drug use, 14 percent reported experiencing homelessness, 12 percent reported recent incarceration, and 3 percent reported recent international travel, the study authors found. They also noted that 5 percent of males with hepatitis A infection identified as men who have sex with men. Additionally, they determined that 61 percent of persons with hepatitis A were hospitalized and there were 380 outbreak-associated deaths, or about 1 percent.

A majority of the hepatitis A cases were among males (62 percent) and white individuals (81 percent), the study authors said. Most of the cases were among those aged 30 to 49 years, and the median age was 38 years, the study authors reported.

Hepatitis B and hepatitis C virus past or current infection was found in 5 and 30 percent of patients with that data available, respectively, the study authors observed.

The study authors wrote that vaccination is the most effective method to prevent and control hepatitis A outbreaks, which lead to the Advisory Committee on Immunization Practices (ACIP) in 2019 recommending that those who experience homeless should be vaccinated, as well as reinforcing vaccination recommendations for drug users. Since then, the number of states with outbreaks has dropped from 37 to 13, the study authors noted.

“Increased hepatitis A vaccination coverage, particularly through implementation of successful, nontraditional vaccination strategies among disproportionately affected populations, is needed to continue progress in halting current outbreaks and preventing similar outbreaks in the future,” the study authors wrote.

In 2017, the CDC launched a large-scale, multidisciplinary response to encourage hepatitis A vaccination in disproportionately affected communities, including hosting satellite vaccination clinics (including at correctional facilities, substance use treatment facilities, syringe services programs, and homeless shelters), and broadening the scope of health care professionals permitted to administer the vaccines. The study authors also described how the CDC also partnered with longstanding organizations who had relationships with people at risk for hepatitis A to overcome barriers to vaccination such as mistrust, stigma, and vaccine hesitancy. These outreach programs have contributed to 24 states declaring their outbreaks over, and a decrease in case counts in the remaining 13 states, the study authors wrote.

“Increased hepatitis A vaccination coverage, through implementation of nontraditional vaccination strategies to reach disproportionately affected populations, along with improved universal and catch-up childhood vaccination, will be necessary to respond to the current hepatitis A outbreaks and prevent similar outbreaks in the future,” the study authors concluded. “Continued improvements in vaccination infrastructure, immunization information systems, and education and outreach are critically needed to build vaccine confidence and improve vaccine delivery in nontraditional settings.”

Hepatitis A infections occurred almost exclusively among adults in states with outbreaks. 

Rachel Lutz

Articles

Latest News