John Parkinson

Eli Lilly has requested the Food and Drug Administration rescind its Emergency Use Authorization for its COVID-19 therapy, Bamlanivimab. The company has made the request as part of its plan to use Bamlanivimab and etesevimab as a combination therapy for treatment of the virus.

This follows the modification of contracts with the United States government to ensure adequate supply of etesevimab to be used together with bamlanivimab. In addition, the company said with the emerging variants, the standalone therapy might not be as efficacious.

"Lilly moved quickly to make bamlanivimab alone available as a potentially lifesaving medicine at a time when Americans were hardest hit by COVID-19," said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories.  "With the growing prevalence of variants in the US that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together."

Over 400,000 American patients have been treated with bamlanivimab, which according to Lilly, potentially prevented more than 20,000 hospitalizations and at least 10,000 deaths during the worst of the pandemic in the US.

Lilly is not requesting the EUA withdrawal its therapy alone in any other jurisdiction. However, it did say the use of bamlanivimab with etesevimab, where authorized and available, is preferred.

Lilly, in collaboration with Amgen—the manufacturer of etesevimab—expects to manufacture sufficient supply of the therapies to meet global demand.

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The company wants to transition to combination therapy of bamlanivimab and etesevimab together for COVID-19 treatment.

Lilly Asks FDA to Revoke its EUA for Bamlanivimab Alone

For most people living with HIV (PLWH) the challenge of having to take a daily oral regimen to stay virally suppressed is demanding. While it has enabled PLWH to maintain a mostly healthy lifestyle, there is always the desire for potentially life-improving changes when it comes to therapy regimen.

ViiV Healthcare has developed a number of combination therapies looking at PrEP and HIV care. For example, its cabotegravir and rilpivirine (Cabenuva) therapy is a long-acting injectable that was approved by the Food and Drug Administration (FDA) earlier this year. With the approval, it became the first complete long-acting regimen for the treatment of HIV in adults in those who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]).

Last year, ViiV presented at The Conference on Retroviruses and Opportunistic Infections (CROI) with findings of long-term data from its global phase 3b ATLAS-2M study of cabotegravir and rilpivirine at 48 weeks. 

At the same conference this year, ViiV presented its 96 week findings, which reinforced the week 48 primary endpoint (proportion of participants with plasma HIV-1 RNA ≥50 c/mL  (Snapshot, ITT-E), and secondary endpoints (proportion of participants with plasma HIV RNA ≥50 or <50 c/mL at Week 96 (Snapshot, ITT-E). 

ATLAS-2M met its primary endpoint at Week 48, demonstrating that the efficacy of long-acting cabotegravir and rilpivirine dosed every 2 months was non-inferior to monthly dosing. The week 48 primary endpoint (proportion of participants with plasma HIV-1 RNA ≥50 c/mL) results showed every 2-month dosing (9/522 [1.7%]) and monthly dosing (5/523 [1.0%]) were similarly effective (adjusted difference: 0.8%, 95% confidence interval [CI]: -0.6, 2.2).

And the week 96 findings reinforced the primary endpoint: the efficacy of every 2-month dosing was non-inferior to monthly dosing of long-acting cabotegravir and rilpivirine, with 2.1% (11/522) and 1.1% (6/523) of participants, respectively, having HIV-1 RNA ≥50 c/mL (adjusted difference: 1.0%, 95% CI: -0.6-2.5).

The aforementioned data shows the potential for PLWH to alter their current therapy regimen and look at new treatment options. “It really challenges the current treatment paradigm,” Patricia de los Rios, global medical affairs director, ViiV Healthcare. "ATLAS-2M showed that a regimen of monthly injectable cabotegravir plus rilpivirine long-acting could reduce that frequency to 6 times per year with the every two-month dosing regimen.”

She noted that shortly after the FDA’s approval in January, the US Department of Health and Human Services (HHS) HIV treatment guidelines committee added long-acting cabotegravir plus rilpivirine to treatment guidelines as an optimize strategy for people who are already have virus suppression, and they haven’t had treatment failures with other therapies. HHS also mentioned some potential beneficiaries to this treatment including those who might be suffering from pill fatigue, or stigma, or potential improvement of quality of life.


spoke to de los Rios about the injectable’s mechanism of action, further insights from the ATLAS 2M study including durability data, and follow-up studies to find out more about implementation of the therapy.

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The ATLAS 2M study results showed non-inferiority in 2-month dosing compared to 1-month dosing for the cabotegravir and rilpivirine long-acting injectable. 

Long-Acting Injectable Offers a Potential Alternative HIV Treatment Option

Young people are vulnerable to COVID-19 reinfection and should consider vaccination when eligible says authors from a new study. In the study looking at US Marine recruits, 10% (19 out of 189) of participants were reinfected with the virus.

“Our study shows that some individuals with lower levels of neutralizing antibodies were reinfected, indicating that it is possible that previously infected and recovered people are susceptible to new SARS-CoV-2 infection at a later time,” coauthor Lieutenant Dawn Weir, PhD, of the Navy Medical Research Center, said.

The participants included 2346 Marines, with 189 being seropositive and 2247 being seronegative at the start of the study. Across both cohorts, there were 1098 (45%) new infections during the study.

In order to learn why reinfections were occurring, the investigators examined the antibodies of both the infected and the non-infected participants. They found that, among the seropositive group, participants who became reinfected had lower antibody levels against the SARS-CoV-2 virus than those who did not become reinfected. In addition, in the seropositive group, neutralizing antibodies were less common—neutralizing antibodies were detected in 45 (83%) of 54 uninfected, and in six (32%) of 19 reinfected participants during the six weeks of observation.

Comparing new infections between seropositive and seronegative participants, the authors found that viral load in reinfected seropositive recruits was on average only 10 times lower than in infected seronegative participants, which could mean that some reinfected individuals could still have a capacity to transmit infection, but the authors noted that it would need further investigation to confirm.

And new infections occurred in approximately 48% (1079 out of 2247) of participants who had not previously been infected.

The study found most new COVID-19 cases were asymptomatic: 84% (16 out of 19 participants) in the seropositive group vs 68% (732 out of 1079 participants) in the seronegative group. Some experienced mild symptoms but none were hospitalized.

In addition, the study’s authors point out the reinfection rate might not be replicated because of the nature of the environment amongst marines living in tight living quarters and close contact for training. They point to another study in Denmark that included 4 million people which found the risk of reinfection was only 0.65%. However, in the same study, the risk of infection was also five times higher in people who had not previously had COVID-19. 

This marine study was funded by the Defense Health Agency and Defense Advanced Research Projects Agency, and It was conducted by researchers from the Naval Medical Research Center, Icahn School of Medicine, Mount Sinai, New York, Naval Medical Research Unit SIX, Peru, University of Texas Medical Branch Galveston, University of Vermont and the Naval Medical Readiness and Training Command Beaufort.

“The takeaway message for all young people, including our military service members, is clear. Immunity resulting from natural infection is not guaranteed; you still need to be vaccinated even if you have had COVID-19 and recovered,” Weir concluded.

Study finds a 10% reinfection rate amongst a mostly 18-20 year old United States Marine population in a closed setting.

Previous COVID-19 Infection in Young Adults Does Not Fully Protect Against Reinfection

In the United States, residents and the staff at long-term care facilities (LTCF) have had a high COVID-19 incidence, and the former is associated with one of the highest mortality rates in the country.

As states have rolled out their COVID-19 vaccine programs, a study from the Nebraska Department of Health & Human Services looked at COVID-19 transmission association with staff and residents after the first-dose of a two-dose vaccine regimen in LTCF in that state.

The state began its COVID-19 vaccines at LTCF on December 28, 2020 as part of the Centers for Disease Control and Prevention (CDC) Pharmacy Partnership for Long-term Care Program. By February 5, 159 Skilled Nursing Facilities (SNF) have completed their first vaccine (clinic-1) and 7271 residents and 6768 staff had been administered their first dose.

The investigators used the Federal and Pharmacy Partnership database to gather the vaccination numbers of residents and staff. They followed the SNFs for 21 days after clinic-1 from December 28-February 5 for any first-time COVID positives. The National Healthcare Safety Network (NHSN) database was used to collect the information on the number of residents present at the facility on the day of clinic-1. The staff count for each facility was extracted from NE-Licensure for LTCF. The investigators gathered case information from the state surveillance, NHSN, and Test-Nebraska platform.

The findings showed that staff vaccine coverage was associated with a reversal of cases, but no reversal of cases was found in resident coverage of the vaccine and new resident transmission.

For the staff, the results showed a progressive result for, “each percentage increase in staff vaccine coverage, the odd of having a new staff positive case 7 days and 14 days after clinic-1 decrease by 26% and 48% respectively,” the investigators reported.

For the residents, “possible confounding exists when infected residents might have tested positive 7 to 14 days after clinic-1 that were not impacted by the vaccine.”

While there was a positive association witnessed in the staff population, the investigators wanted more data after the second dose.

“Although we observed the association between lower case-count with increased facility-level vaccine coverage, we would need to wait for the administration of the second dose of vaccine before assessing the level of association between coverage and new transmission,” the investigators wrote. “Further initiatives are warranted to increase the sub-optimal vaccine coverage for staff.”

Increased facility-level vaccine coverage amongst residents and staff was associated with lower cases in the latter population.