12 January 2023 Blog Post: On COVID Boosters

12 January 2023 Blog Post: On COVID Boosters

It is a question I get a lot these days – “How is the bivalent booster working?”

Not well is the answer.

Without even delving into the immunogenicity and efficacy data, the booster isn’t working well simply when its most important metric – uptake.  To date, an abysmal 15.4% of the population eligible for the bivalent booster have received it (link: https://covid.cdc.gov/covid-data-tracker/#datatracker-home).

A critical fraction of individuals must be vaccinated in order to either control or eradicate an infection with a specific base reproductive ratio (remember in 2020 when we were talking about R-naught / R0?). For disease with high transmission potential, the vaccination fraction would be higher than for those diseases with lower transmission potential.  Generally the R0 of COVID is felt to be between 1.8  and 2.5 which would mean that about 40-50% of the population would need to be vaccinated to make an appreciable difference in transmission rates.

In a concise and readable format, Dr. Paul Offit from the Vaccine Education Center at UPenn, details the “underwhelming” immunity response derived from the bivalent boosters (link: https://www.nejm.org/doi/full/10.1056/NEJMp2215780) suggesting that booster dosing is ‘probably best reserved for the people most likely to need protection against severe disease.” He argues against boosting healthy young people with “vaccines containing mRNA from strains that might disappear a few months later.”

And, in fact, the public would agree – even Maine which has amongst the highest booster vaccination rates in the US.  By age group (link:https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop65):

Age Group             Percentage of Population with Updated Booster Dose

5+:                          28.5%

12+:                        30.2%

18+:                        31.7%

65+:                        63.6%

But, with all due respect to Dr. Offit, this isn’t really public health policy – all he has done is held up a reflective glass to the actual population trend (and supported such with immunologic data). But kudos for dealing with reality.

A more effective public health strategy, I would argue, would be to boost the population (with priority to those most susceptible to severe disease) with vaccines containing mRNA from strains that will appear. We already do this for influenza wherein the components of the annual flu shot are based upon data from 144 national influenza centers in over 114 countries that conduct year-round surveillance for flu viruses. Vaccine components are selected based upon which viruses are making individuals sick, the extent to which those viruses are spreading prior to the upcoming season and how well the previous year’s vaccine might protect against such. A combination of active surveillance and retrospective analysis of the variants that have emerged (alpha, delta, BA.1, BA.4, BA.5) would be our best chance of developing a more effective, longer lasting booster. 

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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January 2023 Newsletter

January 2023 Newsletter

Welcome to the January 2023 Newsletter for Santa Monica Primary Care – our first newsletter of the New Year!

In this issue, we are going to cover the current state COVID cases and will share our practice experience with COVID plus trends in LA County at large. 

We will also highlight a couple of initiatives that we have planned for 2023.

COVID-19 at Santa Monica Primary Care and in LA County

Readers may find it surprising that we actually saw less COVID in December than we did in November. COVID-19 cases in our practice decreased by more than 50% month over month (Graph below). After managing 27 cases in November (one of which required hospital level care), December brought 13 cases.  Of these 3 (23%) were repeat infections.

As I collated Los Angeles County numbers I noticed that we are on row 1035 of the spreadsheet. Little did I imagine in March of 2020 when I began collating the case counts that we would find ourselves in Year 3 of the pandemic.

Cases in Los Angeles County show essentially the same trend, although press reports relying heavily on guidance from County officials would lead one to believe otherwise (link: https://abc7.com/coronavirus-los-angeles-la-covid-cases-new-years-eve/12629266/).  Cases in the County also dropped nearly 50% from 34.5 to 19.8 new daily cases per 100,000 population between from the start until the end of December. 

What County officials are not talking about, however, are persistently elevated COVID mortality rates, despite a decline in cases (Figure below).

In 2020, the average mortality rate was 0.37 deaths per 100,000 population per day.  In 2021 this rose to 0.41 daily deaths per 100,000 population (largely driven by rates >2 in January and early February before vaccines were widely available).

So where would you expect mortality rates to be in 2022 given widespread vaccination, boosters and effective treatments such as Paxlovid.  Much lower, right?  Would 90% be a reasonable assumption – I would think so given that clinical trials have shown up to a 94% reduction in mortality risk with 3 mRNA vaccine doses during Omicron (link: https://www.cdc.gov/mmwr/volumes/71/wr/mm7112e1.htm?s_cid=mm7112e1_w)

Instead we are really only seeing about a 50% reduction in mortality, as at the end of 2022 the mean number of daily deaths stood at 0.18 daily deaths per 100,000 population. Yet I’ve seen little substantive discussion from the County attempting to understand who is dying of COVID and why that is occuring, but instead a dogged / singular focus on reducing cases (which is sound public health policy as reducing cases reduces mortality but there seems to be some subtlety that they are missing). 

One question which I would like to put to Dr. Ferrar is as follows:  Why in July of 2022 was the mortality rate 0.16 with a case rate of 61.8 but in December there was a mortality rate of 0.12 with a case rate of 19.8?

Paxlovid Prescription Trends and “Rebound”

Given the strong clinical data on the significant reduction in long COVID among those treated with Paxlovid (covered in December’s newsletter), utilization rates of this medication have gone up in our practice . Of the 13 individuals who tested positive for COVID-19 in December, 7 elected to begin Paxlovid (53%). Similarly, in November 17 of 27 (63%) took Paxlovid. In October only 3 of 13 cases (23%) chose to begin the antiviral.

The biggest downside of Paxlovid is the “rebound” phenomenon with a return of symptoms and again testing positive, usually about two weeks after the initial positive test. Overall about 25% of the patients for whom we have prescribed Paxlovid experience clinical and testing rebound of the disease but in December only 1 of 7 treated rebounded.

The biggest upsides of Paxlovid include a rapid clinical response where those treated are feeling better, faster – usually in 1-2 days after starting the medication. There is also strong clinical evidence of an up to 30% reduction in the risk of long COVID symptoms as well.

Two New Initiatives in 2023

Each year I try to do “one new thing” in the practice, although it always seems to be more than one. So in the spirit of realism, I will highlight the two new things we will introduce in 2023.

Get DNAbled Program

In 2022 we took our first foray into formal genetic risk analysis with the Galleri cancer screen, based on DNA methylation patterns. While this remains a viable next step (but not a replacement for) routine cancer screening (e.g. mammography, prostate examinations / PSA, and colonoscopy) this year we will also offer a comprehensive pathway for full genome scanning via a partnership with DNAbled – https://getdnabled.com/our-program.html .

For additional detail,see also: https://drbretsky.com/genomic-analysis/

Aledade

In 2023 our Medicare Shared Savings Program will begin formally as part of our ongoing collaboration with Aledade to improve both quality of care and value of care. The lynchpin for this effort will be the annual wellness examination – software developed by Aledade integrates to our Electronic Medical Record platform and identifies patients that are due for such as well as any gaps in their care. Specific emphasis will be on hypertension, diabetes and women’s health initially. Further, with their support, we will seek to manage transitions of care – such as from the hospital to skilled nursing facility and back home. Or, even better, find opportunities to keep patients out of the hospital entirely.

 

We have spent much of 2022 in a slow ramp up position for this effort which will be considerable as Medicare-age patients are a much higher proportion of our practice at Santa Monica Primary Care than most general scope practices – reflecting the age structure of the geographic area.  We have a parallel program already with Anthem Blue Cross that has been running in 2022 and will continue into 2023.  For more information on the transformative work that Aledade is doing with practices across the country, check them out at https://www.aledade.com/our-solutions

Blogs This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. Our blog post this month covered a couple of COVID topics.

In the first, “Observed Over Expected” we attempted to quantify the true population rates of COVID infection given that the overwhelming majority of cases are now diagnosed by home antigen testing – something that is no longer reportable to the Country Health Department.  The link for this blog is: https://drbretsky.com/13-december-2022-blog-post-observed-over-expected/ 

In our second effort, we covered yet again another Board of Supervisors foray into COVID policy, something I always find interesting because the Health Department falls under the governing scope of the LA Board of Supervisors. Nevertheless, Supervisor Hahn chose to give her thoughts to Fox 11 News.  That link: https://drbretsky.com/15-december-2022-on-protecting-yourself/ 

Variants, Variants and more Variants

Both BA.4 and BA.5 (included in the currently available bivalent booster which has been administered to a whopping 15% of the eligible population over the age of 5) are occupying a smaller and smaller proportion of currently circulating and forecasted variants.  

For Region 9 (which includes Arizona, California, Hawaii and Pacific Territories), BA.5 makes up only 3.9% of currently circulating variants as compared to 90.1% in early August. BQ.1 and BQ.1.1 are estimated to comprise 31.1% (holding steady, was 31.5% in early December) and 40.6 (rising from 31.1% in early December) respectively of the total population of variants (link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions). KBB and KBB.1.5 comprise 7.6% and 7.0% of the total.

A late November CDC study suggests that the bivalent booster provided additional (but not great) protection against symptomatic SARS-CoV2 infection, even in time periods where BA.4/BA.5 sublineages (including BQ1 and BQ1.1) predominated. In this study including over 350,000 (of whom a shocking 25% were unvaccinated) the bivalent vaccine efficacy topped out at 56% (for reference, seasonal influenza vaccine is about 50% effective) amongst those 18-49 who were more than 8 months out from their prior booster. For the highest risk group (those 65+), the bivalent booster was only 43% effective when given 8 months or more after the prior booster. If given within 2-3 months, it was 28% effective. Link: https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e1.htm?s (Note that Table 3 is the most useful representation of their data).

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15 December 2022 Blog Post: On “Protecting Yourself”

15 December 2022 Blog Post: On "Protecting Yourself"

Supervisor Janice Hahn this week in a wide ranging Fox 11 interview spent about a minute discussing her opinion on an indoor mask mandate (link: https://www.foxla.com/video/1153724).  She correctly points out that most of the public would not follow such a mandate. She stated “a better approach is to prevent us actually having to get to that pont.” She suggests that we ‘protect ourselves’ instead of relying on a public health mandate.

Granted, Supervisor Hahn has no actual public health experience so it would be a little unfair to press her on specifics of how we ‘protect ourselves’ so I thought that since I have some public health experience, I would try to answer that question. While a bit pejorative, we could start with Francis Bacon’s “knowledge is power” or Jefferson’s refinement of it to “knowledge is power and that ignorance is weakness.”

One measure of knowledge that can be helpful is the current COVID-19 prevalence rate in the County – a rate that represents the number of active infections. Currently that rate (calculated as a function of new case numbers and test positivity rate) is at 2.2%. This has risen steadily since October but is quite a bit below the mid-summer peak of 9.7%

Comparing year over year prevalence, 2022 (in yellow) is currently right between the low rate seen in 2021 (red) and the 4.1% prevalence of 2020 (blue). 

What happens next is well documented from our prior years’ experience – a significant increase in cases rising in both years (2020: blue, 2021: red) to a maximum of 25 active cases per 100 population.

Given that we already know what is going to happen, we need to fill gaps in our current public health approach. Avoiding congregate settings, wearing a mask, testing after exposure or group gathering, opting for outdoor activities rather than indoor ones – the list goes on. All of these things can be done without a mask mandate per se, but communication of actual numbers and emphasizing what we know is going to happen in late December and through January will help the community make better and more informed decisions. Yet, Supervisor Hahn would rather opt for people to ‘protect themselves’ rather than communicating numbers and actual risk – which is precisely why she needs to be running the political spectrum of the County, not its Health.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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13 December 2022 Blog Post: Observed over Expected

13 December 2022 Blog Post: Observed over Expected

One commonly used statistical tool called the chi-squared test is used to formally evaluate the difference between numbers observed versus numbers expected. Don’t worry, there are no statistics in this Blog post but the concept of Observed over Expected is one that is helpful in framing this season’s risk of COVID-19.

As I prepared this month’s Newsletter, I collated the total number of COVID cases seen by month in our practice (Observed) along with the number of repeat infections (individuals experiencing their second infection). It led to the following graphic which we published in the Newsletter.

It led me to ask the following – what sort of numbers might we expect in the practice if our experience was a reflection of COVID-19 rates in Los Angeles County as a whole?  Performing these calculations gives the following graph:

If we had used incidence rates from the County to estimate an expected COVID-19 case load for our practice we would have massively underestimated our observed numbers (a disaster if we used these to modify staffing levels). The lowest magnitude of difference was in January (8.9 fold underestimate) and the highest was November (239.1 fold underestimate). In November, for instance, County estimates predicted that we would see 0.11 cases when, in fact, we had 27 new COVID cases.

There are a number of potential explanations for these discrepancies, the first being ascertainment. In all likelihood, our patients as a function of having a regular primary care provider and access to testing will more often come to our attention and be diagnosed with COVID-19 than might be expected. In some instances, subclinical or those with even mild symptoms will present for care which otherwise might be missed – particularly since 10.2% of LA County residents lack health insurance entirely.

Is it possible that the patients in our practice are more likely to contract COVID-19 or are simply more susceptible? We do have a population that is somewhat older than the LA County average – about 30% of the practice is over the age of 65 as compared to 15% for the County as a whole. It could be that our patients travel more, work in larger congregate settings or have other characteristics that lead to a higher risk of exposure.

Interestingly, the lowest observed to expected ratio was in January when rapid antigen tests were scarce and individuals were relying on PCR testing to a greater degree. Results from rapid antigen testing stopped being reportable to the County in January of this year as well.

So what does this mean from a practical standpoint? We know that the County numbers are an underestimate of the ‘true’ population incidence. Further, using the County numbers in my own practice is a massive underestimate of what I am actually seeing in the clinic.  Nevertheless, a year over year plot of cases (graph below) shows that 2022 (yellow line) is very much on the same trajectory that we saw in 2020 (blue) and 2021 (red). 

SARS-CoV2 continues to display a clear seasonal pattern – one that becomes obvious even in a context of clear under-reporting of cases. I think it is reasonable to assume that these cases will continue to grow, perhaps not to the magnitude of the Omicron surge we experienced in January 2022, but one that will occupy a significant amount of time and effort in the clinic.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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December 2022 Newsletter

December 2022 Newsletter

Welcome to the December 2022 Newsletter for Santa Monica Primary Care – our final newsletter of the year!

In this issue, we are going to cover the (expected) seasonal rise in COVID cases and will share our current practice experience with COVID plus trends in LA County at large. 

 

We could call this issue the Paxlovid Issue, as there is a lot of detail about its usefulness both in acute illness but also in the prevention of Long COVID.

COVID-19 in the Practice and in LA County 

COVID-19 cases in our practice have increased significantly this month, more than doubling in the past month (Graph below). After the relative lull of September (8 cases), these numbers increased to 13 in October and 27 in November. Repeat cases in September were 18% of the total.  Year-to-date, 25 of our 193 cases (13%) have been repeat infections.

Cases in Los Angeles County show essentially the same trend, although the actual numbers are massive underestimates of the true incidence as positive home tests are not reportable to the County  (Figure below). Cases in the County have more than doubled from 10.5 to 25.9 new daily cases per 100,000 population between October and November. 

Based on these numbers, we would expect 4 cases in our practice at Santa Monica Primary Care when, in reality, we saw 27 suggesting a 6 fold underestimate at the County level.

The current prevalence rate (active cases per 100 individuals) stands at 2.2%, the highest it has been since the end of August.

Paxlovid Prescription Trends and “Rebound”

One of the biggest changes seen in the past month is the greater interest in Paxlovid. Some of this may be due to the large VA study showing a 30% reduction in Long COVID among those treated with Paxlovid (covered in our blog, see #3 below). Of the 27 individuals who tested positive for COVID-19 in November, 17 (63%) elected to begin Paxlovid. In October only 3 of 13 cases (23%) chose to begin the antiviral.

The Atlantic covered the paradoxical prescribing practices surrounding Paxlovid in a piece cleverly entitled “Inside the Mind of an Anti-Paxxer” (link: https://www.theatlantic.com/health/archive/2022/11/paxlovid-covid-drug-hesitancy/672210/).  Nationally, fewer than 1/3rd of Americans over the age of 80 ended up with the medication after a COVID diagnosis, a group who would benefit most from the treatment. The biggest downside to Paxlovid remains rebound, which typically presents about two weeks after the initiation of treatment. While rebound is typically a more mild clinical condition lasting a few days but can still interfere with work and life activities. A positive rapid antigen test coinciding with symptoms will have an individual back in isolation which itself is difficult.

While my experience is that patients feel better faster within 24-48 hours often (this is in contrast to the article which suggests that Paxlovid treated patients are ‘kind of sick’ for two weeks), rebound is a frequently occurring phenomenon. Of the 79 patients for whom we prescribed Paxlovid since the beginning of 2022, 21 of them (26.6%) have experienced a rebound phenomenon (confirmed by positive antigen testing at the time of returning symptoms).

Blogs This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. Our blog post this month covered in significant detail the compelling VA study showing an overall 26% reduction in Long COVID symptoms among those prescribed Paxlovid.

On Paxlovid and Long COVID:  https://drbretsky.com/21-november-2022-blog-post-paxlovid-and-long-covid/ 

One interesting take away from the article is that the authors go into a bit more detail in an attempt to better describe the utility of Paxlovid by testing its association with Long COVID according to the number of baseline risk factors (‘comorbidities’). Among those with 1-2 risk factors, Paxlovid reduced the risk of long COVID by 33%. The same magnitude of effect was seen among patients with 3-4 risk factors but dropped slightly for those with 5 or more to 30%. 

One downside of the study is that 87% of the study participants were male, something that reflects the VA population as a whole, but making the results less generalizable to women.

The Alphabet Soup of Variants

BA.5 (included in the currently available bivalent booster) is occupying a smaller and smaller proportion of currently circulating and forecasted variants.  BA.5 makes up only 13.3% of the variants seen in the West Coast, Pacific and Hawaii region currently as compared to 90.1% in early August. BQ.1, and BQ.1.1 which were among variants of concern are estimated to comprise 31.5% and 31.1% respectively of the total population of variants (link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions).

However, both of these are offshoots from Omicron (as is BA.5) so we remain hopeful that the bivalent booster will display efficacy against these variants as well, given their genetic relationship.

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21 November 2022 Blog Post : Paxlovid and Long COVID

21 November 2022 Blog Post : Paxlovid and Long COVID

A recent study published through the Department of Veterans Affairs has suggested that Paxlovid treatment within 5 days of COVID-19 symptoms can reduce the risk of long COVID (news story link: https://www.militarytimes.com/news/coronavirus/2022/11/07/va-study-finds-paxlovid-may-help-prevent-long-covid-19-problems/).  Researchers examined a total of 56,340 participants of whom 9,217 were treated with Paxlovid and 47,123 who were treated with supportive care (i.e. no antivirals or monoclonal antibodies within 30 days of infection). Study dates were from March 1st to June 30th 2022 (paper link: https://www.medrxiv.org/content/10.1101/2022.11.03.22281783v1.full.pdf). 

The authors define long COVID as “Post-Acute Sequelae of SARS-CoV-2” or PASC and, in the study, identified those individuals who suffered from at least one extended outcome from a total of 12 pre-specified outcomes beginning 30 days after infection (and, importantly, did not display this outcome prior to COVID-19 infection). The same primary author had characterized PASC to include pulmonary, cardiovascular, hematologic, GI, kidney, mental health, musculoskeletal, and neurologic disorders as well as fatigue (link: https://www.nature.com/articles/s41586-021-03553-9). 

So looking at the study, it was interesting to see that about 16% of the cohort (all outpatient as Paxlovid is approved for non-hospital use) was prescribed Paxlovid. As a comparison, in our practice, 44 of 166 patients diagnosed in 2022 have been prescribed Paxlovid (26.5%). The mean age in the VA study was 65 years (65.06 for those prescribed Paxlovid and 65.07 for those who received supportive care). One limitation of the VA study, however, is that it was predominately (87.6%) male perhaps limiting conclusions about Paxlovid efficacy among women (this is, of course, a reflection of the VA population as a whole and not a specific critique of this study in particular). An additional oddity in the data was that 25% of the VA population studied in this effort was unvaccinated which is slightly higher than the 20% of the US population that has not received any COVID vaccination whatsoever.

Additionally, Paxlovid was given in the majority of occasions (80% of the time) to individuals who had completed a primary series of vaccination or had a primary series plus a booster. Only 16% of the time was the treatment given to an unvaccinated individual which, of interest, is the only cohort in whom Paxlovid has been shown to have significant clinical benefit. As an aside, a relative risk reduction of about 50% was seen in terms of likelihood of hospitalization or death among those who had received the COVID-19 vaccine, but this did not attain statistical significance (link: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-additional-data-paxlovidtm-supporting). This intersection between vaccination and treatment also extended to influenza vaccination where 71% of those treated with Paxlovid had received a seasonal flu vaccination as opposed to 60.2% of those in the control group.

On the other hand, it did appear that Paxlovid was given appropriately to those with more chronic clinical conditions that would leave them at increased risk of poor outcome.  Those in the treatment group were heavier (BMI: 30.94 versus 30.55; as a quick aside the mean BMI of all participants was 30.61 and obesity is defined as a BMI above 30), more frequently had a cancer diagnosis (15.0% versus 12.9%), diabetes (33.9% versus 29.8%; again noting that the prevalence of diabetes was 30.5% in the entire cohort), cardiovascular disease (30.9% versus 29.1%) and elevated cholesterol (80.9% versus 71.4%; noting that 73% of the entire study group had high cholesterol).

In the VA study, Paxlovid treatment was associated with a reduced frequency of long COVID (PASC) with 9.43 per 100 individuals reporting long COVID symptoms at 90 days in the control group as compared to 7.11 among those treated with Paxlovid – a 26% reduction in risk. Despite being less well at baseline, those treated with Paxlovid also had reduced rates of hospitalization (2.57 events per 100 patients as compared to 3.66 in the control group) and fewer deaths (0.30 deaths per 100 patients treated versus 0.58 in the control group), also at 90 days.  As a comparison, mortality rates for those hospitalized with COVID-19 during Delta were 15.1 per 100 and during Omicron, 4.9 per 100. Numbers reported in this VA study were during Omicron as well.

The authors take their analyses a couple of steps further, which is helpful to better elucidate the precise role of Paxlovid beyond a statement that it ‘reduces Long COVID.’  They tested the association between Paxlovid and the risk of PASC according to the number of baseline risk factors for progression to severe acute COVID-19 illness. While Paxlovid was associated with reduced risk of PASC in people across different risk factors strata, no pattern emerged.  Among those with fewer than 2 risk factors, Paxlovid reduced the risk of long COVID by 33%. The same magnitude of effect was seen among patients with 3-4 risk factors but dropped slightly for those with 5 or more to 30%.

We know from Pzifer’s clinical trial studies that the greatest magnitude of protective effect in terms of reduction of hospitalization and death rates was seen among those who were unvaccinated. A similar pattern emerged in this study when it came to long COVID. While Paxlovid reduced the risk of PASC/Long COVID among those vaccinated and boosted by 21%, it lowered the risk by 32% among the unvaccinated.

Lastly, Paxlovid was associated with reduced risk of PASC in people with primary SARS-CoV-2 infection and in people with reinfection to an identical degree, both with a 25% reduction in Long COVID risk.

To date, Paxlovid has been a ‘no brainer’ treatment among those who are unvaccinated, given strong clinical evidence of efficacy in reducing hospitalization and death. Of course, the vaccination and boosters have also shown strong efficacy in reducing COVID-19 hospitalization and death but that is a separate discussion.  This current VA study suggests that among their cohort (average age of 65 years, 75% Caucasian, 20% African American, 87% male and 42% former smokers), there may be an additional benefit – namely in the reduction of Long COVID. As with the general indications for prescribing Paxlovid in general, it seems that among an older, male population with comorbidities including prior tobacco, that Paxlovid is efficacious. It would be helpful to see additional studies in other populations, particularly comprised of a greater proportion of women.

𝗦𝗶𝗴𝗻 𝗨𝗽 𝗳𝗼𝗿 𝗢𝘂𝗿 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿

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November 2022 Newsletter

November 2022 Newsletter

Welcome to the November 2022 Newsletter for Santa Monica Primary Care. 

In this issue, we are going to cover the alphabet soup of COVID variants and try to predict what may happen as we enter the Holiday Season. We will share our current practice experience with COVID cases as well as trends we are seeing in LA County at large. Lastly, we cover this month’s Blog posts, including one on the utility of colonoscopies in reducing colon cancer mortality rates.

COVID-19 in the Practice and in LA County 

COVID-19 cases in our practice have shown a slight rebound as compared to the dramatic slowing of September (Figure below).  The month of October left us with 10 cases, one of which was a repeat infection and the remaining 9 all initial infections. Cases were generally mild (5 of the 10 were characterized as such) but one did lead to hospitalization.  Of the three cases treated with Paxlovid, one led to a rebound phenomenon.

Cases in Los Angeles County, on the other hand, continue to be on the decline, and are now the lowest levels since March of this year (Figure below). The most recent daily incidence rate is 7.4 new daily cases per 100,000 population down from 7.9 the week prior.

This trend runs in direct opposition to comments from the LA County Health Department which notes that ‘coronavirus cases are no longer declining at the rate seen over the summer and appear to have plateaued.’ LA County Health Department Director Dr. Ferrer commented, “We’re no longer seeing a steady decline in cases” as LA County’s case rate began showing week-over-week increases just after mid-October (link: https://www.latimes.com/california/story/2022-11-01/new-coronavirus-omicron-subvariants-bq1-bq11-ba5).   

The prevalence rate is also the lowest it has been in many months at 3 active cases per 1000 residents (Figure below).

Lastly, mortality rates have shown a steady decline since mid-summer and are now as low as they have been since April 2022.

BA.4/BA.5 Bivalent Booster Uptake Remains Slow

In August, the FDA authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose to be given at least 2 months after completion of a primary series or the most recent booster dose of a monovalent (original) COVID-19 vaccine. The Pfizer booster is authorized for individuals 12 years of age and older. The Moderna for those 18 years and older.

According to the latest CDC data (link: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop), only 22 million – or 7.3% of those eligible – have received a bivalent booster dose.  This has increased from 7.6 million (3.5%) last month at this time.

Blogs This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. As a bit of a departure, we covered a recent report suggesting that colonoscopies were not as effective in reducing colon cancer mortality. While this generated a fair amount of press coverage, the study itself was actually not all that compelling and certainly was not enough to change clinical recommendations of colonoscopy as a screening tool

On Colonoscopies:  https://drbretsky.com/11-october-2022-blog-post-on-colonoscopies/

We also covered COVID-19 in 2022 as compared to 2020 and 2021 in our second blog:

https://drbretsky.com/13-october-2022-blog-post-a-crazy-covid-year/

The Alphabet Soup of Variants

BA.5, BQ.1, and BQ.1.1 are among the ever growing population of variants of concern. But, in reality, tried and true BA.4.6 and BA.5 make up 84.6% of the variants sequenced across the United States (link: https://covid.cdc.gov/covid-data-tracker/#variant-proportions) and 83.3% of the variants seen in HHS Region 9 which includes California, Arizona, Nevada and Hawaii. While the proportion of BA.4 and BA.5 is decreasing over time (Figure below), they are nevertheless the overwhelming majority of variants seen both regionally and nationally. With booster vaccines that are directly matched to these variants, we should continue to see decreasing case rates and mortality rates.

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13 October 2022 Blog Post: A Crazy COVID Year

13 October 2022 Blog Post: A Crazy COVID Year

Reflecting on this weekend’s LA Times article headlined “With COVID on the retreat, are Halloween, Thanksgiving and winter holiday gatherings safe?” (link: https://www.latimes.com/california/story/2022-10-10/with-covid-on-the-retreat-how-safe-are-holiday-gatherings), my first question was – “is COVID really on the retreat?”

The short answer is, yes. Although what a year we have had!  Things started out with an Omicron bang in January as both incidence and prevalence rates hit dizzying new heights. Test positivity rates were so high in January that it broke our prevalence calculator which estimated that for the week ending 1/11/2022 that 72% of the County residents had the infection. We are much, much, much lower now with a 0.5% (1 in 200 residents) with active infection – down from a midsummer high of 9.8%. Our best week was that ending 3/22/2022 at 0.05% (1 in 2000 residents). So, yes, depending on your perspective COVID is in retreat. Figure 1 below graphs prevalence rate.

A similar trend is seen in incidence rates – readers will know that I have moved away from this metric as it does not include results from home rapid antigen (lateral flow) tests as the County does not tabulate these or permit reporting of these results. But even looking at only PCR results from accredited laboratories, this rate too is in retreat with 9.97 new daily cases per 100,000 for the week ending 10/4/2022 (most recent week for which complete data are available). This rate was 453.19 new daily cases per 100,000 the week ending 1/11/2022.  Figure 2 below graphs incidence rate.

Mortality follows cases and, as expected, current COVID-19 mortality rates are also “retreating”.  There are currently 0.03 daily deaths per 100,000 population in the County, as compared to our peak of 0.82 daily deaths per 100,000 the week ending 2/8/2022 (note the lag time between peak prevalence/incidence and peak mortality of about 3 weeks – again a pattern we’ve seen time and time again during the pandemic).  Figure 3 below graphs mortality rate.

Historically, October has been a time of relative COVID lull. Interestingly, 2022 (Yellow) had the highest historical midsummer prevalence rate (nearly 10% at maximum) as compared to 2020 (Blue) and 2021 (Red).  Prevalence rates for the week ending October 4th were low in all years:

 

2020:  0.4%

2021: 0.1%

2022: 0.5%

Enjoy the lull, because based on our 2020 and 2021 experiences, it isn’t a great secret about what happens next (Figure 5 below).

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11 October 2022 Blog Post: On Colonoscopies

11 October 2022 Blog Post: On Colonoscopies

Interestingly enough, the effectiveness of colonoscopy has never been evaluated using a gold-standard clinical trial wherein one group (treatment) is evaluated for colon cancer with a colonoscopy and a comparison (control) group is not. This week, the New England Journal of Medicine published results from a “pragmatic” clinical trial wherein over 84,000 men and women between the ages of 55 and 64 years of age from Poland, Norway, Sweden and the Netherlands were split (1:2 ratio) between being “invited” to have a colonoscopy versus “usual care” (no colonoscopy or screening offered).  The study recruited patients between 2009 and 2014, and followed them for up to 10 years (Bretthauer et al.  Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2208375). 

The study found a risk of colon cancer at 10 years to be 0.98% in the invited group versus 1.20% in the usual care group. Mortality rates were 0.28% in the invited group versus 0.31% in the usual care group. 

So at face value, colonoscopy seems to be a pretty underwhelming screening tool – but a couple of caveats:

  1. The invited study population was between 55 and 64. Current US recommendations are for colonoscopy to begin at age 45. Earlier screening, in general, has more robust benefits rather than later screening so the older age cohort is a limitation of this study.
  2. Colon cancer itself, generally speaking and exclusive of more aggressive cases, can take many years to progress from polyp to cancer may be greater than the 10 years of follow-up undertaken by this current study. So a longer study period would be preferable.
  3. Of those study participants invited to have a colonoscopy (total of 28,220 individuals) only 42% (11,483) underwent the procedure. This is a significantly lower percentage of colonoscopy uptake than is typically seen in the US where about 70% of those who are offered colonoscopy then have one.

So overall a very interesting study and even when analyzed with ‘intent to treat’ (i.e. considering all 28.220 as having had a colonoscopy even though only 11,483 did), there was an 18% risk reduction effect associated with the procedure. In short:

“I don’t think this should change our practice,” said Dr. Robin Mendelsohn, a gastroenterologist at Memorial Sloan Kettering Cancer Center in New York City. “The bottom line is still get screened, still have the discussions” with your doctor.

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October 2022 Newsletter

October 2022 Newsletter

Welcome to the October 2022 Newsletter for Santa Monica Primary Care. 

In this issue, we are going to try to triangulate the state of COVID-19 in Los Angeles County. We will share the current practice experience with COVID and explain how the bivalent boosters might be so exciting. We will also cover the Blogs posted by Dr. Bretsky this month.

1. COVID-19 in the Practice and in LA County

COVID-19 cases in our practice have slowed dramatically (Figure below) with only 5 cases reported the entire month (2 repeat infections, 3 first time infections).  In August we had 12 cases (3 were 2nd infections).  In July we had 18 cases (3 were  2nd infection), June saw 29 cases (3 were 2nd infections) and in May we managed 33 infections (3 were 2nd infections). I had expected a bit of an uptick in cases with the start of school but this has not occurred, at least in our small sample.

Trying to figure out what is occurring in terms of case rates at the County level is still a bit of a guessing game – most notably hampered by the fact that the overwhelming majority of cases are diagnosed via home testing and, by the County’s case definition, are not reportable. That notwithstanding, incidence case rates have declined steadily since mid July (Figure below).

In previous issues we have discussed how a calculated prevalence rate might be a more accurate representation of the true case frequency. Current prevalence rates are as low as they have been since May at 0.7 active cases per 100 individuals.

2. BA.5 Bivalent Booster Uptake

As most of you likely know, the FDA authorized the use of Moderna and Pfizer Bivalent Vaccines for a single additional booster dose at the end of August. This updated booster is to be given at least 2 months after completion of a primary series or the most recent booster dose of a monovalent (original) COVID-19 vaccine. The Pfizer booster is authorized for individuals 12 years of age and older. The Moderna for those 18 years and older.

According to the latest CDC data (link: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop), only 7.6 million individuals – about 3.5% of those eligible for the updated COVID booster – have received one. Of additional concern is that awareness of the new boosters is “modest” according to a recent survey (link: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2022/). One in five people surveyed have heard “nothing at all” about the new booster as compared to 17% who have heard “a lot.”

Personally, I’m pretty pumped (as Parker Schnabel would say – for my fellow Gold Rush fans out there – Discovery Channel Friday nights) about the new booster and am hopeful that it generates more specific and durable immunity than the prior boosters. Why would I feel this way?

Well, firstly, the current booster is matched with the dominant circulating strains as it contains an mRNA component from the BA.4 and BA.5 Omicron variants. The graphic below shows that these account for the overwhelming majority of variants isolated in the United States: BA.5 at 85% and BA.4 at 13%.

Additionally, this is one of the first times that we have not been vaccinating or boosting into the teeth of a case rise. Given such, the relatively slow uptake of the booster dose is less concerning as we do have the luxury of time, for once. With a general rule of thumb being that it takes about two weeks for the booster effect to take hold in our immune system, the continued decline in cases makes it less likely that one will be exposed to the virus soon after the booster dose – perhaps before it takes effect. 

I generally have been advising patients to strongly consider having the booster by the end of October – which is also a guideline for the seasonal influenza vaccine. While you can have both at the same time, it may be more prudent to separate the two. That way in the case of an unlikely, but possible, vaccine reaction – the cause will be apparent.

3. Blogs This Month

Our blog posts this and previous months can be found archived on our website at www.drbretsky.com/blog. This month we had two Blogs covering booster shots. One in the context of the seasonality of COVID (a trend which has clearly emerged) and the other structured as a Q&A session on the boosters itself.

Booster Shots and COVID Seasonality: https://drbretsky.com/9-september-2022-blog-post-new-booster-shot-heralds-covid-seasonality/

Booster Q&A: https://drbretsky.com/13-september-2022-blog-post-fall-2022-covid-boosters/

Our third blog covered more well-trod ground looking at incidence and prevalence rates of COVID-19 in Los Angeles:

https://drbretsky.com/14-september-2022-blog-post-mid-september-covid-case-numbers/ 

And out final monthly blogged looked at the idea that the US ‘follows’ the UK when it comes to COVID case rates (spoiler alert: it sort of does, but not always): https://drbretsky.com/28-september-2022-blog-post-following-the-uks-lead/ 

This final blog garnered some interesting Twitter reactions, namely critiques of the Zoe Health Study which is composed of self-selected participants who record COVID like symptoms into an app along with any COVID testing results.

4. On Patient Reviews

Patients who have seen us in the office recently will know that we have been actively seeking patient feedback about our services on rating sites, including Google, Facebook and Yelp. These have become increasingly important in quality metrics that measure the patient experience. We appreciate the time and effort that you have taken to post your experience.

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