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Covid 19. Latest news on Hydroxychloroquine Treatment

There has been much controversy over the effectiveness of hydroxychloroquine as a treatment for Covid 19.  The story was confused after two publications that not only showed that HCQ was ineffective, but may even be more dangerous than no treatment at all.  Both of these papers were published in well respected, peer reviewed journals, The Lancet (United Kingdom) and the New England Journal of Medicine (United States).  Based on these studies, the World Health Organization (WHO) and many countries stopped the use of HCQ.  However, since that time, both journals have RETRACTED the publication due to errors and presentation of data that were deemed misleading.

However, more recently another publication has shown convincing and verified data that strongly suggest that HCQ is very effective against covid 19 if prescribed at the right time in the right dose.

Retractions

The two retracted studies were published in the Lancet and the New England Journal of Medicine.

Due concerns regarding the paper after the publications, the editors of the journals requested more detailed information from the authors.  The Lancet editors stated “The study was withdrawn because the company that provided data would not provide full access to the information for a third-party peer review, saying to do so would violate client agreements and confidentiality requirements.”

The reviewers were unable to conduct “an independent and private peer review” and withdrew from the process, The Lancet said.

Similarly, the NEJM stated “because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.”1 We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused.

https://www.nejm.org/doi/full/10.1056/NEJMoa2007621

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext

This means that the articles that lead to the announcement that hydroxychloroquine was ineffective could not be verified making the results highly questionable.

Fortunately, another publication was soon published and has withstood investigation

ACCEPTED PUBLICATION – Positive Results

https://www.ijidonline.com/article/S1201-9712(20)30534-8/fulltext

A team of physicians had their publication accepted by the Journal of Infectious Disease in June.  Their study including 2514 covid 19 infected patients showed that HCQ significantly reduced the mortality rate.  The mortality rate without treatment was 26.4%.  The mortality rate with HCQ was 18.1%  These results were statistically significant.

All patients were in the Henry Ford Health System in Detroit, Michigan.  All patients were hospitalized through the emergency department.  All patients were over the age of 18.  HCQ was given beginning on day 1 of admission.  The majority of patients had body mass index values >30.

There were actually 4 groups of patients.  A group that received no mediation, received HCQ alone, received azithromycin (AZM) alone  or HCQ + AZM.  AZM is antibiotic that is used to treat a variety of infections and has been suggested as a covid 19 treatment.

The following table summarizes the number of patients and their comorbidities fot each treatment group vs NO treatment.

 HCQ vs No TreatmentAZM vs No TreatmentHCQ+AZM vs No Treatment
Hazard Ratio.3401.05.294

Treatment with HCQ reduced the chance of death by 66% and the use of HCQ+AZM reduced the chance of death by 71% compared to no treatment.  AZM alone slightly increased the risk of death.

This is in direct contrast to the two retracted publications and indicate that the early use of HCQ may be an effective method to reduce fatalities, even in patients with comorbidities and high body mass index.

The study needs to be repeated in a larger number of hospitals.  It is not known if HCQ will prevent infection if taken prior to infection or if covid 19 will increase recovery rates in patients that do not die.

There is still research that must be done, but this is an important finding that provides another treatment against covid 19 fatalities.

 

Covid 19: How to interpret increase in infections.

There has been an increase in the number of covid 19 cases in the US in the past 2 weeks.  In some states, there have even been single day record high number of new cases reported.  However, it is important to consider other factors in addition to the number of new cases to assess how the return to the activities of ‘normal’ activities is effecting our society.

The key concepts in this blog are:

  1. In 39 states, there is an increase in the number of Covid 19 reported cases.
  2. The total number of tests are also increasing, so this increases the reported cases.
  3. There are more reported cases than there number of new tests-so infections are rising.
  4. The age group of the infected people is MUCH lower, less than 30 years old.
  5.  There is existing hospital capacity to handle the current increases
    1. Texas hospitals are at around 75% capacity
  6. The number of deaths from covid 19 have been continually DECREASING
  7. Younger patients and drugs like Remdesevir shorten the length of hospital stays.
  8. The curve is still flattened in that hospitals are not over capacity and deaths are way down.

Public Policy

Given that there is a rise in covid 19 infections, what should the public policy be?  We know much more about the disease now than we did in February.  Some point to consider:

  1. Where are the infections? If the infections are localized, then it is not necessary to shut down or place strict controls on businesses, travel, restaurants etc. in areas where infections are low.
  2. Localized areas of infection should be analyzed to find where the infections are coming from. For instance, if the people who get infected did not go to the beach, then there is no reason to close the beaches just because there were a lot of people on the beach.  The same is true for bars or other places where larger number of people gather.  If it is where the infections are occurring, then those places need to drastically change their practices or close. Recall that in New York 66% of infected patients were stay-at-home.New York Covid. Most new infections occuring in the home.
  3. Hospitalizations should be closely monitored. It is possible that there may be areas where hospital capacity could become an issue.  However, our past experience is that additional hospital beds and equipment can be set up quickly where they are needed.  Recall that even at the peak of infections a few months ago, thousands of beds were placed in NYC, but never used.
  4. People must maintain discipline of social distancing, hand washing and wearing face masks. Failure to do these things will insure the infection will continue to thrive, regardless of shut downs and stay-at-home orders.

In particular, the most important data regarding covid 19 are the number of deaths and the number of hospitalizations.  It is reminded that the stay-at-home orders, closing of stores and businesses and limiting travel were meant to prevent an overload of the hospital system.  Fortunately, even at the peak of the virus infections in February and March, there were no incidences where hospitals could not accept patients.  There was never a shortage of ventilators.  Thousands of temporary hospital facilities around the country including the USN Comfort and Mercy went unneeded.

Although the reports of increasing number of new cases is concerning, the new cases are not generally causing significant hospital utilization and the number of deaths has been consistently decreasing and is at all time low since February.

We should not be surprised at the increase in cases as people leave their homes.  Further, the new cases are predominantly in the under 35 age group.  This group has much lower fatality rates and hospitalization rates than people over the age of 65.

The number of increasing cases in the younger population suggests that they may not be practicing social distancing or wearing face masks as much as the older population.  It is possible that better compliance would lower the new case rate.

Not all all states report covid 19 data in the same way, nor do they all report the same statistics.  However, the data from California clearly illustrates the effect of age and covid infections.

AgeCases% CasesDeaths% Deaths% Population
<541791.8005.8
5-17144966.20016.7
18-34587947466432.1631.124.3
35-495879425.329294.919.3
50-5934890155559.312.5
60-64132595.74307.25.9
70-7467872.964010.74.1
75-7950382.272112.12.7
80=109804.7273445.73.9
146780542245

There have been 5422 fatalities from Covid 19 in Ca.  However, 86% of the deaths have occurred over the age of 70.  Only 6% of the fatalities have occurred in people under the age of 50.

Another way to express is that 11% of the population tested was over 70 but they accounted for 86% of the fatalities.  Conversely, 66% of the people tested were under 50 but only accounted for 6% of the fatalities.

The following shows the increase in reported US new cases in the past 2 weeks.

As will be discussed below, the median age of those that tested positive in Florida was 30 years old.  This is a critical fact as the number of new infections is occurring in a mucy younger group of patients who can resist the disease better (more asymptomatic), require less hospitalization and have very low fatality rates.

In this same time period, there has been an increase in the number of people tested.  This increase contributes to the increase in the number of cases.

However, it is clear that the number of new cases is more than just due to the number of increased tests.  The number of tests has been increasing steadily since the end of April.  The sudden increase in cases can not be due to increased testing alone.

Fortunately, the nature of the increasing number of cases appears to be different from that encountered just a couple of months ago.

Hospitalization

In February, the key concern regarding the covid 19 virus was the possibility that the number of cases would be more than the hospitals could handle.  There was also concern over the possibility of a shortage of ventilators and other protective equipment.  Fortunately, even at the peak of covid 19 infections and deaths in April there was NOT a shortage of hospital beds, ventilators or protective equipment.  The number of cases and deaths began decreasing and in the past month, most states lifted parts of their lockdown, business shutdown and stay-at-home orders.

The reopening of beaches, bars and other venues allowed large numbers of people to gather for the first time in months and often social distancing and face masks were not being used.  Further, large numbers of people were participating in protests and other rallies where, again, masks and social distancing rules were not followed.

Although the exact reasons are not known, it is clear that in many (not all) states, the number of cases has increased.  Fortunately, the number of hospitalizations has generally not increased.  Despite record number of new daily cases in some states (eg Florida, Texas), hospitalizaitons only slightly increased.  More importantly, the number of deaths from covid 19 is at the lowest level since February.

Note: the spike of deaths on Jun 20 was due to a single day ‘correction’ report from New Jersey which changed recording methods.

Two states Florida and Texas have been in the news because both states relaxed restrictions early and have had some of the highest number of new cases.

There was clearly and increase in cases on 6/23 but the number of cases seems to be decreasing again.

The following chart shows that the number of deaths has remained steady or slightly decreased since the beginning of June.  Florida has reported 168 deaths/million which ranks 30th in the US.

More importantly, the median age of people who were infected as 29 years old.  This is a very important change as age is closely associated with both hospitalizations and deaths.  The young age of those who are newly infected is likely the reason that both hospitalizations and deaths are down in Florida.

However, the increase in cases does suggest that younger people may not be maintain social distancing and/or wearing face masks.  In recognition of this, Florida has temporarily closed bars this weekend.

Similarly, Texas has also shown a recent increase in cases.

Similar to Florida, the number of deaths has remained constant despite the increase in the number of cases.  Florida also has fatality rate of 89 deaths/million, which ranks it 44th in the US.

Although the number of cases in the US is higher than the European union.  The Fatality rates are comparable.

The recent increases in Texas has created areas where hospitals are nearing, but not over capacity.  Overall. It is estimated that 75% of the hospital beds are being utilized.  Should the need arise, more beds can be added to most hospitals and as demonstrated in NY, thousands of beds can be added in days and two hospital ships can be brought in.

The unknowns are the length of hospital stays with a younger group of patients.  Also, the drug Remdesevir, not available a month ago, reduces the length of hospital stays 25-30%.  All of these factors will influence if there are more patients that can be handled.

Conclusions.

In over half of the states, there has been a significant increase in the number of covid 19 cases.

Although some of this increase can be explained by increased testing, the number of new cases can not all be accounted for simply by the number of tests.

Fatality rates are at the lowest number since February despite the number of increased cases.

There has only been a small increase in hospitalizations during this time of increased new cases.

The age of the people getting infected is much younger than just a few weeks ago.  The median age of new infections in Florida was less than 30 years old.

The increase number of new cases in younger people may reflect the need to reinforce the continued need for social distancing and the wearing of face masks.