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Sofosbuvir and Daclatasvir for the Treatment of COVID 19

Is Sofosbuvir + Daclatasvir a Cheap and Effective Treatment For COVID 19?

Like nearly everyone else in the world, I have been watching the unfolding of the COVID 19 pandemic with a mixture of astonishment and horror.

But my position is a little different from the average observer because the last six years of my life have been spent, almost entirely, fighting a very similar virus, the Hepatitis C virus.

I have lived in the world of the virus for the last six years. A virus nearly killed me and since that battle ended I have been helping other people defeat the viral infection.

So when I hear about the coronavirus I do understand what is happening when the Coronavirus attacks a person’s body. COVID 19 damages and destroys humans in a very similar way to Hep C.

This is because the Hep C virus and the COVID 19 virus are very similar beasties, they come from the same family of viruses. A bit like a tiger and a lion are both cats.

Both Hepatitis C (HCV) and SARS-CoV-2 are positive-sense RNA viruses, this means that Hep C and COVID 19 share many similar features. Like tigers and lions, they are more similar than different. They feed on slightly different things and live in slightly different environments (HCV lives in the cells of the liver and COVID 19 lives in the cells of the lungs) but in most other ways they are very alike.

The Hep C and COVID 19 viruses are more alike than different.

In previous posts, over the past few weeks, I have been sharing some insights into the relationship between Hep C and COVID 19 and speculating about how Hep C antiviral drugs might work in the fight against COVID 19. And I was greatly puzzled by how little research was being done into Hep C antivirals as a treatment for COVID 19.

There was some early research work on Sofosbuvir vs COVID 19 in January and February that looked very promising but nothing I was aware of since then until recently and that is what this article is about.

Well, as it turned out I was not alone in being puzzled about the lack of research into Sofosbuvir as a treatment for COVID 19 because a couple of days back I received an email from Dr. James Freeman, a fellow worker in the field of Hep C treatment, who was speculating along the same lines as myself.

So after communicating with Dr. Freeman, we decided it would be good to publish some relevant information about Hepatitis C antivirals and the treatment of COVID 19.

Below is a summary of the work Dr. Freeman, myself, and others have done on the Hepatitis C Antivirals,  Sofosbuvir and Daclatasvir, and the treatment of COVID 19.

Sofosbuvir and Daclatasvir, Covid 19 and Iran

Most people will remember that the first two big outbreaks of COVID 19 outside of China were in Iran and Italy. Iran has a population of about 80 million people and Italy has a population of about 60 million people.

On the 1st of March 2020 Italy had 1,128 cases of Coronavirus and Iran had 978 cases of coronavirus, no significant difference. In the 24 hours of 31st of March 2020, Italy got 4,050 new cases of Coronavirus and on the same day Iran got 3,110 new cases.

As of today (23rd April)  Italy has had 187,000 cases and 25,000 deaths while Iran has had 87,000 confirmed cases of COVID 19 and 5,481 deaths.

Today the daily death rate in Italy is around 450 whilst the death rate in Iran is only around 90 per day.

Another point of comparison is the deaths per million of the population from Coronavirus COVID 19.

USA:     158 deaths per million

Spain:  482 deaths per million

Italy:   430 deaths per million

Belgium: 597 deaths per million

UK:      287 deaths per million

Iran:  66 deaths per million

Why has Italy and the other countries in Europe done so poorly? Or why has Iran done so well?

Iran has a larger population than Italy but has had half the number of COVID 19 cases and, pro-rata, Iran has 70% less deaths than Italy or Spain or France or Belgium.

In other words, most European countries (except Germany) have almost 8 times the death rate of Iran. So what is happening in Iran?

Sanctions and Self Sufficiency

It may surprise many people to know that the Iranians have been manufacturing Sofosbuvir and Daclatasvir to treat Hepatitis C in Iran and neighboring countries for a couple of years now.  Like India, Iran has a very competent pharmaceutical manufacturing capacity.

Iran has had to become very self-sufficient because of the crippling sanctions placed on Iran by the USA.

When Iran was hit with its first wave of COVID 19 infections the Iranians knew that they had little hope of getting outside help so doctors in Iran commenced 109 clinical trials looking for treatments for COVID-19 and have recently announced that they have found a cure.

The Iranian claim is that their cure is cheap and effective. It is a cure that offers no ICU deaths and rapid recovery for infected patients.

The Iranians appear to be keeping the name of the drug responsible secret however it definitely appears to be the locally produced combination of Sofosbuvir (Sovaldi) and Daclatasvir (Daklinza) which is widely used to treat Hepatitis C virus. But the Iranians are being a bit coy about exactly what drugs they are using.

It is a staggering oversight that doctors in developed countries are not testing this combination. It has been right under our noses the whole time and it seems like we have left it to Iran to prove that it works.

The Technical Stuff

Keeping in mind that both Hepatitis C (HCV) and COVID 19 are positive-sense RNA viruses (that is to say they are very similar) it would be reasonable to assume that drugs proven to work for HCV might work on COVID 19

There are a number of drugs shown to effect  SARS – COVID 19 type viruses and these include Ribavirin, Remdesvir and Sofosbuvir, which are all drugs that interfere with the virus’s ability to “reproduce”.

Sofosbuvir has a staggering potency, but the key feature of Sofosbuvir is its lack of toxicity. Almost every other similar drug developed for HCV, HIV and other viruses has failed, not due to a lack of potency, but rather due to toxicity on human cells. in other words, some of these drugs were great at killing the viruses but also damaged or killed the patient. Interferon treatment of Hep C is a great example of the cure often being worse than the disease.

The amazing thing about Sofobuvir is that it produces a rapid and massive reduction in viral numbers in Hepatitis C patients. I regularly see people with a Hep C viral load of more than 10 million reach undetectable levels in less than a week (that’s 10 million virus particles in a drop of blood). Imagine if it worked the same on COVID 19 viral load levels!

Sofosbuvir is deadly to positive-sense RNA viruses but not toxic to humans.

While there are high hopes for another Gilead drug called Remdesvir, the reality is that Remdesvir is given intravenous and currently only exists at experimental scale, so, even if it is proven to work, it’s not going to be much use unless you are super-rich.

Conversely, Sofosbuvir is a tablet and widely available. We know already know that Sofosbuvir is safe in humans, we know the doses. This all makes Sofosbuvir a superior COVID 19 trial candidate, so why are we not testing it?

We did, in fact, consider testing Sofosbuvir against COVID 19 way back in February. In vitro testing (in a laboratory not in humans) showed promising results but for reasons that are unclear that avenue of investigation appears to simply have stopped. (Was it pressure from GILEAD who did not want their hugely profitable Hep C drug made cheaply and widely available?)

Why is it that such an obviously promising drug was not tested in any Western country? These are countries where Big Pharma has Big Power!

Fortunately, there are some countries where Big Pharma has little or no influence and in one of those countries, Iran, people are testing Sofosbuvir and Daclatasvir, in humans, and the results appear very encouraging.

In an article titled Abadan Protocol in the Treatment of COVID-19 (in Persian) we see a news report, which translated to English reads as follows:

( click this link to read the news article)

Abadan Protocol in the Treatment of COVID-19

Today, Iranian news agencies reported the success of a new treatment in Abadan that has been effective in improving patients with COVID-19. But unlike the usual procedure, no explanation has been given about the details of the treatment.

“In this study, the effect of an antiviral drug on critically ill patients with COVID-19 was examined at Ayatollah Taleghani Hospital in Abadan,” said Dr. Salmanzadeh, head of the Abadan School of Medical Sciences.

Dr. Sara Mubarak, the faculty’s vice chancellor for education and research, said: “Patients were divided into two groups: the first group received the national standard protocol and the second group received the proposed Abadan protocol, and the result was zero. “The group has also declined.”

“It was very important that the people who were in the intensive care unit and received artificial respiration return to normal breathing after four days and get the conditions for discharge from the hospital,” Mubarak added.

Due to the unknown type of treatment, we asked one of the members of the treatment team for this research. He also insisted on not naming the drug used, citing the possibility of individuals and patients invading pharmacies to supply and use it arbitrarily, adding that “we have left the Ministry of Health to confirm the results of the study and the introduction of the drug.”

“According to the national protocol, hydroxychloroquine is in the treatment and only one antivirus has been added to the protocol,” he said in a brief description of the treatment.

“The new protocol was prescribed to 30 patients and compared with 30 patients in the control group compared to the national protocol after one month,” the researcher said of the study groups.

The doctor of Taleghani Hospital in Abadan also said about the results: “Five patients who were intubated were all extubated.” [ie patients on ventilators were taken off them]

A longer version of this press release was published by the Islamic Republic News Agency here and sheds more light on the clinical impact of the Abadan Protocol. The report selected was used to shed some light on the secrecy around this.

Why Is Iran Not Sharing This Information?

The reason why Iran is keeping this information quiet seems quite obvious.

What country is being hardest hit by COVID 19?

The USA.

What country is Iran’s worst enemy?

The USA.

So I suspect Iran is thinking, “Let’s keep this quiet for as long as we can and let the USA sustain as much damage as possible from COVID 19.”

Why do we think the Iranian COVID 19 Cure is Sofosbuvir + Daclatasvir?

Here are some brief explanatory notes that shed some light on what drug(s) correspond to the mysterious “one antivirus” mentioned in the intriguing Iranian news report above.

  1. In Iran, Sofosbuvir/Daclatasvir is available as a locally manufactured single-pill fixed-dose combination under the name Sovodak. It sells for less than US$250 for a 12-week treatment.
  2. There are a total of 109 clinical trials for COVID-19 registered in Iran with 5 trials of Sofosbuvir/Daclatasvir, one each for Sofosbuvir/Velpatasvir and Sofosbuvir alone, and 102 others researching other possible COVID 19 treatments.
  3. A trial of Sofosbuvir/Daclatasvir for COVID-19 in Abadan, for 60 patients (30 controls, 30 treatment) – is listed on the Iranian Clinical Trials Registry and the responsible person listed is Dr. Sara Mubarak as mentioned in the news story.
  4. There are 4 COVID-19 trials registered as being in progress in Abadan, so with N-acetylcysteine, Vitamin D, Vitamin C and Naproxen not being recognized as antiviral medications the only candidate trial that fits the mystery description of “one antiviral” is the Sofosbuvir/Daclatasvir trial noted above.
  5. An astute observer will note this trial corresponds to the time the death rate in Iran started to fall and further note the Abadan trial has recently been updated with a comment “Adding other hospitals for recruiting patients”.
  6. Although relations between many nations and Iran are frosty their medical system is first class and their clinical trial system stringent, so it seems unwise to simply ignore or discount their observations.

With respect to Daclatasvir, we know it is easy to make, in the Medicines Patent Pool, and currently widely deployed. It is broad-spectrum on Hepatitis C (working for all genotypes) and has very few side effects. It was predicted by South Korean rational drug designers to be active against SARS-CoV-2 back at the end of January but to the best of my knowledge is not being tested outside of Iran although trials are scheduled to start in Algeria and Uruguay soon.

Treating COVID 19 with Sofosbuvir + Daclatasvir

Judging from the results in Iran it is likely that a Sofosbuvir based treatment of COVID 19 would be of less than 28 days duration. We know that the combination of Sofosbuvir and Daclatasvir can be manufactured and sold at a small profit for less than US$40 for a 28-day treatment. This would mean that treating COVID 19 with Sofosbuvir + Daclatasvir would cost less than US$50.

Currently, all other existing trials that are running for COVID 19 treatments have not produced a significant virological breakthrough.

Because the drug used in the Abadan protocol is a fixed-dose combination of Sofosbuvir and Daclatasvir it is unclear if the efficacy observed relates to only one, or both components.

Urgent further investigation seems warranted so my call to action is for researchers worldwide to add this seemingly proven combination to the array of medications we are looking to re-purpose. It would be very sad if the cure for COVID 19 was indeed right under our noses but we refused to research/use it because Iran found it first.

A short Word on COVID 19 Vaccines

COVID 19 is a coronavirus. Science has been trying to develop a coronavirus vaccine for many, many years without success. People are thinking that by throwing huge amounts of money at the project we will quickly come up with a vaccine for COVID 19.

This approach did not work with HIV. There is still no HIV vaccine.

This approach also did not work for Hepatitis C, there is still no vaccine for Hepatitis C.

Viruses are tricky beasts. It may be that we do develop a vaccine for COVID 19 but we may not. In the short term finding an effective cure for COVID 19, as happened with Hep C, is definitely the fastest and cheapest way to bring this beast under control.

Interestingly if it did turn out that Sofosbuvir + Daclatasvir was effective against COVID 19 having cheaply available Sofosbuvir + Daclatasvir would also wipe out the Hepatitis C pandemic, which has killed a LOT more people than COVID 19.

(Please note that I am not saying that the combination of Sofosbuvir and Daclatasvir is definitely a cure for COVID 19, what I am saying is that Sofosbuvir and Daclatasvir need to be investigated as a possible cure for COVID 19.)

((Please note that Dr. James Freeman supplied a significant amount of the technical information in this post.)

Greg Jefferys

Greg Jefferys

2 Comments

  •    Reply
    christina budzynski April 23, 2020 at 2:18 pm

    Keep fighting the good fight greg jeffreys your an amazing man and this medicine needs to hit the western world keep fighting for the people of the usa since our government is not!! Thank u for everything u do ❤

  •    Reply

    When i first heard oft he new virus , i though what about the hep c anti virals? Would the harvoni combination work against it if infected?

    Could Daclatasvir be safely added to harvoni short term for covid treatment ?

    Or would one need to buy separate Daclatasvir tablets and Sofosbuvir? Can you get them separately or in combination if not on harvoni? i would like to purchase either way

    . Especially for not only myself but my son since he has heart failure and his cardiologistt says the covid virus would most likely kill him. And i have low but stable kidney function and am cautioined infection could destroy what’s left of function. i feel the safest thing would be to have the meds on hand just in case. Please inform

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