After being fired, I became the light of medicine
Chapter 75: The first month of Phase 2 clinical trial of Efovir!
Chapter 75 The first month of Phase II clinical trial of elofovir!
What is interferon?
There are currently two treatment options for chronic hepatitis B worldwide.
1. The purpose of taking antiviral drugs is to inhibit the replication of hepatitis B virus and thus reduce the damage of the virus to the liver.
Among the first-line drugs are: tenofovir alafenamide, tenofovir disoproxil tablets, and entecavir.
Entecavir is the oldest generation of products among them. Due to its low price and long history, it currently has the highest coverage rate.
Tenofovir disoproxil tablets are a new drug that has been introduced in recent years. They have a high inhibitory effect on hepatitis B virus, but they are nephrotoxic and may cause kidney problems in patients.
Tenofovir alafenamide is the second generation of tenofovir, commonly known as TAF. It reduces kidney damage by 75% compared to the first generation of tenofovir. It is currently the truly top-level drug for the treatment of hepatitis B.
However, these drugs can only inhibit viral replication and cannot achieve a cure.
The only way to truly achieve a cure is to rely on interferon - recombinant human interferon α2b.
In fact, interferon is not only used for hepatitis B, but is also widely used in various major diseases such as leukemia, tumors, and AIDS.
The core of its treatment is to use interferon to make the body's own immune system long-term excited, and to eliminate various viruses through the body's own immune system.
In terms of hepatitis B treatment, since curing hepatitis B is not a short-term process, once interferon injections are started, the treatment time will almost last up to one year.
Prolonged immune system excitement will cause the body to be in a feverish state frequently and may even damage multiple organs such as the kidneys and heart.
Therefore,
If interferon is used to treat hepatitis B, it is generally necessary to start before the age of 40. The older the age, the higher the risk.
In addition, interferon is expensive, costing more than 4 yuan a year and cannot be reimbursed. At the same time, the clinical probability of achieving cure through interferon is only about 20%.
This makes interferon not actually recommended medically.
Even so, countless patients still try interferon every year at great risk.
The reason is simple: I just hope to get rid of hepatitis B completely.
Xu Bo is such a person, he hopes to give it a try.
Today happened to be the day he had been injected with interferon for a year. He excitedly went to the hospital to have his blood drawn early in the morning, but the result was...
Not quite satisfactory.
Director Chen Wen gently adjusted the frame of his glasses on his nose and shook his head slightly:
"Xu Bo, the result of the two-pair-and-a-half test is still 135, which means you are still a chronic hepatitis B patient from a medical point of view."
Xu Bo sighed helplessly. The moment he got the test results, he actually knew the answer.
For the past 20 years, the results of the two pairs of halves have been the same every time. The first, third and fifth indicators are positive, commonly known as small triple positive.
I thought that after injecting interferon for a year, the goddess of luck would favor me, but the goddess of luck slapped me in the face again and abandoned me as ruthlessly as she did more than 20 years ago.
He adjusted his mood slightly and asked bitterly:
"Then Director Chen, do you think it is necessary for me to continue injecting interferon?"
"That's not necessary."
Chen Wen put the inspection report on the table and looked at Xu Bo.
"Your hepatitis B DNA virus count is already below the detection line, and the hepatitis B surface antigen has also dropped below 100 units. If your interferon level has not turned negative after a year of treatment, there is no need to continue the vaccination."
"Not to mention the waste of time and money, the longer the time goes by, the greater the side effects of interferon will be!" Xu Bo sighed heavily again.
After a moment, he said in a low voice:
"Director, then the only option is to continue taking antiviral drugs?"
“Will I end up taking medication for the rest of my life?”
Chen Wen was also quite helpless.
At this moment, he suddenly thought of the innovative drug code-named "QS-001" mentioned by President Zhou yesterday.
Last night, he specifically looked through the data of the Phase I clinical trial of the new drug "QS-001". After careful analysis, he also felt that although "QS-001" was somewhat cytotoxic, this novel idea might indeed open up another channel in the direction of curing hepatitis B.
Seeing Xu Bo's eager eyes, he thought for a moment and said slowly:
"There is really no good way at the moment. As you know, there is no drug in the world that can claim to be 100% effective in curing hepatitis B."
"But our country has recently launched a 'Starlight Project', and one of the drugs in it is pretty good..."
As he spoke, Chen Wen introduced to Xu Bo in detail the drug mechanism and cytotoxicity of "Ekofovir".
ten minutes later,
Xu Bo, who was not afraid of the side effects of interferon, nodded.
"Okay, Director Chen, even if there is only a glimmer of hope, I am still willing to give it a try!"
It has to be said that the doctor's explanation and recommendation still play an extremely critical role. With the explanation and recommendation of the outpatient doctor, coupled with the already high trial subsidy, the Phase II clinical trial of "Ekofovir" was finally successfully launched.
One week later, compared with only five patients recruited in the first week, the number of patients willing to participate in the Phase II clinical trial of "Ekofovir" reached twelve this week.
Zhang Yang was touched when he learned that it was Dean Zhou who provided such great help, and he immediately started a clinical trial involving a group of 15 people.
The number of patients designed for the Phase II clinical trial of "Ekofovir" was 125. After the first batch of 15 people started, the second batch of patients was successfully formed a week later.
The first thirty patients were all under the age of 35. Some of them had poor family conditions and valued the yuan reward. More of them were patients like Xu Bo who had not turned negative after taking interferon, and they were willing to make a final attempt.
Dean Zhou has been following the progress of the "Ekofovir" project, and he was delighted to see that two trial groups were successfully launched in just two weeks.
"It's finally officially launched, but we can't relax and we have to continue to help them."
“Once they stop, I’m afraid it will be difficult for them to recruit patients again!”
Dean Zhou made a decision secretly in his heart, but before he could make any further arrangements, a shocking piece of news suddenly came out.
During a routine checkup just one month after the first batch of subjects taking "Ekofovir", one patient turned negative and was cured!
The news immediately attracted the attention of Dean Zhou, Feng Gang and Chen Wen. You know, Phase II clinical trials are completely different from Phase I clinical trials.
There are normal subjects participating in the Phase I clinical trial, while all the participants in the Phase II clinical trial are hepatitis B patients!
Is there a hepatitis B patient who has turned negative? Is this a coincidence?
Is Qingshan Pharmaceutical's "Afovir" really effective? !
In the office of the Clinical Trial Center, three people sat together in amazement.
"Director Chen, this patient named Xu Bo was recommended by you, right?"
"Tell me quickly, what's his situation?!"
……
PS: Thanks to Explosion MA*** for the 500 coins reward!
(End of this chapter)
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