anyone on hbv cure trial glaxo GSK3228836?

[stef2011]

glaxo GSK3228836 is obviously the first hbv cure on large trials now available, those having 3logs hbsag and under long term nucs get cured fast by 4weeks drug use without any major side effects

this time the drug will be used for 48weeks so much more cure rates and maybe side effects too.it would be very useful to share here or participate on this trial

[melcul]

Is there any "glaxo GSK3228836" clinical trial held in England, by any chance ?

[stef2011]

https://clinicaltrials.gov/ct2/show/NCT04449029

United Kingdom
GSK Investigational Site Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: US GSK Clinical Trials Call Center    877-379-3718    ***@****  
Contact: EU GSK Clinical Trials Call Centre    [phone]    ***@****  
Principal Investigator: Stephen Ryder        
GSK Investigational Site Recruiting
London, United Kingdom, WC1E 6JB
Contact: US GSK Clinical Trials Call Center    877-379-3718    ***@****  
Contact: EU GSK Clinical Trials Call Centre    [phone]    ***@****  
Principal Investigator: Richard Gilson        
GSK Investigational Site Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: US GSK Clinical Trials Call Center    877-379-3718    ***@****  
Contact: EU GSK Clinical Trials Call Centre    [phone]    ***@****  
Principal Investigator: Matthew Cramp    

[stef2011]

there are many locations even more than on this list, in italy there are 4 hospitals but they only mention one in this list

[melcul]

Thank a lot, I will definitely ask my doctor about it, I've read about one trial, but they only accepted naive patients.  I'll ask more details.
Are you trying to get into the trial ?

[stef2011]

i can t, i had a severe trauma to my shoulder bones and humeral head got an osteonecrosis area (i suspect tenofovir helped this) so i need to address this first and i can t risk anything experimental

[thanks2018]

Yesterday updation for your info.

https://www.globenewswire.com/news-release/2020/11/16/2127145/0/en/Arbutus-Announces-Additional-Robust-HBsAg-Decline-Data-with-AB-729-in-Chronic-Hepatitis-B-Subjects.html

[stef2011]

very week results compared to glaxo drug and we are missing the most important thing is hbsag decline sustained off therapy, glaxo drug is sustained

[halt651]

hi stef, hbsag decline sustained off therapy makes us to understand if it is a functional cure or complete cure right ?

[stef2011]

i think it will be a complete cure for those on nucs many years and hbsag<1000iu/ml, for the others we need to see what happens on this trial which is 48weeks and not few weeks like previous one

[Royal36]

Hi Stef i am on nucs since 2014. Do you think helpful participating in this trial ? Thanks stif as always.

[stef2011]

it is helpfull indeed, especially if hbsag is low around 1000iu/ml
pros, hbsag loss if low hbsa baseline
cons, we dont know results and side effects on 1 year therapy but there should not be Substantial differences from previous short time human trial

they found hbsag loss and no serious side effects in one month of therapy

[Constantin90]

Hi Stef, I’ve been accepted on this trail. I am already on 5 years of tenofovir, and last 2 years on Vemildy.

Something interesting happened.  2 month ago my Hbs Quantity was around 8000 ui and now is around 4000 ui. During this time interval i took 1 month of isoprinosine, 6 pills per day.

Below are my lab results

Category Test Name Units Range "Screening   03-Dec-2020"
Chemistry AST/PLT Ratio Index - <= 0.5 0.2
Chemistry Alanine Aminotransferase (ALT) U/L 10 - 40 25
Chemistry Albumin g/dL 3.5 - 5.5 5.8
Chemistry Alkaline Phosphatase U/L 43 - 115 39
Chemistry Alpha-Fetoprotein IU/mL <= 6.9 3.3
Chemistry Aspartate Aminotransferase (AST) U/L 10 - 43 21
Chemistry Blood Urea Nitrogen mg/dL 5 - 20 14
Chemistry C Reactive Protein mg/L < 5.0 0.7
Chemistry Calcium mg/dL 8.5 - 10.5 10.5
Chemistry Complement C3 mg/dL 90 - 180 159
Chemistry Complement C4 mg/dL 10 - 40 20
Chemistry Creatinine mg/dL 0.7 - 1.4 0.9
Chemistry Creatinine Clearance (CKD-EPI) ml/min/1.73 m^2 85 - 125 114
Chemistry Direct Bilirubin mg/dL 0 - 0.4 < 0.20
Chemistry Estradiol pg/mL <= 48.9 < 17.00
Chemistry Follicle Stimulating Hormone mIU/mL 1.5 - 12.4 2.3
Chemistry Glucose, Random mg/dL 71 - 138 81
Chemistry Hepatitis B Surface Antigen II Quantitative IU/mL < 0.05 4224.00
Chemistry Indirect Bilirubin mg/dL UTP
Chemistry Potassium mEq/L 3.5 - 5.0 4.5
Chemistry Protein g/dL 6.0 - 8.0 8.5
Chemistry Sodium mEq/L 133 - 145 143
Chemistry Total Bile Acid micromol/L < 10 2
Chemistry Total Bilirubin mg/dL <= 1.1 0.48
Coagulation Activated Partial Thromboplastin Time Seconds 25.1 - 36.5 29.9
Coagulation Prothrombin Time Seconds 9.4 - 12.5 10.9
Coagulation Prothrombin Time - INR - 0.9 - 1.1 0.9
Hematology Basophils % 0.0 - 3.0 0.7
Hematology Basophils (Absolute Ct) x 10^3/uL 0.00 - 0.30 0.04
Hematology Eosinophils % 0.0 - 7.0 0.7
Hematology Eosinophils (Absolute Ct) x 10^3/uL 0.00 - 0.80 0.04
Hematology Hematocrit % 37.0 - 51.0 50.0
Hematology Hemoglobin g/dL 12.5 - 17.0 15.6
Hematology Immature Granulocyte % 0.0 - 1.0 0.5
Hematology Lymphocytes % 12.0 - 46.0 35.4
Hematology MCH pg 27.0 - 34.0 29.3
Hematology Mean Corpuscular Volume fL 78.0 - 100.0 94.0
Hematology Monocytes % 0.0 - 11.0 6.0
Hematology Neutrophils % 34.0 - 71.0 57.2
Hematology Platelet Count x 10^3/uL 163 - 375 263
Hematology Red Blood Cells x 10^6/uL 4.63 - 6.08 5.32
Hematology WBC Differential, Immature Granulocytes x 10^3/uL 0.00 - 0.07 0.03
Hematology WBC Differential, Lymphocytes x 10^3/uL 0.90 - 3.60 2.13
Hematology WBC Differential, Monocytes x 10^3/uL 0.00 - 1.20 0.36
Hematology WBC Differential, Neutrophils x 10^3/uL 1.70 - 7.90 3.45
Hematology White Blood Cells x 10^3/uL 3.70 - 11.00 6.02
Miscellaneous Hepatitis Be Ag, Quantitative U/mL < 0.09 1.70
Miscellaneous Monocyte Chemotactic Protein 1 pg/mL 200.0 - 722.0 442.4
Referral Hepatitis Delta Ab - Negative Negative
Referral Neutrophil Cytoplasmic Antibody (ANCA), cANCA - Negative Negative
Referral Neutrophil Cytoplasmic Antibody (ANCA), pANCA - Negative Negative
Urinalysis Urinary Bilirubin - Negative Negative
Urinalysis Urinary Blood - Negative Negative
Urinalysis Urinary Color - Yellow,Amber Yellow
Urinalysis Urinary Glucose mg/dL Negative Negative
Urinalysis Urinary Ketones mg/dL Negative Negative
Urinalysis Urinary Nitrite - Negative Negative
Urinalysis Urinary Protein mg/dL Negative Negative
Urinalysis Urine Appearance - Clear Clear
Urinalysis Urine Leukocyte Esterase - Negative Negative
Urinalysis Urine Specific Gravity - 1.002 - 1.035 1.008
Urinalysis Urine pH pH 5.0 - 8.0 6.0
Urinalysis Urobilinogen mg/dL 0.2,1.0 0.2
Urine Chemistry Urinary Creatinine mg/dL 40 - 278 43
Urine Chemistry Urine Albumin mg/dL <= 2.00 < 1.00
Urine Chemistry Urine Albumin/Creatinine Ratio mg/mg Creatinine UTP
Viral HIV 1&2 - Negative Negative
Viral Hepatitis B, Viral Load DNA (Quantitative) IU/mL < 20 < 20
Viral Hepatitis C Antibody - Negative Negative
Clinical Property Is patient currently on nucleos(t)ide analogue therapy? Yes - Stable
Clinical Property Is serum pregnancy test required? No

[stef2011]

thank you for your feedback on isoprinosine, i should try it too but it is not available in italy.which brand did you buy?i should def try it

[Constantin90]

A box is around 14 euros in Romania. ISOPRINOSINE 500 mg, 50 comprimate, Ewopharma

[stef2011]

in italy it is sold as methisoprinol (viruxan) for herpes, i guess it is the same compound as the one you tried.i also found it on amazon but they sell brands from latvia/ukraine/russia, i guess they are ok too

[luckyman316]

Thanks for sharing this! I need to follow this. No wonder why my doctor hinted that a new trial is "in the pipeline" and things may change with qualifications by this time next year, which is when I'll probably be done with my current trial.

[notmylife]

I am on that trial since 03 Dec. Greetings from Hambung, Germany.

[stef2011]

wonderful, any side effects?is your baseline hbsag high or low?

[FingHb]

Wow. You been on that for 17 years!  That’s a long time for a trial.  How are you doing on it.