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°Ñ¦Ò¸ê®Æ¡GLi and De Clercq, (2020). Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nature Reviews Drug Discovery, doi: 10.1038/d41573-020-00016-0.

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www.koreabiomed.com/news/articleView.html?idxno=7360&fbclid=IwAR1kDHSeswCRo64o-ALqQQ47PYLU7iJAXuACzBPHlU93jxFrjmD1SX3rouY

Published 2020.02.04 16:39

Interferon, Kaletra to get insurance benefit for new coronavirus treatment

The government said it would allow health insurance benefits for patients who received interferon or combo therapy of lopinavir plus ritonavir, for treating the confirmed or suspected new coronavirus (2019-nCoV) infection.

The Ministry of Health and Welfare announced a revision of details in reimbursement criteria and methods on Monday. The revision added 2019-nCov to the existing section of the MERS (Middle East Respiratory Syndrome)-CoV.

The government also amended the details to allow a full reimbursement for a patient, instead of asking a patient to pay part of the cost that exceeds the limited use of the reimbursable drug.

The reimbursement will be available for patients confirmed with the new coronavirus infection or with a suspected infection of the virus. Such patients should receive either the combo of interferon (including peginterferon, not recommended for monotherapy) with lopinavir+ritonavir or lopinavir+ritonavir only, for 10 to 14 days. If necessary, a physician may adjust the administration period.

¡§There is insufficient data on the study of the new coronavirus infection. However, given the World Health Organization¡¦s declaration of the public health emergency of international concern (PHEIC) and the urgency of clinical care, we will expand reimbursement benefits above the approval condition,¡¨ the health and welfare ministry said.

In Korea, AbbVie¡¦s Kaletra is the only authorized combo drug mixing lopinavir with ritonavir.

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en.granma.cu/mundo/2020-02-10/cuban-medication-interferon-alpha-selected-among-drugs-to-combat-coronavirus

february 10, 2020 11:02:03

Cuban medication Interferon alpha selected among drugs to combat coronavirus

Cuban President Miguel Díaz-Canel noted the Chinese government¡¦s determined efforts to confront coronavirus epidemic, with positive results becoming evident, including the recovery of more than 1,500 patients

Cuban President Miguel Díaz-Canel noted the Chinese government¡¦s determined efforts to confront the coronavirus 2019-NCOV epidemic, with positive results now becoming evident, including the recovery of more than 1,500 patients.

Díaz-Canel tweeted: Interferon alpha 2B: Cuban drug used in China against coronavirus. Our support to the Chinese government and people in their efforts to combat the coronavirus, while noting the use of an anti-viral product from the country¡¦s biotechnology industry.

The drug, IFNrec, is one of about 30 medications selected by the Chinese National Health Commission to treat the respiratory condition and, according to statements on Cuban television by Dr. Luis Herrera Martinez, scientific and commercial advisor to the President of BioCubaFarma, its selection was based on effectiveness shown previously against viruses with characteristics similar to those of this coronavirus.

It has the advantage, in situations like these, of functioning as a protective mechanism, preventing patients from getting worse, reaching a severe stage, with death as the outcome, the specialist explained.

Dr. Herrera noted that Cuba shared the technology to produce the drug some years ago, with the opening of the ChangHeber joint Chinese-Cuban facility in the town of Changchun, Jilin province. This plant makes the same product we do,¡¨ he noted, ¡§with exactly the same technology, meeting quality standards approved by Chinese and Cuban regulatory authorities.

The Cuban embassy in China reported on its Twitter account, The Chinese-Cuban Changheber plant in Jilin has been producing Interferon alpha (IFNrec) with the use of Cuban technology since the first day of the Lunar New Year. The Chinese Health Commission has selected our product among those used in the fight against coronavirus.

¦b¹ï§Ü«aª¬¯f¬rªºÃĪ«¤¤¿ï¾Ü¥j¤ÚÃĪ«Interferon alpha

¥j¤ÚÁ`²Î¦Ì®æº¸¡P­}¨È´µ¡P¥d¤ºº¸¡]MiguelDíaz-Canel¡^«ü¥X¡A¤¤°ê¬F©²¬°À³¹ï«aª¬¯f¬r¬y¦æ°µ¥X¤F°í©wªº§V¤O¡A¨ú±o¤F¿n·¥¦¨ªG¡A¥]¬A±d´_¤F1500¦h¦W±wªÌ

¥j¤ÚÁ`²Î¦Ì®æº¸¡P­}¨È´µ¡P¥d¤ºº¸¡]MiguelDíaz-Canel¡^«ü¥X¡A¤¤°ê¬F©²¬°À³¹ï2019-NCOV«aª¬¯f¬r¦Ó°µ¥Xªº°í©w§V¤O¡A²{¤wÅã²{¥X¿n·¥¦¨ªG¡A¨ä¤¤¥]¬A1,500¦h¦W±wªÌªº±d´_¡C

Díaz-Canelµo¤F¤@±ø±À¤å¡G¡§¤zÂZ¯À£\2B¡G¦b¤¤°ê¨Ï¥Îªº¥j¤Ú§Ü«aª¬¯f¬rÃĪ«¡C§Ú­Ì¤ä«ù¤¤°ê¬F©²©M¤H¥Á§ÜÀ»«aª¬¯f¬r¡¨¡A¦P®É«ü¥X¸Ó°ê¥Íª«§Þ³N¦æ·~¨Ï¥Î¤F§Ü¯f¬r²£«~¡C

BioCubaFarmaÁ`µô¬ì¾Ç©M°Ó·~ÅU°ÝLuis Herrera Martinez³Õ¤h¦b¥j¤Ú¹qµø¤WµoªíªºÁn©ú»¡¡AIFNrec¬O¤¤°ê°ê®a½Ã¥Í©e­û·|¿ï¾Üªº¬ù30ºØªvÀø©I§l¹D¯e¯fªºÃĪ«¤§¤@¡A¸ÓÃĪ«ªº¿ï¾Ü¥¦°ò©ó¥ý«eÅã¥Üªº°w¹ï»P³oºØ«aª¬¯f¬r¬Û¦ü¯S¼xªº¯f¬rªº¦³®Ä©Ê¡C

±M®a¸ÑÄÀ»¡¡G¡§¦b³oºØ±¡ªp¤U¡A¥¦¨ã¦³°_¨ì«OÅ@¾÷¨îªº§@¥Î¡A¥i¨¾¤î±wªÌ¯f±¡´c¤Æ¡A¶i¤JÄY­«¶¥¬q¡A¬Æ¦Ü¾É­P¦º¤`¡C¡¨

Herrera³Õ¤h«ü¥X¡A´X¦~«e¡AÀHµÛ¦N¦Ê¬Ù¦NªL¬Ùªø¬K¥«ªºChangHeber¤¤¥jÁp¦X¤u¼t¶}·~¡A¥j¤Ú¦@¨É¤F¥Í²£¸ÓÃĪº§Þ³N¡C¥L«ü¥X¡A³o®a¤u¼t¥Í²£ªº¡§²£«~»P§Ú­Ì¬Û¦P¡A§Þ³N§¹¥þ¬Û¦P¡A²Å¦X¤¤°ê©M¥j¤ÚºÊºÞ​​¾÷ºc§å­ãªº½è¶q¼Ð·Ç¡C¡¨

¥j¤Ú¾n¤¤°ê¤j¨ÏÀ]¦b¨äTwitter±b¤á¤W³ø§i»¡¡G¡§¦Û¹A¾ä¦~ªì¤@¥H¨Ó¡A¦NªLªº¤¤°ê¥j¤Ú©÷ªe§B¤u¼t¤@ª½¦b¨Ï¥Î¥j¤Ú§Þ³N¥Í²£°®ÂZ¯À£\¡]IFNrec¡^¡C¤¤°ê½Ã¥Í©e­û·|¤w¿ï¾Ü§Ú­Ìªº²£«~³Q¥Î©ó¹ï§Ü«aª¬¯f

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MARCHIO

Besremi

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250 mcg/0,5 ml soluzione iniett. uso sottoc. cart. in pen. prer.0,5 ml 1 penna preriempita + 2 aghi

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besremi 500 mcg/0,5 ml soluzione iniett. uso sottoc. cart. in pen. prer.0,5 ml 1 penna preriempita + 2 aghi

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ropeginterferone alfa 2b

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medicinale soggetto a prescrizione medica limitativa da rinnovare volta per volta vendibile al pubblico su prescrizione di centri ospedalieri o di specialisti - ematologo, internista, geriatra

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www.koreabiomed.com/news/articleView.html?idxno=7360&fbclid=IwAR1kDHSeswCRo64o-ALqQQ47PYLU7iJAXuACzBPHlU93jxFrjmD1SX3rouY

Published 2020.02.04 16:39

Interferon, Kaletra to get insurance benefit for new coronavirus treatment

The government said it would allow health insurance benefits for patients who received interferon or combo therapy of lopinavir plus ritonavir, for treating the confirmed or suspected new coronavirus (2019-nCoV) infection.

The Ministry of Health and Welfare announced a revision of details in reimbursement criteria and methods on Monday. The revision added 2019-nCov to the existing section of the MERS (Middle East Respiratory Syndrome)-CoV.

The government also amended the details to allow a full reimbursement for a patient, instead of asking a patient to pay part of the cost that exceeds the limited use of the reimbursable drug.

The reimbursement will be available for patients confirmed with the new coronavirus infection or with a suspected infection of the virus. Such patients should receive either the combo of interferon (including peginterferon, not recommended for monotherapy) with lopinavir+ritonavir or lopinavir+ritonavir only, for 10 to 14 days. If necessary, a physician may adjust the administration period.

¡§There is insufficient data on the study of the new coronavirus infection. However, given the World Health Organization¡¦s declaration of the public health emergency of international concern (PHEIC) and the urgency of clinical care, we will expand reimbursement benefits above the approval condition,¡¨ the health and welfare ministry said.

In Korea, AbbVie¡¦s Kaletra is the only authorized combo drug mixing lopinavir with ritonavir.

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www.clinicaltrials.gov/ct2/show/NCT04285086

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Sponsor:

PharmaEssentia

Collaborators:

Medpace, Inc.

EPS International

Brightech International

Information provided by (Responsible Party):

PharmaEssentia

Brief Summary:

This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.

Detailed Description:

PharmaEssentia Corporation is developing a pegylated (PEG) IFN-£\ product, P1101, for the treatment of ET.

Available clinical data and experience with P1101 in PV shows that the compound, with proper dose modifications, is effective in controlling disease in a significant proportion of subjects with ET. Further, its increased serum half-life presents distinct advantages for ET treatment over that of standard IFN-£\ and other available PEG IFN-£\ therapy. This pivotal Phase 3 study will establish the efficacy and safety of P1101 in ET subjects.

The enrolled subjects will be randomized into two arms, the test arm is P1101, the control arm is ANA. The overall duration for each eligible patient is 14 months, including screening (1 month), treatment (12 months) and follow-up (1 month) period. Efficacy evaluations, safety assessments, and PK and immunogenicity evaluations of P1101 will be performed.

Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling, EQ-5D-3L, and MPN-SAF TSS completion.

Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.

Study Type : Interventional (Clinical Trial)

Estimated Enrollment : 160 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Experimental Drug (Biological): Ropeginterferon alfa-2b (P1101), Q2W, SC injection Control Drug: Anagrelide, capsules, daily, p.o.

Masking: None (Open Label)

Primary Purpose: Treatment

Official Title: A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess Pharmacokinetics and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as Second Line Therapy for Essential Thrombocythemia

Estimated Study Start Date : May 2020

Estimated Primary Completion Date : February 2022

Estimated Study Completion Date : March 2022

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www.sciencedirect.com/science/article/pii/S2352302619302364?dgcid=coauthor

The Lancet Haematology

Volume 7, Issue 3, March 2020, Pages e196-e208

Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study

[Implications of all the available evidence]

Taken together with pre-existing evidence, these findings suggest that ropeginterferon alfa-2b can be considered as first-line cytoreductive therapy instead of hydroxyurea and should therefore change treatment algorithms for polycythaemia vera.

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2020/2/21 ¤U¤È 07:48:00²Ä 7959 ½g¦^À³
Good day!

I am 32 years old, diagnosed a year ago.

PV + Jak2 (7.34%) Now on phlebotomy every 3 weeks + 100mg ASS daily.

This is my first drug, Ropeginterferon alfa-2b

I will make my first injection next week and would like to hear your feedback, what can I expect?

I¡¦ve read a lot about the many possible side effects.

There is a slight panic because my doctor couldn¡¦t say much about side effects.

The main thing that interests me and what information I didn¡¦t really find is - will I be fertile while on this medicine? Can my girlfriend get pregnant while I am on it without any danger to

fetus ???!

What about mood - guys ???

Any dose recommendations? I will start with 100mcg.

My doctor didn¡¦t know much because the medicine was new, I thought it should be near similar to Pegasys.

In what time frame should I expect any improvement in numbers or symptoms?

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Pegasys 2026¦~°±²£?

I have been on Pegasys for 4.5 years with excellent results and now only inject every 3 weeks. I will only switch to a new interferon when I am forced to. My haemo says Pegasys is expected to be discontinued in 2026 😥 At the moment RoPEG is approved to use in PV but there is no funding for it in the U.K. NHS. She hopes this will be sorted by 2026.

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PEGASYS (Interferone alfa 2a pegilato)

Aic 035683097/E: 135 mcg - soluzione iniettabile - uso sottocutaneo - penna preriempita - 0.5 ml (270mcg/ml) 1 penna preriempita.

Aic 035683123/E: 180mcg - soluzione Iniettabile - uso sottocutaneo- penna preriempita - 0.5 ml (360mcg/ml) 1 penna preriempita.

Il titolare Aic Roche Registration GmbH ha comunicato di voler cessare, in maniera permanente entro il 2026, la produzione del medicinale in tutti i Paesi in cui è attualmente commercializzato.

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Today, about 80% of pharmaceuticals sold in the U.S. are produced in China. This number, while concerning, hides an even greater problem: China is the largest and sometimes only global supplier for the active ingredient of some vital medications. The active ingredients for medicines that treat breast cancer and lung cancer and the antibiotic Vancomycin, which is a last resort antibiotic for some types of antimicrobial resistant infections, are made almost exclusively in China. Additionally, China controls such a large market portion of heparin, a blood thinner used in open-heart surgery, kidney dialysis and blood transfusions that the U.S. government was left with no choice but to continue buying from China even after a contamination scandal in 2007.

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Interferon drug shows promise in treating Ebola

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Myeloproliferative Neoplasms (MPNs) Update - Spring 2020

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Dr. Ruben Mesa (@mpdrc) and Dr. Robyn Scherber (@RobynScherber) hematologists from the Mays Cancer Center, home to UT Health San Antonio MD Anderson (@uthealthsamda) discuss the latest updates regarding new treatments for myeloproliferative neoplasms (MPNS) including essential

www.youtube.com/watch?v=CR_pgCIFFRo&fbclid=IwAR3TaP3L7avAQ2D6YmCQ4hkmIFobL_e7riapsxAU0vM1I3gMrUy3yop8qy4&app=desktop

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Updates in ET

Ropeginterferon

Updates in PV

Ropeginterferon new interferon agent

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onlinelibrary.wiley.com/doi/10.1002/cam4.2741?fbclid=IwAR1I1qpGWNRmIIGwmiBtHRpY0H05L1n-SaU_1WfErvwp70UfG0m_XyPeaso

Data‐driven analysis of JAK2V617F kinetics during interferon‐alpha2 treatment of patients with polycythemia vera and related neoplasms

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Rasmus K. Pedersen Morten Andersen Trine A. Knudsen Zamra Sajid Johanne Gudmand‐Hoeyer Marc J. B. Dam Vibe Skov Lasse Kjær Christina Ellervik Thomas S. Larsen Dennis Hansen Niels Pallisgaard Hans C. Hasselbalch Johnny T. Ottesen ¡K See fewer authors

First published: 28 January 2020

Although our data are supportive of early intervention with IFN it is important to underscore that our data do not deliver the clinical proof for this early intervention recommendation. This proof can only be delivered by the demonstration of reduction in clinically relevant end‐points such as thrombotic events, rate of transformation to myelofibrosis and acute leukemia. Indeed, the demonstration of these hard end‐points would require long‐term follow up of large cohorts of patients treated with IFN and a well‐designed control group. This study has never been reported and will likely never be reported in these orphan diseases, where randomized studies are so difficult to conduct ‐ in particular with follow‐up times of decades rather than for instance 5 years, when taking into account that leukemic transformation in general is a late event, developing in the advanced myelofibrosis stage of MPNs. Importantly, the randomized Proud/Continuation‐PV Phase III Trials showed RopegIFN (Besremi®) to be associated with a clear benefit over control (ie hydroxyurea) in achieving significant higher maintenance rates of complete hematological remission (CHR) over the course of treatment and in showing a significant lower risk of losing CHR. Since CHR can be considered as surrogate for risk of thrombosis, RopegIFN may be an optimal treatment modality for managing risk of thrombosis.

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ich lebe in Deutschland und ich habe die Interferon Therapie mit Besmeri letzte Woche gestartet. Ich habe auch einen Kinderwunsch und mich gegen die Chemotherapie Hydroxyurea entschieden. Ich bin 33 und hoffe das ich die Therapie gut vertrage.

I live in Germany and I started interferon therapy with Besmeri last week. I also have a desire to have children and decided against chemotherapy hydroxyurea. I am 33 and hope that I can tolerate the therapy well.

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Dr. Ruben Mesa (@mpdrc) and Dr. Robyn Scherber (@RobynScherber) hematologists from the Mays Cancer Center, home to UT Health San Antonio MD Anderson (@uthealthsamda) discuss the latest updates regarding new treatments for myeloproliferative neoplasms (MPNS) including essential

www.youtube.com/watch?v=CR_pgCIFFRo&fbclid=IwAR3TaP3L7avAQ2D6YmCQ4hkmIFobL_e7riapsxAU0vM1I3gMrUy3yop8qy4&app=desktop

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