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Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort
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B. Fostemsavir in highly treatment-experienced participants: 24-week phase 3 results

i-base.info/htb/32869

........Side effects leading to discontinuation were reported by 12 (4%) participants in the randomised group vs and 9 (9%) in the open-label group(13/19 used the investigational mAb ibalizumab¦b³o²Õ).

C. Fostemsavir: 48-week phase 3 results from BRIGHTE study i-base.info/htb/35310

.........Serious adverse events were common in both arms, reflecting the advanced HIV stage, but were higher in the open label group(13/19 used the investigational mAb ibalizumab¦b³o²Õ): 31% vs 44%; grade 3/4: 26% vs 47%; and deaths 4% vs 14%.

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[Serious adverse events were common in both arms, reflecting the advanced HIV stage, but were higher in the open label group: 31% vs 44%; grade 3/4: 26% vs 47%; and deaths 4% vs 14%.]

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11/10«¥¬ªÅS¤Ñ¾÷»¡¤FÃö©óViiV Fostemsavir,§ë¸êªÌ¯à°µ¦a:¸ß°Ý¤¤¸Î¤½¥q (¬Ý§¹©³¤U¸ê®Æ³o¬q¤å¦r13/19 used the investigational mAb ibalizumab.¦n©ÎÃa»P«¥µL¤z,°Ý¤£°Ý¤½¥q¦b±z­Ì,)/ÀRµ¥FDA®ø®§(«¥99%¬Û«H·|³QFDA§@¬°breakthroughÀò±oÀu¥ý§å­ã, ¦Ó±z­Ì¬O¤£«H¦a¨º1%)!

12 November 2018. Related

Fostemsavir: 48-week phase 3 results from BRIGHTE study (i-base.info/htb/35310)

....................Baseline characteristics were similar for the open-label group, with the important exception that 80% had no active drugs in the OBR and 20% had only one active drug. In this group, >95% had integrase experience and 70% had used T-20. Of the 19 people with sensitivity to one drug,

[13/19 used the investigational mAb ibalizumab.]

By week 24, viral suppression was reported for 54% of participants, with 71% and 77% using <200 and <400 copies/mL cut-offs respectively.

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¡uKey safety results, including deaths, serious adverse events (SAEs), discontinuations due to AEs, results of laboratory tests, and immunogenicity¡v

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¡uThe safety profile of ibalizumab was favorable. The most common adverse reactions (i.e., adverse events deemed related to study drug by investigator) reported in at least 5% of subjects were diarrhea (8%), dizziness (8%), nausea (5%), and rash (5%). Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: one subject had a severe rash and one subject developed immune reconstitution inflammatory syndrome (IRIS) manifested as an exacerbation of progressive multifocal leukoencephalopathy.¡v

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¡]­Ó¤Hµù¸Ñ¡GSAE in trial TMB-301¡G2¦ì/40¦ì¡×5¢H¡F¦ý¬O¥u¦³1¦ì³Q»{¬°»PIbalizumab¦³ÃöÁp©Ê¡F¦ýFDAªº¼f®Ö¤H­û³Ì«á¤´¤£Âk¦]©ó¬OIbalizumab©Ò­P¡F³o¤@ÂI«á­±ªº±Ô­z·|´£¨ì¡F¦P®É½Ðª`·N¨ì¡uÃöÁp©Ê¡vrelated to»P¡uÂk¦]©ó¡vattributed to³o¨âªÌ¥Îµüªº¤£¦P·N¸q¡C¡^

¡uFour deaths occurred in TMB-301, none of which were attributed to ibalizumab. They included: 1) respiratory arrest secondary to Kaposi¡¦s sarcoma; 2) hepatic failure secondary to cirrhosis due to hepatitis C infection; 3) lymphoma and; 4) presumed HIV wasting syndrome. ¡v

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¦bÁ{§É¸ÕÅçTMB-301¤¤¦³4¦ì¦º¤`¡A¨S¦³¥ô¦ó¤@¦ìÂk¦]©óIbalizumab¡C³o´X¦ì¥]§t¤F¡G¡]1¡^¦]Kaposi¡¦s¦×½F¦Ó©I§l¤¤¤î¡F¡]2¡^¦]·P¬VC«¬¨xª¢¦Ó¨xµw¤Æ©Ò¾É­Pªº¨x°IºÜ¡F¡]3¡^²O¤Ú½F¡F¡]4¡^ºÃ¦ü·R´þ¯f¬r®ø¯Ó©Ê¯g«J¸s(HIV wasting syndrome)¡C

¡]­Ó¤Hµù¸Ñ¡GKaposi¡¦s¦×½F¡B·R´þ¯f¬r®ø¯Ó©Ê¯g«J¸s¬O¬Æ»ò¡H§Ú¤£¶i¤@¨B»¡©ú¤F¡A½Ð¦Û¦æGoogle¡F­«ÂI¬O¡G¡u¨S¦³¥ô¦ó¤@¦ì¦º¤`¨ü¸ÕªÌÂk¦]©óIbalizumab¡v¡A©Ò¥Hdeath secondary to Ibalizumab¡G0¢H¡^

¡uNine TMB-301 subjects experienced 16 SAEs, including ten SAEs that were reported in subjects who died. The six SAEs experienced by subjects who survived included: diplopia, pulmonary hypertension, progressive multifocal leukoencephalopathy and IRIS, cytomegalovirus (CMV) viremia, fever, and squamous cell carcinoma of the anus and rectum. The only event considered to be related to ibalizumab (per investigator) was immune reconstitution inflammatory syndrome manifested as an exacerbation of progressive multifocal leukoencephalopathy. We agree with the investigator¡¦s causality determination as IRIS is a common event following the initiation of effective ART in severely immunosuppressed patients.¡v

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9¦ìTMB-301ªº¨ü¸ÕªÌ¥X²{¤F¤Q¤»¶µÄY­«¤£¾A¤ÏÀ³¡]SAE¡^¡A¨ä¤¤¤Q¶µ¨Ó¦Û©ó¦º¤`­Ó®×¡A¤»¶µ¨Ó¦Û©ó¤´¦s¬¡­Ó®×¡C³o¨ÇÄY­«¤£¾A¤ÏÀ³¡]SAE¡^¥]¬A¤F½Æµø¡BªÍ°ªÀ£¡B¶i¦æ©Ê¦h¨_©Ê¤j¸£¥Õ½è¸£¯fÅÜ¡B§K¬Ì­««Øµoª¢¯g­Ô¸s¡]IRIS¡^¡B¥¨²Ó­M¯f¬r¦å¯g¡Bµo¿N¤Î¨zªù»Pª½¸zªºÅ쪬²Ó­MÀù¡C°ß¤@³Q»{¬°¸òIbalizumab¦³ÃöÁpªº¦º¤`­Ó®×¡]¥ÑÁ{§É¸ÕÅç¥D«ù¤H©Ò´£¨Ñ¸ê®Æ¡^¬O§K¬Ì­««Øµoª¢¯g­Ô¸s¡]IRIS¡^¡A§e²{¥X¶i¦æ©Ê¦h¨_©Ê¤j¸£¥Õ½è¸£¯fÅÜ¡]progressive multifocal leukoencephalopathy¡^¡C§Ú­Ì¦P·NÁ{§É¸ÕÅç¥D«ù¤Hªº¦]ªGÃö«Yªº§P©wµ²ªG¡A»{¬°IRIS¬O¦bÄY­«ªº§K¬Ì¥\¯à¤£¥þ±wªÌ±µ¨ü¦³Àø®Äªº§Ü¤ÏÂà¿ý¯f¬rÀøªk¡]ART¡^ªºªì´Á±`¥X²{ªº¯gª¬¡C

¡]­Ó¤Hµù¸Ñ¡GTMB-301ªº¨ü¸ÕªÌÁö¹ïART¤w¦³¦h­«§ÜÃÄ©Ê¡A¦ý¯Ç¤J¦¬®×«á¤´­ã¤©Ä~Äò¨Ï¥Î­ì¨ÓªºÃĪ«¡A´N¬O©Ò¿×ªº³Ì¾A­I´ºÀøªk¡]´N¬O©Ò¿×ªºOBT¡^¡F¤]´N¬O»¡FDA¦P·N±N¨º¦ì¨ü¸ÕªÌªºIRIS¯gª¬Âk¦]©óART¡F©Ò¥HÂk¦]©óIbalizumabªºÄY­«¤£¾A¤ÏÀ³¡]SAE¡^¡G0/40¡×0¢H¡^

¡uFour TMB-301 subjects stopped study drug due to an AE, including three participants who died (described above) and one participant who developed IRIS (described above). The nature and frequency of the significant safety events (deaths, SAEs, and discontinuations due to AEs) reported largely reflect the patient population targeted for enrollment, i.e., advanced HIV/AIDS patients with MDR HIV infection, failing current ART.¡v

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investorshub.advfn.com/boards/read_msg.aspx?message_id=140655723

paltrydeliberateovertheinvestment.blogspot.com/2018/08/pro-140-cytodyn-11-pro-140-81-vs.html

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PRO 140¬O¤p¤À¤lÃħa¡H»¡¨S¦³¥ô¦ó¯f¤H¦³­«¤j¤£¾A¯g¡A¦b¤U¦³ÂIµLªk¬Û«H¡C

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www.cytodyn.com/media/press-releases/detail/284/cytodyn-announces-positive-results-from-completed-pivotal

¡§These results show suppression rates with PRO 140 that are very impressive,¡¨ said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. ¡§A small molecule CCR5 antagonist approved for a multidrug class resistance population has shown a viral suppression rate of 48% after 48 weeks, [ and the latest antibody therapeutic approved for a multidrug class resistance population achieved a 43% viral suppression rate after 24 weeks.]

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·|­û¡GÀH½t¦Û¦b10147011  µoªí®É¶¡:2018/11/10 ¤U¤È 06:12:01²Ä 557 ½g¦^À³
Fostemsavir

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P3

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TMB355 ?/40¤H Discontinued due to AE or death---13% www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf

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DHL ¤j¶Kªº¬OUB421, ¤p§Ì¶K fostemsavir

clinicaltrials.gov/ct2/show/record/NCT02362503?cond=NCT02362503&rank=1&view=record

Estimated Study Completion Date April 15, 2020

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BRIGHTE (NCT02362503):

A safety analysis at Week 24 found that 91% of participants experienced at least 1 side effect during this Phase III study, though most were mild in severity. Moderate to severe side effects occurred in 18% of participants and included nausea, diarrhea, headache, vomiting, fatigue, and weakness or lack of energy. Nine participants had serious side effects that were related to treatment with fostemsavir, and 21 participants had side effects that caused them to leave the study.

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Phase II阶¬qªº数Õu显¥Ü¡A头µh¡B¥Ö¯l¥H¤Î§¿频¬OFostemsavir±`见ªº°Æ§@¥Î¡A¦ý¦h数³£较为温©M¡A¥¼观¹î¨ì严­«ªº°Æ§@¥Î¡CPhase III阶¬qªº试验显¥Ü¡A91%ªº参ÉOªÌ¦Ü¤Ö发¥Í¤@Ïú°Æ¤Ï应¡A约18%ªº¨ü试ªÌ产¥Í¤¤«×¦Ü­««×ªº°Æ¤Ï应¡A¦p¸¡泻¡B恶¤ß¡B呕¦R¡B¥H¤Î虚®zµ¥¡A21¦W¨ü试ªÌ¦]°Æ¤Ï应°h¥X¡C

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Research Toward a Cure Trials www.treatmentactiongroup.org/cure/trials

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[At ViiV Healthcare we remain dedicated to developing innovative medicines for all people living with HIV and expect to seek regulatory approval for fostemsavir in 2019.¡¨]

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1.2019--ViiV fostemsavir

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·N¦®³o¬q:[Most patients who received fostemsavir experienced at least one adverse event (AE) by week 48. The most commonly reported drug-related AEs were diarrhoea, nausea and headache. Thirty-five percent of participants had one or more serious adverse events (SAE), most commonly related to infections, and these occurred in the most immunocompromised patients. Three percent (3%) of SAEs related to the study medication, and seven percent (7%) of participants discontinued due to an AE.]

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2018.10.31³Ì·s®ø®§:

ViiV Healthcare announces positive phase 3 results from the BRIGHTE study of fostemsavir in heavily treatment-experienced patients with HIV

www.viivhealthcare.com/media/press-releases/viiv-healthcare-announces-positive-phase-3-results-from-the-brighte-study-of-fostemsavir-in-heavily-treatment-experienced-patients-with-hiv.aspx

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Policy Guidelines

Virologic failure may be defined as not achieving a viral load of <200 copies/mL within 24 weeks of initiating antiretroviral therapy or as sustained recurrence of viremia to >200 copies/mL (ie on two consecutive measurements) after initial viral suppression.

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