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¤å³¹¥X³Bwww.hivplusmag.com/resistance/2018/8/20/new-treatment-effective-against-advanced-drug-resistant-hiv

New Treatment Effective Against Advanced Drug-Resistant HIV

Ibalizumab is designed to help when other drugs fail

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·í¨ä¥LºØÃĪ«¬ÒµL®Ä®Éibalizumab§Y®É±Ï´©

There is hope for those who are in the advanced stages of drug-resistant HIV. Skipping days of medication can allow the virus to multiply, causing it to mutate and adapt to the medication, rendering drugs useless. Worse, drug-resistant HIV can be passed onto another person before they even get a chance to take medication.

¹ï©ó¨º¨Ç¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r²£¥Í§ÜÃĩʪº¥½´Á¶¥¬q¯f±w¡AªvÀø¥X²{¤@½uÀÆ¥ú¡C ¦³´X¤Ñ¨S¦³½T¹êªAÃÄ¥i¯à¨Ï±o¯f¬r½Æ»s¡A³y¦¨¯f¬r²£¥Í¬ðÅÜ¡A¨Ã¥B¦]À³ÃĪ«¦Ó²£¥Í§ïÅÜ¡A¦]¦Ó¾É­PÃĪ«µL®Ä¡C §óÁV¿|ªº¬O¡A²£¥Í§ÜÃĩʪº¤HÃþ§K¬Ì¯Ê¥F¯f¬r¦b¤H­Ì©|¥¼¯à¦³¾÷·|ªAÃĤ§«e¥i¯à´N¶Ç¬Vµ¹¥t¤@­Ó¤H¡C

We reported on ibalizumab last year and it was shown to reduced HIV replication and boosted immune cells in people with ¡¯advanced, drug-resistant HIV. The drug is delivered by injection and could rewrite how people deal with complex HIV-related situations.

§Ú­Ì¥h¦~³ø¾É¹Libalizumab¡A¥¦¡]ibalizumab¡^ ¸gÃÒ¹ê¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r²£¥Í§ÜÃĩʪº¡¯¥½´Á¯f±w¥i¥H­°§C¤HÃþ§K¬Ì¤£¥þ¯f¬r¶q¡A¨Ã¥B¼W±j§K¬Ì²Ó­M¡C ÃĪ«¶Ç¾É¤è¦¡¬O¸g¥Ñª`®g¡A¥i¯à§ï¼g¤H­Ì³B²z»P¤HÃþ§K¬Ì¤£¥þ¯f¬r¬ÛÃöªº³\¦h½ÆÂø±¡ªp¡C

¡¯Advanced¡G ¦bÀù¯g¯f¤H¶¥¬q¨Ó»¡´N¬O¡u¥½´Á¡v¡A¦ý¬O¹ï©óHIV¯f±w¨Ó»¡¡AWHO¦³²M·¡©w¸qadvanced ·N¸q¡A©¾©ó©w¸q¡A§Ú±N¤§Â½Ä¶¦¨¡u­«¯g¡v¡C

¥H¤U¸ê®Æ¨Ó·½WHO

The burden of morbidity and mortality associated with HIV infection has decreased over the past decade as access to antiretroviral therapy (ART) has increased. Nevertheless, around 1 in 3 people living with HIV (PLHIV) present to care with advanced HIV disease (figure 1); this proportion is higher in low and middle-income settings. Additionally, a growing number of PLHIV are returning to care with advanced disease following a period of treatment interruption. People with advanced HIV disease are at high risk of death, even after starting ART, with this risk increasing with decreasing CD4 cell count. The most common causes of death are tuberculosis (TB), severe bacterial infections, and cryptococcal meningitis. WHO is releasing new guidelines recommending that people who present with advanced HIV disease should be provided with a defined package of care, which includes screening, treatment and prevention of major opportunistic infections, in order to reduce morbidity and mortality. (WHO)

¦b¹L¥h¤Q¦~¥Ñ©ó¨Ï¥Î§Ü¤ÏÂà¿ý¯f¬rÃĪ«ªvÀøªº¯f±w¼W¥[¡A»PHIV·P¬V¦³ÃöªºªvÀø©Ò¤Þ°_ªºÂåÃÄ°ÝÃD¥H¤Î¦º¤`µ¥À£¤O«ùÄò´î¤Ö¡C µM¦Ó¡A»PHIV¦@¦sªº¯f±w¡]PLHIV¡^¤§¤¤¡A¤j¬ù¨C¤T¤H´N¦³¤@¤H±µ¨üªvÀø®É¤w§e²{­«¯g¡]advanced¡^ HIV¯e¯f¡F­Y¦b§C¦¬¤J¨ì¤¤¦¬¤J±ø¥ó³]©w¤U¡A±wªÌ¤ñ¨Ò­n¨Ó±o§ó°ª¡C ¦¹¥~¡A»PHIV¦@¦sªº¯f±w¦b¤@¬qªvÀøªÅµ¡´Á«á¡Aªð¦^±µ¨üªvÀø®É¤w§e²{­«¯g¡A³o¼Ëªº±wªÌ¤H¼Æ¿E¼W¡C ±a¦³­««×HIV¯e¯fªº¯f±w¡A§Y¨Ï¦b¶}©l¨Ï¥Î§Ü¤ÏÂà¿ý¯f¬rÃĪ««á¡A¤´¦]CD4²Ó­M¼Æ¥ØÆJ´î¦Ó­·ÀI¼W¥[¡A¦Ó­±Á{¦º¤`ªº°ª­·ÀI¡C ³Ì±`¨£ªº¦º¤`­ì¦]¬OªÍµ²®Ö¡]TB¡^¡BÄY­«ªº²Óµß·P¬V¡A¥H¤ÎÁô²yµß©Ê¸£½¤ª¢¡C ¥@¬É½Ã¥Í²Õ´¡]WHO¡^µo§G¤@¥÷·sªºªvÀø«ü¾É¤è°w¡A¨ä¤¤«Øij»Ý°w¹ï­«¯gHIV¯e¯f±wªÌ´£¥X¤@®M²M·¡©w¸qªº·ÓÅ@¤è®×¡A¨ä¤¤¥]¬A¿zÀË¡BªvÀø¥H¤Î¹w¨¾¥D­nªº´XºØ¾÷·|©Ê·P¬V¡A¥H´î§C¦]ªvÀø©Ò¤Þ°_ªºÂåÃÄ°ÝÃD¥H¤Î¦º¤`¡C(WHO)

A phase 3 study was published on Aug. 16 in the The New England Journal of Medicine. Co-authored by Yale assistant professor of medicine Brinda Emu, M.D., the study furthers the case for the new drug candidate in patients with severe drug-resistant HIV.

²Ä¤T´Á¬ã¨s©ó¤K¤ë¤Q¤»¤é¥Zµn¦b·s­^®æÄõÂå¾Ç´Á¥Z¡C ¥Ñ­C¾|ÂåÃľǨt°Æ±Ð±ÂBrinda Emu©Ò¦@¦P°õµ§¡A¦¹¶µ¬ã¨s¶i¤@¨B½T¥ß¤F¦¹ÃĪ«¹ï©ó¤HÃþ§K¬Ì¤£¥þ¯f¬r²£¥ÍÄY­«§ÜÃĩʪº¯f±w·sÃÄ­Ô¿ï¤Hªº®×¨Ò¡C

These patients had extremely ¡¯advanced HIV and resistant virus with limited options,¡¨ Emu told Science Daily. ¡§To see viral suppression in a significant percentage of these patients at six months is heartening. The result represents a much-needed new mechanism of action for patients who have highly resistant HIV.

³o¨Ç¯f±w¿©±w­«¯gHIV¥H¤Î§ÜÃĩʯf¬r¨Ã­±Á{¦³­­ªvÀø¿ï¶µ¡AEmu §i¶D Science¤é³ø¡C ¦b¤»­Ó¤ë®É¬Ý¨ì³o¨Ç¯f±wùص´¤j¦h¼Æ¯f¬r¤w¸g¨ü¨ì±±¨î¡A¬O¤@¥ó¥O¤H³¶ÅDªº¨Æ¡C ³o¶µµ²ªG¥Nªíªº¬O¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r²£¥Í°ª«×§ÜÃĩʪº¯f±w¦Ó¨¥¡A¤@­Ó­¢¤Á»Ý­nªº·s«¬§@¥Î¾÷Âà¡C

For the study, 40 adults with multidrug-resistant HIV-1 infection were enrolled into the program. All had a higher-than-acceptable viral load under their current treatment plan. All had endured multiple failed antiretroviral drugs. The patients were given incremental doses of ibalizumab, beginning with 2000 mg. The ibalizumab was combined with their current failing drug for weed one, and combined with optimized treatments for the next six months. By week 25, nearly 50 percent had reached undetectable levels. In total, 83 percent, or 33 of the patients observed, experienced a decrease in viral load over the course of the study. ¡§Significant antiviral activity¡¨ in normally struggling health situations was reported. A total of 31 patients completed the study, researchers reported.

¦b³o¶µ¬ã¨s¤¤¡A¹ï¥|¤Q¦W¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r ¡]HIV-1¡^²£¥Í¦h­«§ÜÃĩʪº¦¨¤H¶i¦æ¦¬®×¡C ¥|¤Q¦W¯f±w¦b¥L­Ì²{¦æªºªvÀø­pµe¤U¡A¬Ò¥X²{¶W¹L¥i¥H±µ¨ü½d³òªº¯f¬r¶q¡C ©Ò¦³ªº¯f±w¬Ò¸g¹L¦h¦¸µL®Äªº§Ü¤ÏÂà¿ý¯f¬rÃĪ«¡C ¤@¶}©lµ¹¤©¯f±w2000mgªºibalizumab¡A±µµÛ¤U¨Óibalizumab ¾¯¶qºCºC¼W¥[¡C ¦b²Ä¤@¶g®É¡Aibalizumab »P¯f±w¥Ø«eµL®ÄªºÃĪ«¦X¨Ö¨Ï¥Î¡A¨Ã¦b±µ¤U¨Ó¤»­Ó¤ë»P³Ì¨Î¤ÆÀøµ{¦X¨Ö¨Ï¥Î¡C ¨ì¤F²Ä25¶g¡A±Nªñ¦Ê¤À¤§¤­¤Qªº¯f±w¯f¬r¶q­°¦ÜµLªk°»´úªºµ{«×¡C ³Ì«áÁ`µ²¦Ê¤À¤§83¡A¤]´N¬O©ÒÆ[¹î¨ì¯f±w¤¤ªº33¦W¡A¦b¦¹¶µ¬ã¨sªº¹Lµ{¤¤¸g¾ú¤F¯f¬r¶q¤U­°¡C ³ø¾É«ü¥X¦b¥¿±`±¡ªp¤U««¦º±Ã¤ãªº°·±dª¬ºA¤¤¡A¥X²{·¥¬°ÅãµÛªº§Ü¯f¬r¬¡°Ê ¡]significant antiviral activity¡^¡C ¬ã¨sªÌ³ø¾ÉÁ`¦@¦³31¯f±w§¹¦¨¤F¦¹¶µ¬ã¨s¡C

Four patients in the study died, reaffirming the significance of taking drug-resistant HIV seriously, in a day and age when the darkest parts of the AIDS epidemic sometimes seem like a thing of the past. One adverse event was also noted. That patient experienced ¡¯immune reconstitution inflammatory syndrome.

¥|¦W°Ñ»P¬ã¨sªº¯f±w¦º¤`¡A¦A¦¸½T»{¦b²{¤µ³o­Ó¥@¥N¡A·íAIDS¥@¬ö¬y¦æ¯f³Ì¶Â·tªº³¡¤À¦³®É¬Ý¦ü¤w¸g¦¨¬°¹L¥h¾ú¥v¡AÄYµÂ¬Ý«Ý¤HÃþ§K¬Ì¯Ê¥F¯f¬r§ÜÃÄ©Ê¥X²{ªº­«­n©Ê¡C ¤@¥ó¤£¨}¨Æ¥ó¤]³Qµù°O¡C ¨º¦ì¯f±w¸g¾ú¤F¡¯§K¬Ì­««Øµoª¢¯g­Ô¸s¡C

But in most outcomes ¡X ibalizumab was not only a last resort, but a life-saver. Presumably, most of the participants were out of options to pick and choose from.

µM¦Ó¡A¤j¦h¼Æ§e²{ªºµ²ªG¡Aibalizumab¤£¦ý¬O³Ì«á¤@½u§Æ±æ¡A¦Ó¥B§ó¬O¤@­Ó±Ï©R¥P¤¦¡C ¦¹³B¦X²zªº°²³]¬O¤j¦h¼Æªº°Ñ»PªÌ¬Ò¬°µLÃÄ¥i¿ï¡AµLÃÄ¥i¥Î¡C

Drug makers call ibalizumab the first monoclonal antibody approved to treat HIV, a class of antibodies developed in a laboratory. It¡¦s ushering in a whole class of medicine and a new mode of delivery for the treatment of HIV, added Emu. I look forward to discussions in the community about how such a therapy will fit into the current treatment paradigm for HIV infection.

ÃĪ«»s³y°ÓºÙ¡uibalizumab¡v¬°­º­Ó¸g¹L®Ö­ã¥Î©óªvÀø¤HÃþ§K¬Ì¯Ê¥F¯f¬rªº³æ®è§ÜÅé¡A¬O¤@ºØ¦b¹êÅç«Ç©Òµo®i¥X¨Óªº§ÜÅéÃþ«¬¡C Emu¸É¥R¨ì¡A¦¹ÃĪ««ü¤Þ¥X¤@ºØ§¹¾ãÃþ«¬ªºÃĪ«¡A¥H¤ÎªvÀø¤HÃþ§K¬Ì¯Ê¥F¯f¬r¤@ºØ·s«¬ºAªº¶Ç¾É¤è¦¡¡C §Ú°J¤ß´Á¬ß¬Ý¨ìªÀ·|¤W¥X²{¦p¦ó¯àÅý¦¹ºØÀøµ{¦b¥¼¨Ó¿Ä¤J¤HÃþ§K¬Ì¯Ê¥F¯f¬r¡]HIV¡^·P¬V®É²{¦æªºªvÀø½d¨Ò¬ÛÃöªº°Q½×¡C

Patients with that level are relatively rare, as noted in the study, but it¡¦s comforting to know that there are options are being developed to turn to when common medications fail.

¦b¬ã¨s¤¤ÂI¥X¡AÄݩ󨺼˵{«×ªº¯f±wÁÙ¬O¬Û·íµ}¤Ö¡AµM¦Óª¾¹D·í¤@¯ëÃĪ«¬ÒµL®Ä®É¡A¯à°÷§ä¨ì²{¤µ¥¿¦bµo®i¤¤ªº¤@¨Ç¿ï¶µ¬O¥O¤H·P¨ì¼e¼¢ªº¨Æ¡C

Adherence to antiretroviral medications daily or as directed is key to preventing drug resistance. Of course ¡X not all of us have that luxury. Some HIV strains are much more serious than others. Developments in the drug industry are trying to make sure that everyone has a way to control HIV.

¨C¤é-©ÎªÌ¬O-«ö·Ó«ü¥Ü ¨Ï¥Î§Ü¤ÏÂà¿ý¯f¬rÃĪ«¬O¹w¨¾ÃĪ«²£¥Í§ÜÃĩʪºÃöÁä¡C ·íµM°Õ- §Ú­Ì¨Ã¤£¬O³£¦³¨º»ò¦hªº®É¶¡¡C ³¡¤Àªº¤HÃþ§K¬Ì¯Ê¥F¯f¬r®è¡A¬Û¸û©ó¨ä¥LºØÃþ¦Ó¨¥¡A·|¨Óªº§ó¥[¼F®`¡C ÃĪ«¤u·~µo®iºÜºÉ§V¤O¥H½T«O¨C¦ì¯f±w³£¦³±±¨î¤HÃþ§K¬Ì¯Ê¥F¯f¬r¡]HIV¡^ªº¤@®M¤èªk¡C

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¤å³¹¥X³Bwww.hivplusmag.com/resistance/2018/8/20/new-treatment-effective-against-advanced-drug-resistant-hiv

New Treatment Effective Against Advanced Drug-Resistant HIV

Ibalizumab is designed to help when other drugs fail

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There is hope for those who are in the advanced stages of drug-resistant HIV. Skipping days of medication can allow the virus to multiply, causing it to mutate and adapt to the medication, rendering drugs useless. Worse, drug-resistant HIV can be passed onto another person before they even get a chance to take medication.

¹ï©ó¨º¨Ç¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r²£¥Í§ÜÃĩʪº¥½´Á¶¥¬q¯f±w¡AªvÀø¥X²{¤@½uÀÆ¥ú¡C ¦³´X¤Ñ¨S¦³½T¹êªAÃÄ¥i¯à¨Ï±o¯f¬r½Æ»s¡A³y¦¨¯f¬r²£¥Í¬ðÅÜ¡A¨Ã¥B¦]À³ÃĪ«¦Ó²£¥Í§ïÅÜ¡A¦]¦Ó¾É­PÃĪ«µL®Ä¡C §óÁV¿|ªº¬O¡A²£¥Í§ÜÃĩʪº¤HÃþ§K¬Ì¯Ê¥F¯f¬r¦b¤H­Ì©|¥¼¯à¦³¾÷·|ªAÃĤ§«e¥i¯à´N¶Ç¬Vµ¹¥t¤@­Ó¤H¡C

We reported on ibalizumab last year and it was shown to reduced HIV replication and boosted immune cells in people with ¡¯advanced, drug-resistant HIV. The drug is delivered by injection and could rewrite how people deal with complex HIV-related situations.

§Ú­Ì¥h¦~³ø¾É¹Libalizumab¡A¥¦¡]ibalizumab¡^ ¸gÃÒ¹ê¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r²£¥Í§ÜÃĩʪº¡¯¥½´Á¯f±w¥i¥H­°§C¤HÃþ§K¬Ì¤£¥þ¯f¬r¶q¡A¨Ã¥B¼W±j§K¬Ì²Ó­M¡C ÃĪ«¶Ç¾É¤è¦¡¬O¸g¥Ñª`®g¡A¥i¯à§ï¼g¤H­Ì³B²z»P¤HÃþ§K¬Ì¤£¥þ¯f¬r¬ÛÃöªº³\¦h½ÆÂø±¡ªp¡C

¡¯Advanced¡G ¦bÀù¯g¯f¤H¶¥¬q¨Ó»¡´N¬O¡u¥½´Á¡v¡A¦ý¬O¹ï©óHIV¯f±w¨Ó»¡¡AWHO¦³²M·¡©w¸qadvanced ·N¸q¡A©¾©ó©w¸q¡A§Ú±N¤§Â½Ä¶¦¨¡u­«¯g¡v¡C

¥H¤U¸ê®Æ¨Ó·½WHO

The burden of morbidity and mortality associated with HIV infection has decreased over the past decade as access to antiretroviral therapy (ART) has increased. Nevertheless, around 1 in 3 people living with HIV (PLHIV) present to care with advanced HIV disease (figure 1); this proportion is higher in low and middle-income settings. Additionally, a growing number of PLHIV are returning to care with advanced disease following a period of treatment interruption. People with advanced HIV disease are at high risk of death, even after starting ART, with this risk increasing with decreasing CD4 cell count. The most common causes of death are tuberculosis (TB), severe bacterial infections, and cryptococcal meningitis. WHO is releasing new guidelines recommending that people who present with advanced HIV disease should be provided with a defined package of care, which includes screening, treatment and prevention of major opportunistic infections, in order to reduce morbidity and mortality. (WHO)

¦b¹L¥h¤Q¦~¥Ñ©ó¨Ï¥Î§Ü¤ÏÂà¿ý¯f¬rÃĪ«ªvÀøªº¯f±w¼W¥[¡A»PHIV·P¬V¦³ÃöªºªvÀø©Ò¤Þ°_ªºÂåÃÄ°ÝÃD¥H¤Î¦º¤`µ¥À£¤O«ùÄò´î¤Ö¡C µM¦Ó¡A»PHIV¦@¦sªº¯f±w¡]PLHIV¡^¤§¤¤¡A¤j¬ù¨C¤T¤H´N¦³¤@¤H±µ¨üªvÀø®É¤w§e²{­«¯g¡]advanced¡^ HIV¯e¯f¡F­Y¦b§C¦¬¤J¨ì¤¤¦¬¤J±ø¥ó³]©w¤U¡A±wªÌ¤ñ¨Ò­n¨Ó±o§ó°ª¡C ¦¹¥~¡A»PHIV¦@¦sªº¯f±w¦b¤@¬qªvÀøªÅµ¡´Á«á¡Aªð¦^±µ¨üªvÀø®É¤w§e²{­«¯g¡A³o¼Ëªº±wªÌ¤H¼Æ¿E¼W¡C ±a¦³­««×HIV¯e¯fªº¯f±w¡A§Y¨Ï¦b¶}©l¨Ï¥Î§Ü¤ÏÂà¿ý¯f¬rÃĪ««á¡A¤´¦]CD4²Ó­M¼Æ¥ØÆJ´î¦Ó­·ÀI¼W¥[¡A¦Ó­±Á{¦º¤`ªº°ª­·ÀI¡C ³Ì±`¨£ªº¦º¤`­ì¦]¬OªÍµ²®Ö¡]TB¡^¡BÄY­«ªº²Óµß·P¬V¡A¥H¤ÎÁô²yµß©Ê¸£½¤ª¢¡C ¥@¬É½Ã¥Í²Õ´¡]WHO¡^µo§G¤@¥÷·sªºªvÀø«ü¾É¤è°w¡A¨ä¤¤«Øij»Ý°w¹ï­«¯gHIV¯e¯f±wªÌ´£¥X¤@®M²M·¡©w¸qªº·ÓÅ@¤è®×¡A¨ä¤¤¥]¬A¿zÀË¡BªvÀø¥H¤Î¹w¨¾¥D­nªº´XºØ¾÷·|©Ê·P¬V¡A¥H´î§C¦]ªvÀø©Ò¤Þ°_ªºÂåÃÄ°ÝÃD¥H¤Î¦º¤`¡C(WHO)

A phase 3 study was published on Aug. 16 in the The New England Journal of Medicine. Co-authored by Yale assistant professor of medicine Brinda Emu, M.D., the study furthers the case for the new drug candidate in patients with severe drug-resistant HIV.

²Ä¤T´Á¬ã¨s©ó¤K¤ë¤Q¤»¤é¥Zµn¦b·s­^®æÄõÂå¾Ç´Á¥Z¡C ¥Ñ­C¾|ÂåÃľǨt°Æ±Ð±ÂBrinda Emu©Ò¦@¦P°õµ§¡A¦¹¶µ¬ã¨s¶i¤@¨B½T¥ß¤F¦¹ÃĪ«¹ï©ó¤HÃþ§K¬Ì¤£¥þ¯f¬r²£¥ÍÄY­«§ÜÃĩʪº¯f±w·sÃÄ­Ô¿ï¤Hªº®×¨Ò¡C

These patients had extremely ¡¯advanced HIV and resistant virus with limited options,¡¨ Emu told Science Daily. ¡§To see viral suppression in a significant percentage of these patients at six months is heartening. The result represents a much-needed new mechanism of action for patients who have highly resistant HIV.

³o¨Ç¯f±w¿©±w­«¯gHIV¥H¤Î§ÜÃĩʯf¬r¨Ã­±Á{¦³­­ªvÀø¿ï¶µ¡AEmu §i¶D Science¤é³ø¡C ¦b¤»­Ó¤ë®É¬Ý¨ì³o¨Ç¯f±wùص´¤j¦h¼Æ¯f¬r¤w¸g¨ü¨ì±±¨î¡A¬O¤@¥ó¥O¤H³¶ÅDªº¨Æ¡C ³o¶µµ²ªG¥Nªíªº¬O¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r²£¥Í°ª«×§ÜÃĩʪº¯f±w¦Ó¨¥¡A¤@­Ó­¢¤Á»Ý­nªº·s«¬§@¥Î¾÷Âà¡C

For the study, 40 adults with multidrug-resistant HIV-1 infection were enrolled into the program. All had a higher-than-acceptable viral load under their current treatment plan. All had endured multiple failed antiretroviral drugs. The patients were given incremental doses of ibalizumab, beginning with 2000 mg. The ibalizumab was combined with their current failing drug for weed one, and combined with optimized treatments for the next six months. By week 25, nearly 50 percent had reached undetectable levels. In total, 83 percent, or 33 of the patients observed, experienced a decrease in viral load over the course of the study. ¡§Significant antiviral activity¡¨ in normally struggling health situations was reported. A total of 31 patients completed the study, researchers reported.

¦b³o¶µ¬ã¨s¤¤¡A¹ï¥|¤Q¦W¹ï©ó¤HÃþ§K¬Ì¯Ê¥F¯f¬r ¡]HIV-1¡^²£¥Í¦h­«§ÜÃĩʪº¦¨¤H¶i¦æ¦¬®×¡C ¥|¤Q¦W¯f±w¦b¥L­Ì²{¦æªºªvÀø­pµe¤U¡A¬Ò¥X²{¶W¹L¥i¥H±µ¨ü½d³òªº¯f¬r¶q¡C ©Ò¦³ªº¯f±w¬Ò¸g¹L¦h¦¸µL®Äªº§Ü¤ÏÂà¿ý¯f¬rÃĪ«¡C ¤@¶}©lµ¹¤©¯f±w2000mgªºibalizumab¡A±µµÛ¤U¨Óibalizumab ¾¯¶qºCºC¼W¥[¡C ¦b²Ä¤@¶g®É¡Aibalizumab »P¯f±w¥Ø«eµL®ÄªºÃĪ«¦X¨Ö¨Ï¥Î¡A¨Ã¦b±µ¤U¨Ó¤»­Ó¤ë»P³Ì¨Î¤ÆÀøµ{¦X¨Ö¨Ï¥Î¡C ¨ì¤F²Ä25¶g¡A±Nªñ¦Ê¤À¤§¤­¤Qªº¯f±w¯f¬r¶q­°¦ÜµLªk°»´úªºµ{«×¡C ³Ì«áÁ`µ²¦Ê¤À¤§83¡A¤]´N¬O©ÒÆ[¹î¨ì¯f±w¤¤ªº33¦W¡A¦b¦¹¶µ¬ã¨sªº¹Lµ{¤¤¸g¾ú¤F¯f¬r¶q¤U­°¡C ³ø¾É«ü¥X¦b¥¿±`±¡ªp¤U««¦º±Ã¤ãªº°·±dª¬ºA¤¤¡A¥X²{·¥¬°ÅãµÛªº§Ü¯f¬r¬¡°Ê ¡]significant antiviral activity¡^¡C ¬ã¨sªÌ³ø¾ÉÁ`¦@¦³31¯f±w§¹¦¨¤F¦¹¶µ¬ã¨s¡C

Four patients in the study died, reaffirming the significance of taking drug-resistant HIV seriously, in a day and age when the darkest parts of the AIDS epidemic sometimes seem like a thing of the past. One adverse event was also noted. That patient experienced ¡¯immune reconstitution inflammatory syndrome.

¥|¦W°Ñ»P¬ã¨sªº¯f±w¦º¤`¡A¦A¦¸½T»{¦b²{¤µ³o­Ó¥@¥N¡A·íAIDS¥@¬ö¬y¦æ¯f³Ì¶Â·tªº³¡¤À¦³®É¬Ý¦ü¤w¸g¦¨¬°¹L¥h¾ú¥v¡AÄYµÂ¬Ý«Ý¤HÃþ§K¬Ì¯Ê¥F¯f¬r§ÜÃÄ©Ê¥X²{ªº­«­n©Ê¡C ¤@¥ó¤£¨}¨Æ¥ó¤]³Qµù°O¡C ¨º¦ì¯f±w¸g¾ú¤F¡¯§K¬Ì­««Øµoª¢¯g­Ô¸s¡C

But in most outcomes ¡X ibalizumab was not only a last resort, but a life-saver. Presumably, most of the participants were out of options to pick and choose from.

µM¦Ó¡A¤j¦h¼Æ§e²{ªºµ²ªG¡Aibalizumab¤£¦ý¬O³Ì«á¤@½u§Æ±æ¡A¦Ó¥B§ó¬O¤@­Ó±Ï©R¥P¤¦¡C ¦¹³B¦X²zªº°²³]¬O¤j¦h¼Æªº°Ñ»PªÌ¬Ò¬°µLÃÄ¥i¿ï¡AµLÃÄ¥i¥Î¡C

Drug makers call ibalizumab the first monoclonal antibody approved to treat HIV, a class of antibodies developed in a laboratory. It¡¦s ushering in a whole class of medicine and a new mode of delivery for the treatment of HIV, added Emu. I look forward to discussions in the community about how such a therapy will fit into the current treatment paradigm for HIV infection.

ÃĪ«»s³y°ÓºÙ¡uibalizumab¡v¬°­º­Ó¸g¹L®Ö­ã¥Î©óªvÀø¤HÃþ§K¬Ì¯Ê¥F¯f¬rªº³æ®è§ÜÅé¡A¬O¤@ºØ¦b¹êÅç«Ç©Òµo®i¥X¨Óªº§ÜÅéÃþ«¬¡C Emu¸É¥R¨ì¡A¦¹ÃĪ««ü¤Þ¥X¤@ºØ§¹¾ãÃþ«¬ªºÃĪ«¡A¥H¤ÎªvÀø¤HÃþ§K¬Ì¯Ê¥F¯f¬r¤@ºØ·s«¬ºAªº¶Ç¾É¤è¦¡¡C §Ú°J¤ß´Á¬ß¬Ý¨ìªÀ·|¤W¥X²{¦p¦ó¯àÅý¦¹ºØÀøµ{¦b¥¼¨Ó¿Ä¤J¤HÃþ§K¬Ì¯Ê¥F¯f¬r¡]HIV¡^·P¬V®É²{¦æªºªvÀø½d¨Ò¬ÛÃöªº°Q½×¡C

Patients with that level are relatively rare, as noted in the study, but it¡¦s comforting to know that there are options are being developed to turn to when common medications fail.

¦b¬ã¨s¤¤ÂI¥X¡AÄݩ󨺼˵{«×ªº¯f±wÁÙ¬O¬Û·íµ}¤Ö¡AµM¦Óª¾¹D·í¤@¯ëÃĪ«¬ÒµL®Ä®É¡A¯à°÷§ä¨ì²{¤µ¥¿¦bµo®i¤¤ªº¤@¨Ç¿ï¶µ¬O¥O¤H·P¨ì¼e¼¢ªº¨Æ¡C

Adherence to antiretroviral medications daily or as directed is key to preventing drug resistance. Of course ¡X not all of us have that luxury. Some HIV strains are much more serious than others. Developments in the drug industry are trying to make sure that everyone has a way to control HIV.

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Looking for high-growth stock can be a full-time job in itself. Finding stocks that qualify as high-growth, but that also have healthy assets to back it up can be even harder.

One of the best ways to be sure that your high-growth stock will deliver the goods is to take a look at its market share. While most companies have a lot of competitors, every now then you will come across a stock that seemingly has none.

Let¡¦s delve into the factors that might make today¡¦s high-growth stock with a squeaky-clean balance sheet a buy.

Say hello to one of the top pharma stocks on the TSX

Theratechnologies Inc. (TSX:TH) is a specialist pharmaceutical stock in the HIV patient industry. While other stock markets have competitors in this field, Theratechnologies has the monopoly on the TSX index. With solutions for comfortable ageing and quality of life for HIV patients that are largely unmet, Theratechnologies is what you might call a pure-play pharma stock.

It¡¦s also a hungry stock with a canny management strategy. Through its distributors, Theratechnologies has extended its reach across Europe, Israel, Norway, Switzerland, and Russia, as well as making recent inroads in Mexico and Brazil. Offering solutions for drug-resistant HIV sufferers, it¡¦s involved with the development of a novel drug called Ibalizumab. Its main income is from the sales and distribution of its number one product: an abdominal fat reducing drug called EGRIFTA. A market-cornering drug, it has applications beyond HIV patients and can be used to treat forms of diabetes.

Insider investment is a bullish sign in general, and Theratechnologies has seen a rise in insider buying over the last nine months, further adding to the analysis that this stock is worth buying. However, with an overvalued share price of $13.41 compared to its projected future cash flow value of $0.99, value investors may be left scratching their heads.

A cheap stock with a very comfortable future

With under 30 employees and no debt, Theratechnologies qualifies as one of the healthiest high-growth stocks on the TSX. It has a very low level of unsold physical assets, and as such, it looks more than able to deliver on its high growth. Where risk does come into play is its reliance on distributor RxCrossroads, based in the U.S., and its price, which may be overdue for correction. Indeed, the latter may already be happening, as its recent share price spike seems to be declining.

That said, its expected annual growth in earnings is phenomenal. At a massive 105.3%, Theratechnologies could multiply your investment literally a hundredfold. It goes without saying that this beats the expected annual growth of the TSX index by a huge margin, so you can see why analysts are saying that this stock is a strong buy.

The bottom line

Never mind the overvalued share price ¡V this stock is a potential gold mine. Theratechnologies is one of those rare stocks that can seriously multiply your investment. Given that its market is largely untapped ¡X it meets medical needs that no other stock on the TSX is involved with ¡X this stock automatically has the monopoly. All told, it looks like a strong buy from here.

On April 25th, the ultimate buy signal started flashing...

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To discover the brand-new triple down recommendation, simply click here. You¡¦ll be whisked to a special investor memo prepared by The Motley Fool Canada. The only catch is you¡¦ll have to hurry! This brand-new report could be withdrawn at any time.

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Theratechnologies Files Marketing Authorization Application for Trogarzo™ in Europe

GlobeNewswire¡EAugust 28, 2018

MONTREAL, Aug. 28, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TH.TO) is pleased to announce that the application for marketing authorization of Trogarzo™ (ibalizumab) was filed with the European Medicines Agency (¡§EMA¡¨) through its centralized procedure. Theratechnologies seeks to obtain approval for ibalizumab for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1) in the European Union.

The EMA has until mid-September to confirm whether the application is complete, in which case, it will initiate the review of Trogarzo™ under the accelerated assessment procedure.

The accelerated assessment procedure, which was granted in an earlier decision from the EMA, reduces the timeframe for a recommendation by the EMA to 150 review days from 210 review days for the normal procedure.

The application is based on the same clinical trial data that was reviewed by the FDA to grant marketing authorization of Trogarzo™ in the United States.

¡§Europe is the second most important market in the world for Trogarzo™. Many patients in Europe could benefit from this product if it becomes available in this territory. Knowing what Trogarzo™ represents for patients who have been on various treatment regimens but have a viral load still above detection level, we have spared no effort to ensure that we could file the application within six months after obtaining approval in the United States,¡¨ said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.

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Ibalizumab Provides New Option for Patients with Multidrug-Resistant HIV

AUGUST 23, 2018

Jared Kaltwasser

Brinda Emu, HIV, multidrug resistant HIVBrinda Emu, MD A newly published phase 3 study of patients with multidrug-resistant (MDR) HIV shows that ibalizumab can be a safe and effective option for patients with limited other avenues of treatment.

The study was the culmination of years of research into a drug designated a breakthrough therapy and fast-tracked by the US Food and Drug Administration (FDA). The FDA approved ibalizumab for the treatment of patients with MDR HIV in March 2018. The drug is being marketed by TaiMed Biologics under the brand name Trogarzo.

Corresponding author Brinda Emu, MD, an assistant professor of medicine at Yale University, said the vast majority of patients with HIV find success taking existing antiretroviral therapies (ARTs), if they take the drugs consistently. The success of ART is broad, she said, thanks to the fact that the current ART drugs have varying mechanisms of action, high barriers to resistance, relatively few side effects, and a low pill burden.

¡§Due to these advances, the number of patients with multidrug-resistant virus is small,¡¨ she said. ¡§However, this small group of individuals with MDR HIV is at high risk for virologic and immunologic failure, putting them at risk for development of serious AIDS related illnesses and death.¡¨

Emu said there can be several reasons why a patient could harbor multidrug-resistant HIV, but she said the main reason is sequential use of drug regimens that have been unable to control viremia, possibly due to poor potency, low patient adherence, or other issues.

The phase 3 study included 40 patients with multidrug-resistant HIV-1, each of whom had viral loads exceeding 1000 copies of HIV-1 RNA per milliliter (c/mL). Patients in the study spent the first week on their existing therapies, then received a loading dose of 2000 mg of ibalizumab, followed by 800-mg doses of ibalizumab every 2 weeks through week 25 of the study.

The primary endpoint of the study was the proportion of patients who achieved a reduction in viral load of at least 0.5 log 10 c/mL. At 25 weeks, patients who had taken ibalizumab in combination with a background regimen had an average decrease of 1.6 log 10 c/mL from their baseline load, and 43% of patients had a viral load of less than 50 c/mL. Fully half (50%) of patients had a viral load of less than 200 c/mL.

Emu said ibalizumab is a monoclonal antibody that works by binding to the CD4 receptors on host cells, thus preventing viral entry.

¡§The key to targeting drug-resistant virus is finding new mechanisms of action with non-overlapping resistance and evidence of potent antiviral activity,¡¨ she said. ¡§Ibalizumab fits that definition, thus making it an attractive option for patients who have limited alternative options.¡¨

Ibalizumab is a good choice for a very specific group of patients, she said, but added that physicians should weigh each patient¡¦s specific risks and needs carefully. One issue that differentiates ibalizumab from other ARTs is that it¡¦s administered intravenously, rather than as a pill.

¡§Providers should engage in dialogue with patients about their interest and ability with complying with the regimen,¡¨ she said. ¡§Potential logistical hurdles of biweekly IV administration must be weighed against the potential benefits of frequent visits, including the ability to quickly ascertain side effects to all medications, reminders about adherence, and building strong provider-patient relationships.¡¨

Ibalizumab¬°¦hÃÄ­@ÃĪºHIV±wªÌ´£¨Ñ¤F·sªº¿ï¾Ü

2018¦~8¤ë23¤é

Jared Kaltwasser

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¸Ó¬ã¨s¬O¦h¦~¨Ó¹ï¬ü°ê­¹«~©MÃĪ«ºÞ²z§½¡]FDA¡^§Ö³t°l踪ªº¤@ºØ¬ð¯}©ÊªvÀøÃĪ«¬ã¨sªº°ª¼é¡C¦bFDA§å­ã¥Î©ó¦ã¤Ú§Q¯]³æ§Üªº±wªÌMDR HIVªvÀø¦b2018¦~¤T¤ëªºÃĪ«¬O¥ÑTaiMed¥Íª«»s«~ªº«~µP¦WºÙTrogarzo¾P°â¡C

³q°T§@ªÌ¡A­C¾|¤j¾ÇÂå¾Ç§U²z±Ð±ÂÂå¾Ç³Õ¤hBrinda Emuªí¥Ü¡Aµ´¤j¦h¼Æ¦ã´þ¯f¯f¬r·P¬VªÌ¦pªG«ùÄòªA¥Î³o¨ÇÃĪ«¡A´N·|¦¨¥\ªA¥Î²{¦³ªº§Ü°fÂà¿ý¯f¬rÀøªk¡]ARTs¡^¡C¦o»¡¡AARTªº¦¨¥\¬O¼sªxªº¡A³o­nÂk¥\©ó¥Ø«eªºARTÃĪ«¨ã¦³¤£¦Pªº§@¥Î¾÷¨î¡A§Üªý¤O°ª¡A°Æ§@¥Î¬Û¹ï¸û¤Ö¡AÃĤY­t¾á§C¡C

¡§¥Ñ©ó³o¨Ç¶i¨B¡A¦h­«­@Ãįf¬rªº±wªÌ¤H¼Æ«Ü¤Ö¡A¡¨¦o»¡¡C¡§µM¦Ó¡A³o¤@¤p³¡¤À±w¦³MDR HIVªº¤H±w¯f¬r¾Ç©M§K¬Ì¾Ç¥¢±Ñªº­·ÀI«Ü°ª¡A¨Ï¥L­Ì­±Á{ÄY­«ªº¦ã´þ¯f¬ÛÃö¯e¯f©M¦º¤`ªº­·ÀI¡C¡¨

Emu»¡¡A¬°¤°»ò¯f¤H¥i¥HÄâ±a¦h­«­@ÃĪºHIV¥i¯à¦³´X­Ó­ì¦]¡A¦ý¦o»¡¥D­n­ì¦]¬O³sÄò¨Ï¥ÎµLªk±±¨î¯f¬r¦å¯gªºÃĪ«ªvÀø¤è®×¡A¥i¯à¬O¥Ñ©ó®Ä¤O®t¡A±wªÌ¨Ì±q©Ê§C©Î¨ä¥L°ÝÃD¡C

²Ä3¶¥¬q¬ã¨s¥]¬A40¦W±w¦³¦h­«­@ÃÄHIV-1ªº±wªÌ¡A¨C¦W±wªÌªº¯f¬r¸ü¶q¶W¹L1000«þ¨©¨C²@¤ÉHIV-1 RNA¡]c / mL¡^¡C¬ã¨s¤¤ªº±wªÌ¦b¥L­Ì²{¦³Àøªkªº²Ä¤@©P«×¹L¡AµM«á±µ¨ü­t²ü¾¯¶qªº2000mg¦ã¤Ú§Q¯]³æ§Ü¡AµM«á¦b¬ã¨sªº²Ä25¶g¨C2¶g±µ¨ü800mg¾¯¶qªº¦ã¤Ú§Q¯]³æ§Ü¡C

¸Ó¬ã¨sªº¥D­n²×ÂI¬O¯f¬r¸ü¶q­°§C¦Ü¤Ö0.5 log 10 c / mLªº±wªÌ¤ñ¨Ò¡C¦b25¶g®É¡AªA¥Î¦ã¤Ú§Q¯]³æ§ÜÁp¦X­I´º¤è®×ªº±wªÌ±q°ò½u­t²ü¥­§¡­°§C1.6 log 10 c / mL¡A43¢Hªº±wªÌ¯f¬r¸ü¶q§C©ó50 c / mL¡C§¹¥þ¤@¥b¡]50¢H¡^ªº±wªÌªº¯f¬r¸ü¶q§C©ó200 c / mL¡C

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¡§°w¹ï­@Ãįf¬rªºÃöÁä¬O§ä¨ì·sªº§@¥Î¾÷¨î¡A¨ã¦³«D­«Å|§Ü©Ê©M±j®Ä§Ü¯f¬r¬¡©ÊªºÃÒ¾Ú¡A¡¨¦o»¡¡C¡§Ibalizumab²Å¦X³o­Ó©w¸q¡A¦]¦¹¹ï©ó¨º¨Ç¿ï¾Ü¦³­­ªº±wªÌ¨Ó»¡¡A¥¦¬O¤@­Ó«Ü¦³§l¤Þ¤Oªº¿ï¾Ü¡C¡¨

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BENEFIT CONSIDERATIONS

Before using this policy, please check the member specific benefit plan document and any federal or state mandates,if applicable.

Essential Health Benefits for Individual and Small Group

For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual

COVERAGE RATIONALE

Trogarzo (ibalizumab-uiyk) is proven and/or medically necessary for

the treatment of multi-drug resistant human immunodeficiency virus (HIV) in patients

who meet ALL of the following criteria:

 For initial therapy, all of the following:

o Both of the following:

 Diagnosis of HIV-1 infection

 Physician attestation that the patient has multi-drug resistant HIV-1 infection

and

o Physician confirms that the patient has been prescribed an optimized backround antiretroviral regimen, containing at least one antiretroviral agent that demonstrates full viral sensitivity/susceptibility; and

o Ibalizumab initial and maintenance dosing is in accordance with the US Food and Drug Administration

prescribing information: A single loading dose of 2,000mg intravenously (IV) followed by a maintenance dose of 800mg IV every two weeks thereafter; and

o Initial authorization is for no more than 6 months.

 For continuation therapy, all of the following:

o Patient has previously received treatment with ibalizumab; and

o Physician confirms that the patient has achieved a clinically significant viral response to ibalizumab therapy; and

o Physician confirms that the patient will continue to take an optimized background antiretroviral regimen, in combination with ibalizumab; and

o Ibalizumab maintenance dosing is in accordance with the US Food and Drug Administration prescribing information; and

o Authorization is for no more than 12 months.

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Wow, good news!

TH really does something now.

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www.marketwatch.com/press-release/european-medicines-agency-authorizes-deferral-of-paediatric-investigation-plan-for-trogarzotm-2018-08-20

PRESS RELEASE

European Medicines Agency Authorizes Deferral of Paediatric Investigation Plan for Trogarzo(TM)

By

Published: Aug 20, 2018 7:30 a.m. ET

Theratechnologies Inc. (Theratechnologies) (TH) today announced that the Paediatric Committee of the European Medicines Agency (EMA) has accepted to defer the initiation of the Paediatric Investigation Plan for Trogarzo(TM) after the application for marketing authorization in Europe for Trogarzo(TM) has been filed with the EMA.

European Union regulations state that paediatric investigation plans should normally be conducted prior to an application for marketing authorization being filed for a medicinal product for human use. Notwithstanding, those regulations also provide for deferrals to avoid delaying access to other patient populations.

Given the deferral granted by the EMA, Theratechnologies can now focus on finalizing the application for marketing authorization for Trogarzo(TM) in Europe.

Europe represents a significant market for Trogarzo(TM). We want to be in a position to launch it as quickly as we can. Obtaining a deferral for the paediatric investigation plan represents another major step towards meeting that objective, said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.

About Theratechnologies

Theratechnologies (TH) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. Further information about Theratechnologies is available on the Company¡¦s website at www.theratech.com and on SEDAR at www.sedar.com.

Forward-Looking Information

This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management¡¦s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as may, will, should, could, would, outlook, believe, plan, envisage, anticipate, expect and estimate or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, the timeline to file a submission with the EMA and Theratechnologies¡¦ capacity to obtain approval for Trogarzo(TM) in Europe.

Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies¡¦ control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: no additional clinical studies will need to be conducted to obtain approval of Trogarzo [TM] from the EMA, no event will delay the timeline to file a marketing authorization application with the EMA, and Trogarzo [TM] will be approved by the EMA with the current data on file.

Advertisement

These risks and uncertainties include, but are not limited to, the risk that the timeline to file a marketing authorization application with the EMA is delayed, and the risk that the EMA does not approve Trogarzo [TM] .

We refer potential investors to the Risk Factors section of our Annual Information Form dated February 6, 2018 available on SEDAR at www.sedar.com for additional risks and uncertainties about Theratechnologies and its business. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

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¸`¿ý¢æ¦w§ëÅU¹ï¤¤¸Îªº²£·~³ø§i­«ÂI¡]¸Ó³ø§i¼g©ó2018.08¤ëªì¡^¡G

¤¤¸Î¹w¦ôMDR¥½´Á¥ÎÃįf¤H1¸U -1.2¸U¡C¡]³Ì·s6/6±i¸³Á¿1.2-1.3¸U¡H¡^

¢æ¦w¡Gº¯³z²v50%­pºâ¡A¹w¦ô ¬ü°ê¥«³õ¬ù5000¤H¨Ï¥Î Trogarzo¡C

¢æ¦w¡G¥«³õº¯³z²v¥Ø«e²Å¦X¹w´Á¡A¹w¦ô²Ä¤@¦~³B¤èñ¤H¼Æ¹F1000¤H¦¸¡C

¢æ¦w¡G¤U¥b¦~¡u³æ©u¡v¦³¾÷·|¥X³f¶W¹L¸U²~¡C¡]¨ì©³±i¸³Á¿³æ©uÁÙ¬O³æ¤ë¡H¡H¡^

¢æ¦w¡G­«ÂIÆ[¹î²Ä¥|©u¡A°²³]¡u³æ©u¡v¥X³f¶W¹L¸U²~¡Aªí¥Ü°ª®p´Á5000¤H¨Ï¥Î¥i±æ¹F¦¨¡A¥X³f¶W¹L128»õ¡C

¢æ¦w¡G¥Ø¼Ð»ù¼È©w¬°280¤¸¡C

ÁÙ¦³¦C¡u¤£­pºâ²Ä¤G¡B¤T¥N¾¯«¬¡A¥u­pºâ trogarzo¥½½u¥ÎÃĤU¡vªº¨CªÑ¬Õ¾l¡C(¬Ý±Ô­z¤]¥u³æ¯Â¬Ý¬ü°ê¡A¨Sºâ¶i¼Ú¬w¥«³õ)

2018 -1.33

2019 -0.18

2020 1.54

2021 4.73

2022 9.36

2023 10.91

2024 12.45

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¶¶«K¦b¦¹¤]¡u¤£­nÁy¡vªºÀµ¨Dª©¥D¡A§Æ±æ±z¦³¾÷·|¦b¤½°ÈÁc¦£¤§¾l¡A¦hÀ°ª©²³´£¨Ñ±zªº¨£¸Ñ©Î¸ê°T¡C¥Ø«eTrogarzoµo®i¶i«×´X¥G§¹¥þ²Å¦X±z¦bª©¼Ð©Ò¨¥¡A¥»¤H°£¤F·j´M¥«³õ¸ê¶q¯à¤O¤£¨¬¡B¨S¾÷·|°Ñ»P¤¤¸Î·|ij¥~¡A­^¤å¯à¤O¤]¦³­­¡A¤£¾å±o±z¦³³Ì·s¸ê°T¥i¨Ñ°Ñ¦Ò-¤U¤@¨Bªº¤è¦V·|¬O¦p¦ó¡H

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©1996-2018, Oxford Health Plans, LLC

BENEFIT CONSIDERATIONS

Before using this policy, please check the member specific benefit plan document and any federal or state mandates,if applicable.

Essential Health Benefits for Individual and Small Group

For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insurednon-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for tencategories of Essential Health Benefits (¡§EHBs¡¨). Large group plans (both self-funded and fully insured), and small

group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to

provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be

removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is

made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit

plan document to determine benefit coverage.

COVERAGE RATIONALE

Trogarzo (ibalizumab-uiyk) is proven and/or medically necessary for1

the treatment of multi-drug

resistant human immunodeficiency virus (HIV) in patients who meet ALL of the following criteria:

 For initial therapy, all of the following:

o Both of the following:

 Diagnosis of HIV-1 infection

 Physician attestation that the patient has multi-drug resistant HIV-1 infection

and

o Physician confirms that the patient has been prescribed an optimized backround antiretroviral regimen,

containing at least one antiretroviral agent that demonstrates full viral sensitivity/susceptibility; and

o Ibalizumab initial and maintenance dosing is in accordance with the US Food and Drug Administration

prescribing information: A single loading dose of 2,000mg intravenously (IV) followed by a maintenance dose

of 800mg IV every two weeks thereafter; and

o Initial authorization is for no more than 6 months.

 For continuation therapy, all of the following:

o Patient has previously received treatment with ibalizumab; and

o Physician confirms that the patient has achieved a clinically significant viral response to ibalizumab therapy;

and

o Physician confirms that the patient will continue to take an optimized backround antiretroviral regimen, in

combination with ibalizumab; and

o Ibalizumab maintenance dosing is in accordance with the US Food and Drug Administration prescribing

information; and

o Authorization is for no more than 12 months.

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor, in combination with other

antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug

resistant HIV-1 infection failing their current antiretroviral regimen.

BACKGROUND

Ibalizumab is a humanized monoclonal antibody for the treatment of MDR HIV-1 infection. Ibalizumab binds primarily

to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II

molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological

function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents.1

APPLICABLE CODES

The following list(s) of procedure

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RE:Pro140 vs Trogarzo?

Let¡¦s just assume PRO 140¡¦s results are legitimate. It really doesn¡¦t

matter much to Trogarzo as Trogarzo will already have most of the available

MDR patients on it by the time PRO 140 gets on the market (assuming that even happens).

Once you are on an HIV drug, you stay on until it stops working.

PRO 140 has a very hard road ahead of it since CYDY is very poorly financed,

PRO 140 does not have BTD and CYDY recently announced it is trying to move into cancer

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1. MDR±wªÌ¥u­n¤@¥¹¥ÎÃÄ¡A´N±o¥Î¨ì¥X²{§ÜÃĬ°¤î¡ATrogarzo¤w´£«e¥´¶i¥«³õ(ÁöµM¥Ø«e¨S±À¥X¨Ó)¡A¥B¶ZÂ÷Pro140¤W½uÁÙ¦³¤@¬q®É¤é¡A¥u­n¯à¦b¤@¦~¤º©Ô¶}¡A³£¨S°ÝÃD°Õ~¥BPro140¯à¤£¯à¤W½u¡AÁÙ¤£ª¾¹D³á¡I

2. Pro140°w¹ïªº¬OMDR¸Ìªº¤@³¡¯f±w¦Ó¤w¡A§í¨î¤O°ªªº¼Æ¾Ú¨Ó·½¥ç¬°¦p¦¹¡C¦ÓTrogarzo¹ïªº¬O¾ã­ÓMDR±Ú¸s¡C

3. CYDY(Pro140ªº¤½¥q)¦³°]°È¤Wªº°ÝÃD¡A³Ìªñ°£¤F¦b¨D°â¥H¥~¦P®É¤½¥q¤jÀY¤]¦bÂà¤â«ùªÑ¡AªÑ»ù³¡¤À¡A¦U¦ì¦Û¤v¥hÂI¨Ó¬ÝÐù

4. Pro140¨S¦³BTD(¬ð¯}©ÊÀøªk)¡A¥Bªñ´Á¦³©¹Àù¯gªvÀø¬ã¨sÂà´«­y¹Dªº±¡ªp(±À¦ô´N¬O¦]¬°¤F¸ÑµLªkÀ»±Ñtrogarzo

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