FDA ho'āpono mai, Vosevi no Hepatitis C

Ke US Food a me Uluwehi O kia'āina 'i keia la i apono Vosevi e pono nā mākua me ka maʻi hepatitis C mea hoʻomaʻi (HCV) genotypes 1-6 me cirrhosis (ake maʻi) a me ka mehana cirrhosis. Vosevi mea he paa-mahele lāʻau, me ka hui pu papa he mau mua apono ia ai '- sofosbuvir a me ka velpatasvir - a me ka hou lāʻau, voxilaprevir. Vosevi o ka mua iapaau ana i aponoia no e hoomanawanui i ka poe i ua mua ia me ka pololei-hana antiviral lāʻau sofosbuvir 'ole' ē aʻe ai 'no ka HCV e inhibit he kumuʻiʻo kapaia NS5A.

"Direct-hana antiviral ai 'pale aku i ka mea hoʻomaʻi mai ka hoonui a me ka pinepine hoola HCV. Vosevi hoʻolako i ka iapaau ana hōʻoia no kekahi e hoomanawanui i ka poe i ole ana ia ia me nā HCV ai 'i loko o ka hala, "wahi a Edward Punk, HI, ka luna hoʻokele o ka Office o Antimicrobial Products i loko o ka FDA ka Center no Uluwehi O loiloi' a me Research.

Hepatitis C mea he mea hoʻomaʻi maʻi i kumu li nui o ke akepaʻa e hiki alakai i maila ka ikaika ake hana a me ake ole. E like me ka-oaio? A no ka maʻi Na Makuahine a me Kāohiʻana, he oaeuiinoe 2,7 e 3,9 miliona kanaka i loko o ka United States i maʻi HCV. Kekahi e hoomanawanui i ka poe e ae mai ka maʻi HCV maʻiʻaʻai no na makahiki i i jaundice (yellowish maka a ili) a me ka ulu complications, e like me kahe ana ke koko, loli hoʻomāhuahua i loko o ka abdomen, nā mea palahēhē, ake maʻi 'aʻai a me ka make.

Aia nō ma ka liʻiliʻi loa eono okoa HCV genotypes, a me ke kanana nei, i mea genetically okoa hui o ka mea hoʻomaʻi. Ike i ka ke kanana nei o ka mea hoʻomaʻi ke kōkua hai aku lapaau koi. Kahi o 75 pakeneka o ka Americans me ka HCV i genotype 1; 20-25 pakeneka i genotypes 2 a 3; a he uuku ka helu o nā mea maʻi i iho mailoko me genotypes 4, 5 a me 6.

Ke ola a me ka hopenaʻoi loa o Vosevi i loiloi 'ia ma nā pae 3 lapaʻau e hookolokolo ai i heluʻia o ka hola 750 nā mākua me ka cirrhosis a me ka mehana cirrhosis.

Ka hoao mua hoohalikeia 12 pule o Vosevi lapaʻau me ka placebo i loko o nā mākua me ka genotype 1 ka poe i mua ole lapaʻau me ka NS5A inhibitor lāʻau. Nā mea maʻi i genotypes 2, 3, 4, 5 a me 6 a pau i loaa mai Vosevi.

Ka lua o ka hookolokolo ana hoohalikeia 12 pule o Vosevi me ka mua i aponoia ai 'sofosbuvir a velpatasvir i loko o nā mākua me nā genotypes 1, 2 a me 3 i mua nele lapaʻau me ka sofosbuvir akā,ʻaʻole he NS5A inhibitor lāʻau.

Hopena o nā hookolokolo i hōʻikeʻike ia 96-97 pakeneka o nā mea maʻi i loaa Vosevi i ole mea hoʻomaʻi akomi i loko o ke koko 12 pule hoʻopau lapaʻau ma hope, A laila'ōlelo akula i nā mea maʻi 'maʻiʻaʻai i ua ola.

Iapaau ana koi no ka Vosevi mea okoa ke kaumaha ma muli mea hoʻomaʻi genotype, a mamua lapaʻau mōʻaukala.

Ka loa, he pono ole adverse reactions i loko o nā mea maʻi lawe Vosevi he headache, luhi, a me ka diarrhea nausea.

Vosevi ua contraindicated i loko o nā mea maʻi e lawe i ka lāʻau rifampin.

Hepatitis B mea hoʻomaʻi (HBV) reactivation Ua hoike ma HCV / HBV coinfected makua e hoomanawanui i ka poe i undergoing a ua pau lapaʻau me ka HCV kauoha-hana antivirals, a me ka poe i ole ka loaa HBV antiviral Inc. HBV reactivation i loko o nā mea maʻi ia me ka pololei-e hana antiviral lapaau e 'ai pono i ka mea ake pilikia a me ka make i loko o kekahi nā mea maʻi. Health mālama 'Oihana e pale a pau nā mea maʻi no ka hoike o ka papa' ole ma mua o HBV maʻiʻaʻai mua hoʻomaka lapaau me Vosevi.

Ke FDA i keia palapala noi  makakoho Review  a me ka  Hopu Inc designations.  
 
The FDA granted approval of Vosevi to Gilead Sciences Inc.

Ka FDA, he oihana i loko o ka US Keʻena o Health a me ka hōʻike 'Services, i malama ma ka hoʻomau i ka maluhia, laulā, a me ka maluhia o ke kanaka a me kauka holoholona ai', vaccines a me nā liluwelo huahana no kanaka pono, a me ka 'inikua maalea i ka lehulehu ola. Ka oihana i kekahi mea kuleana no ka maluhia a me ka maluhia o ko mākou lāhui kanaka i ka ai lako, nā mea hoʻonani, dietary pakuʻi ai, me nā huahana e haawi aku lolouila pāhawewe, a no ka hooponopono ana i ka paka me nā huahana.

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Post manawa: Nov-24-2017
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