1.
1) /
Ŭ̵ ü Ÿ Ʈι̷ ġ 쿡 ġ ʸ Ǿ. ̵ κ Լ Ÿ. Ⱓ Ŭ̵ ִ. ȯ ˷ Ұ ִ ȯڿ Ŭ̵ ü ؾ ϸ, ˷ Ұ ȯڿ ʰ ִ. Ǵ ѷ ( ƹ̳ȿ Ÿ ) ǽ ӻ Ǵ ̻ Ÿ ȯڿ ؼ ߴؾ Ѵ.
2) ġ ߴ ȭ
HBV ġ ߴ ȭ ִ. ߴ HBV ȯڴ ̻ ӻ Ǵ ˻縦 ͵Ǿ Ѵ. B ġḦ ٽ ִ.
2. ȯڿ
1) Ǵ ٸ п ִ ȯ
2) ϰ Ƿ, ҳ(galactose intolerance), Lapp ȿ (Lapp lactase deficiency) Ǵ - (glucose-galactose malabsorption) ִ ȯڿԴ ϸ ȵȴ.
3. ȯڿ
1) Ǵ ȭ
׳ Ģ 忡 輳ȴ. ź ڴ ı( λ ż ջ) ʵ Ǿ.
ġḦ ϱ ̾ ġḦ ӻ ϰ ȯ ũƼ û ġ ϴ ȴ. Ƶ ϴ ̻ ȯڸ ִ ȯ 쿡 ġḦ ϱ ġ ֱ ũƼ û ġ, û λ, ܹ ϴ ȴ.
ũƼ û 50mL/min ̸ ȯڿ ϰ ϴ ȴ. ħ Ͽ ȯڿ ȿ Ͱ Ƿ, ġ ̵ ؾ Ѵ.
ŵ ִ (: 뷮 Ǵ ̵强 ҿ(NSAID) ) ̰ų ֱٿ 쿡 ʴ´. ű ڸ HIV ȯ ׳ Ͻ Ǫ꿰 NSAID 뷮 Ǵ ź ʰ ־. Ϻ ȯڿ Կ Ŵü (renal replacement therapy) ʿߴ. ű ִ ȯڿ ʿ NSAID Ǿ Ѵ.
Ǵ ȭǴ , , /Ǵ Ǵ ȭ (proximal renal tubulopathy) ¡ 豺 ȯڿ ű ؾ Ѵ.
2) ٸ
׳ Ե (׳/ƮŸ Ǵ ׳/ƮŸ/Ǻ Ǵ ׳/ƮŸ/ױ/ںýŸƮ ) ʴ´.
Ƶ ؼ ȵȴ.
3) HIV-1 HBV ÿ ȯ
HIV-1 HIV-1 HBV ȯڿ Ʈι̷ ȯθ ؾ Ѵ.
ġḦ ϱ HBVȯڿ HIV-1 ü ˻縦 ؾ Ѵ. HIV-1ȯڰ ̾ ġḦ ϱ B ˻縦 ȴ.
4)
е:
HIV-1 ο ӻ迡 ణ е(BMD) ҿ ȯ(bone turnover) Ÿ ȭ ǥ ° Ÿ. û ΰ ȣ ġ 1,25 Ÿ D ġ Ÿ(4. ̻ ).
Ҿ ûҳ ӻ Ǿ. ϻ Ҿ ȯڿ BMD Ѵ. 2 ̻ 18 ̸ HIV ȯڿ ־ ȯڿ Ͱ ߰ Ÿ´. ġ HIV-1 Ҿ ȯڿ ü BMD . B 12 ̻ 18 ̸ ûҳ ȯڿ Ǿ. Ҿ 迡 (Ű) ʴ Ÿ(4. ̻ ).
е ȭ ǥ ȭ ǰ 迡 ġ ˷ ʾҴ. ְų ٰ Ǵ ִ Ҿ ȯڿ е ؾ Ѵ. Į Ÿ D ȿ ʾ ̷ ȯڿ ִ. ̻ ǽɵǴ ƾ Ѵ.
ȭ :
Ǵ Ÿ ĥ ִ, ȭ ʰ Ͽ Ǿ. ̷ ȭ ʰ ׳ Ͻ Ǫ꿰 Ͽ Ǿ(4. ̻ ). ʿ Ǵ ȭ Ǿ. ׳ Ͻ Ǫ꿰 ϴ Ǵ ȭ Ǵ ̴ ű ȯڿ λ ȭ Ǿ Ѵ(3. ȯڿ 1) Ǵ ȭ ).
5) Ȳ5ȣ(¿ο FCF, Sunset Yellow FCF) ϰ Ƿ п ϰų ˷ ִ ȯڿ Ѵ.
4. ̻
1) ӻ 迡 ̻
ӻ ϰ پ ǿ ǹǷ, ӻ 迡 Ǵ ̻ ٸ ӻ 迡 Ǵ ̻ , Ǵ ݿ ִ.
HIV-1 ȯڿ ӻ
12,000 ̻ ȯڰ ܵ Ǵ Ÿ Ʈι̷ Ǿǰ Ͽ ӻ ټ Ȯ α(expanded access program) 28Ͽ 215ֱ ġḦ Ҵ. 1,544 ȯڰ ӻ 迡 1 1ȸ ׳ Ͻ Ǫ꿰 300mg 11,000 ̻ ȯڰ ټ Ȯ α Ҵ.
Ը ӻ 迡 , , , , , ̻(ߺ 10% ̻, 2-4) ȮεǾ.
. ġ HIV-1 ȯ
903 - ġ ̻ : 144 ׳(N=299) Ǵ Ÿε(N=301) ̺ε ĺ Ͽ ġ 600 ġ ȯڿ ߸Ͱ 迡 Ÿ ̻ ߵ ̾.
̻( 1) ġᱺ , ̿ شѴ. ߵ ġ ̻ ǥ 2 Ǿ ִ.
ǥ 2 903(0-144) 5% ̻ ġ ̻a( 2-4)
| +̺ε+ĺ | Ÿε+̺ε+ĺ |
N=299 | N=301 |
߿ | 14% 13% 8% 7% 9% 6% | 17% 12% 7% 12% 8% 7% |
ȭ ȭҷ | 11% 8% 4% 5% | 13% 9% 5% 9% |
̿b | 1% | 8% |
ٰ | 5% 3% | 7% 5% |
Ű Ҹ Ű溴c Ҿ | 11% 5% 3% 1% 6% | 10% 8% 6% 5% 6% |
ȣ | 5% | 5% |
Ǻ d | 18% | 12% |
a. ̻ ϰ ġ ̻ʸ Ѵ.
b. ̿ ݿ ǵ ı ƴ϶ ڰ پ ̻ʸ ǹѴ.
c. Ű溴 Ű濰 Ű溴 Ѵ.
d. , , ݱ, ε巯, ִ.
ӻ˻ġ ̻ : ݷ Ʈ۸ ׳ (19% 1%) Ÿε (40% 9%) ϰ ϰ, 迡 쿡 ӻ˻ġ ̻ ߴ. 3 4 ǥ 3 ִ.
ǥ 3 903(0-144) ġᱺ 1% ̻ 3/4 ӻ˻ġ
| +̺ε +ĺ | Ÿε+̺ε +ĺ |
| N=299 | N=301 |
3 ̻ ̻ | 36% | 42% |
ݷ (240mg/DL ʰ) | 19% | 40% |
ũƾ Ȱȿ (M: 990U/L ʰ) (F: 845U/L ʰ) | 12% | 12% |
û ƹж (175U/L ʰ) | 9% | 8% |
AST (M: 180U/L ʰ) (F: 170U/L ʰ) | 5% | 7% |
ALT (M: 215U/L ʰ) (F: 170U/L ʰ) | 4% | 5% |
(100 RBC/HPF ʰ) | 7% | 7% |
(750/mm3 ̸) | 3% | 1% |
Ʈ۸ (750mg/dL ʰ) | 1% | 9% |
934 - ġ ̻ : Ʈι̷ ġ 511 ڰ ĺ ׳ + ƮŸ (N=257) Ǵ ĺ ε/̺ε (N=254) ġҴ. 迡 ̻ ġ ְų ġ ڸ Ϲ ġߴ(ǥ 4).
ǥ 4 934(0-144) 5% ̻ ġ ̻a ( 2-4)
| +ƮŸ +ĺb | ε/̺ε +ĺ |
| N=257 | N=254 |
| 9% 9% 2% | 5% 7% 5% |
Ϲ Ƿ | 9% | 8% |
κ εο | 8% 8% 5% | 4% 5% 3% |
Ű | 6% 8% | 5% 7% |
Ҹ | 9% 5% | 7% 7% |
Ǻ | 7% | 9% |
a. ̻ ϰ ġ ̻ʸ Ѵ.
b. 96-144 迡 ڴ ĺ + + ƮŸ ĺ + /ƮŸ Ҵ.
c. , Ż , ż , , ݱ , Ҿ Եȴ.
ӻ˻ġ ̻ : 迡 ӻ˻ġ ̻ Ϲ 迡 Ÿ Ͱ ġߴ(ǥ 5).
ǥ 5. 934(0-144) 1% ̻ ӻ˻ġ ̻
| +ƮŸ +ĺa | ε/̺ε +ĺ |
| N=257 | N=254 |
3 ̻ ̻ | 30% | 26% |
ݷ (240mg/DL ʰ) | 22% | 24% |
ũƾ Ȱȿ (M: 990U/L ʰ) (F: 845U/L ʰ) | 9% | 7% |
û ƹж (175U/L ʰ) | 8% | 4% |
Į Ÿ (550U/L ʰ) | 1% | 0% |
AST (M: 180U/L ʰ) (F: 170U/L ʰ) | 3% | 3% |
ALT (M: 215U/L ʰ) (F: 170U/L ʰ) | 2% | 3% |
۷κ (8.0mg/dL ̸) | 0% | 4% |
(250mg/dL ʰ) | 2% | 1% |
(75 RBC/HPF ʰ) | 3% | 2% |
索 (3+ ̻) | <1% | 1% |
(750/mm3 ̸) | 3% | 5% |
Ʈ۸ (750mg/dL ʰ) | 4% | 2% |
a. 96-144 迡 ȯڴ ĺ + ƮŸ ĺ + ׳ DF/ƮŸ ġḦ Ҵ.
. ġ ִ HIV-1 ȯ
ġ ̻ : ġ ִ ڿ Ÿ ̻ , , ظ ߵ ̻ ϸ, ġ ڿ Ÿ ̻ Ϲ ġߴ. 1% ̸ ڰ ̻ ӻ ߴߴ( 907).
907 ó 48 ȿ ߵ ġ õ ̻ ǥ 6 ִ.
ǥ 6 907(0-48) 3% ̻ ġ ̻a( 2-4)
| | | | ü |
(N=368) | (N=182) | (N=368) | (N=170) |
(0-24) | (0-24) | (0-48) | (24-48) |
߿ | 7% 7% 5% 4% 3% 3% 2% | 6% 7% 5% 3% 3% 1% 2% | 11% 12% 8% 7% 4% 3% 4% | 1% 4% 2% 6% 2% 2% 2% |
ȭ Ŀ ȭҷ ظ | 11% 8% 4% 3% 3% 3% | 10% 5% 1% 2% 2% 1% | 16% 11% 7% 4% 4% 4% | 11% 7% 5% 1% 2% 1% |
ȣ | 2% | 0% | 3% | 2% |
Ű Ҹ ʽŰ溴b | 4% 3% 3% 1% | 3% 2% 3% 3% | 8% 8% 5% 3% | 4% 4% 2% 1% |
Ǻ c | 5% 3% | 4% 2% | 7% 3% | 1% 1% |
ٰ | 3% | 3% | 4% | 1% |
ü | 2% | 1% | 4% | 2% |
a. ̻ ϰ ġ ̻ Ѵ.
b. Ű溴 Ű濰 Ű溴 Ѵ.
c. , , ݱ, ε巯, ִ.
ӻ˻ġ ̻ : 迡 ӻ˻ġ ̻ ġ 쿡 ߴ. 3 4 ̻ ǥ 7 ִ.
ǥ 7 907(0-48) ġᱺ 1% ̻ 3/4 ӻ˻ġ ̻
| ׳ (N=368) (0-24) | (N=182) (0-24) | ׳ (N=368) (0-48) | ׳( ׳ ü) (N=170) (24-48) |
3 ̻ ̻ | 25% | 38% | 35% | 34% |
Ʈ۸ (750mg/dL ʰ) | 8% | 13% | 11% | 9% |
ũƾ Ȱȿ (M: 990U/L ʰ) (F: 845U/L ʰ) | 7% | 14% | 12% | 12% |
û ƹж (175U/L ʰ) | 6% | 7% | 7% | 6% |
索 (3+ ̻) | 3% | 3% | 3% | 2% |
AST (M: 180U/L ʰ) (F: 170U/L ʰ) | 3% | 3% | 4% | 5% |
ALT (M: 215U/L ʰ) (F: 170U/L ʰ) | 2% | 2% | 4% | 5% |
û(250U/L ʰ) | 2% | 4% | 3% | 3% |
(750/mm3 ̸) | 1% | 1% | 2% | 1% |
. 12 ̻ Ҿ HIV-1 ȯڿ ӻ
184 HIV-1 Ҿ ȯ(2 ̻ 18 ̸) ٸ Ʈι̷ Ͽ 48ְ (N=93) Ǵ /Ȱ(N=91) ġḦ 2 ӻ( 321) ٰŷ ̻ ̷. ġḦ Ҿ ȯڿ ̻ ο ӻ迡 ϰǰ Ÿ.
B ȯڿ ӻ
. B ȯ ִ ȯڿ ӻ
ġ ̻: B ڿ ӻ(0102 0103) 48ְ Ͱ Ⱓ ̾ ġḦ ڰ ߴ( 9% vs Ƶ Ǻ 2%). ġḦ ȯ 5% ̻ Ÿ ġ ̻δ , , , , Ƿ, εο, , Ǻ Եȴ.
0102 0103 迡 ġϴ ܰ(48 − 384) 2% (13/585) û ũƼ 0.5 mg/dL ȮεǾ.
迡 ִ 384 ġḦ ڿ ༺ ȭ ʾҴ.
ӻ˻ġ ̻ : 48ְ 3 4 ̻ ǥ 8 ִ. 3 4 ӻ˻ġ ̻ ִ 384 ġḦ ڿ Ÿ ̻ ߴ.
ǥ8. 102 103 ġ 쿡 1% ̻ 3/4 ̻
| ׳ (N=426) | Ƶ (N=215) |
3 ̻ ̻ | 19% | 13% |
ũƾ Ȱȿ (M: 990U/L ʰ) (F: 845U/L ʰ) | 2% | 3% |
û ƹж(175U/L ʰ) | 4% | 1% |
索(3+ ̻) | 3% | <1% |
AST (M: 180U/L ʰ) (F: 170U/L ʰ) | 4% | 4% |
ALT (M: 215U/L ʰ) (F: 170U/L ʰ) | 10% | 6% |
----------------------------------------
ġ ALT ( ְų , û ALT ġ 2 ʰ̰ ġ 10 ʰ ǵ) (2.5%) Ƶ(2%) ߴ. ALT Ϲ ġ ù 4-8 Ÿ, HBV DNA ġ ҿ Բ ߴ. ¡ĸ ڴ . Ϲ ALT ʾƵ 4-8 ̳ ذȴ.
B ̺ε ġ ȯڿ ̻ ٸ B ӻ迡 Ͱ ϰǰ Ÿ.
. B ȯ ִ ȯڿ ӻ
ұԸ Ͱ, Ȱ (0108) CHB ȯ ΰ ִ ȯڸ ִ 48 Ǵ Ÿ ̷ ġߴ. ġḦ 45 ȯڰ ߴ ġ ̻ (22%), (20%), Ҹ(18%), (16%), (13%), (13%), ߿(11%)̾. 45 2(4%) 48ְ Ⱓ ȯ ʿ ߴ. 45 3(7%) ̻ ġḦ ߴߴ. 45 4(9%) û ũƾ 0.5 mg/dL Ǿ( 1 48 û λ 2mg/dL ̸ Ǿ). ̷ 3( Child-Pugh 10 ̻̰, MELD 14̻̾) ջ ȭǾ. ȯ ɿ Ƿ, ܿ ջ ģ ˾Ƴ ƴ.
45 48 Ⱓ ġ .
. 12 ̻ Ҿ B ȯڿ ӻ
106 B Ҿ(12 ̻ 18 ̸) ȯڸ 72ְ (N=52) Ǵ (N=54) ġḦ ӻ( GS-US-174-0115) ̻ ̷. ġḦ Ҿ ȯڿ ̻ ο ӻ迡 ϰǰ Ÿ.
е ġᱺ ġᱺ Ҵ.
2)
̻ ȮεǾ. ̻ ҸȮ Ը ܿ ڹ DZ ŷڼ ְ ϰų ΰ 踦 ϴ ִ.
鿪
˷ ( )
, Į, λ
ȣ,
ȣ
忰, ƹж ,
㳶
, , ȿ ( Ϲ AST ALT GT)
Ǻ
ٰݰ
Ⱦ , ȭ( Ÿ, ), ȭ, ȯ
ź, ź, , ڴ ı, , ſ( ), 强 , ź, ũƼ , ܹ鴢, ٴ
Ϲ
ü Ͽ ̻ ִ: Ⱦ , ȭ, Į, ȭ, ȯ, λ
ɻ縦 Ͽ 6 746 B ڸ ǽ , ̻ ΰ 11.66%(87/746, 225) Ǿ. ΰ ߴ ̻ ΰ踦 ߴ ̻ Ʒ ǥ Ͽ.
| SOC | ΰ ߴ ̻ 3.62%(27/746, 50) | ΰ踦 ߴ ̻ 0.40%(3/746, 4) |
ʰ (0.1~1%̸) | | ȭҷ(0.13%(1/746), 1), (0.13%(1/746), 1), ĵ(0.13%(1/746), 1), (0.13%(1/746), 1), (0.13%,(1/746), 1), ظ(0.13%(1/746), 1) | - |
ħ | ΰ(0.27%(2/746), 2), 忰(0.13%(1/746), 1), (0.13%(1/746), 1), (0.13%(1/746), 1), ũ(0.13%(1/746), 1) | (0.13%(1/746), 1) |
| (0.13%(1/746), 1), ¾ȭ(0.13%(1/746), 1) | - |
| ALT(0.40%(3/746), 3), AST(0.40%(3/746), 3) | ALT(0.13%(1/746), 1), AST(0.13%(1/746), 1) |
Ż 缺, Ǽ Ҹ( ) | (0.94%(7/746), 7), ̼(0.13%(1/746), 1) | - |
ٰݰ | ٰ(0.27%(2/746), 2), (0.13%(1/746), 1), (0.13%(1/746), 1), ô(0.13%(1/746), 1) | ٰ(0.13%(1/746), 1) |
Ű | (0.13%(1/746), 1), (0.13%(1/746), 1), 索Ű溴(0.13%(1/746), 1), 缺(0.13%(1/746), 1), (0.13%(1/746), 2) | - |
㵵 | 㼮(0.13%(1/746), 1), 溯(0.13%(1/746), 1), ڿüȭ(0.13%(1/746), 1), (0.13%(1/746), 1), ȭ(0.13%(1/746), 1) | - |
ջ, ߵ ü պ | հ(0.13%(1/746), 1) | - |
| ߿ȣ߱(0.13%(1/746), 1), (0.13%(1/746), 1) | - |
| ɺ(0.13%(1/746), 1) | - |
ð | (0.13%(1/746), 1) | - |
鿪 | ̽ȯ(0.13%(1/746), 1) | - |
, ΰ ̻ʿ ΰ踦 ̻ ǥ Ͽ.
| SOC | ΰ ̻ 9.12% (68/746, 146) | ΰ踦 ̻ 2.01% (15/746, 22) |
ϰ (1~10%̸) | Ż 缺, Ǽ Ҹ( ) | (1.07%(8/746), 8) | - |
ʰ (0.1~1%̸) | | ȭҷ(0.94%(7/746), 7), (0.40%(3/746), 3), ˾(0.40%(3/746), 3), (0.40%(3/746), 3), ĵ(0.40%(3/746), 3), κ(0.27%(2/746), 3), (0.27%(2/746), 2), (0.27%(2/746), 2), ġ(0.27%(2/746), 2), (0.27%(2/746), 2), ظ(0.13%(1/746), 1), ġ(0.13%(1/746), 1), (0.13%(1/746), 1), ˾(0.13%(1/746), 2), ġ(0.13%(1/746), 1), ȭ(0.13%(1/746), 1), ưм(0.13%(1/746), 1) | ȭҷ(0.13%(1/746), 1), ĵ(0.13%(1/746), 1), κ(0.13%(1/746), 1), (0.13%(1/746), 1), ġ(0.13%(1/746), 1), (0.13%(1/746), 1) |
ħ | (0.40%(3/746), 3), ΰ(0.40%(3/746), 3), 忰(0.13%(1/746), 1), ︮ڹͰ(0.13%(1/746), 1), (0.13%(1/746), 1), Ұ(0.13%(1/746), 1), ġֿ(0.13%(1/746), 1), (0.13%(1/746), 1), ġġ(0.13%(1/746), 1), ũ(0.13%(1/746), 1) | (0.13%(1/746), 1) |
| (0.13%(1/746), 1), ¾ȭ(0.13%(1/746), 1), ̻ϰԴ(0.13%(1/746), 1), (0.13%(1/746), 1), (0.13%(1/746), 1) | ̻ϰԴ(0.13%(1/746), 1), (0.13%(1/746), 1) |
| ü߰(0.27%(2/746), 2), 1¾ƴܹ(0.13%(1/746), 1), ĮŸ(0.13%(1/746), 1), ݷ(0.13%(1/746), 1), ȣ߱(0.13%(1/746), 1), Һ(0.13%(1/746), 1) | ü߰(0.13%(1/746), 1), Һ(0.13%(1/746), 1) |
Ż 缺, Ǽ Ҹ( ) | ̼(0.13%(1/746), 1), Ż(0.13%(1/746), 1), Ǻ(0.13%(1/746), 1) | - |
Ǻ | Ż(0.13%(1/746), 1), ȫ(0.13%(1/746), 1), (0.13%(1/746), 1), չ鰨(0.13%(1/746), 1), ε巯(0.13%(1/746), 1) | Ż(0.13%(1/746), 1), ε巯(0.13%(1/746), 1) |
ٰݰ | ٰ(0.27%(2/746), 2), (0.13%(1/746), 1), ټ(0.13%(1/746), 1), (0.13%(1/746), 1), ߰Ż(0.13%(1/746), 1), (0.13%(1/746), 1), (0.13%(1/746), 1), ȴٸ(0.13%(1/746), 1), Ƽ(0.13%(1/746), 1) | ٰ(0.13%(1/746), 1) |
Ű | (0.27%(2/746), 2), (0.13%(1/746), 1), ġ(0.13%(1/746), 1), 索Ű溴(0.13%(1/746), 1), 缺(0.13%(1/746), 1), (0.13%(1/746), 1), (0.13%(1/746), 2) | - |
㵵 | 㼮(0.27%(2/746), 2), 㳶ȯ(0.27%(2/746), 2), 溯(0.27%(2/746), 2), 㳶(0.13%(1/746), 1), ڿüȭ(0.13%(1/746), 1), (0.13%(1/746), 1), (0.13%(1/746), 1), ȭ(0.13%(1/746), 1) | 㼮(0.13%(1/746), 1), 㳶ȯ(0.13%(1/746), 1) |
ջ, ߵ ü պ | 뷮(0.13%(1/746), 1), ̹(0.13%(1/746), 1), հ(0.13%(1/746), 1), ϰ(0.13%(1/746), 1), δ뿰(0.13%(1/746), 1) | - |
| (0.13%(1/746), 1) | (0.13%(1/746), 1) |
| 汤̻(0.13%(1/746), 1), ΰἮ(0.13%(1/746), 1), 财(0.13%(1/746), 1), ų(0.13%(1/746), 1), Ἦ(0.13%(1/746), 1) | - |
| (0.13%(1/746), 1), ߿ȣ߱(0.13%(1/746), 1), (0.13%(1/746), 2), (0.13%(1/746), 1), ǰ(0.13%(1/746), 1) | ǰ(0.13%(1/746), 1) |
| Ŀ尨(0.27%(2/746), 3), Ļ(0.27%(2/746), 2) | Ŀ尨(0.13%(1/746), 2) |
ȣ, | ħ(0.27%(2/746), 2), (0.13%(1/746), 1), ħı(0.13%(1/746), 1) | - |
| (0.40%(3/746), 3), ɺ(0.13%(1/746), 1) | - |
ð | ḷ(0.13%(1/746), 1), (0.13%(1/746), 1), ȱ(0.13%(1/746), 1), ȱ(0.13%(1/746), 1) | ḷ(0.13%(1/746), 1), ȱ(0.13%(1/746), 1) |
鿪 | ̽ȯ(0.13%(1/746), 1) | - |
İ | 缺(0.13%(1/746), 1) | - |
5. Ϲ
1) B ġḦ ġḦ ϴ ؾ Ѵ.
. ο Ŭ̵ ġ ȯڿ ̺ε ġ ִ ڷκ ȿ ڷḦ Ѵ. ڴ ȯ ִ HBeAg 缺 HBeAg B ȯڿ.
. B ȯ ִ ѵ ڿ Ǿ(4. ̻ ).
. ӻ迡 Ƶ ġȯ ִ ȿɿ .
2)
߽ , Ȯ(ȷ Ȥ), Ҹ, ȸ Ҹ, Ȯ ̾ HIV ȯ ü / Ʈι̷ ġḦ ȯڿԼ Ǿ. ̷ ˷ ʾҴ. ΰ ʾҴ.
3) 鿪 籸 ı
Ͽ Ʈι̷ ġḦ ȯڿԼ 鿪 籸 ı Ǿ. Ʈι̷ ġ ʱ ܰ迡 鿪谡 ϴ ȯڴ Ǵ ܷ ȸ( ٱ , Ŵ뼼̷, , Ǵ ) , ߰ ġᰡ ʿ ִ.
鿪 籸 Ǵ ڰ鿪ȯ(̺꽺, ٹٿ, ٷı ) Ǿ. , ߺ ñ پϸ, ġ ڿ ִ.
4) ʱ ̷
HIV ȯ ӻ 迡 Ŭ̵ ȿ (NRTI) ԵǾ ִ Ư Ϲ NRTI Ŭ̵ ȿ Ǵ HIV-1 ܹ ȿ Ե ȿ ٴ Ǿ. Ư, ʱ ̷ ġȯ Ǿ. Ŭ̵ ؾ Ѵ. Ŭ̵ Ͽ ġḦ ȯڴ Ͽ ϸ ġ ؾ Ѵ.
6. ȣۿ
ӻ ȣۿ
1) ٳ
ٳ ؾ ϸ, ̷ ġ ȯڴ ٳ ̻ ϰ ؾ Ѵ. ٳ ̻ ȯڴ ٳ ߴؾ Ѵ.
ٳ Cmax AUC ũ ߴ. ̷ ȣۿ ˷ ʾҴ. ٳ Ǹ 忰 Ű溴 ٳ ̻ Ȯ . ٳ 400mg Բ ȯڿԼ CD4+ Ǵ Ǿ.
ü 60kg ʰϴ ȯڿ ׳ ٳ 뷮 1 1ȸ 250mg ٿ Ѵ. ü 60kg ̸ ȯڿ ÿ ٳ 뷮 1 1ȸ 200mg ٿ Ѵ. ׳ ٳ Ǵ Ļ(400kcal, 20% ̸) Բ ִ.
2) HIV-1 ܹȿ
Ÿڳ AUC Cmin ҽŲ. Ÿڳ 300mg 䳪 100mg Բ Ѵ. 䳪 Ÿڳ Բ ʴ´.
dz/䳪, 䳪 Ÿڳ ׳ ̴ Ÿ. ׳ Ͻ Ǫ꿰 P-ܹ(P-gp) ϳܹ(BCRP) ü ̴. ׳ Ͻ Ǫ꿰 ̵ ü Ǹ ϴ ȴ. dz/䳪, 䳪 Ÿڳ Ǵ 䳪 ٷ糪 , ׳ õ ̻ ؾ Ѵ. ׳ ̻ ȯڴ ߴؾ Ѵ.
3) C ̷
׳ Ͻ Ǫ꿰 Ľ/κ ׳ Ű Ÿ.
HIV-1 ܹȿ /䳪 Ǵ HIV-1 ܹȿ /ںýŸƮ Ľ/κ ȯڿ Ͽ ׳ Ͻ Ǫ꿰 ̻ ϵ Ѵ.
HIV-1 ܹȿ /䳪 Ǵ HIV-1 ܹȿ /ںýŸƮ Բ Ľ/κ 쿡 ־ µ ׳ Ȯ ʾǷ, ̵ ȯڿ ؼ ü ִ HCV ġ Ǵ Ʈι̷ ġḦ ϵ Ѵ. ʿ 쿡 ׳ Ͻ Ǫ꿰 õ ̻ ϵ Ѵ.
4) ɿ ִ
׳ Ģ 忡 輳DZ ҽŰų ɵ к ϴ Բ ϸ ׳ û Űų 忡 ŵǴ ٸ ִ. ݵ ̿ δ õ, ƽŬκ, ũκ, ߶Ŭκ, ߰Ŭκ, ƹ̳۸ڻ̵(: Ÿ̽) 뷮 Ǵ ݺ NSAID (3. ȯڿ 1) Ǵ ȭ ) ִ.
B ġ Ƶ Ǻǰ ؼ ȵȴ.
7. Ӻ, ο
1) ӽ
ӽ ϰ . ɷ ִ ƴϱ ӽ ߿ Ȯ ʿ 쿡 ؾ Ѵ.
:
üǥ ʷ 뷮 ִ 14迡 19 뷮 Ʈ 䳢 ǽ, ׳ ɷ ֳ ¾ ջ Ŵ Ÿ ʾҴ.
2)
HIV-1 ƿ HIV-1 ϱ Ѵ. 1 5 HIV-1 κ ÿ ׳ кǴ Ǿ. ̷ ƿ ġ ˷ ʾҴ. ƿ HIV-1 ̻ Ƿ ް ִ ʵ ؾѴ.
8. Ҿƿ
12 ̸ Ǵ 35 kg ̸ B Ҿ ȯڿ ȿ ʾҴ.
9. ڿ
ӻ 迡 ڿ ٸ ϴ Ǵ ŭ 65 ̻ ڸ ߴ. Ϲ ȯڿ 뷮 ؾ ϸ , , ȯ Ǵ Ÿ ġ ٴ ؾ Ѵ.
10. ȯڿ
ũƼ û ġ 50mL/min ̸̰ų ʿ ȯ ȯ ϴ ȴ( 뷮 ).
11. óġ
ġ 뷮 300mg 뷮 뿡 ӻ ̴. 901, ׳ϽǪ꿰 600mg 28 8 ȯڿ 汸 ̻ ʾҴ. 뷮 ø Ϳ ˷ ʾҴ.
Ͽ ȯڸ ؾ ϰ ʿ ǥ ġ ǽѴ.
׳ ȿ ŵȴ( 54% ). 300 mg 4ð ׳ 뷮 10% ŵǾ.
12. ǻ
1) ǿ(1 - 30 ) Ѵ.
2) ʴ
3) Ǿǰ ٸ ϴ Ǿǰ 뿡 ̳ Ǿǰ ǰ Ƿ ְ ݾ Ѵ.
13. Ǿǰ
׳ϽǪ꿰300и(dz()) (׳ϽǪ꿰)(渮̾ڸ()) 2X2 1 ǰ 32 ȸ 汸Ͽ ׳ , ġ(AUCt, Cmax) αȯϿ óϿ , ġ 90% ŷڱ log 0.8 log 1.25 ̳μ Ͽ.
| | |
AUC0-72hr (nghr/mL) | Cmax (ng/mL) | Tmax(hr) | t1/2(hr) |
| (渮̾ڸ()) | 2266549 | 301.0104.9 | 0.75 (0.50~2.00) | 23.014.34 |
| ׳Ͻ Ǫ꿰300и (dz()) | 2221580 | 286.989.8 | 0.75 (0.50~3.00) | 23.005.22 |
90% ŷڱ* ( : log 0.8 ~ log 1.25) | log0.9297~ 1.0273 | log0.8901~ 1.0447 | - | - |
(AUCt, Cmax, t1/2 ; հǥ, Tmax ; ߾Ӱ(), n=32) AUCt : ð ߳ ð t ߳-ðϸ Cmax : ְ߳ Tmax : ְ߳ ð t1/2 : ҽ ݰ * ġ αȯ ġ 90%ŷڱ |