natgillin/translations-raw huggingface dataset:
Dasabuvir safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Bezpečnosť a účinnosť dasabuviru bola stanovená v kombinácii s ombitasvirom/ paritaprevirom
In Part 1a, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 weeks.
V časti 1a boli všetci pacienti liečení dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom s ribavirínom počas 12 alebo 24 týždňov.
Mechanism: CYP3A4 induction by carbamazepi ne.
Mechanizmus: indukcia CYP3A4 karbamazepínom.
Genotype 1a, without cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Genotyp 1a, bez cirhózy dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirín*
Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of dasabuvir and ombitasvir/paritaprevir/ritonavir and concomitant medicinal products.
% interval spoľahlivosti) vplyv na koncentráciu dasabuviru a ombitasviru/paritapreviru/ritonaviru a súbežne podávaných liekov.
Genotype 1a, with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Genotyp 1a, s kompenzovanou cirhózou dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirín*
SAPPHIRE I
SAPPHIRE
CONTRACEPTIVES ethinyloestra diol/ norgestimate 0.035/0.25 m g once daily
KONTRACEPTÍVA Etinylestradiol/ norgestimát 0,035/0,25 mg jedenkrát denne dasabuvir + ombitasvir/ paritaprevir/ ritonavir
↔ carba mazepine
AbbVie GmbH
In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine with or without naloxone (N=19) received 12 weeks of dasabuvir in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
V multicentrickej, otvorenej štúdii fázy 2 s jedným ramenom 38 predtým neliečených pacientov alebo liečených PegIFN/RBV bez cirhózy s infekciou genotypom 1, ktorí boli na stabilných dávkach metadónu (N =
↑ fluvastatin ↑ pitavastatin ↔ dasabuvir ↔ ombitasvir ↔ paritaprevir
↑ fluvastatín ↑ pitavastatín ↔ dasabuvir ↔ ombitasvir ↔ paritaprevir
↑ sulfasalazine
Očakáva sa: ↑ sulfasalazine
Mechanism: CYP3A4 inhibition by ritonavir.
Mechanizmus: inhibícia CYP3A4 ritonavirom.
Pharmacokinetics of the combination of dasabuvir 400 mg, with ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were evaluated in subjects with mild (Child-Pugh A), moderate (ChildPugh B) and severe (Child-Pugh C) hepatic impairment, relative to subjects with normal hepatic function.
Farmakokinetické vlastnosti kombinácie dasabuviru 400 mg s ombitasvirom 25 mg, paritaprevirom 200 mg a ritonavirom 100 mg boli hodnotené u pacientov s miernou (trieda
Sulfamethoxazole, trimethoprim
Sulfametoxazol, trimetoprim dasabuvir +
global multicentre, open-label
globálne multicentrické, otvorené
The overall safety profile in HCV-infected transplant recipients who were administered dasabuvir and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with dasabuvir and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Celkový bezpečnostný profil u pacientov infikovaných HCV po transplantácii pečene, ktorým bol podávaný dasabuvir a ombitasvir/paritaprevir/ritonavir a ribavirín (popri imunosupresívnych liekoch),
While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Aj keď v prípade warfarínu sa neočakáva žiadna zmena vo farmakokinetike, odporúča sa pravidelné monitorovanie medzinárodného normalizovaného pomeru (INR) u všetkých antagonistov vitamínu K. Je to z dôvodu zmien funkcie pečene počas liečby s dasabuvirom + ombitasvirom/paritaprevirom/ritonavirom.
No (for any parameter listed above) *AFP= serum alpha fetoprotein
*AFP = alfa-fetoproteín v sére
Genotype 1b, without cirrhosis or with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir
1b, bez cirhózy alebo s kompenzovanou cirhózou dasabuvir + ombitasvir/paritaprevir/ritonavir
• Vomiting
• svrbenie;
Trial
Skúšanie
Subjects with liver transplant and GT4 infection were dosed with ombitasvir/paritaprevir/ritonavir with RBV (noncirrhotic for 12 weeks [n=2] and cirrhotic for 24 weeks [n=1].
Pacienti s transplantáciou pečene a infekciou GT4 dostávali ombitasvir/paritaprevir/ritonavir s RBV (bez cirhózy 12 týždňov
Darunavir/ ritonavir 600/100 mg twice daily
Lopinavir/ritonavir 400/100 mg dvakrát
Prior relapse
Relaps Ostatnéc
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection.
U pacientov s neznámym podtypom genotypu 1 alebo so zmiešanou infekciou genotypu 1
In Part 1a, SVR12 was achieved by 29/31 (93.5%) subjects on the 12-week arm (95% CI: 79.3%98.2%) and by 29/32 (90.6%) subjects on the 24-week arm (95% CI: 75.8% - 96.8%).
%) pacientov v 12-týždňovom ramene (95 % CI: 79,3 %98,2
Refer to the tacrolimus or sirolimus Summary of Product Characteristics for additional dosing and monitoring instructions.
Ďalšie informácie o dávkovaní a monitorovaní, pozri súhrn charakteristických vlastností pre takrolimus alebo sirolimus.
Treatment duration 12 weeks
Dĺžka liečby
HCV Genotype 1b dasabuvir and ombitasvir/paritaprevir/ritonavir
HCV genotyp 1b dasabuvir a ombitasvir/paritaprevir/ritonavir
Risk of hepatic decompensation and hepatic failure in patients with cirrhosis
Riziko dekompenzácie pečene a zlyhania pečene u pacientov s cirhózou Dekompenzácia pečene a zlyhanie pečene, vrátane transplantácie pečene alebo fatálnych následkov,
S-warfarin dasabuvir ombitasvir paritaprevir
S-warfarín dasabuvir ombitasvir paritaprevir
PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
PEARL-III - genotyp 1b, predtým neliečení pacienti, bez cirhózy Dizajn:
The activity of dasabuvir was reduced by 5- and 11-fold by C316N and S556G, respectively; 46-fold by M414T or Y448H; and 1569-fold by the C316Y substitutions in the genotype 1b replicon.
Aktivita dasabuviru bola znížená 5-násobne substitúciou C316N a 11-násobne substitúciou S556G; 46-násobne substitúciou M414T alebo Y448H; a 1569-násobne substitúciou C316Y v replikóne genotypu 1b. Dasabuvir si zachoval plnú aktivitu proti replikónom obsahujúcim substitúcie S282T na nukleozidovom väzobnom mieste, M423T v mieste “lower thumb“, a P495A/S, P496S alebo V499A v mieste “upper thumb“.
dasabu vir +
NA Pri podávaní s dasabuvirom +
In the greater than 200 genotype 1b baseline samples in this analysis, the most frequently observed resistance-associated variants observed were Y93H (7.5%) in NS5A, and C316N (17.0%) and S556G (15%) in NS5B.
Vo viac ako 200 východiskových vzorkách genotypu 1b boli v tejto analýze najčastejšie pozorovanými mutáciami spojenými s rezistenciou Y93H (7,5
NA No dose adjustment for cyclobenzaprine required; increase dose if clinically indicated.
NA Nie je potrebná úprava dávkovania cyklobenzaprínu; zvýšte dávkovanie, ak je to klinicky indikované.
ANTICONVULSANTS carbamazepine dasabu vir +
ANTIKONVULZÍVA Karbamazepín dasabuvir + ↔ karba
Medicines you must not take with Exviera Medicine or active substance
Lieky, ktoré nesmiete užívať s Exvierou
randomised, global multicentre, open-label, regimen-controlled
randomizované, globálne multicentrické, otvorené, s kontrolovaným režimom
ANTIARRYTHMICS Digoxin
↔ digoxín
Atazanavir can be used in combination with dasabuvir with ombitasvir/paritaprevir/ritonavir if administered at the same time.
Atazanavir sa môže používať v kombinácii s dasabuvirom s ombitasvirom/paritaprevirom/ritonavirom,
0.5 mg single dose
0,5 mg jednorazová dávka
Tell your doctor if you have a history of depression or psychiatric illness.
Ak ste niekedy mali depresiu alebo psychiatrické ochorenie, informujte o tom svojho lekára.
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-III: pacienti, predtým neliečení alebo predtým liečení pegIFN + RBV s kompenzovanou cirhózou
ombitasvir/paritaprevir/ritonavir with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
ombitasvir/paritaprevir/ritonavir s dasabuvirom alebo bez nej spolu s ribavirínom dávkovaným podľa hmotnosti alebo bez neho počas 12 alebo 24 týždňov
Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser HCV genotype 1b
Pacienti s relapsom po predchádzajúcej liečbe pegIFN/RBV HCV genotyp 1b
Sixty four of 68 (94.1%) subjects achieved SVR12.
Šesťdesiatštyri zo 68 (94,1
Prior pegIFN/RBV relapser
Pacienti s relapsom po predchádzajúcej liečbe pegIFN/RBV
Tacrolimus 2 mg was dosed alone and 2 mg was administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Takrolimus 2 mg bol podávaný samostatne a súbežne s dasabuvirom + ombitasvirom/paritaprevirom/ritonavirom.
HCV Genotype 1a dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV
HCV genotyp 1a dasabuvir a ombitasvir/paritaprevir/ritonavir s RBV
randomised, global multicentre, open-label
randomizované, globálne multicentrické, otvorené
See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Odporúčania týkajúce sa dávkovania pre pacientov infikovaných HCV so súbežnou infekciou vírusom HIV-1, pozri časť 4.2.
Baseline platelet count, median (× 109/L) < 90, n (%) ≥ 90, n (%) Pooled analyses of clinical trials Durability of response Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Celkovo 660 pacientov v klinických skúšaniach fázy 2 a 3 malo výsledky HCV RNA tak v časovom bode SVR12, ako aj SVR24.
No dose adjustment of dasabuvir is required in patients with mild hepatic impairment (Child-Pugh A).
U pacientov s miernou poruchou funkcie pečene nie je potrebná úprava dávky dasabuviru (trieda A
TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
TURQUOISE-II - pacienti, predtým neliečení alebo predtým liečení pegIFN + RBV s kompenzovanou cirhózou
Mechanism: P-gp inhibition by dasabuvir, paritaprevir, and ritonavir.
Mechanizmus: inhibícia P-gp dasabuvirom, paritaprevirom a ritonavirom.
Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily dasabu vir + ombitas vir/parit aprevir/ ritonavi r
200 mg jedenkrát denne/ 300 mg jedenkrát denne dasabuvir + ombitasvir/ paritaprevir/ ritonavir
Mechanism: decrease possibly due to CYP1A2 induction by ritonavir dasabu vir +
Mechanizmus: zníženie pravdepodobne v dôsledku indukcie CYP1A2 ritonavirom dasabuvir + ombitasvir/ paritaprevir/ ritonavir
SVR12 for genotype 1-infected treatment-naïve subjects in SAPPHIRE-I
Tabuľka 7. SVR12 u predtým neliečených pacientov infikovaných genotypom 1 v štúdii SAPPHIRE-I
buprenorphin e/ naloxone 4-24 mg/16 mg once daily8
4-24 mg/ 1-6 mg jedenkrát denne8
• Serious allergic reactions, signs may include: o Difficulty breathing or swallowing o Dizziness or light-headedness, which may be due to low blood pressure o Swelling of the face, lips, tongue or throat o Rash and itching of the skin
• závrat alebo točenie hlavy, ktoré môžu byť spôsobené nízkym krvným tlakom;
Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Mechanizmus: pravdepodobne dôsledok inhibície UGT paritaprevirom, ombitasvirom a dasabuvirom.
ANTIFUNGALS Ketoconazol e
Ketokonazol
Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
% z nich boli muži; 3,2 % boli černosi; 14,7 % malo počet krvných doštičiek nižší ako 90 x 109/l; 49,7 % malo hodnotu albumínu nižšiu ako 40 g/l; 86,1% malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 24,7 % malo v anamnéze depresiu alebo bipolárnu poruchu; 68,7 % malo infekciu HCV genotypu 1a; 31,3 % malo infekciu HCV genotypu 1b.
AUC Ctrough
Ctrough
Esomeprazol e
TaqMan®
NA No dose adjustment is necessary for paracetamol when administered with dasabuvir +
Nie je potrebná úprava dávkovania dasabuviru +
Co-administration of efavirenz (enzyme inducer) based regimens with paritaprevir /ritonavir + dasabuvir resulted in ALT elevations and therefore, early discontinuation of the study.
+ dasabuvir malo za následok zvýšenie hladín ALT a v dôsledku toho predčasné ukončenie štúdie.
DIURETICS Furosemide 20 mg single dose
20 mg jednorazová dávka
12 or 24 weeks N = 380 n (%)
11) respektíve 0,46 nM (rozsah 0,2 až 2 nM, n =
Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV
Rameno A: dasabuvir a ombitasvir/paritaprevir/ritonavir + RBV
Desmethyl citalopram
ANTIDEPRESÍVA Escitalopram
dasabuvir and ombitasvir/paritaprevir/ritonavir without ribavirin or with weight-based ribavirin for 12 weeks
dasabuvir a ombitasvir/paritaprevir/ritonavir bez ribavirínu alebo s ribavirínom dávkovaným podľa hmotnosti počas 12 týždňov
No dose adjustment is necessary for emtricitabine/tenofovir and dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Nie je potrebná úprava dávkovania emtricitabínu/tenofoviru a dasabuviru + ombitasviru/ paritapreviru/ritonaviru.
• Diarrhoea
• hnačka.
NA ombitasvir/paritaprevir/ ritonavir).
a v súhrne charakteristických vlastností pre ombitasvir/paritaprevir/ritonavir.
Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim ombitasvir
Mechanizmus: zvýšenie expozície dasabuviru je dôsledkom inhibície CYP2C8 a zvýšenie paritapreviru je pravdepodobne dôsledkom inhibície OATP1B1 gemfibrozilom.
When taking Exviera and ombitasvir/paritaprevir/ritonavir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - Feel sick (nauseous), are sick (vomit) or lose your appetite.
Ak sa u vás počas užívania Exviery a ombitasviru/paritapreviru/ritonaviru vyskytnú nasledujúce príznaky, informujte o tom lekára, pretože môže ísť o prejavy zhoršenia ochorenia pečene:
aprevir/ ritonavi r ombitasvir with dasabuvir and ombitasvir/paritaprevir/r itonavir due to increase in paritaprevir exposures (see Summary of Product Characteristics of ombitasvir/paritaprevir/r itonavir).
paritaprevir/ ritonavir dasabuvir denne alebo 800/200 mg jedenkrát denne je kontraindikovaný s dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom kvôli zvýšeniu expozícií paritapreviru (pozri súhrn charakteristických vlastností lieku pre ombitasvir/paritaprevir/ ritonavir ).
TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HCV GT1 or GT4/HIV-1 coinfection, without cirrhosis or with compensated cirrhosis
GT1 alebo GT4/HIV-1 infekciou, bez cirhózy alebo s kompenzovanou cirhózou Dizajn:
↑ hydrocod one
hydrokodón
dasabuvir and ombitasvir/paritaprevir/ritonavir with weight-based ribavirin for 12 or 24 weeks
dasabuvir a ombitasvir/paritaprevir/ritonavir s ribavirínom dávkovaným podľa hmotnosti počas 12 alebo 24 týždňov
CORAL-I: treatment-naïve or pegIFN + RBV-experienced, GT 1 or GT4 infected, at least 3 months post liver transplant or 12 months post renal transplant
GT4, najmenej 3 mesiace po transplantácii pečene alebo 12 mesiacov po transplantácii obličiek
Dose normalized tacrolimus ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Pomery takrolimu normalizované na dávku sú uvedené pre interakciu s dasabuvirom + ombitasvirom/paritaprevirom/ritonavirom.
PVC/PE/PCTFE aluminium foil blister packs.
Exviera filmom obalené tablety sú dodávané v blistroch vyrobených z PVC/PE/PCTFE blistrové balenie s hliníkovou fóliou.
Pruritus
Pravastatín
dasabuvir and ombitasvir/paritaprevir/ritonavir with or without RBV for 12 or 24 weeks
dasabuvir a ombitasvir/paritaprevir/ritonavir s RBV alebo bez RBV počas 12 alebo
dasabuvir and ombitasvir/paritaprevir/ritonavir without ribavirin for 12 weeks
dasabuvir a ombitasvir/paritaprevir/ritonavir bez ribavirínu počas 12 týždňov
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
+ ribavirínom infikovaných genotypom 1b v štúdii PEARL-II
Ciclosporin 100 mg dosed alone and 30 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Cyklosporín 100 mg podávaný samostatne a 30 mg podávaný súbežne s dasabuvirom + ombitasvirom/paritaprevirom/ritonavirom.
Fluvastatin
Fluvastatín
Cross-resistance
Skrížená rezistencia
ANTIHYPERLIPIDAEMICS Gemfibrozil
ANTIHYPERLIPIDEMIKÁ
↑ norgestrel ↑ nor elgestromin e
Očakáva sa: ↑ dabigatránetexilát
Dasabuvir and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
U pacientov po transplantácii pečene sa dasabuvir a ombitasvir/paritaprevir/ritonavir v kombinácii s ribavirínom odporúča počas 24 týždňov.
↑ levothyroxine
levotyroxínu
The pharmacokinetic properties of the combination of dasabuvir with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 18 shows mean Cmax and AUC of dasabuvir 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers.
Tabuľka 18 ukazuje priemernú hodnotu Cmax a AUC dasabuviru 250 mg dvakrát denne s ombitasvirom/paritaprevirom/ritonavirom 25 mg/150 mg/100 mg jedenkrát denne po opakovaných dávkach užívaných s jedlom u zdravých dobrovoľníkov.
Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV
Výsledok liečby dasabuvir a ombitasvir/paritaprevir/ritonavir počas 12 týždňov S RBV
13/15 (86.7)c a. Calculated using the normal approximation to the binomial distribution b. 1 patient discontinued due to non-compliance c. Relapse in 2/15 patients (confirmed HCV RNA ≥ 15 IU/mL post-treatment before or during SVR12 window among subjects with HCV RNA < 15 IU/mL at last observation with at least 51 days of treatment).
Vypočítané pomocou normálnej aproximácie k binomiálnej distribúcii b. 1 pacient prerušil liečbu z dôvodu jej nedodržania c. Recidíva (potvrdené HCV RNA ≥
A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with dasabuvir + ombitasvir/paritaprevir /ritonavir.
ombitasvirom/paritaprevirom/ritonavirom sa má zvážiť zníženie dávkovania hydrokodónu o 50 % a/alebo klinické monitorovanie.
A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
% malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 15,4 % malo portálnu fibrózu (F2) a 8,7 % malo premosťujúcu fibrózu (F3); 67,7 % malo infekciu HCV genotypu 1a; 32,3 % malo infekciu HCV genotypu 1b.
Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Rameno B: dasabuvir a ombitasvir/paritaprevir/ritonavir
GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (12 weeks)
GT1b dasabuvir a ombitasvir/paritaprevir/ritonavir (12
Mechanism: Increase in dasabuvir exposure is due to
Poznámka: Dávky používané pre dasabuvir
dasabuvir and ombitasvir/paritaprevir/ritonavir with weight-based ribavirin for 12 weeks
dasabuvir a ombitasvir/paritaprevir/ritonavir s ribavirínom dávkovaným podľa hmotnosti počas 12 týždňov
Nevirapine etravirine dasabu vir + ombitas vir/parit aprevir/ ritonavi r
Nevirapín etravirín dasabuvir + ombitasvir/ paritaprevir/ ritonavir
Endpoint dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 Weeks N = 200a
Cieľový ukazovateľ dasabuvir a ombitasvir/paritaprevir/ritonavir s ribavirínom alebo bez neho počas 12 alebo 24 týždňov
Dabigatran etexilate Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir.
Mechanizmus: inhibícia intestinálneho P-gp paritaprevirom a ritonavirom.
dasabu vir + ombitas vir/parit aprevir/ ritonavi r atazanavir
dasabuvir + ombitasvir/ paritaprevir/ ritonavir atazanavir
↑ GS
Ezomeprazol
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
inhibícia OATP1B paritaprevirom a inhibícia BCRP dasabuvirom, paritaprevirom a ritonavirom.
GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (8 weeks)
GT1b dasabuvir a ombitasvir/paritaprevir/ritonavir (8
CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir.
Mechanizmus: zvýšenie expozícií paritapreviru môže byť dôsledkom inhibície CYP3A/efluxových transportérov lopinavirom a vyššou dávkou ritonaviru.
SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III
SVR12 u predtým neliečených pacientov infikovaných genotypom 1b v štúdii
Dasabuvir should not be used in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2).
Dasabuvir nemajú používať pacienti so stredne ťažkou až ťažkou poruchou funkcie pečene (trieda
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir
Mechanizmus: inhibícia CYP3A4 ritonavirom paritaprevir/ ritonavir
No dose adjustment is necessary for norethindrone or dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Nie je potrebná úprava dávkovania noretindrónu alebo dasabuviru + ombitasviru/paritapreviru /ritonaviru.
Pravastatin 10 mg once daily
10 mg jedenkrát denne
No dose adjustment of dasabuvir is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 4.2).
U pacientov s miernou, strednou alebo závažnou poruchou funkcie obličiek alebo v konečnom štádiu ochorenia obličiek na dialýze nie je potrebná úprava dávky dasabuviru (pozri časť
Paracetamo l
BCRP paritaprevirom
PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis
PEARL-IV - genotyp 1a, predtým neliečení pacienti, bez cirhózy Dizajn:
Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects).
Celková SVR12 HCV genotyp 1a Predtým neliečení Pacienti s predchádzajúcou nulovou odpoveďou na pegIFN/RBV Pacienti s predchádzajúcou čiastočnou odpoveďou na pegIFN/RBV Pacienti s relapsom po predchádzajúcej liečbe pegIFN/RBV HCV genotyp 1b
SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
SAPPHIRE-I - genotyp 1, predtým neliečení pacienti, bez cirhózy Dizajn:
BIGUANIDE ORAL ANTIHYPERGLYCEMICS Metformin
PERORÁLNE ANTIDIABETIKÁ, BIGUANIDY
In subjects with mild, moderate and severe renal impairment, dasabuvir mean AUC values were 21% higher, 37% higher and 50% higher, respectively.
U pacientov s miernou, stredne ťažkou a ťažkou poruchou funkcie obličiek boli priemerné hodnoty AUC o 21
dasabuvir and ombitasvir/paritaprevir /ritonavir
dasabuvir + ombitasvir/ paritaprevir/ ritonavir
↔ es citalopram
+ ribavirín
Summary of the safety profile
Súhrn usporiadania štúdie
Skin and subcutaneous tissue disorders Very common Pruritus Common
Poruchy kože a podkožného tkaniva
Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
% boli černosi; 20,7 % malo v anamnéze depresiu alebo bipolárnu poruchu; 86,6 % malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 18,4