natgillin/translations-raw huggingface dataset:
Sulfamethoxazole, trimethoprim 
Sulfametoxazol, trimetoprim dasabuvir +
400 mg once daily 
400 mg jedenkrát denne
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
600 mg twice daily 
600 mg dvakrát denne
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
Mechanism: CYP2C19 induction by ritonavir. 
Mechanizmus: indukcia CYP2C19 ritonavirom.
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
40 mg once daily 
40 mg jedenkrát denne
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
50 mg once daily 
50 mg jedenkrát denne
400 mg twice daily 
400 mg dvakrát denne
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,
How to take Exviera 
Ako užívať Exvieru
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
A temporary suspension of pitavastatin/fluvastatin is recommended for the duration of treatment with ombitasvir/paritaprevir/ritonavir. 
Počas liečby ombitasvirom/paritaprevirom/ritonavirom sa odporúča dočasné pozastavenie podávania pitavastatínu/fluvastatínu.
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
Exviera contains lactose. 
Exviera obsahuje laktózu.
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
No dose adjustment is necessary for buprenorphine/naloxon e and dasabuvir + ombitasvir/paritaprevir/ ritonavir. 
Nie je potrebná úprava dávkovania buprenorfínu/naloxónu a dasabuviru + ombitasviru/ paritapreviru/ritonaviru.
Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir dasabu vir + 
Mechanizmus: inhibícia BCRP a P-gp paritaprevirom, ritonavirom a dasabuvirom dasabuvir + ombitasvir/ paritaprevir/ ritonavir
NA No dose adjustment needed for abacavir or lamivudine when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir. 
NA Nie je potrebná úprava dávkovania abakaviru alebo lamivudínu pri podávaní s dasabuvirom ombitasvirom/paritaprevirom/ritonavirom.
ANTIMYCOBACTERIALS Rifampicin 
C8 rifampicínom.
SVR12 for genotype 1a-infected treatment-naïve subjects in PEARL IV 
Tabuľka 9. SVR12 u predtým neliečených pacientov infikovaných genotypom 1a v štúdii
NA No dose adjustment needed for sofosbuvir when administered with dasabuvir + ombitasvir/paritaprevir /ritonavir. 
NA Nie je potrebná úprava dávkovania sofosbuviru pri podávaní s dasabuvirom + ombitasvirom/paritaprevirom/ritonavirom.
9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection). 
% zlyhala predchádzajúca liečba pegIFN/RBV; 68 % malo infekciu HCV genotypu 1a.
Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks 
dasabuvir a ombitasvir/paritaprevir /ritonavir 12 týždňov
ANTIDEPRESSANTS Escitalopram 10 mg single dose dasabu vir + 
10 mg jednorazová dávka dasabuvir
No dose adjustment needed for dolutegravir when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir. 
Nie je potrebná úprava dávkovania dolutegraviru pri podávaní s dasabuvirom + ombitasvirom/paritaprevirom/ritonavirom.
↔ R 
(N =