natgillin/translations-raw huggingface dataset:
Clinical studies in patients with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231) 
Klinične študije pri bolnikih s kroničnim hepatitisom C genotipa 2 in 3
Table 11: Response rates in study POSITRON 
Preglednica 11: Stopnje odziva v študiji POSITRON SOF+RBV
No dose adjustment of sofosbuvir or emtricitabine is required when sofosbuvir and emtricitabine are used concomitantly. 
Pri sočasni uporabi sofosbuvirja in emtricitabina odmerka sofosbuvirja ali emtricitabina ni treba prilagajati.
Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA) 
↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57) Cmin (n/n)
The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1). 
Klinični podatki, ki bi podprli uporabo zdravila Sovaldi pri bolnikih z okužbo s HCV genotipa 5 in 6,
Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 1, 4, 5 or 6 HCV infection. 
Odrasli bolniki, ki se predhodno še niso zdravili - NEUTRINO (študija 110) Študija NEUTRINO je bila odprta študija z enim krakom, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem v kombinaciji s peginterferonom alfa 2a in ribavirinom pri zdravljenju bolnikov z okužbo s HCV genotipa 1, 4, 5 ali 6, ki se predhodno še niso zdravili.
Metabolism and nutrition disorders: Very common decreased appetite 
zelo pogosti zmanjšan apetit pogosti zmanjšanje telesne mase
The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant). 
Primarni opazovani dogodek študije je bil virološki odziv po presaditvi (pTVR-post-transplant virologic response;
Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection 
Preglednica 23: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipov 4, 5 in 6
Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C. 
Zdravilo Sovaldi vedno jemljite v kombinaciji z drugimi zdravili proti hepatitisu C. Težave z ledvicami
Impact of DAA therapy on drugs metabolized by the liver 
Vpliv zdravil z direktnim delovanjem na viruse (DAA - direct-acting antivirals) na zdravila, ki se presnavljajo v jetrih
• Decide what other medicines you should take with Sovaldi and for how long; 
• odloči, katera druga zdravila morate jemati z zdravilom Sovaldi in kako dolgo • potrdi, da je bilo pri vas zdravljenje učinkovito in da ste brez virusa hepatitisa C
Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection 
Predhodno zdravljeni bolniki z okužbo s HCV genotipa 1, 4, 5 in 6
b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy). 
b. Razmisliti je treba o možnem podaljšanju trajanja zdravljenja na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (npr. napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28B, predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom).
SOF+RBV 24 weeks (n = 250) 
SOF+RBV 24 tednov (n = 250)
SOF+PEG+RBV 12 weeks 
SOF+PEG+RBV 12 tednov
The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106). 
Povprečje ± SD EC50 za sofosbuvir proti himeričnim replikonom, ki kodirajo zaporedje NS5B iz kliničnih izolatov, je bilo 0,068 ± 0,024 μM za genotip 1a (n = 67),
SVR12 to SVR24 concordance 
Ujemanje med SVR12 in SVR24
PEG+RBV 24 weeks (n = 176) 
PEG+RBV 24 tednov (n = 176)
No dose adjustment of sofosbuvir or methadone is required when sofosbuvir and methadone are used concomitantly. 
Pri sočasni uporabi sofosbuvirja in metadona odmerka sofosbuvirja ali metadona ni treba prilagajati.
The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1). 
Profil varnosti sofosbuvirja in ribavirina pri odraslih bolnikih, sočasno okuženih z virusoma HCV in HIV, je bil podoben tistemu, ki so ga opazili pri bolnikih, okuženih samo z virusom HCV, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
SOF+RBV 16 weeks 
SOF+RBV 16 tednov
Dose modification in adults Dose reduction of Sovaldi is not recommended. 
Zmanjšanje odmerka zdravila Sovaldi se ne priporoča.
GS 331007 ↔ Cmax 1.04 (0.97, 1.11) ↔ AUC 0.99 (0.94, 1.04) Cmin (NA) 
GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04) Cmin (n/n) (indukcija P-gp)
SOF+RBV 24 weeks 
SOF+RBV 24 tednov
The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 6). 
Pri uporabi sofosbuvirja v kombinaciji z ribavirinom ali v kombinaciji s peginterferonom alfa in ribavirinom so ugotovili naslednje neželene učinke zdravila (preglednica 6).
Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA) 
↑ AUC 1,34 (1,12; 1,59) Cmin (n/n)
Not applicable. 
Niso voljni
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172) 
smukec (E553b) rumeni železov oksid (E172)
Norgestrel ↔ Cmax 1.18 (0.99, 1.41) 
↔ Cmax 1,18 (0,99; 1,41)
Co-administration of Sovaldi with rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi. 
Sovaldi z rifapentinom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
Renal impairment No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment. 
Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Sovaldi ni treba prilagajati.
No dose adjustment of sofosbuvir or rilpivirine is required when sofosbuvir and rilpivirine are used concomitantly. 
Pri sočasni uporabi sofosbuvirja in rilpivirina odmerka sofosbuvirja ali rilpivirina ni treba prilagajati.
Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype). 
Razmisliti je treba o zdravljenju teh bolnikov in morebitnem podaljšanju trajanja zdravljenja s sofosbuvirjem, peginterferonom alfa in ribavirinom na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28b).
Ethinyl estradiol ↔ Cmax 1.14 (0.96, 1.36) 
↔ Cmax 1,14 (0,96; 1,36)
Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate. 
Pri uporabi režimov zdravljenja, ki vključujejo sofosbuvir v kombinaciji z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
PEG+RBV 24 weeks (n = 243) 
PEG+RBV 24 tednov (n = 243)
Sofosbuvir is a nucleotide prodrug that is extensively metabolised. 
5.2 Farmakokinetične lastnosti Sofosbuvir je nukleotidno predzdravilo, ki se obsežno presnavlja.
GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA) 
↓ Cmax 0,77 (0,70; 0,84) ↔ AUC 0,84 (0,76; 0,92) Cmin (n/n)
SOF+RBV 16 weeks (n = 98)a 
SOF+RBV 16 tednov (n = 98)a
Co-administration of Sovaldi with modafinil is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi. 
Sovaldi z modafinilom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
No dose adjustment of sofosbuvir or raltegravir is required when sofosbuvir and raltegravir are used concomitantly. 
Pri sočasni uporabi sofosbuvirja in raltegravirja odmerka sofosbuvirja ali raltegravirja ni treba prilagajati.
Table 9: Response rates in study FISSION 
Preglednica 9: Stopnje odziva v študiji FISSION SOF+RBV
The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 adult patients with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve patients with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in patients with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve patients, one in interferon intolerant, ineligible or unwilling patients, one in patients previously treated with an interferon-based regimen, and one in all patients irrespective of prior treatment history or ability to receive treatment with interferon. 
Druge štiri študije pa so opravili pri bolnikih s kroničnim hepatitisom C genotipa 2 ali 3 v kombinaciji z ribavirinom, in sicer eno študijo z bolniki, ki se predhodno še niso zdravili, eno študijo z bolniki, ki niso prenašali interferona ali za zdravljenje z njim niso bile primerni ali voljni, eno študijo z bolniki, ki so bili predhodno zdravljeni z režimom na podlagi interferona, in eno študijo z vsemi bolniki, ne glede na predhodno anamnezo zdravljenja ali zmožnost zdravljenja z interferonom.
Until liver transplantationc 
Do presaditve jeterc
FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 2 or 3 HCV infection. 
Odrasli, ki se predhodno še niso zdravili - FISSION (študija 1231) Študija FISSION je bila randomizirana, odprta, z aktivno učinkovino kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom v primerjavi s 24-tedenskim zdravljenjem s peginterferonom alfa 2a in ribavirinom za zdravljenje bolnikov, ki se predhodno še niso zdravili, z okužbo s HCV genotipa 2 ali 3.
No dose adjustment of Sovaldi is required when concomitantly used with rifabutin. 
Pri sočasni uporabi z rifabutinom odmerka zdravila Sovaldi ni treba prilagajati.
No dose adjustment of sofosbuvir or ciclosporin is required at initiation of co-administration. 
Odmerka sofosbuvirja ali ciklosporina ob uvedbi sočasnega dajanja ni treba prilagajati.
Co-administration with other direct-acting antivirals against HCV 
Sočasno dajanje z drugimi zdravili proti HCV z direktnim delovanjem na viruse
SOF+RBV 12 weeks (n = 183) 
SOF+RBV 12 tednov (n = 183)
No dose adjustment of sofosbuvir or tacrolimus is required at initiation of co-administration. 
Odmerka sofosbuvirja ali takrolimusa ob uvedbi sočasnega dajanja ni treba prilagajati.
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf (400 mg twice daily) 
Raltegravirf (400 mg dvakrat na dan)
a. See Table 4 for weight based ribavirin dosing recommendations b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy). 
a. Glejte preglednico 4 za priporočila o odmerjanju ribavirina na podlagi telesne mase b. Razmisliti je treba o možnem podaljšanju trajanja zdravljenja na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (npr. napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28B, predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom).
PEG+RBV 24 weeks (n = 67) 
PEG+RBV 24 tednov (n = 67)
Sofosbuvir was administered at a dose of 400 mg once daily. 
Sofosbuvir so dajali v odmerku 400 mg enkrat na dan. Odmerek ribavirina je bil določen na podlagi telesne mase in je znašal
The exposure to GS-331007 was not altered in the presence of a high-fat meal. 
Prisotnost obroka z visoko vsebnostjo maščobe ni spremenila izpostavljenosti presnovku GS-331007.
Treatment-experienced co-infected with HIV (PHOTON-1) 
Predhodno zdravljeni s sočasno okužbo s HIV
Rilpivirine ↔ Cmax 1.05 (0.97, 1.15) ↔ AUC 1.06 (1.02, 1.09) ↔ Cmin 0.99 (0.94, 1.04) 
↔ Cmax 1,05 (0,97; 1,15) ↔ AUC 1,06 (1,02; 1,09)
Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA) 
↓ AUC 0,52 (0,46; 0,59) Cmin (n/n)
Genotype 2/3 treatment-naïve SOF+RBV 12 weeks (n = 68) 
Genotip 2/3 predhodno zdravljeni SOF+RBV 24 tednov (n = 28)
Intolerant 
ANALEPTIKI
Sofosbuvir ↔ Cmax 0.87 (0.71, 1.08) ↔ AUC 0.95 (0.82, 1.09) Cmin (NA) 
↔ Cmax 0,87 (0,71; 1,08) ↔ AUC 0,95 (0,82; 1,09) Cmin (n/n)
Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, 1.40) Cmin (NA) 
↓ Cmax 0,73 (0,59; 0,90) ↔ AUC 1,09 (0,84; 1,40) Cmin (n/n)
Discontinuation of dosing in adults and adolescents If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.4). 
Dajanje zdravila Sovaldi kot monoterapija se ne priporoča, zato ga je treba predpisati v kombinaciji z drugimi zdravili za zdravljenje okužbe s hepatitisom C. Ob trajni ukinitvi drugih zdravil, ki se uporabljajo v kombinaciji z zdravilom Sovaldi, je treba ukiniti tudi uporabo zdravila Sovaldi (glejte poglavje 4.2).
Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection 
Preglednica 20: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 1
SOF+RBV 12 weeks 
SOF+RBV 12 tednov
SOF+RBV 12 weeks (n = 73)a 
SOF+RBV 12 tednov (n = 73)a
Emtricitabine ↔ Cmax 0.97 (0.88, 1.07) ↔ AUC 0.99 (0.94, 1.05) ↔ Cmin 1.04 (0.98, 1.11) 
↔ Cmax 0,97 (0,88; 1,07) ↔ AUC 0,99 (0,94; 1,05)
Overall Genotype 1a Genotype 1b No cirrhosis Cirrhosis 
Skupaj Genotip 1a Genotip 1b
Treated patients (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the patients were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL; 16% had cirrhosis; 49% had HCV genotype 3. 
Mediana starost zdravljenih bolnikov (n = 278) je bila 54 let (razpon: 21 do 75); 54 % bolnikov je bilo moških; 91 % je bilo belcev; 5 % je bilo črne rase; 11 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 18 do 53 kg/m2); 70 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 16 % jih je imelo cirozo; 49 % jih je imelo HCV genotipa 3.
The safety and efficacy of Sovaldi in adolescents aged 12 to <18 years are based on data from 50 patients who were treated with Sovaldi and ribavirin for 12 weeks (genotype 2 patients) and 24 weeks (genotype 3 patients) in a Phase 2, open-label clinical trial. 
50 bolnikov, zdravljenih z zdravilom Sovaldi in ribavirinom 12 tednov (bolniki z genotipom 2) oz.
Norgestromin ↔ Cmax 1.06 (0.93, 1.22) 
↔ Cmax 1,06 (0,93; 1,22)
↔ AUC 1.19 (0.98, 1.44) 
↔ AUC 1,19 (0,98; 1,44) Cmin (n/n)
ANALEPTICS Modafinil 
Modafinil
Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection 
Preglednica 21: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 2
Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 20 to Table 23) present data from Phase 2 and Phase 3 studies relevant to the dosing to help clinicians determine the best regimen for individual patients. 
V naslednjih preglednicah (preglednica 20 do preglednice 23) so predstavljeni podatki študij 2. faze in
Co-administration of Sovaldi with oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi. 
Sovaldi z okskarbazepinom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
Treated patients (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the patients were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL; 34% had cirrhosis; 63% had HCV genotype 3; 75% were prior relapsers. 
Mediana starost zdravljenih bolnikov (n = 201) je bila 56 let (razpon: 24 do 70); 70 % bolnikov je bilo moških; 87 % je bilo belcev; 3 % so bili črne rase; 9 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 29 kg/m2 (razpon: 19 do 44 kg/m2); 73 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 34 % jih je imelo cirozo; 63 % jih je imelo HCV genotipa 3; 75 % jih je imelo predhodno relaps.
Treated patients (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the patients were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6. 
Mediana starost zdravljenih bolnikov (n = 327) je bila 54 let (razpon: 19 do 70); 64 % bolnikov je bilo moških; 79 % je bilo belcev; 17 % je bilo črne rase; 14 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 29 kg/m2 (razpon: 18 do 56 kg/m2); 78 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 17 % jih je imelo cirozo; 89 % jih je imelo HCV genotipa 1 in 11 % jih je imelo HCV genotipa 4, 5 ali 6.
SOF+RBV 16 weeks (n = 35) 
SOF+RBV 16 tednov (n = 35)
Table 22: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection 
Preglednica 22: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 3
Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12) 
↓ Cmax 0,57 (0,44; 0,75) ↓ AUC 0,73 (0,59; 0,91)
Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype). 
Razmisliti je treba o zdravljenju teh bolnikov in morebitnem podaljšanju trajanja zdravljenja s sofosbuvirjem, peginterferonom alfa in ribavarinom na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom, napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču,
Treated patients (n = 499) had a median age of 50 years (range: 19 to 77); 66% of the patients were male; 87% were White; 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU/mL; 
Mediana starost zdravljenih bolnikov (n = 499) je bila 50 let (razpon: 19 do 77); 66 % bolnikov je bilo moških; 87 % je bilo belcev; 3 % so bili črne rase; 14 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 17 do 52 kg/m2); 57 % jih je imelo ravni RNA HCV ob izhodišču višje od 6 log10 i.e./ml; 20 % jih je imelo cirozo; 72 % jih je imelo HCV genotipa 3.
SOF+RBV 12 weeks (n = 11) 
SOF+RBV 12 tednov (n = 11)
↔ AUC 1.08 (0.93, 1.25) 
↔ AUC 1,04c (0,89; 1,22)
↔ AUC 1.05 (0.92, 1.20) 
↔ AUC 1,05 (0,92; 1,20) Cmin (n/n)
Response rates for patients with cirrhosis at baseline are presented in Table 10 by HCV genotype. 
Stopnje odziva za bolnike s cirozo ob izhodišču so predstavljene v preglednici 10 po genotipu HCV. Preglednica 10: Stopnje SVR12 po cirozi in genotipu v študiji FISSION
Overall No cirrhosis 
Brez ciroze Ciroza
No dose adjustment of sofosbuvir or tenofovir disoproxil is required when sofosbuvir and tenofovir disoproxil are used concomitantly. 
Pri sočasni uporabi sofosbuvirja in dizoproksiltenofovirata odmerka sofosbuvirja ali dizoproksiltenofovirata ni treba prilagajati.
SOF+RBV 16 weeks (n = 63) 
SOF+RBV 16 tednov (n = 63)
Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders: 
Infekcijske in parazitske bolezni:
• shortness of breath, cough 
• zasoplost, kašelj
• Rifampicin (antibiotic used to treat infections, including tuberculosis); • St. John's wort (herbal medicine used to treat depression); 
• rifampicin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
SOF+RBV 12 weeks (n = 73) 
SOF+RBV 12 tednov (n = 73)
SOF+RBV 12 weeks (n = 64) 
SOF+RBV 12 tednov (n = 64)
Table 13: Response rates in study FUSION 
Preglednica 13: Stopnje odziva v študiji FUSION SOF+RBV
SOF+RBV 12 weeks (n = 39) 
SOF+RBV 12 tednov (n = 39)
GS-331007 ↔ Cmax 1.23 (1.14, 1.34) ↔ AUC 0.95 (0.88, 1.03) Cmin (NA) 
GS 331007 ↔ Cmax 1,15 (1,03; 1,27) ↔ AUC 1,03 (0,95; 1,12) Cmin (n/n)
Tablet core: 
Bolezni prebavil:
GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13) Cmin (NA) 
↔ Cmax 0,97 (0,83; 1,14) ↔ AUC 1,00 (0,87; 1,13) Cmin (n/n)
Sofosbuvir ↓ Cmax 0.23 (0.19, 0.29) ↓ AUC 0.28 (0.24, 0.32) Cmin (NA) 
↓ AUC 0,28 (0,24; 0,32) Cmin (n/n)
Sofosbuvir ↓ Cmax 0.64 (0.53, 0.77) 
↓ Cmax 0,60 (0,53; 0,69)
GS-331007 ↔ Cmax 0.97 (0.90, 1.05) ↔ AUC 1.24 (1.18, 1.30) Cmin (NA) 
↔ Cmax 0,97 (0,90; 1,05) ↔ AUC 1,24 (1,18; 1,30) Cmin (n/n)
Tenofovir ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91, 1.05) ↔ Cmin 0.99 (0.91, 1.07) 
↔ AUC 0,98 (0,91; 1,05) ↔ Cmin 0,99 (0,91; 1,07)
20% had cirrhosis; 72% had HCV genotype 3. 
HCV ob izhodišču je bila 6,4 log10 i.e./ml; 21 % jih je imelo cirozo; 78 % jih je imelo HCV
No dose adjustment of sofosbuvir or efavirenz is required when sofosbuvir and efavirenz are used concomitantly. 
Pri sočasni uporabi sofosbuvirja in efavirenza odmerka sofosbuvirja ali efavirenza ni treba prilagajati.
Treated patients (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the patients were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers. 
Mediana starost zdravljenih bolnikov (n = 419) je bila 51 let (razpon: 19 do 74); 60 % bolnikov je bilo moških; mediani indeks telesne mase je bil 25 kg/m2 (razpon: 17 do 44 kg/m2); povprečna raven RNA