FrancophonIA/ELRC3.0 huggingface dataset:
English: Simeprevir in combination with peginterferon alfa and ribavirin The efficacy of simeprevir in combination with peginterferon alfa and ribavirin was evaluated in patients with HCV genotype 1 or 4 infection, with or without HIV-1 co-infection, who were treatment-naïve or treatment-experienced (following prior interferon-based therapy) (tables 17 and
Danish: Simeprevir i kombination med peginterferon alfa og ribavirin Effekten af simeprevir i kombination med peginterferon alfa og ribavirin blev undersøgt hos behandlingsnaive eller behandlingserfarne (efter tidligere interferon-baseret behandling) patienter med HCV-genotype 1- eller 4-infektion med eller uden samtidig HIV 1-infektion (tabel 17 og 18).
English: Treatment-experienced to prior treatment with peginterferon and ribavirin.
Danish: Behandlingserfaren med tidligere behandling med peginterferon og ribavirin.
English: Simeprevir in combination with sofosbuvir: ‘Blood bilirubin increased' was reported in 1.0% of patients receiving 12 weeks of treatment compared to 3.2% in patients receiving 24 weeks of treatment (all grades).
Danish: Simeprevir i kombination med sofosbuvir: Forhøjet bilirubin i blodet blev indberettet for 1,0% af de patienter, der fik 12 ugers behandling, sammenlignet med 3,2% af de patienter, som fik 24 ugers behandling (alle grader).
English: Sixty-five percent (53/81) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 79%.
Danish: 65% (53/81) af de simeprevir-behandlede HCV-genotype 1a-inficerede patienter med Q80K-polymorfisme havde ikke-detekterbart HCV-RNA i uge 4; hos disse patienter var SVR12-raten 79%.
English: Refer to the respective Summary of Product Characteristics of the medicinal products used in combination with simeprevir regarding their use in patients with renal impairment.
Danish: Der henvises til de respektive produktresumeer for de lægemidler, der anvendes i kombination med simeprevir, for så vidt angår deres anvendelse til patienter med nyreinsufficiens.
English: Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and
Danish: Tabel 17: Studier udført med simeprevir + peginterferon alfa + ribavirin: population og resumé af studiedesign
English: or amiodarone to treat irregular heart beat - clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to treat bacterial infections - warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Danish: Fortæl det især til din læge eller apotekspersonalet, hvis du tager et eller flere af disse lægemidler: - digoxin, disopyramid, flecainid, mexiletin, propafenon eller quinidin (når det tages gennem munden) eller amiodaron til behandling af uregelmæssig hjerterytme - clarithromycin, erythromycin (når det tages gennem munden eller gives som en injektion) eller telithromycin til behandling af bakterieinfektioner - warfarin og andre tilsvarende lægemidler, der kaldes for vitamin K-antagonister, der bruges til fortynding af blodet.
English: Includes relapsers, partial and null responders to prior treatment with peginterferon and ribavirin.
Danish: Inkluderer patienter med recidiv og patienter med delvist eller nul respons inden behandling med peginterferon og ribavirin.
English: Increased plasma concentrations of orally administered calcium channel blockers may be expeced.
Danish: Der kan forventes forhøjede plasmakoncentrationer af oralt administrerede
English: Resistance in clinical studies
Danish: Klinisk studie med undersøgelse af QT-intervallet
English: Cases of bradycardia have been observed when OLYSIO is used in combination with sofosbuvir and concomitant amiodarone (see sections 4.4 and 4.5).
Danish: Der er observeret tilfælde af bradykardi, når OLYSIO blev anvendt i kombination med sofosbuvir og samtidig amiodaron (se pkt.
English: 2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
Danish: 2; median HCV-RNA ved baseline var 6,35 log10 IE/ml; 18% havde cirrose; 25% havde HCV-genotype 4a og 73% HCV-genotype 4d; 85% havde non-CC IL28B-alleler (CT eller TT); 33% var behandlingsnaive, og 68% var behandlingserfarne.
English: Prior partial responders N = 10 % (n/N)
Danish: Partienter med tidligere delvist respons N = 10 % (n/N)
English: 12 or 24 weeks SMV + sofosbuvir, with or without ribavirin patients without cirrhosis: 8 or 12 weeks SMV + sofosbuvir; patients with cirrhosis:
Danish: Patienter uden cirrose: 8 eller 12 ugers SMV + sofosbuvir; patienter med cirrose:
English: To prior treatment with peginterferon alfa and ribavirin.
Danish: På tidligere behandling med peginterferon alfa og ribavirin.
English: Table 16: Treatment outcome in HCV genotype 4 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC2014 and HPC3021) Treatment outcome
Danish: Tabel 16: Behandlingsresultat hos HCV-genotype 4-inficerede patienter, der fik 12 ugers behandling med simeprevir + sofosbuvir (studie HPC2014 og HPC3021)
English: Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 12 weeks of peginterferon alfa + ribavirin.
Danish: Behandling med OLYSIO skal initieres i kombination med peginterferon alfa + ribavirin og administreres i 12 uger efterfulgt af yderligere 12 uger med peginterferon
English: The median baseline CD4+ cell count in patients on highly active antiretroviral
Danish: De mediane CD4+ tal ved baseline hos patienter, der fik højaktiv antiretroviral behandling (HAART), var 561 x 10
English: Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018)
Danish: Tabel 13: Behandlingsresultat hos HCV-genotype 1-inficerede patienter, der fik 12 ugers behandling med simeprevir + sofosbuvir (studie HPC3017 og HPC3018) Behandlingsresultat
English: In study HPC2002, photosensitivity reactions (grouped term) was reported in 7.1% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 5.6% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Danish: I studie HPC2002 blev der indberettet lysfølsomhedsreaktioner (grupperet term) hos 7,1% af de patienter, der fik 12 ugers behandling med simeprevir og sofosbuvir uden ribavirin, vs. 5,6% af de patienter, som fik 12 ugers behandling med simeprevir og sofosbuvir med ribavirin.
English: No dose adjustment is required for either drug when OLYSIO is co-administered with maraviroc.
Danish: Det er ikke nødvendigt at justere dosis for hverken OLYSIO eller maraviroc ved samtidig administration.
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk anvendelse, direkte virkende
English: Discontinue peginterferon alfa and ribavirin (treatment with OLYSIO is complete at week 12)
Danish: Seponér peginterferon alfa og ribavirin (behandlingen med OLYSIO er afsluttet i uge 12) Seponér peginterferon alfa og ribavirin
English: The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir
Danish: Tabel 15 viser responsraterne for patienter med cirrose (METAVIRscore F4), der fik 12 eller 24 ugers behandling med simeprevir + sofosbuvir.
English: In the pooled analysis of studies C208 and C216, 69% (58/84) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism at baseline were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 78%.
Danish: I den puljede analyse af studierne C208 og C216 var 69% (58/84) af de simeprevir-behandlede HCVgenotype 1a-inficerede patienter med Q80K-polymorfisme ved baseline egnede til i alt 24 ugers behandling.
English: OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults.
Danish: OLYSIO anvendes sammen med andre lægemidler til behandling af kronisk (langvarig) hepatitis C
English: Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 36 weeks of peginterferon alfa + ribavirin.
Danish: Behandling med OLYSIO skal initieres i kombination med peginterferon alfa + ribavirin og administreres i 12 uger efterfulgt af yderligere 36 uger med peginterferon
English: In study C206 (ASPIRE), patients who failed prior peg-IFN/RBV therapy received 12, 24 or 48 weeks simeprevir (100 mg or 150 mg once daily) in combination with 48 weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Danish: I studie C206 (ASPIRE) fik patienter, der ikke havde opnået effekt af tidligere peg-IFN/RBVbehandling, 12, 24 eller 48 ugers behandling med simeprevir (100 mg eller 150 mg én gang dagligt) i kombination med 48 ugers behandling med peginterferon alfa-2a + ribavirin (se tabel 17 og 18).
English: Mild
Danish: Køn
English: Table 20: Treatment outcome in treatment-experienced 1 HCV genotype 1 infected patients
Danish: Tabel 19: Behandlingsresultat hos behandlingsnaive HCV-genotype 1-inficerede patienter
English: When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, testing for NS3 Q80K polymorphism should be performed before starting treatment (see section 4.4).
Danish: Hvis kombinationsbehandling med OLYSIO og peginterferon alfa og ribavirin overvejes til patienter med HCVgenotype 1a, skal test for NS3 Q80K-polymorfisme gennemføres inden behandlingsstart (se pkt.
English: During your treatment with OLYSIO, use appropriate sun protection (such as a sun hat, sunglasses and sunscreen).
Danish: Du skal bruge egnet solbeskyttelse (for eksempel en hat, solbriller og solbeskyttelsescreme), mens du er i behandling med OLYSIO.
English: Refer to the respective Summary of Product Characteristics of the medicinal products used in combination with simeprevir regarding their use in patients with hepatic impairment.
Danish: Der henvises til de respektive produktresumeer for de lægemidler, der anvendes i kombination med simeprevir, for så vidt angår deres anvendelse til patienter med leverinsufficiens.
English: If the capsule shell is indented or bent - without being broken or opened - the capsule can still
Danish: Kapslen kan stadig bruges, selvom der er hakker i kapselskallen, eller den er bøjet, så længe skallen ikke er brudt eller åbnet.
English: 12 weeks SMV + sofosbuvir
Danish: 12 ugers SMV + sofosbuvir
English: If pregnancy occurs during this period, you must contact your doctor straight away.
Danish: Kontakt straks din læge, hvis du eller din partner bliver gravid i denne periode.
English: If you develop a photosensitivity reaction during treatment, contact your doctor immediately.
Danish: Kontakt straks din læge, hvis du får en lysfølsomhedsreaktion under behandlingen.
English: The primary enzyme involved in the biotransformation of simeprevir is CYP3A4 (see section 5.2) and clinically relevant effects of other medicinal products on simeprevir pharmacokinetics via CYP3A4 may occur.
Danish: 5.2), og der kan opstå klinisk relevante virkninger fra andre lægemidler på simeprevirs farmakokinetik via CYP3A4.
English: It is not recommended to co-administer OLYSIO with systemic dexamethasone as co-administration may result in loss of therapeutic effect of OLYSIO.
Danish: Det anbefales ikke at administrere OLYSIO sammen med systemisk dexamethason, da det kan medføre manglende terapeutisk virkning af OLYSIO.
English: You must take OLYSIO as part of a course of treatment with other medicines for treating your chronic hepatitis C infection.
Danish: Du skal tage OLYSIO i kombination med andre lægemidler til behandling af kronisk hepatitis Cinfektion.
English: Forty-five percent (13/29) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 77%.
Danish: 45% (13/29) af de simeprevir-behandlede HCVgenotype 1a-inficerede patienter med Q80K-polymorfisme havde ikke-detekterbart HCV-RNA i uge 4; SVR12-raten var 77% for disse patienter.
English: As liver function may change during treatment with OLYSIO, close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Patienter i behandling med vitamin K-antagonister: Da leverfunktionen kan ændre sig under behandling med OLYSIO, anbefales tæt monitorering af INR
English: Prior relapsers N = 15 % (n/N)
Danish: Patienter med tidligere recidiv N = 15 % (n/N)
English: Increased plasma concentrations of pitavastatin and pravastatin are expected.
Danish: Der forventes forhøjede plasmakoncentrationer af pitavastatin og
English: Prior null responders N = 28 % (n/N)
Danish: Patienter med tidligere nul respons N = 28 % (n/N)
English: Table 22: Treatment outcome in HCV genotype 1 infected patients with HIV-1 co-infection
Danish: Tabel 22: Behandlingsresultat hos HCV-genotype 1-inficerede patienter med samtidig HIV 1
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Danish: Fortæl det til lægen, inden du tager dette lægemiddel, hvis din læge har fortalt dig, at du ikke tåler visse sukkerarter.
English: Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments)
Danish: Tabel 7: Behandlingsrelaterede laboratorieanomalier , som blev observeret med en højere incidens hos patienter, der fik simeprevir i kombination med peginterferon alfa og ribavirin (puljede fase 3-studier C208, C216 og HPC3007; de første 12 ugers simeprevir + peginterferon alfa + ribavirin N = 781 n (%)
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Danish: 4.4 og 5.1 vedrørende den genotypespecifikke aktivitet af hepatitis C-virus (HCV).
English: No dose adjustment is necessary based on race.
Danish: Dosisjustering på baggrund af patientens race er ikke nødvendig.
English: Table 15: Treatment outcome in HCV genotype 1 infected patients with cirrhosis receiving 12 or 24 weeks simeprevir + sofosbuvir, with or without ribavirin
Danish: Tabel 15: Behandlingsresultat hos HCV-genotype 1-inficerede patienter med cirrose, der fik 12 eller 24 ugers behandling med simeprevir + sofosbuvir med eller uden ribavirin (studie HPC2002) Behandlingsresulta
English: Prior relapsers N = 22 % (n/N)
Danish: Patienter med tidligere recidiv N = 22 % (n/N)
English: The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in
Danish: Alle patienter med eller uden cirrose, der fik 12 ugers behandling med simeprevir + sofosbuvir,
English: However, reports of hepatic decompensation and hepatic failure during OLYSIO combination therapy have been received in the post marketing setting (see section 4.4).
Danish: Det er dog efter markedsføring indberettet leverdekompensation og leverinsufficiens, hos patienter der blev behandlet med OLYSIO i kombinationsbehandling (se pkt 4.4).
English: Prior null responders N = 40 % (n/N)
Danish: Patienter med tidligere nul respons N = 40 % (n/N)
English: If you are not sure, talk to your doctor or pharmacist before taking OLYSIO.
Danish: Hvis du ammer, skal du spørge din læge til råds, før du tager OLYSIO.
English: Titrate the pitavastatin and pravastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Danish: Dosis af pitavastatin og pravastatin skal titreres omhyggeligt, og den laveste nødvendige dosis skal anvendes.
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, rash and pruritus were reported in 21.8% and 21.9% of simeprevir-treated patients, compared to 16.6% and 14.6% in placebo-treated patients, respectively (all grades; pooled phase 3).
Danish: Simeprevir i kombination med peginterferon alfa og ribavirin: I løbet af de 12 ugers behandling med simeprevir blev der indberettet udslæt og kløe hos henholdsvis 21,8% og 21,9% af de simeprevir-behandlede patienter sammenlignet med henholdsvis 16,6% og 14,6% i placebo-gruppen (alle grader; puljede fase 3-studier).
English: It is not recommended to co-administer OLYSIO with these anticonvulsants as co-administration may result in loss of therapeutic effect of OLYSIO.
Danish: Det anbefales ikke at administrere OLYSIO sammen med disse antikonvulsiva, da det kan medføre manglende terapeutisk virkning af OLYSIO.
English: In HCV genotype 1a infected patients without cirrhosis, simeprevir efficacy in combination with sofosbuvir at the recommended 12-week treatment duration was not impacted by the presence of the NS3 Q80K polymorphism (see section 5.1).
Danish: Hos HCV-genotype 1a-inficerede patienter uden cirrose blev effekten af simeprevir i kombination med sofosbuvir ved den anbefalede 12-ugers behandlingsvarighed ikke påvirket af forekomst af
English: Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable)
Danish: Raterne for virusrecidiv er beregnet med patienter med ikke-detekterbart (eller ubekræftet detekterbart) HCV-RNA ved
English: (intestinal CYP3A4 enzyme and P-gp transporter inhibition)
Danish: (Hæmning af intestinalt CYP3A4 og P-gp
English: If you develop a rash during treatment, contact your doctor immediately.
Danish: Kontakt straks din læge, hvis du får udslæt under behandlingen.
English: In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 4.4).
Danish: Test for forekomst af Q80K-polymorfisme hos patienter med cirrose, der er inficerede med HCV-genotype 1a, kan overvejes inden initiering af behandling med OLYSIO i kombination med sofosbuvir (se pkt.
English: Significantly increased plasma concentrations of simeprevir are expected.
Danish: Der forventes signifikant forhøjet plasmakoncentration af simeprevir.
English: This effect was observed at higher systemic exposures (11-fold) than those in humans at the
Danish: Denne effekt blev observeret ved højere systemisk eksponering (11 gange) end hos mennesker ved den anbefalede dosis på 150 mg én gang dagligt.
English: Talk to your doctor if you are breast-feeding before taking OLYSIO.
Danish: Tal med din læge eller apotekspersonalet, inden du tager OLYSIO, hvis du er i tvivl om noget.
English: Antiretroviral - protease inhibitors (PIs)
Danish: Antiretrovirale midler - proteasehæmmere (PI'er) Darunavir/ritonavir
English: No data are available.
Danish: Der foreligger ingen
English: Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at actual EOT and with at least one follow-up HCV RNA assessment.
Danish: Raterne for virusrecidiv er beregnet med patienter med udetekterbart HCV-RNA ved den egentlige EOT og med mindst én opfølgende måling af HCV-RNA som nævner.
English: HORMONAL CONTRACEPTIVES Ethinylestradiol and norethindrone
Danish: ANTIHISTAMINER Astemizol
English: No effects on fertility were observed
Danish: Der er ikke observeret nogen effekter på fertiliteten i dyrestudier (se pkt.
English: Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
Danish: Raterne for virusrecidiv er beregnet med patienter med ikke-detekterbart HCV-RNA ved EOT og med mindst én opfølgende HCV-RNA-måling som nævner.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se
English: Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin
Danish: Tabel 5: Identificerede bivirkninger af simeprevir i kombination med sofosbuvir eller simeprevir i kombination med peginterferon alfa og ribavirin Systemorgan simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
English: Efficacy in treatment-naïve patients with HCV genotype 1 infection In studies C208 (QUEST-1) and C216 (QUEST-2), treatment-naïve patients received simeprevir (150 mg once daily) + peginterferon alfa + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa + ribavirin (see tables 17 and 18).
Danish: Effekt hos behandlingsnaive patienter med HCV-genotype 1-infektion Studie C208 (QUEST 1) og studie C216 (QUEST 2) I studierne C208 (QUEST-1) og C216 (QUEST-2) fik behandlingsnaive patienter simeprevir (150 mg én gang dagligt) + peginterferon alfa + ribavirin i 12 uger efterfulgt af yderligere 12 eller 36 uger med peginterferon alfa + ribavirin (se tabel 17 og 18).
English: Treatment discontinuation in patients with inadequate on-treatment virologic response
Danish: Seponering af behandlingen hos patienter med utilstrækkeligt virologisk respons OLYSIO i kombination med sofosbuvir
English: It is not recommended to co-administer OLYSIO with rifabutin or rifapentine as co-administration may result in loss of therapeutic effect of OLYSIO.
Danish: Det anbefales ikke at administrere OLYSIO sammen med rifabutin eller rifapentin, da det kan medføre manglende terapeutisk virkning af OLYSIO.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med OLYSIO Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: The 40 enrolled patients had a median age of 51 years (range 29 to 69 years; with 5% above 65 years); 73% were male; 18% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.35 log10 IU/ml; 18% had cirrhosis; 25% had HCV genotype 4a, and 73% HCV genotype 4d; 85%
Danish: De 63 inkluderede patienter havde en medianalder på 51 år (24 til 68 år, heraf 2% over 65 år); 54% var mænd; 43% havde BMI ≥ 30 kg/m median HCV-RNA ved baseline var 6,01 log10 IE/ml; 37% havde cirrose; 30% havde HCVgenotype 4a, og 56% HCV-genotype 4c eller 4d; 79% havde non-CC IL28B-alleler (CT eller TT); 52% var behandlingsnaive, og 48% var behandlingserfarne.
English: These characteristics have no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Danish: Disse parametre havde ingen klinisk relevant virkning på simeprevirs farmakokinetik, baseret på en farmakokinetisk populationsanalyse af HCV-inficerede patienter, der blev behandlet med simeprevir i kombination
English: 6.1 List of excipients
Danish: 6.6 Regler for bortskaffelse
English: Significantly decreased plasma concentrations of simeprevir are expected.
Danish: Der forventes signifikant nedsat plasmakoncentration af simeprevir.
English: Table 2: Recommended treatment duration for OLYSIO combination therapy with 1 in HCV genotype 1 or 4 Treatment duration
Danish: Tabel 2: Anbefalet varighed af kombinationsbehandling med OLYSIO og peginterferon alfa og ribavirin1 hos patienter med HCV-genotype 1 eller 4 Behandlingsvarighed Behandlingsnaive patienter og patienter med tidligere recidiv
English: In study HPC2002, rash (grouped term) was reported in 10.7% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 20.4% of patients receiving 12 weeks of simeprevir
Danish: I studie HPC2002 blev der indberettet udslæt (grupperet term) for 10,7% af de patienter, der fik 12 ugers behandling med simeprevir og sofosbuvir uden ribavirin, vs. 20,4% af de patienter, der fik 12 ugers behandling med simeprevir og sofosbuvir med ribavirin.