natgillin/translations-raw huggingface dataset:
The safety data provided in the sections below are based on the global, double-blind randomised pivotal phase 3 trial 1199.13 (LUME-Lung 1) comparing treatment with nintedanib plus docetaxel against placebo plus docetaxel in patients with locally advanced, or metastatic, or recurrent NSCLC after first-line chemotherapy.
V spodnjih poglavjih navajamo podatke o varnosti, ki temeljijo na globalnem, dvojno slepem randomiziranem ključnem preskušanju 3. faze 1199.13 (LUME-Lung 1), v katerem so primerjali zdravljenje z nintedanibom in docetakselom s placebom in docetakselom pri bolnikih z lokalno napredovalim ali metastatskim ali ponovljivim NSCLC po kemoterapiji prve izbire.
The safety data were evaluated in 34 patients between 2 to less than 6 years of age, 61 patients between 6 to less than 12 years of age and 94 patients between 12 to less than 18 years of age.
Varnostne podatke so ovrednotili pri 34 bolnikih med 2 in manj kot 6 leti starosti, pri 61 bolnikih med 6 in manj kot 12 leti starosti in pri 94 bolnikih med 12 in manj kot 18 let starosti.
The safety database to support once daily dosing in paediatric patients comes from the ARROW Trial (COL105677) in which 669 HIV-1 infected paediatric subjects (from 12 months to ≤17 years old). received abacavir and lamivudine either once or twice daily (see section 5.1).
Podatkovna baza o varnosti odmerjanja enkrat dnevno pri pediatričnih bolnikih temelji na preskušanju ARROW (COL105677), v katerem je 669 pediatričnih preiskovancev, okuženih s HIV-1, starih od 12 mesecev do vključno 17 let, prejemalo abakavir in lamivudin bodisi enkrat ali dvakrat na dan (glejte poglavje 5.1).
The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Varnostni pripomoček preprečuje poškodbe zaradi vboda z iglo po uporabi, tako da za odstranjevanje niso potrebni nobeni previdnostni ukrepi.
The safety evaluation of Provenge is based on data from 601 prostate cancer patients in four randomized, controlled clinical trials (3 studies in metastatic castrate resistant prostate cancer and 1 study in androgen dependent prostate cancer) and post-marketing surveillance.
Ocena varnosti zdravila Provenge temelji na podatkih 601 bolnika z rakom prostate iz štirih randomiziranih, kontroliranih kliničnih preskušanj (3 študije metastatskega, na kastracijo odpornega raka prostate in 1 študija od androgenov odvisnega raka prostate) in iz spremljanja zdravila v obdobju trženja.
The safety experience with Brimica Genuair comprised exposure at the recommended therapeutic dose for up to 12 months.
Izkušnje o varnosti z zdravilom Brimica Genuair vključujejo izpostavljenost do 12 mesecev pri priporočenem terapevtskem odmerku.
The safety experience with Duaklir Genuair comprised exposure at the recommended therapeutic dose for up to 12 months.
Izkušnje o varnosti z zdravilom Duaklir Genuair vključujejo izpostavljenost do 12 mesecev pri priporočenem terapevtskem odmerku.
The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine -live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Izkušnje o varnosti s trivalentnim cepivom Fluenz so pomembne za uporabo cepiva Fluenz Tetra, saj je Fluenz Tetra (cepivo proti gripi – z živimi oslabljenimi virusi, nosno) identično cepivu Fluenz, pri čemer je edina razlika dodatek četrtega seva (drugi B sev) v cepivu Fluenz Tetra.
The safety findings observed with long-term ambrisentan exposure in this study were generally consistent with those observed in the 12 week placebo-controlled studies.
Izsledki o varnosti, zabeleženi med dolgotrajno izpostavljenostjo ambrisentanu v tej študiji, so se na splošno ujemali s tistimi v 12- tedenskih študijah, kontroliranih s placebom.
The safety has not been established in cats weighing less than 0.6 kg.
Varnost ni bila ugotovljena pri mačkah, ki tehtajo manj kot 0,6 kg.
The safety has not been established in cats younger than 8 weeks of age.
Varnost ni bila ugotovljena pri mačkah, mlajših od 8 tednov.
The safety has not been established in dogs weighing less than 1.5 kg.
Varnost ni bila ugotovljena pri psih, ki tehtajo manj kot 1,5 kg.
The safety has not been established in dogs younger than 8 weeks of age.
Varnost ni bila ugotovljena pri psih, mlajših od 8 tednov.
The safety in paediatric patients has not been established.
Varnost pri pediatričnih bolnikih ni ugotovljena.
The safety information that became available in this reporting period is generally consistent with the known safety profile of vinflunine.
Podatki o varnosti, ki so postali na voljo v tem poročevalnem obdobju, se na splošno skladajo z obstoječim varnostnim profilom vinflunina.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06 – 0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,06– 0,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,06– 0,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06–0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Varno območje, glede na učinke na ledvice, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,06- 0,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06–0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,06- 0,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06–0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,06-0,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06–0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,06– 0,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
The safety observed in the tocilizumab arm was consistent with the known safety profile of tocilizumab and no new or unexpected adverse drug reactions were observed (see Table 1).
Varnost, ki so jo opazili v skupini s tocilizumabom, je bila v skladu z znanim varnostnim profilom tocilizumaba, novih ali nepričakovanih neželenih učinkov niso opazili (glejte preglednico 1).
The safety of Activyl has not been established in dogs and cats younger than 8 weeks of age.
Varnost Activyla ni bila ugotovljena pri psih in mačkah, mlajših od 8 tednov.
The safety of Activyl has not been established in dogs weighing less than 1.5 kg and in cats weighing less than 0.6 kg.
Varnost Activyla ni bila ugotovljena pri psih, ki tehtajo manj kot 1,5 kg, in pri mačkah, ki tehtajo manj kot 0,6 kg.
The safety of Activyl Tick Plus has not been established in dogs weighing less than 1.2 kg.
Varnost zdravila Activyl Tick Plus ni bila ugotovljena pri psih, ki tehtajo manj kot 1,2 kg.
The safety of Activyl Tick Plus has not been established in dogs younger than 8 weeks of age.
Varnost zdravila Activyl Tick Plus ni bila ugotovljena pri psih, mlajših od 8 tednov.
The safety of Advocate has not been evaluated when administered on the same day as an adulticide.
Če dajemo zdravilo Advocate isti dan kot sredstva, ki uničijo odrasle oblike srčne gliste, varnost le tega ni bila ocenjena.
The safety of Agenerase has been studied in adults and children of at least 4 years of age in controlled clinical trials, in combination with various other antiretroviral agents.
Varnost zdravila Agenerase je bila raziskovana pri odraslih in otrocih, starejših od 4 let, v nadzorovanih kliničnih študijah in v kombinaciji s številnimi drugimi protiretrovirusnimi zdravili.
The safety of Agenerase has been studied in adults and children of at least 4 years of age, in controlled clinical trials, in combination with various other antiretroviral agents.
Varnost zdravila Agenerase je bila raziskovana pri odraslih in otrocih, starejših od 4 let, v nadzorovanih kliničnih študijah in v kombinaciji s številnimi drugimi protiretrovirusnimi zdravili.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs.
Varnost zdravila Aivlosin v obdobju brejosti in laktacije pri prašičih ni bila ugotovljena.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs.
Varnosti zdravila Aivlosin med brejostjo in laktacijo pri prašičih niso ugotovili.
The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment.
Varnosti apremilasta pri bolnikih s PsA ali PSOR z okvaro jeter niso ocenjevali.
The safety of apremilast was not evaluated in PsA or PSOR patients with moderate or severe renal impairment in the clinical studies.
V kliničnih študijah niso ocenjevali varnosti apremilasta pri bolnikih s PsA ali PSOR in zmerno ali težko okvaro ledvic.
The safety of AUBAGIO in individuals with latent tuberculosis infection is unknown, as tuberculosis screening was not systematically performed in clinical studies.
Varnost zdravila AUBAGIO pri osebah z latentno tuberkulozo ni znana, saj presejalni test za tuberkulozo ni bil sistematično opravljen v kliničnih študijah.
The safety of Benlysta in patients with SLE has been evaluated in 3 placebo-controlled studies.
Varnost zdravila Benlysta pri bolnikih s SLE so ocenili v 3 s placebom kontroliranih študijah.
The safety of Bexsero was evaluated in 14 studies including 10 randomised controlled clinical trials with 8776 subjects (from 2 months of age) who received at least one dose of Bexsero.
Varnost cepiva Bexsero je bila ocenjena v 14 študijah, vključno z 10 randomiziranimi, kontroliranimi kliničnimi preskušanji z 8776 preiskovanci (starimi vsaj 2 meseca), ki so prejeli vsaj en odmerek cepiva Bexsero.
The safety of BRINAVESS has been evaluated in clinical studies involving 1148 subjects (patients and healthy volunteers) who received treatment with BRINAVESS.
Varnost zdravila BRINAVESS je bila ocenjena v kliničnih študijah, ki so zajele 1.148 oseb (bolnikov in zdravih prostovoljcev), ki so prejeli zdravilo BRINAVESS.
The safety of BROADLINE has not been tested at intervals of less than 2 weeks or in kittens weighing less than 0.6 kg and/or under 7 weeks of age.
Varnost BROADLINE ni bila preskušena v intervalih, krajših od 14 dni in pri mladičkih, lažjih od 0,6 kg in/ali mlajših od 7 tednov.
The safety of Cabometyx is similar to other tyrosine kinase inhibitors used in renal cell carcinoma, and side effects are considered manageable.
Varnost zdravila Cabometyx je podobna ostalim zaviralcem tirozin-kinaze, ki se uporabljajo pri zdravljenju karcinoma ledvičnih celic, neželeni učinki pa so ocenjeni kot obvladljivi.
The safety of cangrelor has been evaluated in over 12,700 treated patients undergoing PCI.
Varnost kangrelorja so ocenili pri več kot 12.700 zdravljenih bolnikih, ki so jim opravili PKI.
The safety of CE/bazedoxifene was evaluated in 4,868 post-menopausal women who participated in 5 Phase 3 trials.
Varnost kombinacije CE/bazedoksifena so ocenili pri 4.868 ženskah v postmenopavzi, ki so sodelovale v 5 preskušanjih 3. faze.
The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant women.
Varnost zdravila Celvapan v nosečnosti in obdobju dojenja je bila preverjena pri majhnem številu nosečnic.
The safety of Cerenia has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches.
Varnost zdravila v odmerku 8 mg/kg (slabost med vožnjo) pri psih, mlajših od 16 tednov, v odmerku 2 mg/kg (bruhanje) pri psih, mlajših od 8 tednov, ter pri psicah v obdobju brejosti in laktacije, ni bila dokazana.
The safety of cobicistat is based on 144-week data from a phase 3, randomised, active-controlled clinical study (GS-US-216-0114), in which 692 treatment-naïve patients received at least one dose of cobicistat-boosted atazanavir (n = 344) or ritonavir-boosted atazanavir (n = 348) administered with emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Varnost kobicistata temelji na podatkih iz 144-tedenske randomizirane, z zdravilno učinkovino kontrolirane klinične študije faze 3 (GS-US-216-0114), v kateri je 692 bolnikov, ki se predhodno še ni zdravilo, prejelo vsaj en odmerek atazanavirja, okrepljenega s kobicistatom (n = 344), ali atazanavirja, okrepljenega z ritonavirjem (n = 348), sočasno s fiksno kombinacijo emtricitabina in dizoproksiltenofovirat fumarata.
The safety of Colobreathe has been assessed in a total of 237 subjects (225 cystic fibrosis patients and 12 healthy volunteers).
Varnost zdravila Colobreathe so ocenili pri skupaj 237 osebah (225 bolnikov s cistično fibrozo in 12 zdravih prostovoljcev).
The safety of continuing somatropin treatment in patients with acute critical illness in intensive care units due to complications following open-heart or abdominal surgery, multiple accidental trauma or acute respiratory failure receiving replacement doses for approved indications has not been established.
Varnost nadaljnjega zdravljenja s somatotropinom v enoti za intenzivno nego pri bolnikih z akutno kritično boleznijo zaradi zapletov po operaciji na odprtem srcu ali abdomnu, po politravmi ali akutni respiratorni odpovedi, ki dobivajo nadomestne odmerke za odobrene indikacije, ni ugotovljena.
The safety of Convenia has not been assessed in animals suffering from severe renal dysfunction.
Varnost Convenie ni bila dokazana pri živalih z okvaro ledvic.
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species.
Pri ciljnih vrstah ni dokazana varnost deksemedetomidina v obdobju brejosti in laktacije.
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species.
Varnost deksmedetomidina med brejostjo in dojenjem pri ciljnih živalskih vrstah ni bil dokazana.
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species.
Varnost deksmedetomidina med brejostjo in dojenjem pri ciljnih živalskih vrstah ni bila dokazana.
The safety of dexmedetomidine has not been established in males intended for breeding.
Pri samcih za razplod varnost deksmedetomidina ni bila ocenjena.
The safety of Dukoral was assessed in clinical trials, including both adults and children from 2 years of age, conducted in endemic and non-endemic countries for cholera and enterotoxigenic Escherichia coli (ETEC) producing heat-labile enterotoxin (LT).
Varnost Dukorala so ocenili v kliničnih preskušanjih, v katerih so sodelovali odrasli in otroci, starejši od 2 let, opravljenih v državah, endemičnih in neendemičnih za kolero in enterotoksigeno Escherichio coli (ETEC), ki proizvaja termolabilni enteroroksin (LT).
The safety of edoxaban has been evaluated in two Phase 3 studies including 21,105 patients with NVAF (ENGAGE AF-TIMI 48 study), and 8,292 patients with VTE (DVT and PE) (Hokusai-VTE study).
Varnost edoksabana so ovrednotili v dveh študijah 3. faze, v kateri je bilo vključenih 21.105 bolnikov z NVAF (študija ENGAGE AF-TIMI 48) in 8.292 bolnikov z VTE (GVT in PE) (študija Hokusai- VTE).
The safety of eltrombopag in severe aplastic anaemia was assessed in a single-arm, open-label trial (N=43) in which 12 patients (28%) were treated for > 6 months and 9 patients (21%) were treated for
Varnost eltrombopaga pri zdravljenju hude aplastične anemije so ocenjevali v odprti študiji z eno samo skupino bolnikov (N=43), v kateri so 12 bolnikov (28 %) zdravili več kot 6 mesecev,
The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Varnost emtricitabina in alafenamidtenofovirata v kombinaciji z elvitagravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov so ocenili pri približno 70 bolnikih s hkratno okužbo s HIV/HBV, ki so se trenutno zdravili zaradi HIV v odprti klinični študiji (GS-US-292-1249).
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an open- label clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina in alafenamidtenofovirata so ocenili v 48 tednih v odprti klinični študiji (GS-US-292-0106), v kateri so predhodno nezdravljeni pediatrični bolniki, okuženi s HIV-1 in stari od 12 do < 18 let, prejemali emtricitabin in alafenamidtenofovirat v kombinaciji z elvitagravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
The safety of emtricitabine and tenofovir alafenamide was evaluated through 96 weeks in an open- label clinical study (GS-US-292-0112) in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina in alafenamidtenofovirata so ocenili v 96 tednih v odprti klinični študiji (GS-US-292-0112), v kateri je 248 bolnikov, okuženih s HIV-1, ki se bodisi predhodno še niso zdravili (n = 6) ali so imeli virusno supresijo (n = 242), z blago do zmerno ledvično okvaro (ocenjena hitrost glomerularne filtracije po metodi Cockcroft-Gault [eGFRCG]: 30-69 ml/min) prejemalo emtricitabin in alafenamidtenofovirat v kombinaciji z elvitagravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
The safety of emtricitabine+tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Varnost emtricitabina in alafenamidtenofovirata v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov so ocenili pri približno 70 bolnikih s hkratno okužbo s HIV/HBV, ki so se trenutno zdravili zaradi HIV v odprti klinični študiji (GS-US-292-1249).
The safety of emtricitabine+tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine+tenofovir alafenamide in combination with elvitegravir+cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina + alafenamidtenofovirata so ocenili v 48 tednih z odprto klinično študijo (GS-US-292-0106), v kateri so predhodno nezdravljeni pediatrični bolniki, okuženi s HIV-1 in stari od 12 do < 18 let, prejemali emtricitabin + alafenamidtenofovirat v kombinaciji z elvitegravirjem + kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
The safety of emtricitabine+tenofovir alafenamide was evaluated through 96 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine+tenofovir alafenamide in combination with elvitegravir+cobicistat as a fixed-dose combination tablet.
Varnost emtricitabina in alafenamidtenofovirata so ocenili v 96 tednih v odprti klinični študiji (GS-US-292-0112), v kateri je 248 bolnikov, okuženih s HIV-1, ki se bodisi predhodno še niso zdravili (n = 6) ali so imeli virusno supresijo (n = 242), z blago do zmerno ledvično okvaro (ocenjena hitrost glomerularne filtracije po metodi Cockcroft-Gault [eGFRCG]: 30-69 mL/min) prejemalo emtricitabin in alafenamidtenofovirat v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.