United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b), velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), voxilaprevir (unii: 0570f37359) (voxilaprevir - unii:0570f37359) - sofosbuvir 400 mg - vosevi is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) infection without cirrhosis or with compensated cirrhosis (child-pugh a) who have [see dosage and administration (2.2) and clinical studies (14)]: - genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an hcv regimen containing an ns5a inhibitor. - genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an ns5a inhibitor. additional benefit of vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an ns5a inhibitor. - additional benefit of vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an ns5a inhibitor. vosevi is contraindicated with rifampin [see drug interactions (7.3), and clinical pharmacology (12.3)]. risk summary no adequate human data are available to establish whether or not vosevi poses a risk to pregnancy outcomes. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of vosevi (sofosbuvir, velpatasvir, or voxilaprevir) at exposures greater than those in humans at the recommended human dose (rhd) [see data] . during organogenesis in the mouse, rat, and rabbit, systemic exposures (auc) of velpatasvir were approximately 23 (mice), 4 (rats), and 0.5 (rabbits) times the exposure in humans at the rhd, while exposures of voxilaprevir were approximately 141 (rats) and 4 (rabbits) times the exposure in humans at the rhd. exposures of the predominant circulating metabolite of sofosbuvir (gs-331007) were approximately 6 (rats) and 16 (rabbits) times the exposure in humans at the rhd. in rat pre/postnatal development studies, maternal systemic exposures (auc) for each component of vosevi were approximately 7 (sofosbuvir metabolite gs-331007), 3 (velpatasvir), and 238 (voxilaprevir) times the exposure in humans at the rhd. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data sofosbuvir: sofosbuvir was administered orally to pregnant rats (up to 500 mg/kg/day) and rabbits (up to 300 mg/kg/day) on gestation days 6 to 18 and 6 to 19, respectively, and also to rats (oral doses up to 500 mg/kg/day) from gestation day 6 to lactation/post-partum day 20. no significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. the systemic exposures (auc) of the predominant circulating metabolite of sofosbuvir (gs-331007) during gestation were approximately 6 (rats) and 16 (rabbits) times the exposure in humans at the rhd. velpatasvir: velpatasvir was administered orally to pregnant mice (up to 1000 mg/kg/day), rats (up to 200 mg/kg/day) and rabbits (up to 300 mg/kg/day) from gestation days 6 to 15, 6 to 17, and 7 to 20, respectively, and also to rats (oral doses up to 200 mg/kg) on gestation day 6 to lactation/post-partum day 20. no significant effects on embryo-fetal (mice, rats, and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. the systemic exposures (auc) of velpatasvir during gestation were approximately 23 (mice), 4 (rats), and 0.5 (rabbits) times the exposure in humans at the rhd. voxilaprevir: voxilaprevir was administered orally to pregnant rats (up to 100 mg/kg/day) and rabbits (up to 600 mg/kg/day) from gestation days 6 to 17, and 7 to 19, respectively, and also to rats (oral doses up to 100 mg/kg) on gestation day 6 to lactation/post-partum day 20. no significant effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed at the highest doses tested. the systemic exposures (auc) of voxilaprevir during gestation were approximately 141 (rats) and 4 (rabbits) times the exposure in humans at the rhd. risk summary it is not known whether the components of vosevi and its metabolites are present in human breast milk, affect human milk production, or have effects on the breastfed infant. when the components of vosevi were administered to lactating rats, gs-331007 (the predominant circulating metabolite of sofosbuvir) and velpatasvir were detected in milk, while voxilaprevir was detected in the plasma of nursing pups likely due to the presence of voxilaprevir in milk. no significant effects of any of the drugs were observed in nursing rat pups [see data]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vosevi and any potential adverse effects on the breastfed child from vosevi or from the underlying maternal condition. data sofosbuvir: no significant effects of sofosbuvir on growth or postnatal development were observed in nursing pups at the highest dose tested in rats. maternal systemic exposure (auc) of the predominant circulating metabolite of sofosbuvir (gs-331007) was approximately 7 times the exposure in humans at the rhd, with exposure of approximately 2% that of maternal exposure observed in nursing pups on lactation day 10. in a lactation study, sofosbuvir metabolites (primarily gs-331007) were excreted into the milk of lactating rats following administration of a single oral dose of sofosbuvir (20 mg/kg) on lactation day 2, with milk concentrations of approximately 10% that of maternal plasma concentrations observed 1 hour post-dose. velpatasvir: no significant effects of velpatasvir on growth or postnatal development were observed in nursing pups at the highest dose tested in rats. maternal systemic exposure (auc) of velpatasvir was approximately 3 times the exposure in humans at the rhd. velpatasvir was present in the milk (approximately 173% that of maternal plasma concentrations) of lactating rats following a single oral dose of velpatasvir (30 mg/kg), and systemic exposure (auc) in nursing pups was approximately 4% that of maternal exposure on lactation day 10. voxilaprevir: no significant effects of voxilaprevir on growth or postnatal development were observed in nursing pups at the highest dose tested in rats. maternal systemic exposure (auc) of voxilaprevir was approximately 238 times the exposure in humans at the rhd, with exposure of approximately 58% that of maternal exposure observed in nursing pups on lactation day 10. safety and effectiveness of vosevi have not been established in pediatric patients. clinical trials of vosevi included 74 subjects aged 65 and over (17% of total number of subjects in the polaris-1 and polaris-4 phase 3 clinical trials). no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment of vosevi is warranted in geriatric patients [see clinical pharmacology (12.3)]. no dosage adjustment of vosevi is recommended for patients with mild, moderate, or severe renal impairment, including esrd requiring dialysis [see dosage and administration (2.3) and clinical pharmacology (12.3)]. no dosage adjustment of vosevi is recommended for patients with mild hepatic impairment (child-pugh a). vosevi is not recommended in patients with moderate or severe hepatic impairment (child-pugh b or c) due to the higher exposures of voxilaprevir (up to 6-fold in non-hcv infected subjects); the safety and efficacy have not been established in hcv-infected patients with moderate or severe hepatic impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. postmarketing cases of hepatic decompensation/failure have been reported in these patients [see warnings and precautions (5.2)].

United States - English - NLM (National Library of Medicine)

asegua therapeutics llc - velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 infection [see dosage and administration (2.2, 2.3, 2.4) and clinical studies (14)] : - without cirrhosis or with compensated cirrhosis - with decompensated cirrhosis for use in combination with ribavirin. sofosbuvir and velpatasvir and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2, 2.3, 2.4)]. risk summary if sofosbuvir and velpatasvir is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy. no adequate human data are available to establish wheth

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - sofosbuvir 400 mg - adult patients: sovaldi is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) infection as a component of a combination antiviral treatment regimen [see dosage and administration (2.2), and clinical studies (14)] - genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin - genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. pediatric patients: sovaldi is indicated for the treatment of chronic hcv genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see dosage and administration (2.3) and clinical studies (14.5)] . when sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. refer to the prescribing information of peginterfe

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - sofosbuvir 400 mg - adult patients: sovaldi is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) infection as a component of a combination antiviral treatment regimen [see dosage and administration (2.2), and clinical studies (14)] - genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis for use in combination with pegylated interferon and ribavirin - genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. pediatric patients: sovaldi is indicated for the treatment of chronic hcv genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin [see dosage and administration (2.3) and clinical studies (14.5)] . when sovaldi is used in combination with ribavirin or peginterferon alfa/ribavi

United States - English - NLM (National Library of Medicine)

asegua therapeutics llc - ledipasvir (unii: 013te6e4wv) (ledipasvir - unii:013te6e4wv), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) [see dosage and administration (2.2 and 2.3) and clinical studies (14)]: - genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis - genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin - genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin if ledipasvir and sofosbuvir is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2)] . risk summary if ledipasvir and sofosbuvir is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. refer to the ribavirin

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - velpatasvir 100 mg - epclusa is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 infection [see dosage and administration (2.2, 2.3, 2.4) and clinical studies (14)] : - without cirrhosis or with compensated cirrhosis - with decompensated cirrhosis for use in combination with ribavirin. epclusa and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2, 2.3, 2.4)]. risk summary if epclusa is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy. no adequate human data are available to establish whether or not epclusa poses a risk to pregnancy outcomes. in

United States - English - NLM (National Library of Medicine)

gilead sciences, inc. - velpatasvir (unii: kcu0c7rs7z) (velpatasvir - unii:kcu0c7rs7z), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - velpatasvir 100 mg - epclusa™ is indicated for the treatment of adults and pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 infection [see dosage and administration (2.2, 2.3, 2.4) and clinical studies (14)] : - without cirrhosis or with compensated cirrhosis - with decompensated cirrhosis for use in combination with ribavirin. epclusa and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2, 2.3, 2.4)]. risk summary if epclusa is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. refer to the ribavirin prescribing information

United States - English - NLM (National Library of Medicine)

gilead sciences, inc - ledipasvir (unii: 013te6e4wv) (ledipasvir - unii:013te6e4wv), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - ledipasvir 90 mg - harvoni is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis c virus (hcv) [see dosage and administration (2.2 and 2.3) and clinical studies (14)] : - genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis - genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin - genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin if harvoni is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and administration (2.2)] . risk summary if harvoni is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. refer to the ribavirin prescribing information for more information on ribav

United States - English - NLM (National Library of Medicine)

gilead sciences, inc - ledipasvir (unii: 013te6e4wv) (ledipasvir - unii:013te6e4wv), sofosbuvir (unii: wj6ca3zu8b) (sofosbuvir - unii:wj6ca3zu8b) - ledipasvir 90 mg - adult patients : harvoni is indicated for the treatment of adult patients with chronic hepatitis c virus (hcv) [see dosage and administration (2.2) and clinical studies (14)] : - genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis - genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin - genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin pediatric patients : harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kg with hcv genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis [see dosage and administration (2.3) and clinical studies (14.6)] . if harvoni is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see dosage and ad

Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - sofosbuvir, quantity: 400 mg; ledipasvir acetone solvate, quantity: 95.9 mg (equivalent: ledipasvir, qty 90 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; silicon dioxide; magnesium stearate; croscarmellose sodium; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - harvoni (ledipasvir/sofosbuvir fixed-dose combination) is indicated for the treatment of chronic hepatitis c (chc) infection in adults. (see precautions and clinical trials sections for information on the available data for hcv patients of each genotype, see dosage and administration section for recommended regimens and treatment durations for different patient subgroups).