Ledipasvir
Ledipasvir
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Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879-88.
O'Brien TR, Lang Kuhs KA, Pfeiffer RM. Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C. Open Forum Infect Dis. 2014;1:ofu110.
Committee for Medicinal Products for Human Use (CHMP). Assessment report Harvoni Procedure No EMEA/H/C/003850/0000. European Medicines Agency (EMA) [updated 2014-09-25, cited 2016-07-22].
Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - HARVONI (ledipasvir/sofosbuvir) [updated 2014-11-03].
Piola P, Nabasumba C, Turyakira E, Dhorda M, Lindegardh N, Nyehangane D et al. Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial. Lancet Infect Dis. 2010;10:762-9.
Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483-93.
Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889-98.
Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ et al. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015;373:705-13.
Walker DR, Pedrosa MC, Manthena SR, Patel N, Marx SE. Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV). Adv Ther. 2015;32:1117-27.
Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 US Veterans. Aliment Pharmacol Ther. 2015;42:559-73.
HARVONI (ledipasvir/sofosbuvir). Summary of Product Characteristics. European Medicines Agency (EMA); 2016.
Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-08-02.]
Sjukdomsstatistik. Solna: Folkhälsomyndigheten. 2016 [cited 2016-04-04.]
- Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879-88.
- O'Brien TR, Lang Kuhs KA, Pfeiffer RM. Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C. Open Forum Infect Dis. 2014;1:ofu110.
- Committee for Medicinal Products for Human Use (CHMP). Assessment report Harvoni Procedure No EMEA/H/C/003850/0000. European Medicines Agency (EMA) [updated 2014-09-25, cited 2016-07-22].
- Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - HARVONI (ledipasvir/sofosbuvir) [updated 2014-11-03].
- Piola P, Nabasumba C, Turyakira E, Dhorda M, Lindegardh N, Nyehangane D et al. Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial. Lancet Infect Dis. 2010;10:762-9.
- Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483-93.
- Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889-98.
- Naggie S, Cooper C, Saag M, Workowski K, Ruane P, Towner WJ et al. Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015;373:705-13.
- Walker DR, Pedrosa MC, Manthena SR, Patel N, Marx SE. Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV). Adv Ther. 2015;32:1117-27.
- Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 US Veterans. Aliment Pharmacol Ther. 2015;42:559-73.
- HARVONI (ledipasvir/sofosbuvir). Summary of Product Characteristics. European Medicines Agency (EMA); 2016.
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-08-02.]
- Sjukdomsstatistik. Solna: Folkhälsomyndigheten. 2016 [cited 2016-04-04.]