6/7/2025

Janusmed sex and gender

Janusmed sex and gender – Ledipasvir

Janusmed Sex and Gender is a knowledge database providing information on sex and gender aspects of drug treatment. The knowledge database is primarily intended to be used by physicians and healthcare professionals. The texts are general and should not be considered as treatment guidelines. The individual patient’s physician is responsible for the patient’s drug treatment.

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Ledipasvir

Ledipasvir

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  1. 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.

  2. 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.

  3. 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].

  4. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - HARVONI (ledipasvir/sofosbuvir) [updated 2014-11-03].

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. HARVONI (ledipasvir/sofosbuvir). Summary of Product Characteristics. European Medicines Agency (EMA); 2016.

  12. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-08-02.]

  13. Sjukdomsstatistik. Solna: Folkhälsomyndigheten. 2016 [cited 2016-04-04.]

  1. 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.
  2. 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.
  3. 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].
  4. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - HARVONI (ledipasvir/sofosbuvir) [updated 2014-11-03].
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. HARVONI (ledipasvir/sofosbuvir). Summary of Product Characteristics. European Medicines Agency (EMA); 2016.
  12. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-08-02.]
  13. Sjukdomsstatistik. Solna: Folkhälsomyndigheten. 2016 [cited 2016-04-04.]