10/14/2025

Janusmed kön och genus

Janusmed kön och genus – Ledipasvir

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Ledipasvir

Ledipasvir

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  1. 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.

  2. 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.

  3. Sjukdomsstatistik. Solna: Folkhälsomyndigheten. 2025 [cited 2025-09-22.]

  4. 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].

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

  6. Harvoni (ledipasvir/sofosbuvir). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2022-10-11, cited 2025-06-18].

  7. Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM et al. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014;146:736-743e1.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2024 [cited 2025-04-23.]

  1. 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.
  2. 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.
  3. Sjukdomsstatistik. Solna: Folkhälsomyndigheten. 2025 [cited 2025-09-22.]
  4. 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].
  5. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - HARVONI (ledipasvir/sofosbuvir) [updated 2014-11-03].
  6. Harvoni (ledipasvir/sofosbuvir). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2022-10-11, cited 2025-06-18].
  7. Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM et al. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014;146:736-743e1.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2024 [cited 2025-04-23.]