Testmiljö
Observera att detta är en testmiljö för utveckling som inte ska användas som underlag för klinisk bedömning. Besök Janusmed här: https://janusmed.se

11/21/2024

Janusmed kön och genus

Janusmed kön och genus – Harvoni

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.

För att komma till startsidan för Janusmed kön och genus och för att göra sökningar klicka här.

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Ledipasvir Testmiljö

Ledipasvir

Klass : A

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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.]
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A A

Sofosbuvir Testmiljö

Sofosbuvir

Klass : A

Visa all info

Skriv ut

Kontakta oss

  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. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61:1127-35.

  4. Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368:1867-77.

  5. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878-87.

  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. Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clin Infect Dis. 2016;62:1489-96.

  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. Thornton K, Deming P, Manch RA, Moore A, Kohli A, Gish R et al. Is response guided therapy dead? Low cure rates in patients with detectable hepatitis C virus at week 4 of treatment. Hepatol Int. 2016 [Online article].

  12. Wu CJ, Roytman MM, Hong LK, Huddleston L, Trujillo R, Cheung A et al. Real-world Experience with Sofosbuvir-based Regimens for Chronic Hepatitis C, Including Patients with Factors Previously Associated with Inferior Treatment Response. Hawaii J Med Public Health. 2015;74:3-7.

  13. 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].

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

  15. Younossi ZM, Stepanova M, Estep M, Negro F, Clark PJ, Hunt S et al. Dysregulation of distal cholesterol biosynthesis in association with relapse and advanced disease in CHC genotype 2 and 3 treated with sofosbuvir and ribavirin. J Hepatol. 2016;64:29-36.

  16. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-06-30.]

  17. 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. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61:1127-35.
  4. Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368:1867-77.
  5. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878-87.
  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. Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clin Infect Dis. 2016;62:1489-96.
  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. Thornton K, Deming P, Manch RA, Moore A, Kohli A, Gish R et al. Is response guided therapy dead? Low cure rates in patients with detectable hepatitis C virus at week 4 of treatment. Hepatol Int. 2016 [Online article].
  12. Wu CJ, Roytman MM, Hong LK, Huddleston L, Trujillo R, Cheung A et al. Real-world Experience with Sofosbuvir-based Regimens for Chronic Hepatitis C, Including Patients with Factors Previously Associated with Inferior Treatment Response. Hawaii J Med Public Health. 2015;74:3-7.
  13. 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].
  14. HARVONI (ledipasvir/sofosbuvir). Summary of Product Characteristics. European Medicines Agency (EMA); 2016.
  15. Younossi ZM, Stepanova M, Estep M, Negro F, Clark PJ, Hunt S et al. Dysregulation of distal cholesterol biosynthesis in association with relapse and advanced disease in CHC genotype 2 and 3 treated with sofosbuvir and ribavirin. J Hepatol. 2016;64:29-36.
  16. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-06-30.]
  17. Sjukdomsstatistik. Solna: Folkhälsomyndigheten. 2016 [cited 2016-04-04.]