Testmiljö
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4/9/2025

Janusmed kön och genus

Janusmed kön och genus – Entecavir Accord

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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Entekavir Testmiljö

Entekavir

Klass : A

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Produkter

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Baraclude, Entecavir Accord, Entecavir Amarox, Entecavir Glenmark, Ent......

Baraclude, Entecavir Accord, Entecavir Amarox, Entecavir Glenmark, Entecavir Medical Valley, Entecavir STADA, Entecavir Sandoz, Entecavir Teva, Entecavir Viatris, Entekavir Ebb
ATC-koder

J05AF10

J05AF10
Substanser

entekavir, entekavirmonohydrat

entekavir, entekavirmonohydrat
Sammanfattning

Även om en mindre andel kvinnor har inkluderats i studierna har effekt av entekavir visats för både kvinnor och män. Vissa studier har rapporterat bättre virologisk effekt hos kvinnor men evidensen är begränsad. Det finns en ökad risk för laktacidos för kvinnor, i synnerhet obesa vilket måste beaktas.

Även om en mindre andel kvinnor har inkluderats i studierna har effekt av entekavir visats för både kvinnor och män. Vissa studier har rapporterat bättre virologisk effekt hos kvinnor men evidensen är begränsad. Det finns en ökad risk för laktacidos för kvinnor, i synnerhet obesa vilket måste beaktas.
Background

Antiretrovirals for treatment of HIV are always given as a combination of at least three medicines. Cobicistat is used to boost the effect of other antiretroviral drugs. As studies on HIV patients always include patients receiving combination therapy it is difficult to know which of the studied medicines that cause changes in effect and/or adverse events.

Pharmacokinetics and dosing
The manufacturer does not recommend different dosing in men and women although kidney function needs to be considered [1]. In the SPC the AUC is reported to be 14% higher in women than in men, a difference that did not remain after adjusting for creatinine clearance and body weight [1].

Effects
Effect of entecavir has been shown in both men and women although the proportion of women in the studies has been rather low (25%) [1]. Some studies have found a better response in women than in men treated with entecavir for chronic hepatitis B. A registry based cohort study in patients treated with entecavir or tenofovir (923 men, 402 women) found the risk of hepatocellular carcinoma to be higher in men (HR 5......

Visa hela bakgrundstexten

Antiretrovirals for treatment of HIV are always given as a combination of at least three medicines. Cobicistat is used to boost the effect of other antiretroviral drugs. As studies on HIV patients always include patients receiving combination therapy it is difficult to know which of the studied medicines that cause changes in effect and/or adverse events. # Pharmacokinetics and dosing The manufacturer does not recommend different dosing in men and women although kidney function needs to be considered [1]. In the SPC the AUC is reported to be 14% higher in women than in men, a difference that did not remain after adjusting for creatinine clearance and body weight [1]. # Effects Effect of entecavir has been shown in both men and women although the proportion of women in the studies has been rather low (25%) [1]. Some studies have found a better response in women than in men treated with entecavir for chronic hepatitis B. A registry based cohort study in patients treated with entecavir or tenofovir (923 men, 402 women) found the risk of hepatocellular carcinoma to be higher in men (HR 5, 95%CI 1.8-13.9). Other associated risk factors were lower platelet, higher age and presence of cirrhosis [2].A Polish study for of correlation between efficacy of antiviral therapy and prevalence of hepatitis B virus pretreatment drug-resistant variants in patients treated with lamivudine only (55%) or in combination with adefovir (2%), entecavir (30%), or tenofovir (13%) (29 men, 25 women) found good response to antiviral therapy to be more common in women. Other positive predictors of good response were younger age, immunocompetence, a low viral load, and higher ALT activity [3]. In contrast to this, in a study from Taiwan, patients with chronic hepatitis B were treated with lamivudine, telbivudine, or entecavir (65 men, 15 women) (14 on lamivudine, 19 on telbivudine, and 47 on entecavir) no differences between men and women were found in relapse rate, cirrhosis or ALT levels [4].  # Adverse effects A prospective study of patients with chronic Hepatitis B (69 men, 38 women) treated with lamivudine (7.5%), tenofovir (35.5%), entecavir (31.8%) or combined treatment (25.2%) found a significant trend for developing lactic acidosis over time in women with cirrhosis [5]. The risk was particularly high in obese women. The products Summary cautions when using entecavir in obese women due to the risk of lactic acidosis [1]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept

Visa hela försäljning på recept

Fler män än kvinnor hämtade ut läkemedel innehållande entekavir (ATC-kod J05AF10) på recept i Sverige år 2017, totalt 531 män och 254 kvinnor [6].
Referenser

Visa referenser

  1. Baraclude (entecavir). Summaru of Product Characteristics. European Medicines Agency (EMA); 2018

  2. Papatheodoridis G, Dalekos G, Sypsa V, Yurdaydin C, Buti M, Goulis J et al. PAGE-B predicts the risk of developing hepatocellular carcinoma in Caucasians with chronic hepatitis B on 5-year antiviral therapy. J Hepatol. 2016;64(4):800-6.

  3. Stalke P, Rybicka M, Wróblewska A, Dreczewski M, Stracewska E, Smiatacz T et al. An initial assessment of correlations between host- and virus-related factors affecting analogues antiviral therapy in HBV chronically infected patients. Med Sci Monit. 2014;20(1):321-8.

  4. Lin CC, Bair MJ, Chen CJ, Lee KH, Chen MJ, Liu CY et al. Off-treatment efficacy of 3-year nucleos(t)ide analogues in chronic hepatitis B patients. Kaohsiung J Med Sci. 2016;32(1):10-5.

  5. Triantos C, Kalafateli M, Aggeletopoulou I, Mandellou M, Assimakopoulos S, Tselekouni P et al. Lactate serum concentrations during treatment with nucleos(t)ide analogues in hepatitis B with or without cirrhosis. Eur J Gastroenterol Hepatol. 2017;29(9):998-1003.

  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.]

  1. Baraclude (entecavir). Summaru of Product Characteristics. European Medicines Agency (EMA); 2018
  2. Papatheodoridis G, Dalekos G, Sypsa V, Yurdaydin C, Buti M, Goulis J et al. PAGE-B predicts the risk of developing hepatocellular carcinoma in Caucasians with chronic hepatitis B on 5-year antiviral therapy. J Hepatol. 2016;64(4):800-6.
  3. Stalke P, Rybicka M, Wróblewska A, Dreczewski M, Stracewska E, Smiatacz T et al. An initial assessment of correlations between host- and virus-related factors affecting analogues antiviral therapy in HBV chronically infected patients. Med Sci Monit. 2014;20(1):321-8.
  4. Lin CC, Bair MJ, Chen CJ, Lee KH, Chen MJ, Liu CY et al. Off-treatment efficacy of 3-year nucleos(t)ide analogues in chronic hepatitis B patients. Kaohsiung J Med Sci. 2016;32(1):10-5.
  5. Triantos C, Kalafateli M, Aggeletopoulou I, Mandellou M, Assimakopoulos S, Tselekouni P et al. Lactate serum concentrations during treatment with nucleos(t)ide analogues in hepatitis B with or without cirrhosis. Eur J Gastroenterol Hepatol. 2017;29(9):998-1003.
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.]
Uppdaterat

Litteratursökningsdatum: 7/18/2018

Litteratursökningsdatum: 7/18/2018
A A
A A

Entekavir Testmiljö

Entekavir

Klass : A

Visa all info

Skriv ut

Kontakta oss

Produkter

Visa alla produkter

Baraclude, Entecavir Accord, Entecavir Amarox, Entecavir Glenmark, Ent......

Baraclude, Entecavir Accord, Entecavir Amarox, Entecavir Glenmark, Entecavir Medical Valley, Entecavir STADA, Entecavir Sandoz, Entecavir Teva, Entecavir Viatris, Entekavir Ebb
ATC-koder

J05AF10

J05AF10
Substanser

entekavir, entekavirmonohydrat

entekavir, entekavirmonohydrat
Sammanfattning

Även om en mindre andel kvinnor har inkluderats i studierna har effekt av entekavir visats för både kvinnor och män. Vissa studier har rapporterat bättre virologisk effekt hos kvinnor men evidensen är begränsad. Det finns en ökad risk för laktacidos för kvinnor, i synnerhet obesa vilket måste beaktas.

Även om en mindre andel kvinnor har inkluderats i studierna har effekt av entekavir visats för både kvinnor och män. Vissa studier har rapporterat bättre virologisk effekt hos kvinnor men evidensen är begränsad. Det finns en ökad risk för laktacidos för kvinnor, i synnerhet obesa vilket måste beaktas.
Background

Antiretrovirals for treatment of HIV are always given as a combination of at least three medicines. Cobicistat is used to boost the effect of other antiretroviral drugs. As studies on HIV patients always include patients receiving combination therapy it is difficult to know which of the studied medicines that cause changes in effect and/or adverse events.

Pharmacokinetics and dosing
The manufacturer does not recommend different dosing in men and women although kidney function needs to be considered [1]. In the SPC the AUC is reported to be 14% higher in women than in men, a difference that did not remain after adjusting for creatinine clearance and body weight [1].

Effects
Effect of entecavir has been shown in both men and women although the proportion of women in the studies has been rather low (25%) [1]. Some studies have found a better response in women than in men treated with entecavir for chronic hepatitis B. A registry based cohort study in patients treated with entecavir or tenofovir (923 men, 402 women) found the risk of hepatocellular carcinoma to be higher in men (HR 5......

Visa hela bakgrundstexten

Antiretrovirals for treatment of HIV are always given as a combination of at least three medicines. Cobicistat is used to boost the effect of other antiretroviral drugs. As studies on HIV patients always include patients receiving combination therapy it is difficult to know which of the studied medicines that cause changes in effect and/or adverse events. # Pharmacokinetics and dosing The manufacturer does not recommend different dosing in men and women although kidney function needs to be considered [1]. In the SPC the AUC is reported to be 14% higher in women than in men, a difference that did not remain after adjusting for creatinine clearance and body weight [1]. # Effects Effect of entecavir has been shown in both men and women although the proportion of women in the studies has been rather low (25%) [1]. Some studies have found a better response in women than in men treated with entecavir for chronic hepatitis B. A registry based cohort study in patients treated with entecavir or tenofovir (923 men, 402 women) found the risk of hepatocellular carcinoma to be higher in men (HR 5, 95%CI 1.8-13.9). Other associated risk factors were lower platelet, higher age and presence of cirrhosis [2].A Polish study for of correlation between efficacy of antiviral therapy and prevalence of hepatitis B virus pretreatment drug-resistant variants in patients treated with lamivudine only (55%) or in combination with adefovir (2%), entecavir (30%), or tenofovir (13%) (29 men, 25 women) found good response to antiviral therapy to be more common in women. Other positive predictors of good response were younger age, immunocompetence, a low viral load, and higher ALT activity [3]. In contrast to this, in a study from Taiwan, patients with chronic hepatitis B were treated with lamivudine, telbivudine, or entecavir (65 men, 15 women) (14 on lamivudine, 19 on telbivudine, and 47 on entecavir) no differences between men and women were found in relapse rate, cirrhosis or ALT levels [4].  # Adverse effects A prospective study of patients with chronic Hepatitis B (69 men, 38 women) treated with lamivudine (7.5%), tenofovir (35.5%), entecavir (31.8%) or combined treatment (25.2%) found a significant trend for developing lactic acidosis over time in women with cirrhosis [5]. The risk was particularly high in obese women. The products Summary cautions when using entecavir in obese women due to the risk of lactic acidosis [1]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept

Visa hela försäljning på recept

Fler män än kvinnor hämtade ut läkemedel innehållande entekavir (ATC-kod J05AF10) på recept i Sverige år 2017, totalt 531 män och 254 kvinnor [6].
Referenser

Visa referenser

  1. Baraclude (entecavir). Summaru of Product Characteristics. European Medicines Agency (EMA); 2018

  2. Papatheodoridis G, Dalekos G, Sypsa V, Yurdaydin C, Buti M, Goulis J et al. PAGE-B predicts the risk of developing hepatocellular carcinoma in Caucasians with chronic hepatitis B on 5-year antiviral therapy. J Hepatol. 2016;64(4):800-6.

  3. Stalke P, Rybicka M, Wróblewska A, Dreczewski M, Stracewska E, Smiatacz T et al. An initial assessment of correlations between host- and virus-related factors affecting analogues antiviral therapy in HBV chronically infected patients. Med Sci Monit. 2014;20(1):321-8.

  4. Lin CC, Bair MJ, Chen CJ, Lee KH, Chen MJ, Liu CY et al. Off-treatment efficacy of 3-year nucleos(t)ide analogues in chronic hepatitis B patients. Kaohsiung J Med Sci. 2016;32(1):10-5.

  5. Triantos C, Kalafateli M, Aggeletopoulou I, Mandellou M, Assimakopoulos S, Tselekouni P et al. Lactate serum concentrations during treatment with nucleos(t)ide analogues in hepatitis B with or without cirrhosis. Eur J Gastroenterol Hepatol. 2017;29(9):998-1003.

  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.]

  1. Baraclude (entecavir). Summaru of Product Characteristics. European Medicines Agency (EMA); 2018
  2. Papatheodoridis G, Dalekos G, Sypsa V, Yurdaydin C, Buti M, Goulis J et al. PAGE-B predicts the risk of developing hepatocellular carcinoma in Caucasians with chronic hepatitis B on 5-year antiviral therapy. J Hepatol. 2016;64(4):800-6.
  3. Stalke P, Rybicka M, Wróblewska A, Dreczewski M, Stracewska E, Smiatacz T et al. An initial assessment of correlations between host- and virus-related factors affecting analogues antiviral therapy in HBV chronically infected patients. Med Sci Monit. 2014;20(1):321-8.
  4. Lin CC, Bair MJ, Chen CJ, Lee KH, Chen MJ, Liu CY et al. Off-treatment efficacy of 3-year nucleos(t)ide analogues in chronic hepatitis B patients. Kaohsiung J Med Sci. 2016;32(1):10-5.
  5. Triantos C, Kalafateli M, Aggeletopoulou I, Mandellou M, Assimakopoulos S, Tselekouni P et al. Lactate serum concentrations during treatment with nucleos(t)ide analogues in hepatitis B with or without cirrhosis. Eur J Gastroenterol Hepatol. 2017;29(9):998-1003.
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.]
Uppdaterat

Litteratursökningsdatum: 7/18/2018

Litteratursökningsdatum: 7/18/2018