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WHO Issues Updated HCV Guidelines for Treatment

BARCELONA — Due to the rapid development and evolution of direct-acting viral treatments, WHO issued updated guidelines for the screening, care and treatment of individuals with chronic hepatitis C virus infection at the International Liver Congress.

WHO first issued recommendations in 2014, and since then, multiple direct-acting antivirals have been developed or are currently in the pipeline. The objective of the updated guidelines is to provide evidence-based recommendations for treating HCV using DAA-only combinations.

The recommended guidelines are geared toward policy-makers in low- and middle-income countries who formulate country-specific treatment guidelines and who plan infectious disease treatment programs and services, as well as clinicians responsible for providing treatment, according to the guidelines. They are intended to promote the “scale-up of HCV treatment”, more specifically among people in low- and middle-income countries, where very few have access to these new treatments.

As of October 2015, eight separate DAAs have been approved for the treatment of HCV: asunaprevir (Bristol-Myers Squibb), Daklinza (daclatasvir, Bristol-Myers Squibb), dasabuvir (AbbVie), ledipasvir (Gilead Sciences), Olysio (simeprevir, Janssen Pharmaceuticals), ombitasvir (AbbVie), paritaprevir (AbbVie) and Sovaldi (sofosbuvir, Gilead Sciences). Taking these into consideration, WHO recommends: 

1. DAA regimens be used for treating HCV instead of regimens with pegylated interferon and ribavirin. However, for patients with HCV genotype 3 with cirrhosis and patients with HCV genotypes 5 and 6 with and without cirrhosis, an interferon-based regimen [sofosbuvir/pegylated interferon plus ribavirin] is still recommended as an alternative treatment option, according to the guidelines.
2. Regimens containing Incivek (telaprevir, Vertex Pharmaceuticals) or Victrelis (boceprevir, Merck) are no longer recommended for treating HCV.   
3. In patients without cirrhosis, daclatasvir/sofosbuvir for 12 weeks or Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) for 12 weeks is the preferred, recommended regimen for HCV genotype 1; sofosbuvir/ribavirin for 12 weeks for genotype 2; daclatasvir/sofosbuvir for 12 weeks or sofosbuvir/ribavirin for 24 weeks for genotype 3; daclatasvir/sofosbuvir for 12 weeks or ledipasvir/sofosbuvir for 12 weeks for genotype 4; and ledipasvir/sofosbuvir for 12 weeks for genotypes 5 and 6.
4. In patients with cirrhosis, daclatasvir/sofosbuvir for 24 weeks, ledipasvir/sofosbuvir for 24 weeks, daclatasvir/sofosbuvir/ribavirin for 12 weeks or ledipasvir/sofosbuvir/ribavirin for 12 weeks is recommended for genotype 1; sofosbuvir/ribavirin for 16 weeks for genotype 2; daclatasvir/sofosbuvir/ribavirin for 24 weeks for genotype 3; daclatasvir/sofosbuvir for 24 weeks, ledipasvir/sofosbuvir for 24 weeks, daclatasvir/sofosbuvir/ribavirin for 12 weeks or ledipasvir/sofosbuvir/ribavirin for 12 weeks for genotype 4; and ledipasvir/sofosbuvir for 24 weeks or ledipasvir/sofosbuvir/ribavirin for 12 weeks for genotypes 5 and 6.
5. The recommendations note that treatment may be shortened in treatment-naive patients without cirrhosis if their HCV RNA level is below 6.8 log IU/mL.
6. Twenty-four weeks of treatment with ribavirin if platelet count is less than 75 x 103/µL.
7. Alternative treatment regimens for patients without cirrhosis include: simeprevir/sofosbuvir or Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, AbbVie) for 12 weeks for genotype 1; daclatasvir/sofosbuvir for 12 weeks for genotype 2; no treatment for genotype 3; simeprevir/sofosbuvir or ombitasvir/paritaprevir/ritonavir/ribavirin for 12 weeks for genotype 4; and sofosbuvir/pegylated interferon/ribavirin for genotypes 5 and 6.
8. The recommendations note that if patients with genotype 1a (with or without cirrhosis) test positive for the Q80K variant, a simeprevir/sofosbuvir regimen should not be used. HCV genotype 1a patients should be treated with ombitasvir/paritaprevir/ritonavir/dasabuvir/ribavirin and genotype 1b patients should be treated with ombitasvir/paritaprevir/ritonavir/dasabuvir.
9. Alternative treatment regimens for patients with cirrhosis include: simeprevir/sofosbuvir or ombitasvir/paritaprevir/ritonavir/dasabuvir for 24 weeks, or simeprevir/sofosbuvir/ribavirin for 12 weeks for genotype 1; daclatasvir/sofosbuvir for 12 weeks for genotype 2; sofosbuvir/pegylated interferon/ribavirin for 12 weeks for genotype 3; simeprevir/sofosbuvir or ombitasvir/paritaprevir/ritonavir/ribavirin for 24 weeks, or simeprevir/sofosbuvir/ribavirin for 12 weeks for genotype 4; and sofosbuvir/pegylated interferon/ribavirin for 12 weeks for genotypes 5 and 6.
10. The recommendations note that daclatasvir/sofosbuvir can be prescribed to patients with genotype 2 with compensated or decompensated cirrhosis. All other regimens are recommended for patients with compensated cirrhosis only due to potential development of liver failure or mortality in decompensated patients.
11. HCV genotype 1a patients should be treated with ombitasvir/paritaprevir/ritonavir/dasabuvir/ribavirin for 24 weeks and genotype 1b patients should be treated with ombitasvir/paritaprevir/ritonavir/dasabuvir/ribavirin for 12 weeks. 

The organization also notes that “implementation of the recommendations may not be immediate,” since new treatments are expensive and may not have gained regulatory approval in certain countries yet.

For more information:

http://www.who.int/hiv/pub/hepatitis/hepatitis-c-guidelines/en/