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08/07/17

8 is the New 12: Shorter Treatment for HCV Coinfection


On August 3, 2017, the US Food and Drug Administration approved a once-daily, pan-genotypic, ribavirin-free fixed-dose combination of glecaprevir (an HCV protease inhibitor) and pibrentasvir (an HCV NS5A inhibitor), called Mavyret. It is used for 8 weeks in non-cirrhotic, treatment-naive adults; duration is extended for 12 to 16 weeks for people with cirrhosis and/or treatment-experience.(1)
Glecaprevir/pibrentasvir has been studied in HIV/HCV; the phase 3 ENDURANCE-1 trial included 33 HIV-positive people coinfected with HCV genotype 1. They were treated for 8 or 12 weeks; 100% were cured.(2) EXPEDITION-2, a 153-person phase 3 trial of glecaprevir/pibrentasvir in HIV-positive adults coinfected with genotypes 1,2,3,4 and 6, enrolled participants were HCV treatment-naive, (except for genotype 3) and treatment-experienced (past use of standard or pegylated interferon, ribavirin, sofosbuvir); 16 had compensated cirrhosis. Duration of treatment for non-cirrhotic participants was 8 weeks, while participants with compensated cirrhosis (n=16) were treated for 12 weeks.

Most participants (93%) were receiving antiretroviral therapy, with dolutegravir, elvitegravir/ cobisistat, rilpivirine, raltegravir with allowed nucleoside/tide reverse transcriptase inhibitors (abacavir; emtricitabine; lamivudine; tenofovir alafenamide and tenofovir disoproxil fumarate). Non-cirrhotic participants could also use boosted darunavir or lopinavir/r (although not recommended, due to drug interactions).(1)
The median CD4 cell count among non-cirrhotic participants was 588 cells/mm3 (range, 154- 2103); it was similar in cirrhotic participants (545 cells/mm3, range 222 – 1806).

Overall, 98% (150/153) were cured; there was 1 discontinuation, 1 viral breakthrough during treatment, and one person (who was cured) did not return for follow-up until post-treatment week 24. None of the serious adverse events were treatment-related; the most common side effects were fatigue, headache, nausea and nasopharygitis.(3)

References:
1.Mayvret. Highlights of prescribing information [Online] 2017 [Cited 2017 August 4] Available from: http://www.rxabbvie.com/pdf/mavyret_pi.pdf?_ga=2.133464590.1024817839.1501870557-600235720.1399220105
2. Zeuzem S, Feld J, Wang S, et al. ENDURANCE-1: A phase 3 evaluation of the efficacy and safety of 8- versus 12-week treatment with glecaprevir/pibrentasvir (formerly ABT-493/ABT-530) in HCV genotype 1 infected patients with or without HIV-1 co-infection and without cirrhosis. (Abstract 253) American Association for the Study of Liver Disease Meeting 11-15 November 2016. Boston, USA.
3. Rockstroh JL, Lacombe K, Viani R, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 study (Abstract 918). 9th International AIDS Society Conference on HIV Science. 23-26 July 2017. Paris. France.


Source: Reporting from Paris for the PRN News: Tracy Swan