Hospital Pharmacy - April 2018 - 83

Levien and Baker
Table 5. Treatment Duration for Glecaprevir/Pibrentasvir.1
Treatment duration
HCV genotype

Prior treatment

No cirrhosis

Compensated cirrhosis
(child-Pugh A)

1, 2, 3, 4, 5 or 6
1

None
NS5A inhibitor without an NS3/4A protease inhibitor
NS3/4A protease inhibitor without an NS5A inhibitor
Interferon, peginterferon, ribavirin, and/or sofosbuvir,
but no NS3/4A protease inhibitor or NS5A inhibitor
Interferon, peginterferon, ribavirin, and/or sofosbuvir,
but no NS3/4A protease inhibitor or NS5A inhibitor

8 wk
16 wk
12 wk
8 wk

12 wk
16 wk
12 wk
12 wk

16 wk

1, 2, 4, 5, or 6
3

Note. HCV = hepatitis C virus.

amlodipine, buprenorphine, caffeine, dextromethorphan,
dolutegravir, elvitegravir/cobicistat, emtricitabine, felodipine, lamivudine, lamotrigine, losartan, methadone, midazolam, naloxone, norethindrone or other progestin-only
contraceptives, omeprazole, raltegravir, rilpivirine, sofosbuvir, tacrolimus, tenofovir alafenamide, tenofovir disoproxil
fumarate, tolbutamide, and valsartan.1,22,23

Recommended Monitoring
Before initiating treatment with glecaprevir/pibrentasvir,
patients should be tested for evidence of current or prior
HBV infection by measuring hepatitis B surface antigen
(HBsAg) and hepatitis B core antibody (anti-HBc).1

Dosing
The recommended dosage is 3 tablets taken once daily with
food (total daily dose, glecaprevir 300 mg/pibrentasvir 120
mg). Treatment duration varies from 8 weeks to 16 weeks,
depending on previous treatment and the presence of cirrhosis
(see Table 5).1
No dosing adjustments are necessary for patients with
mild, moderate, or severe renal impairment, including those
on dialysis.1 No dosing adjustments are necessary for patients
with mild hepatic impairment (Child-Pugh A). Use in patients
with moderate hepatic impairment (Child-Pugh B) is not recommended, and use is contraindicated in patients with severe
hepatic impairment (Child-Pugh C).1

Product Availability
Glecaprevir/pibrentasvir received FDA approval in August
2017.14 It is available as a fixed-dose combination tablet containing glecaprevir 100 mg and pibrentasvir 40 mg, and is
supplied in 4-week or 8-week cartons. Each weekly carton
contains 7 child-resistant daily dose wallets of 3 tablets
each.1 Tablets should be stored at or below 30°C (86°F) in
the original blister package until administered.1

Drug Safety/Risk Evaluation and
Mitigation Strategy (REMS)
No REMS is required for glecaprevir/pibrentasvir.14

Conclusion
Glecaprevir/pibrentasvir is approved for treatment of
patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (ChildPugh A), and for the treatment of patients with HCV
genotype 1 infection who have previously been treated with
a regimen containing an HCV NS5A inhibitor or an NS3/4A
protease inhibitor, but not both. In clinical trials of HCV
patients, glecaprevir/pibrentasvir produced high SVR12
rates in treatment-naive and treatment-experienced patients
with renal impairment, prior renal and liver transplant, or
coinfection with HIV-1. Glecaprevir/pibrentasvir has demonstrated good tolerability but is associated with drug interactions that may limit its use in certain patients.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

References
1. Mavyret (glecaprevir/pibrentasvir) [prescribing information].
North Chicago, IL: AbbVie Inc; August 2017.
2. Epclusa (sofosbuvir/velpatasvir) [prescribing information].
Foster City, CA: Gilead Sciences Inc; August 2017.
3. Vosevi (sofosbuvir/velpatasvir/voxilaprevir) [prescribing
information]. Foster City, CA: Gilead Sciences Inc; July 2017.
4. Ng TI, Krishnan P, Pilot-Matias T, et al. In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus

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