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Novel HCV Regimens Provide Hope for Managing Opiate Addiction
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Two studies presented at recent conferences provided hope that novel drug regimens, including Bristol-Myers Squibb’s daclatasvir and AbbVie’s 3D combination, can be safely administered in patients who are receiving treatment for opiate addiction.
At AIDS 2014, the 20th International AIDS Conference held in Melbourne, Australia, in July, Lalezari and colleagues presented data from a study of 38 patients receiving methadone or buprenorphine who had hepatitis C virus genotype 1 infection and no evidence of cirrhosis. The 3D plus ribavirin regimen included two tablets of the co-formulation of ABT-450 boosted with ritonavir and ombitasvir twice a day, one tablet of dasabuvir once a day and weight-based ribavirin. Sustained virologic response at 12 weeks in an intention-to-treat analysis served as the primary outcome measure.
After one patient dropped out due to adverse events unrelated to the study regimen, all of the remaining patients (97.4%) reached SVR12. No virologic failures were reported. The researchers concluded that the 3D plus ribavirin regimen was well tolerated and effective among patients on stable methadone or buprenorphine therapy.
At IDWeek 2014, Garimella and colleagues reported findings from an open-label study that investigated the pharmacokinetic and pharmacodynamics impact of daclatasvir on patients who were receiving methadone or buprenorphine/naloxone. Fourteen patients received a single-dose oral formulation of methadone (40 to 120 mg) and 11 received buprenorphine/naloxone (8/2 mg to 24/6 mg). All patients received daclatasvir 60 mg once a day on days 2 through 9 of the study.
The researchers observed no clinically meaningful effect of daclatasvir on methadone or buprenorphine/naloxone. Adverse events were mild and easily resolved. Garimella and colleagues concluded that steady-state administration of daclatasvir 60 mg was safe in this patient population, with no need for dose adjustment.
References:
Garimella T. Abstract #1166. Presented at: IDWeek 2014; Oct. 8-12, 2014; Philadelphia.Lalezari J. Abstract #MOAB0103. Presented at: AIDS 2014; July 20-25, 2014; Melbourne.
Disclosures: Garimella and colleagues report associations with Bristol-Myers Squibb. Lalezari and colleagues report associations with AbbVie and Quest Clinical Research.