Results from a recently released study show that HIV and Hepatitis-C virus (HCV) co-infected patients who had not previously been treated for hepatitis C, but received 12 weeks of treatment with sofosbuvir and daclastasvir achieved a 97 percent cure rate. The study, entitled, “Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1,” was published in the latest on-line edition of the New England Journal of Medicine.
This study was the result of a collaborative effort across multiple institutions, including the University of Cincinnati (UC) College of Medicine, with the objective to assess the efficacy and safety of a therapeutic strategy that included both sofosbuvir and a new drug agent known as daclastasvir in patients coinfected with HIV.
To conduct this assessment the researchers enrolled 151 co-infected patients who had not received HCV treatment and 52 previously treated co-infected patients, and randomized them into different treatment groups, that included:
- Untreated patients assigned in a 2:1 ratio to receive 12 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily
- Untreated patients assigned in a 2:1 ratio to receive 8 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily
- Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses.
The findings showed that the tested therapeutic combination was indeed both efficacious and safe, and included the following results:
- Rates of sustained treatment response across all HCV genotypes were 97.0%
- Among patients with certain HCV genotypes, a sustained treatment response was reported in 96.4% who were treated for 12 weeks and in 75.6% who were treated for 8 weeks
- The most common adverse events were fatigue, nausea, and headache
- There were no study-drug discontinuations because of adverse events. HIV-1 suppression was not compromised.
In a University press release about the study, Dr. Kenneth Sherman, MD, PhD, Director of the Division of Digestive Diseases, UC College of Medicine, and study co-author, stated, “This regimen was compatible with almost all HIV drug regimens and that made it relatively unique. We are treating patients who have hepatitis C along with HIV, which have long been considered one of the most difficult groups of patients to treat and manage and in part that’s because of drug interactions between the drugs used to treat HIV and the drugs used to treat hepatitis C.”
Dr. Sherman added, “The shortened therapy demonstrated had good results,” says Sherman. “Two years ago this would have been regarded as excellent and nothing short of incredible. Now we were are looking for rates of 90 percent or better.”