On Monday at the 2013 Conference on Retroviruses and Opportunistic Infections (CROI), results from the ELECTRON study showed 100% of its participants who had hepatitis C but not HIV had a sustained virologic response (SVR) from taking two new drugs (sofosbuvir, ledipasvir) along with ribavirin for 12 weeks. A total of 25 people new to treatment and 9 who were null responders (NPs, never reached undetectable HCV on earlier treatment) have so far maintained undetectable viral loads up to 4 weeks after treatment.
Given the significant side effects from regimens with interferon, this all-oral combination offers people with hepatitis C a simpler and shorter regimen with fewer side effects.
Everyone who enrolled had genotypes 1a and 1b and showed no signs of cirrhosis. About half were male, average age was 48, and nearly all were Caucasian. Average HCV viral loads were high at the start of the study and ranged between 6 and 7 logs. Surprisingly, only 9 of the treatment-naïve and none of the NPs had the favorable IL28B genotype of CC—a genetic mutation that favors a person reaching an SVR.
As seen in the chart below, all but 1 person had reached an undetectable HCV viral load by week 4. The study will continue to follow these individuals through 12 weeks after stopping treatment to see if the SVRs continue.
Common side effects included headache (4%), depression (8%) and mild-to-moderate anemia (20%). More troublesome side effects included bloody urine (36%, mostly women), severe anemia (20%) and increased coagulation (8%). One person stopped the study due to severe side effects.
Moving forward, the company that’s developing these two new drugs will study them combined as a single-dose pill. Other studies will look at the optimal duration of treatment and the possibility of taking ribavirin out of the regimen as well as treating people with cirrhosis.
The results to undetectable HCV viral load:
| Time of treatment | New to treatment (25) | Null responders (9) |
| Week 1 | 11 (44%) | 0 |
| Week 2 | 22 (88%) | 4 (44%) |
| Week 4 | 25 (100%) | 8 (88%) |
| Week 12 | 25 (100%) | 9 (100%) |
| SVR at week 4 | 25 (100%) | 9 (100%) |
SOURCE:
E. Gane, et al. ELECTRON: 100% Suppression of Viral Load through 4 Weeks’ Post-treatment for Sofosbuvir + Ledipasvir (GS-5885) + Ribavirin for 12 Weeks in Treatment-naïve and -experienced Hepatitis C Virus GT 1 Patients, 20th CROI, Atlanta 2013.