On June 28, 2016, Epclusa (ep-Kloo-suh)—a combination of two drugs—sofosbuvir, a polymerase inhibitor, and velpatasvir, an NS5A inhibitor, was approved by the Food and Drug Administration (FDA) to treat adults infected with chronic hepatitis C (HCV) genotype 1, 2, 3, 4, 5 and 6. It is taken with and without ribavirin. It is combined into one pill taken once-a-day. It can be taken with and without food. Epclusa is manufactured by Gilead Sciences INC. The treatment duration is 12 weeks.
All genotypes – Epclusa is the first HCV medication that can successfully treat all six genotypes.
No ribavirin for most people – the cure rates are from 97% to 100% in those without cirrhosis or with compensated cirrhosis. Ribavirin is still needed for those with decompensated cirrhosis, but the treatment duration is the same and the cure rates are 85% to 100%.
Genotype testing – Epclusa cures all HCV genotypes at very high rates and for the same duration. This eliminates the need for expensive genotype testing.
High cure rates for genotype 3 – The clinical trials of people without cirrhosis or compensated cirrhosis achieved cure rates of 95%. In people with decompensated cirrhosis the addition of ribavirin to Epclusa produced 85% cure rates. Previous therapies produced suboptimal cure rates and treatment duration was 24 weeks especially for people with cirrhosis.
Genotype 2 – in clinical trials of Epclusa (without ribavirin) people without cirrhosis or with compensated cirrhosis the cure rate was 100%. In people with decompensated cirrhosis the addition of ribavirin increased the cure rate to 100%. Previously, treatment for all genotype 2 patients included ribavirin for everyone with genotype 2 and the cure rates were not as high.
Lower cost – The wholesale acquisition cost (WAC) for Epclusa is $74,760.00 for a 12-week course of treatment. It is too soon to tell if insurance companies, Medicaid and Medicare will cover it since it was just approved, but since it is lower than the price of Sovaldi and Harvoni there may be more of a chance of coverage when the prices are negotiated.
Gilead’s patient assistance program: Support Path – 1-855-769-7284 – http://www.mysupportpath.com/
Side Effects: The most common side effects of Epclusa that occurred in more than 10% of patients in the clinical trials were headache and fatigue.
Pregnancy: There are no studies of Epclusa in pregnant women. Ribavirin can cause birth defects and miscarriages. If you are a male taking ribavirin, you and your female sexual partner must use two types of effective birth control. Your female sexual partner will have to take a pregnancy test before and during treatment and 6 months after treatment ends. If you are a female taking ribavirin, you and your male sexual partner must use two types of effective birth control. Additionally, women have to take a pregnancy test before, during and 6 months after treatment ends.
Listed below are the cure rates for genotypes 1, 2, 3, 4, 5 and 6.
The results below included patients who were treatment naive and treatment experienced
Epclusa for 12 weeks – no ribavirin in patients without cirrhosis or with compensated cirrhosis
Genotype and cure rates:
Genotype 1: 98% -(323/328 pts*); Genotype 2: 99.5% (237/238 pts); Genotype 3: 95% (528/553 pts); Genotype 4: 100% (116/116 pts); Genotype 5: 97%-(34/35 pts); Genotype 6: 100% (41/41 pts)
*Genotype 1a cure rate = 98% (206 of 210 patients); Genotype 1b cure rate = 99% (117 of 118 patients)
Epclusa plus ribavirin for 12 weeks in patients with decompensated cirrhosis:
Genotype Cure Rate
1a 94% (51/54 pts)
1b 100% (14/14 pts)
2 100% (4/4 pts)
3 85% (11/13 pts)
4 100% (2/2 pts)
Note: no genotype 5 or 6 patients were included in the above study of decompensated cirrhosis patients.
Highlights of Prescribing Information http://hcvadvocate.org/hepatitis/factsheets_pdf/epclusa_pi.pdf
Note: at the beginning of the article I wrote that Epclusa could treat all genotypes. You might have wondered why I didn’t include information about genotype 7. Genotype 7 was discovered a few years ago and only a handful of people have been identified. Come to find out in the clinical trials of Epclusa one patient who was enrolled in Gilead’s Astral 1 trial who was incorrectly identified as gentype 2, but was later retested as genotype 7. The patient was treated with Epclusa for 12 weeks and was cured. So Epclusa does cure all genotypes.
Check out our new HCV Medication Blog for information about all of the direct-acting antiviral medications approved by the Food and Drug Administration (FDA) to treat chronic hepatitis C.
There has been some exciting news on drugs in development. The majority of the trials listed below are ‘active, but not recruiting’ meaning that the clinical trials have been registered and approved by the Food and Drug Administration (FDA) but have not yet started. A word to the wise—keep an eye on them – hepatitis C clinical trials are few and far between. If you are interested in a trial jump on it.
AbbVie’s combination of ABT-493 (protease inhibitor) and ABT-530 (NS5A inhibitor) is entering into phase 3 clinical trials. In phase 2 studies the combination to treat genotype 1, 2 and 3 cured 85% to 100% in 12 weeks. I can not find any open sites in the United States.
If you are interested in this study, you can go to www.clinicaltrials.gov and type in “ABT-493” AND “ABT-530” and look for phase 3 under clinical trial phase. The bottom of the page will include registered clinical trial sites.
Gilead’s salvage therapy sofosbuvir, velpatasvir and voxilaprevir (GS-9857 – protease inhibitor) is entering into phase 3 studies. A salvage therapy is used to treat people who have been previously treated but have not been cured. In phase 2 studies the combination cured 89% to 100% of genotype 1 treatment experience patients with 8 weeks of treatments. In genotype 3 patients, they cured 100% of patients.
If you are interested in this study, you can go to www.clinicaltrials.gov, type in “sofosbuvir” “velpatasvir” AND “GS-9857” and look for phase 3 under the clinical trial phase.
Regulus Therapeutic Inc.
Now the bad news—in June it was reported by Regulus that the Food and Drug Administration (FDA) put their clinical trial of RG-101 on hold due to safety concerns. The safety issue was due to a second serious case of jaundice. Regulus’ press release states that they would work with the FDA to resolve the safety concerns.
Don’t forget to check out the HCV Drug Pipeline at the end of this issue of the HCV Advocate newsletter.