Interferon, a traditional medication sometimes used in combination with ribavirin or other medications to treat hepatitis C infections, has unpleasant side effects, including nausea, fatigue, and depression, creating many compliance problems for patients in opioid treatment programs (OTPs). Newer medications, such as Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) have side effects that are similar to those of interferon, but are far less severe, and Sovaldi usually doesn’t cause nausea.
The new medications can produce cures, but it depends on the genotype of the patient’s HCV. Harvoni is for genotype 1. Sovaldi is approved for genotypes 1 through 4, but it had to be co-administered with ribavirin or with ribavirin and interferon—until now.
On July 25 the Food and Drug Administration approved a new treatment for chronic hepatitis C genotype 3 infections. The medication is Daklinza (daclatasvir), to be given with Sovaldi (sofosbuvir). It’s the first HCV genotype 3 medication that doesn’t need to be given with interferon or ribavirin.
Hepatitis C can eventually lead to liver failure. While most people have no symptoms until liver damage is apparent, liver failure can lead to scarring and to complications such as bleeding, jaundice, and fluid accumulation in the abdomen. People with hepatitis C are also more likely to develop other infections and liver cancer.
Officials in Indiana were so scared by a recent hepatitis C outbreak among injection drug users in one county that they temporarily allowed a needle-exchange program. Nora Volkow, MD, director of the National Institute on Drug Abuse, agrees with public health officials that needle exchanges can prevent hepatitis C, as well as HIV, among injecting drug users, but stresses that medication-assisted treatment is necessary as well.
According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV, approximately 10 percent of them with genotype 3.
“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in making the announcement on July 25.
On July 24, the FDA approved Technivie for the treatment of HCV genotype 4 in patients who do not have cirrhosis. It must be taken with ribavirin, which also has side effects, although they are not as severe as those with interferon.
Treatment with these medications can cost up to $100,000, but 98 percent of patients are cured, and financial help for buying medications is available from a variety of sources. The medications can all be taken with methadone.
For more information, go to http://www.cdc.gov/hepatitis/HCV/index.htm
