Two new hep C meds approved
by Liz Highleyman
The U.S. Food and Drug Administration recently approved the first two direct-acting antiviral drugs to treat chronic hepatitis C, boceprevir (Victrelis) from Merck and telaprevir (Incivek) from Vertex Pharmaceuticals.
"This is really groundbreaking," said Dr. Bradley Hare, medical director of the Positive Health Program at San Francisco General Hospital and a member of the San Francisco Hepatitis C Task Force. "We anticipate that in the next few years many more hepatitis C drugs will become available, so it's a big change, but really just the beginning of a change."
Boceprevir and telaprevir were approved in May for adults with hard-to-treat genotype 1 hepatitis C, to be used in combination with current standard therapy consisting of pegylated interferon (Pegasys or PegIntron) plus ribavirin.
An estimated 3.9 million people in the U.S. have chronic hepatitis C, including approximately 12,000 in San Francisco, according to the task force.
In clinical trials boceprevir or telaprevir added to standard therapy increased the likelihood of achieving a sustained virological response, or cure, and many people were successfully treated with a shorter duration of therapy.
Cure rates for previously untreated genotype 1 patients approached 70 percent for boceprevir and 80 percent for telaprevir, compared with about 40 percent for standard therapy. Although their cure rates were somewhat lower, prior non-responders and relapsers saw the biggest improvement over current treatment.
The most notable side effect of boceprevir is anemia, while the main concern with telaprevir is skin rash – both added on top of the side effects of interferon and ribavirin.
"You're not necessarily going to feel better during treatment, but treatment might be shorter and it might work better," Hare told the Bay Area Reporter.
More in the pipeline
Boceprevir and telaprevir are the frontrunners in a large field of drug candidates that directly interfere with various steps of the hepatitis C virus lifecycle. Interferon works instead by stimulating the immune system to fight the virus.
Though the new drugs must be used with injected interferon for now, all-oral regimens are being studied that could finally allow people to achieve a cure without the notoriously difficult side effects of interferon, which include flu-like symptoms and depression.
Hare said that people debating whether to start one of the new drugs now or wait for an interferon-free regimen should consult their doctor and consider the health of their liver.
"All-oral regimens won't be available for prescription for probably three to five years," he said. "Some may want to wait, but some may decide to give [the new drugs in combination with interferon] a try."
Boceprevir and telaprevir are not yet approved for people with HIV/HCV coinfection, but studies are under way and early results suggest that the new drugs will also improve response rates for the estimated one-third of HIV positive people who also have hepatitis C.
At the retrovirus conference in March researchers presented the first data from a small trial of telaprevir plus pegyalted interferon/ribavirin in coinfected patients taking an antiretroviral regimen of Atripla and atazanavir (Reyataz).
After 12 weeks of treatment, 68 percent of telaprevir recipients had undetectable HCV, compared with just 14 percent using pegyalted interferon/ribavirin alone. Ongoing analysis will show whether this response is sustained after the end of treatment. Telaprevir was generally well tolerated and did not significantly affect HIV drug levels.
Speaking at a press conference, Joseph Eron from the University of North Carolina said he would only feel comfortable giving telaprevir to coinfected people in combination with these specific HIV medications until more drug interaction studies are completed.
Cost and access
The benefits of the new hepatitis C drugs come with a steep cost. Merck set the price for boceprevir at approximately $1,000 per week, while Vertex priced its slightly more effective telaprevir about four times higher.
Boceprevir and telaprevir are both taken three times daily, with treatment duration determined by early viral load reductions. People take boceprevir plus pegylated interferon/ribavirin for 24 to 32 weeks, in some cases continuing pegylated interferon/ribavirin alone through 48 weeks. Telaprevir triple therapy is taken for 12 weeks, with pegylated interferon/ribavirin continued through 24 or 48 weeks.
The longest courses of boceprevir and telaprevir both cost around $48,000, more than doubling the $30,000 tab for current standard therapy. Plus, many people require additional medications to manage anemia and other side effects.
"Both price points are outrageous," said Lynda Dee of the Fair Pricing Coalition, a group formed to advocate for affordable HIV treatment. "What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek."
To enable more people to access the new drugs, both Merck and Vertex recently announced patient assistance programs that partially cover co-pays for people with private insurance and offer free medication for low-income people ineligible for other benefits programs.
Advocates remain concerned, however, that these prices will put further pressure on government programs such as Medicaid and Medicare at a time when they can least afford it.