#Prisonworld Health – Hepatitis C Drug May Shrink High Prison Infection Rate
FDA approves new indication for PROMACTA® (eltrombopag)
First supportive care treatment approved for patients with thrombocytopenia with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. PROMACTA is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts. PROMACTA in combination with interferon-based therapy has been shown to improve a patient’s chance of achieving a sustained virologic response (SVR) or viral cure.
There are limitations to the use of PROMACTA in patients suffering from chronic hepatitis C-associated thrombocytopenia. These include:
- PROMACTA should not be used in an attempt to normalize platelet counts;
- PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy; and
- Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.
“Chronic hepatitis C is a significant public health issue,” said Paolo Paoletti, M.D., President, GlaxoSmithKline Oncology. “Some chronic hepatitis C patients suffer from low blood platelet counts. Commonly prescribed interferon-based therapies can worsen the problem of low blood platelet counts. Today’s FDA approval of PROMACTA gives doctors a tool to address the low platelet challenge. This means more chronic hepatitis C patients may be able to start and stay on interferon-based therapy. That gives these patients a better chance to achieve a viral cure.”
The approval for PROMACTA is based on results from ENABLE 1 and 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE), two Phase III randomized, double-blind, placebo-controlled, multicenter studies, which collectively enrolled 1,521 patients with platelet counts <75,000/µL. ENABLE 1 utilized peginterferon alfa-2a (PEGASYS®) plus ribavirin for antiviral treatment and ENABLE 2 utilized peginterferon alfa-2b (PEGINTRON®) plus ribavirin.
If all of this sounds like a bunch of mumbo jumbo, it’s because the FDA has found a way to make money from the prison system before the deals of private healthcare for inmates are finalized. Make no mistake that this may be an attempt to help inmates but moreso a way to introduce another drug into the system for kickbacks.
Here are the side affects:
PROMACTA may cause hepatotoxicity. PROMACTA, in combination with interferon and ribavirin in patients with chronic hepatitis C, may increase the risk of hepatic decompensation. Patients receiving therapy with PROMACTA must have regular monitoring of serum liver tests (see Laboratory Monitoring). Discontinue PROMACTA if ALT levels increase to ≥3X upper limit of normal (ULN) in patients with normal liver function or ³3X baseline in patients with pre-treatment elevations in transaminases and are: progressive; or persistent for ≥4 weeks; or accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence of hepatic decompensation. Reinitiating treatment with PROMACTA is not recommended and should be considered only with close medical supervision and under exceptional circumstances where the potential benefit outweighs the risk.
FYI – Prisonworld does not endorse medications for inmates.