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Drugs in Development / Clinical Trials—Updated April 16, 2014
Wednesday, April 16, 2014
Around 500 patients with acute liver failure, and/or awaiting liver transplantation, are expected to benefit from the decision to fund Sofosbuvir.
The hepatitis C virus causes inflammation of the liver, affecting its ability to function. Whilst many sufferers naturally clear their infections within six months, others develop chronic hepatitis which is usually life-long without therapy.
Eight patients with a grade 3 morbilliform eruption related to telaprevir (Incivek, Vertex) were evaluated by dermatologists a mean of 13.3 days after symptom onset. All of the patients had an eruption that covered more than half of their total body surface area, which developed a mean of 20.1 days after initiating treatment. The trunk and extremities were affected in all patients, and none had eosinophilia or liver function test results indicating systemic involvement.
Rep. Tom Sherman told a Senate committee Wednesday that he hopes to file another bill next session to complement two the House already has passed in response to David Kwiatkowski. Kwiatkowski is serving 39 years in prison for stealing painkillers and replacing them with saline-filled syringes tainted with his blood.
One bill currently before the Senate would require health care facilities to develop and implement drug-free workplace policies and to test employees for drugs if there is a reasonable suspicion of drug use. The other, which had a public hearing Wednesday, would create a board to register health care workers who are not otherwise already licensed or registered and who have access to both drugs and patients. Hospitals would be required to report disciplinary actions to the board, which could perform its own investigations of wrongdoing.
Sixty-eight PWID participated in the intervention; 87% attended at least one group session, and 46% attended all five.
The Public Health Agency (PHA) coordinated project gives out needles and syringes to people who are injecting intravenous drugs, such as heroin or steroids.
In 2012, 21,220 visits were made to the scheme with 213,295 needles handed out.
The scheme has been in operation since 2005.
Social workers using federal and state resources helped Donna find housing and got her on a state program called "disability Medicaid," which covers health care costs for people who meet federal disability criteria but are not yet on the federal program. This important initiative, common in many states, is a bridge to health services for people applying for federal benefits, which can take years.
Although the program was a lifesaver for Donna, Gov. Bobby Jindal terminated "disability Medicaid" in Louisiana as of Jan. 1, leaving 9,200 people across the state with no coverage.
Nezam Afdhal, MD, of the Beth Israel Deaconess Medical Center in Boston, presented findings for 440 patients from the phase 3 ION-2 study, which investigated the fixed-dose formulation of sofosbuvir (Sovaldi) 400 mg/ledipasvir 90 mg in treatment-experienced patients with genotype 1 disease. The study included four patient cohorts: those treated for 12 weeks with or without ribavirin and those treated for 24 weeks with or without ribavirin.
“We wanted to answer the question of whether a longer duration of therapy is necessary to achieve high [sustained virologic response] rates,” said Afdhal, a member of the HCV Next Editorial Board.