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Pakistan: Factory making fake Hepatitis C drug raided

Assisted by the Federal Investigation Authority (FIA), personnel of the Drug Regulatory Authority of Pakistan (DRAP) raided one of the local industries in Islamabad’s Kahuta industrial area here Saturday, leading to the discovery of unlawful manufacturing of Sofasbuvir tablets, which are used for the treatment of Hepatitis C, and Everlong tablets, the registration of which has long been withdrawn.

Crackdown against unregistered, spurious and fake medicines has been intensified on the directions of Minister for Health Saira Afzal Tarar. Talking to this scribe, the minister said, “I have already announced zero tolerance for manufacturing of unregistered and spurious drugs. Several factories have been sealed and action as per law is being taken without discrimination.” She added that all field offices of DRAP in the provinces have been asked to maintain strict vigil on the criminal trade of spurious drugs and take immediate and stern action under the law.

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Combos Cure HCV in Almost All With HIV Co-infection

Just 12 weeks of treatment eliminated hepatitis C virus in HIV patients.

SEATTLE -- Two drug combinations aimed at hepatitis C (HCV) yielded almost perfect cure rates in patients also infected with HIV, researchers reported here at the 2015 Conference on Retroviruses and Opportunistic Infections.

When the drugs were given for 12 weeks, 96% to 98% of patients had undetectable HCV 12 weeks after the end of therapy -- the so-called SVR₁₂, which is regarded as a cure.

The only blot on the horizon was a 76% SVR₁₂ rate when the combination of daclatasvir and sofosbuvir (Sovaldi) was given for just 8 weeks, reported David Wyles, MD, of the University of California San Diego.

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Doctor Panel to Weigh Hepatitis C Drugs’ Costs in Guidelines

(Bloomberg) -- An influential advisory panel of doctors and health experts will for the first time address the cost-effectiveness of pricey hepatitis C drugs in updated guidelines that may change prescribing and coverage for the medicines.

The 30-member panel is a joint effort by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which together represent more than 10,000 physicians, health workers and scientists. The guidelines are used by doctors for expertise on how to treat patients and by insurers and governments in setting policy.

Health insurers and government programs have been grappling with the cost of the pills. Made by Gilead Sciences Inc. and AbbVie Inc., they offer higher cure rates and fewer side effects than older medicines, though their $1,000-a-day price tag has generated criticism.

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Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV

– 96 Percent SVR12 Rate for Hepatitis C Genotypes 1 and 4 Among HIV-infected Patients on Antiretroviral Therapy – 

SEATTLE--(BUSINESS WIRE)--Feb. 26, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced results from a Phase 3 study, ION-4, evaluating the once-daily single tablet regimen Harvoni^® (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV. In the trial, 96 percent (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. These data were presented in a late-breaker oral session (Session 152LB) at the 22^nd Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“This trial provides strong evidence that people who are co-infected with HIV can achieve very high rates of hepatitis C cure with a combination direct-acting antiviral regimen,” said Susanna Naggie, MD, MHS, Director of Infectious Diseases Research at Duke Clinical Research Institute and Principal Investigator for the ION-4 study. “These high cure rates were observed in most of the historically difficult-to-treat sub-populations, including those who failed previous treatment and those with cirrhosis. We are greatly encouraged by these findings.”

ION-4 is a Phase 3, multicenter, open-label study investigating the efficacy, safety and tolerability of Harvoni treatment for 12 weeks in 335 patients with HCV genotype 1a (75 percent), 1b (23 percent) or 4 (2 percent) and HIV-1 co-infection. The study included HCV treatment-naïve (45 percent) and treatment-experienced (55 percent) patients, including patients with compensated cirrhosis (20 percent), whose HIV was suppressed using one of three HIV antiretroviral (ARV) regimens: tenofovir and emtricitabine with efavirenz (Atripla^®), raltegravir or rilpivirine (Complera^®).

SVR12 rates did not differ significantly by prior HCV treatment status, presence or absence of cirrhosis, or ARV regimen. No patients discontinued Harvoni due to an adverse event (AE). Of the 14 patients that did not achieve SVR12, two patients experienced virologic failure during treatment (likely due to non-compliance per physician reporting), 10 experienced virologic relapse post-treatment, one was lost to follow up and one died due to causes unrelated to study drug. The most common AEs reported were headache (25 percent), fatigue (21 percent) and diarrhea (11 percent).

Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014. Based on the ION-4 trial results, Gilead plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Harvoni to include the results from this study in the U.S. label. Harvoni received marketing authorization in Europe in November 2014, where data from a small study in HIV-HCV co-infected patients (ERADICATE) are included in the prescribing information. -

See more at: http://gilead.com/news/press-releases/2015/2/gilead-announces-svr12-rates-from-phase-3-study-evaluating-harvoni-for-the-treatment-of-chronic-hepatitis-c-in-patients-coinfected-with-hiv#sthash.MHNmiL6v.dpuf

Boone faces heroin, hep C epidemics

Heroin abuse and hepatitis C infections are at epidemic levels in Boone County, local officials told several dozen people attending an Indiana Youth Institute Kids Count 2015 data workshop Tuesday at the Lebanon Public Library.

“We have a heroin epidemic in Boone County,” Sheriff Mike Nielsen said. Cindy Murphy, RN, administrator of the Boone County Health Department, said 40 percent of people who come to the agency’s sexually transmitted diseases clinics admit that they use intravenous drugs.

“We have a hepatitis C epidemic because of IV drug abuse,” Murphy said.

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Baker's hepatitis C screening bill gains House approval

HARRISBURG - The Pennsylvania House of Representatives this week approved House Bill 59 authored by Rep. Matt Baker (R-Tioga/Bradford/Potter), chairman of the House Health Committee, that would require physicians to offer hepatitis C screening to patients born between 1945 and 1965.

"If it is determined a patient tests positive for hepatitis C, he or she would then be offered follow-up health care," said Baker. "Treatment today can vastly improve a person's quality of life and result in better health outcomes, including being cured of the disease."

Baker noted that actively screening for hepatitis C, as opposed to waiting for symptoms and more serious diseases to arise from having the disease, will also result in major cost savings for taxpayers. In fact, the estimated medical costs associated with treating Baby Boomers with hepatitis C, many of whom will age into the Medicare system at age 65, will rise from $30 billion in 2009 to $85 billion annually by 2024.

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