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Alan Franciscus
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HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated February 6, 2015

Saturday, February 28, 2015

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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Friday, February 27, 2015

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 22nd 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.

Thursday, February 26, 2015

ALLY Trial Demonstrates 97% Hepatitis C Cure Rates Among Patients Coinfected with HIV After Ribavirin-Free Investigational 12-Week Regimen of Daclatasvir and Sofosbuvir

Daclatasvir-sofosbuvir 12-week regimen resulted in: 
  • 96% hepatitis C cure rate among patients with HVC genotype 1 disease (n=80/83) 
  • 100% hepatitis C cure rate among patients with HCV genotype 2, 3 and 4 disease (n=26/26) 
High HCV cure rates seen with no need to alter existing HIV medication regimens 

Thursday, February 26, 2015 3:15 pm EST
 
"The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype."

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due to potential drug-drug interactions between the therapy regimens used to treat each infection.

“The results of ALLY-2 signal that nearly all HIV-HCV coinfected patients in the study could be cured of hepatitis C with a 12-week regimen on daclatasvir and sofosbuvir,” said David Wyles, M.D., ALLY-2 Lead Investigator and Associate Professor of Medicine in the Department of Medicine, Division of Infectious Diseases at the University of California San Diego. “The trial demonstrated the dosing flexibility afforded by the daclatasvir-sofosbuvir regimen did not require alteration of HIV medications because of potential drug-drug interactions. This is a paramount consideration for clinicians treating this patient population.”

Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). The study met the primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase.

“While substantial strides have been made in the battle against hepatitis C, a significant number of patients with complicated disease and treatment histories need additional treatment options to help them achieve hepatitis C cure,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “The ALLY-2 results show that daclatasvir paired with sofosbuvir produced high cure rates in this trial regardless of the coinfected patients’ HCV genotype.”

According to the Centers for Disease Control and Prevention (CDC), about one quarter of HIV-infected persons in the United States - approximately 300,000 people - are also infected with hepatitis C, and HCV infection progresses more rapidly to liver damage in people living with HIV.
In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. African-American patients comprised 34% of study participants; in this patient demographic, SVR12 rates were 98% (n=49/50). ALLY-2 also included an 8-week arm; 38 of 50 treatment-naïve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
Additional safety data demonstrated a low rate of Grade 3/4 lab abnormalities in the study: INR (1%), AST (0.5%), Tbili (4%), Lipase (3%).
 
About ALLY-2: Study Design
This Phase III open-label clinical trial randomized 151 treatment-naïve and 52 treatment-experienced HCV (genotypes 1-4) patients coinfected with HIV-1 on a broad range of antiretroviral regimens, into 3 cohorts. Among treatment-naïve patients, one cohort received daclatasvir 30, 60, or 90 mg (dose adjusted for concomitant antiretroviral therapy) plus sofosbuvir 400 mg once daily for 12 weeks, and another received the same dosage and combination for 8 weeks.

The treatment-experienced cohort also received daclatasvir 30, 60, or 90 mg plus sofosbuvir 400 mg once daily for 12 weeks. Daclatasvir was dose-adjusted to accommodate concomitant antiretrovirals: 30 mg with ritonavir-boosted PIs, 90 mg with NNRTIs except rilpivirine. All cohorts had follow-up through post-treatment week 24. The primary endpoint was the SVR12 rate among genotype 1 treatment-naïve patients after 12 weeks of treatment. Patients with cirrhosis were permitted.
 
Read complete press release here:

Langford: Doctors prescribe, not insurance companies

"Our legislators have the opportunity this year to support legislation designed to address problems with excessive use of prior authorization and step therapy, that too often let patients in Florida slip through the cracks with no coverage for appropriate therapies."

More than 15 years ago, I was diagnosed with Hepatitis C. While the disease has created a number of challenges, one particularly frustrating and troublesome problem has been obtaining coverage for medications that my physicians have prescribed because I've been forced into “fail first,” or “step therapy,” protocols.

Fail first protocols are management processes used by health plans that require a patient to try the least expensive treatment to address a problem, despite what his or her physician recommends. Only after trying and failing on the least expensive option, and possibly additional treatments, can a patient receive coverage for the medication the physician originally prescribed.

In 1998, my physician advised me to try a recently approved Hepatitis C treatment, Ribavirin, meant to be taken in addition to Interferon. My insurance company required me to fail on Interferon by itself before I could get the superior combination of the two as prescribed by my doctor.

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