New Cigna, Catamaran Hep C Pacts Put Gilead Drugs to the Test

"Since the December 2014 approval of AbbVie Inc.’s hepatitis C treatment Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets), at least 10 companies have disclosed exclusive or semi-exclusive deals with Gilead Sciences, Inc. that feature the manufacturer’s hepatitis C agents, Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir). But Catamaran Corp. and Cigna Corp. this month unveiled the first outcomes-based arrangements with Gilead that industry observers say could open the door for more value-based deals around hepatitis C and other specialty agents".

"Catamaran on Feb. 3 said it would offer a new hepatitis C patient management program through its specialty pharmacy, BriovaRx, that features Gilead’s Harvoni and Sovaldi as exclusive hepatitis C treatment options (DBN 2/6/15, p. 1). Similarly, Cigna Corp., a long-term Catamaran customer, on Feb. 4 said it would offer Harvoni as the only preferred brand drug treatment for customers with hepatitis C genotype 1 infection as well as develop an outcomes-based incentive program".

"While both companies declined to provide specifics on how the deals are structured, other outcomes-based pharmaceutical arrangements between manufacturers and insurers or PBMs have tied rebate payments to agreed-upon outcomes achieved by the payers’ members. Cigna, for instance, in 2010 embarked on an outcomes-based partnership with Merck & Co. in which the drugmaker provided rebates to Cigna when its members with type 2 diabetes met goals for adherence to prescribed medications and low blood sugar levels (DBN 12/17/10, p. 1). And Prime Therapeutics LLC in 2012 signed an outcomes-based contract with EMD Serono, Inc. for its multiple sclerosis drug Rebif (interferon beta-1a) through which the drugmaker promised to pay rebates to the PBM if its members taking Rebif had a higher total cost of care than people on other MS medications. Adherence levels were also considered. Cigna inked a similar deal with EMD Serono in 2011".

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

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®).

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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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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

Georgia: New Hepatitis C medicine to enter Georgian market in April

Hepatitis C could soon be "completely eliminated” in Georgia, says the country’s Health Minister.


Georgia is preparing to sign a trilateral agreement that will allow a new medicine to be introduced to the market, which aimed to completely eradicate the infectious disease in Georgia.


Today Georgia’s Minister of Health David Sergeenko held a press conference and said the contract about the new Hepatitis C medication would be signed in April between the Government of Georgia, the United States Disease Control Centre and American biotechnology company Gilead Sciences.

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India: Mylan to distribute both Sovaldi and Harvoni for HCV

"Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan Inc., has entered into an agreement with Gilead Sciences to be an exclusive distributor of Sovaldi and Harvoni in India for the treatment of hepatitis C virus infection, according to a press release.

Under the agreement, Mylan will distribute Sovaldi (sofosbuvir, Gilead) and Harvoni, a combination of ledipasvir (Gilead) and sofosbuvir, and also have the rights to manufacture and distribute generic versions of both regimens. In addition, Mylan will also retain manufacturing and distribution rights for the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 upon approval, according to the release.

“Hepatitis C is a growing public health concern, particularly in developing countries such as India where access to high quality, effective and affordable treatment remains a challenge,” Rajiv Malik, president of Mylan, said in the release. “Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India.”

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UnitedHealth Said to Pick Gilead’s Harvoni as Hepatitis C Drug

(Bloomberg) -- UnitedHealth Group Inc., the biggest U.S. health insurer by sales, picked Gilead Sciences Inc.’s Harvoni as its preferred hepatitis C treatment, according to a person familiar with the matter.

The decision applies to UnitedHealth’s fully insured commercial customers, as well as to Medicaid and Medicare members. The Minnetonka, Minnesota-based insurer has about 45 million U.S. health-plan customers, though not all follow the company’s drug picks.

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EnvisionRx and Gilead Sciences Sign Exclusive Agreement to Help in the Fight Against Hepatitis C

TWINSBURG, Ohio, Jan 26, 2015 (BUSINESS WIRE) -- EnvisionRx®, a national, full-service pharmacy benefit management (PBM) company, today announced a partnership with Gilead Sciences Inc., a pioneer in the treatment of the Hepatitis C virus (HCV), to provide availability to HCV infection treatments Sovaldi® and Harvoni™ for EnvisionRx patients on an exclusive basis.

“EnvisionRx is committed to helping patients attain the most effective drugs at affordable prices, and we are proud to be able to offer our patients Sovaldi® and Harvoni™, the market leaders in the treatment of HCV, ” said Dawn Sherman, President of EnvisionRx. “The safety and efficacy profile of Gilead’s HCV products, coupled with the most competitive pricing in the drug class, have solidified EnvisionRx’s choice to place Gilead’s HCV products in an exclusive and preferred formulary position. We believe our comprehensive HCV approach will enable our patients to receive the best available care.”

Consistent with PBM industry practice, exceptions for other hepatitis C drugs will be allowed in some cases. Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), is the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Sovaldi™ (sofosbuvir) 400 mg tablets, is a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

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AASLD 2014: Ledipasvir and Sofosbuvir in African Americans —Alan Franciscus, Editor-in-Chief

This is the last of the AASLD 2014 conference coverage (I promise!), but there was one more study I thought was important to discuss.

 

The Safety and Efficacy of Ledipasvir and Sofosbuvir in African Americans:  A Retrospective Analysis of Phase 3 Data – L Jeffers et al.

The information from the Phase 3 studies of ledipasvir plus sofosbuvir, and of ledipasvir, sofosbuvir plus ribavirin, was compiled, and the information about the African American patients was extracted.  The treatment durations in these studies were 8, 12 or 24 weeks.  The patient characteristics of the African American were generally older, higher Body Mass Index, more likely to have IL28B non-CC (a variation that is less likely to respond to treatment) and lower ALT (liver enzyme levels).

The combined results from all of the phase 3 studies showed the overall cure rates among African Americans to be similar to the non-Blacks in the study groups.   The authors did note that “Although high SVR rates were observed, the limited number of black patients with cirrhosis precludes definitive conclusions in this subpopulation.”  In other words it would be hard to draw conclusions regarding effectiveness of the drugs when comparing African Americans and the other groups because there were so few African Americans in the study who had cirrhosis.

 

Comments: When interferon-based therapy was the standard of care to treat hepatitis C, African Americans had much lower cure rates compared to most other races.  Now that the standard of care is interferon-free therapies, African American cure rates are the same as the cure rates seen in other races.  Many old ‘facts’ die hard; so let’s put this one to rest and get the message out that that African Americans respond just as well to interferon-free therapies as other populations. 

 
This was a presentation that was posted to NATAP courtesy of Jules Levin.


http://hcvadvocate.org/news/newsLetter/2015/advocate0115_mid.html#2

Anthem selects Gilead as primary supplier of hepatitis C drugs

Jan 8 (Reuters) - Health insurer Anthem Inc on Thursday said it reached a deal under which Gilead Sciences Inc's hepatitis C drug Harvoni will be the primary treatment for patients infected with the most common strain of the liver-destroying virus.

Anthem said the deal effectively lowers its hepatitis C treatment costs. "We were able to achieve a very competitive rate and a freeze on retail pricing for 2015," the insurer said in an emailed statement. "That does favorably impact plan costs for 2015."

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