Month: August 2016

Hepatitis B and C dangerous for eyes


Eye problems due to Hepatitis B and C are often not diagnosed properly as the patient does not feel them at first. Despite showing no loss of vision, the infection causes damage near the eye ball region. Infection in the blood leads to itching and formation of pus in the eyes and retinal problems.

Senior ophthalmologist Dr Vijay Kiran said there was very little awareness on how hepatitis affects the eye. “People are not aware hence they do not get their eyes checked. Most patients with retinal problems, uveitis and ocular infection go to an ophthalmologist too late when treatment becomes very restricted,” he said.

Diagnosing a patient with the infection is difficult. Dr Sreelakshmi Nimmagadda, refractive eye surgeon, said those suffering from dry eyes continuously need to be evaluated.



Looking for an End to the Waiting Game in Acute HCV

Somewhere between one-quarter and one-half of acute hepatitis C infections clear spontaneously, usually within 6 months, depending on the population or cohort. Accordingly, the authors of the joint American Association for the Study of Liver Diseases and Infectious Diseases Society of America HCV guidelines recommend a watching and waiting strategy for patients with recent or acute disease. The societies adopted this approach in the interferon era, when treatment was often more complicated and toxic than the disease itself, particularly for patients with no symptoms. But now that patients can be treated with direct-acting antivirals effectively and largely without incident, that approach may be outdated.

Katja Deterding, MD, of HepNet Study-House and the Hannover Medical School in Hannover, Germany, and colleagues presented a paper on acute HCV at the International Liver Congress in April that drew some attention. The study involved 20 patients with symptomatic acute HCV accrued during 2014 and 2015. There were 11 patients with genotype 1a disease and nine patients with genotype 1b. All patients completed 6 weeks of ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) treatment and 12 weeks of follow-up.

“After only 2 weeks of treatment, already nine patients had undetectable HCV RNA,” Deterding said in her presentation. She added that by week 4 of treatment, HCV RNA was below 15 IU/mL for all 20 patients. “After 6 weeks of treatment, all patients had undetectable HCV RNA.”

Although higher baseline viral load was associated with a slight delay in virological response, follow-up results indicated a 100% SVR12 rate, according to Deterding. “So 6 weeks of antiviral treatment was enough for all patients to clear the acute HCV infection,” she said. As with most DAA therapies, the regimen was well-tolerated.

These findings, then, provide a compelling jumpstart to the discussion of whether the clinical community should consider treating patients with acute infection.


Colorado board recommends expanded coverage for hepatitis C drug

Board: More needy should get new drugs
By John Ingold
| The Denver Post

Staff attending the Colorado Medicaid drug utilization review committee of Colorado Medicaid.

Staff attending the Colorado Medicaid drug utilization review committee of Colorado Medicaid.

(Denver) — A state board recommended Tuesday night that more needy Coloradans receive potentially curative treatments for hepatitis C.
But the board stopped short of recommending that the treatments — new drugs that have been shown to have a 90 percent cure rate — be extended to all Coloradans on Medicaid. And that means the American Civil Liberties Union may file a federal lawsuit against the state to force it to provide treatment to everyone.
“It’s not just the right thing to do,” Mark Silverstein, the legal director for the ACLU in Colorado, said at Tuesday’s meeting. “It’s also what’s legally required.”


Members of the Colorado Medicaid drug utilization review committee

The recommendation came after more than two hours of debate by Colorado’s Medicaid Drug Utilization Review Board, which provides guidance for how the state should provide medication to needy patients. A final decision on the hepatitis C treatments ultimately will come next month from the state Department of Health Care Policy and Financing.
Hepatitis C is a virus that attacks the liver and can lead to prolonged illness and death. Starting in 2011, federal authorities began approving new antiviral drugs for hepatitis C that were seen as breakthroughs with low side effects and high cure rates. There is one hitch: They’re expensive.
Because of the cost, the state pays for the breakthrough drugs only if a patient is in the final two stages of liver damage, known as F3 and F4. The state has so far spent $26.6 million treating 326 hepatitis C patients. Private health insurance and Medicare cover the drug for all hepatitis C patients.
The review board on Tuesday recommended that the state cover the new drugs for all Medicaid patients at a lower stage of liver damage, F2. The board also said the state should cover the drugs for all women at any stage of liver damage who are of child-bearing age — to prevent transmission of the disease to newborn children.
But those recommendations were not without debate.
Supporters of expanding access presented an economic analysis Tuesday that argued Colorado would save money in the long run by curing all hepatitis C patients early in their infection and eliminating the treatment costs later.
“I think the investment now makes sense down the road,” said Dr. Jim Regan, a board member.
But others worried whether the state could afford the initial investment. There are more than 9,000 hepatitis C patients on the state’s Medicaid rolls, but it’s unknown how many would use the new drugs or how much should be budgeted each year to provide them.
“If resources were unlimited that would absolutely be ideal,” Dr. Kerstin Froyd, another board member, said of covering all patients. “But they are not.”
The ACLU’s Silverstein, meanwhile, said federal law requires the state to provide Medicaid patients with all medically necessary care — which he said the new hepatitis C drugs are. If the state does not provide the drugs to all patients, he said the ACLU would probably file a federal lawsuit.

Chronic hepatitis B in Korean Americans: decreased prevalence and poor linkage to care



Chronic hepatitis B virus(HBV) infection is a major cause of liver related morbidity and mortality. HBV infection remains largely under diagnosed in Asian American population, and it is also poorly linked to clinical care. We, therefore, assessed the HBV prevalence and evaluated linkage to care among Korean Americans in order to develop strategic plans to reduce the impact of HBV in a high risk community.


Denver Health Authority letter to Colorado Medicaid




June 29, 2016

Sue Birch

Executive Director, Colorado Department ofHealthcare Policy and Finance

1570 Grant St.

Denver, Colorado 80203

Dear Director Sue Birch,

As the largest provider of health care for low-income individuals in Denver, we are concerned that the current Medicaid restrictions on treatment for Hepatitis C (HCV) infection are leading to worsening morbidity, mortality, and health disparities. We strongly encourage HCPF to make curative therapy more broadly available, in accordance with guidance from the Centers for Medicare and Medicaid Services.


HCV causes a chronic infection in 70-80% of infected persons, leading to severe, irreversible liver damage (advanced fibrosis and cirrhosis) in 20-30% of individuals with persistent infection. Furthermore, HCV infection at all stages of liver fibrosis is associated with adverse health effects. The burden of HCV-related disease is alarming; CDC estimates that HCV kills more people than the 60 other reportable infections combined. Fortunately, new medications are now available that reliably cure HCV and are very well­ tolerated. Furthermore, treatment can prevent transmission to others. Treatment as prevention is working for HIV disease: widespread use of antiretroviral therapy has decreased the rate of new HIV infections in Denver by more than 60% over the past decade. Despite these benefits to the individual and the community, a recent analysis from the state’s all-payer claims database estimated that only 10% of individuals living with chronic HCV in Colorado have been treated.

Current restrictions

Current Colorado Medicaid guidelines require evidence of stage 3 or 4 liver fibrosis. This restriction is problematic for several reasons. First, staging is imprecise. What is assigned F2 on a biopsy may actually be F3 or F4 but the pathology report may inaccurate due to sampling error. Second, the rate of progression to cirrhosis is not always linear. Once a person has F2 fibrosis, progression to cirrhosis may occur quickly. Thus, a person denied treatment for an F2 score one year may present for follow up a year later and be diagnosed with cirrhosis, which is irreversible and associated with an increased risk of cancer and death, even after HCV infection is cured. Third, access to the accepted staging methods is limited. Liver biopsy is associated with a low but significant risk of serious complications including hemorrhage and therefore no longer the preferred staging modality. Fourth, HCV infection is more difficult to cure when individuals develop cirrhosis. Finally, individuals with all levels of fibrosis have been shown to have significant rates of extrahepatic disease (kidney disease, hypertension, lymphoma, diabetes, intractable fatigue, arthritis, vasculitis, thyroid disease, depression, memory loss).

The second major area of concern regarding current Colorado Medicaid HCV treatment restrictions is the requirement that individuals be free of illicit substances, alcohol and marijuana for six months prior to approval of treatment. This restriction is not evidence-based and restricts access to treatment for many individuals with advanced HCV liver disease. Several studies have demonstrated successful treatment ofHCV among drug users. Most ofthe drugs prohibited by the restrictions (including marijuana) have no effect on liver health.  Furthermore, we are not aware of other diseases for which treatment is restricted for Medicaid recipients based on lifestyle choices.

Access to specialty care is often very limited for patients with Medicaid in Colorado. Reports from around the country demonstrate high levels of success with primary care-based treatment of HCV.  Thus, eliminating the specialty provider restriction could have tremendous benefit to Colorado Medicaid recipients.


HCV disproportionately affects lower income populations. Current Colorado Medicaid treatment restrictions may worsen socio-economic  health disparities. Our experience providing HCV treatment at Denver Health reveals an alarming disparity in access to care. Patients covered by Medicare and commercial insurance are universally approved for HCV treatment with new treatment regimens. However, the vast majority of our patients enrolled in Colorado Medicaid have been denied access to treatment for the reasons listed above. Even individuals with advanced disease (compensated cirrhosis) who are at the highest risk of severe complications of HCV infection are denied treatment by Medicaid if substance use disorders exist. Finally, limiting approved HCV treatment prescribers to specialists creates unnecessary barriers for Medicaid patients. For these reasons, morbidity and mortality from HCV-related illness will continue to increase among our state’s lowest income residents.

Real World Experience

Current HCV treatment regimens are very safe and highly-effective.  More than 6,000 patients have participated in phase 3 clinical trials of the recommended regimens. From “The safety profiles of all the recommended regimens above are excellent. Across numerous phase III programs, less than 1% of patients without cirrhosis discontinued treatment early and adverse events were mild. Discontinuation rates were higher for patients with cirrhosis (approximately 2% for some trials) but still very low.”

The experience of treating HCV-HIV co-infected patients in the Denver Health Infectious Diseases Clinic and University of Colorado Infectious Diseases Group Practice Clinic illustrates the real-world efficacy of therapy in a high-risk group. In 2015, our clinics treated a total of 93 co-infected patients. The cure  rate for individuals who completed treatment and were assessed for sustained virologic  response was 96%. Only two patients were lost to follow-up while on treatment, one patient’s treatment was stopped for an unrelated medical event, and three patients with severe liver disease (two were on the liver transplant list) failed treatment. No patient stopped treatment for a medication related side effect or adverse event. Twenty patients had evidence of active substance abuse and nearly all were successfully treated through the AIDS Drug Assistance Program (which does not restrict treatment of individuals with addictions or substance use disorders).


While treatment is relatively expensive,  prices are decreasing as new medications are approved (see Figure). Meanwhile, the costs of withholding HCV treatment are growing. In the past decade, hepatocellular carcinoma cases have doubled in Denver and hospitalizations  for HCV-related conditions are steadily increasing. Multiple studies have shown that treatment with these new regimens cuts hospitalizations in half and leads to significantly lower follow-up healthcare costs compared to untreated individuals.

costs-approved-treatmentsImportantly, the evidence from  other states  demonstrates that  expanding access will not result  in dramatically increased treatment costs. Only a minority of HCV-infected persons will seek care in a given year and they must complete the stages of diagnosis, linkage to care, and initial medical evaluation prior to initiating treatment. Mass Health, Massachusetts’ Medicaid program, reported that in the first 18 months after treatment restrictions were eliminated, only 14% ofHCV-infected individuals in their administrative database were treated. Similar findings were noted in New York.

A phased approach to expanding access to treatment can allow broader access to treatment while controlling treatment costs. In California, the Medicaid program has eliminated urine drug and alcohol screens and extended treatment access to individuals with F2 or greater fibrosis, leading to better health care access for California residents, while still maintaining a prioritization process that cushions the Medicaid program from the full impact ofHCV costs for the next couple of year as medication prices decrease.

Without a change, HCV treatment policies for Colorado Medicaid may be made in a courtroom, rather than in the exam room. Medicaid treatment restrictions in Washington state resulted in a federal court ruling that all restrictions be eliminated, a more costly outcome than the three changes to treatment restrictions that we recommend above. Similar lawsuits are underway regarding the Indiana Medicaid program and two state prison systems. Colorado should follow the lead of Medicaid programs in Florida, Connecticut, New York and Pennsylvania in increasing access to treatment rather than engage in expensive legal battles.

Proposed Changes

While we believe that all individuals living with chronic HCV need treatment, three revisions to the current CO Medicaid treatment criteria would substantially improve access, while controlling the costs of treatment. First, we recommend removing drug and alcohol restrictions from the prior approval process so that all individuals with evidence of advanced disease can be treated. Second, we recommend extending treatment access to individuals with any evidence of F2 fibrosis.  Third, we recommend that primary care providers be able to prescribe HCV treatment.


William J. Burman, M.D.

Interim CEO, Denver Health and Hospital Authority

ACLU letter to Colorado Medicaid


 VIEW ACLU letter in PDF

July 22, 2016


Susan Birch, Executive Director
Colorado Department of Health Care & Policy Financing
1570 Grant St.
Denver, CO 80203

Dear Director Birch:

We write on behalf of Colorado Medicaid beneficiaries with Hepatitis C who, as a result of Health Care Policy and Financing (“HCPF”) prescription drug policies, are unable to access medically necessary treatment.

The HCPF’s Prior Authorization Criteria for Hepatitis C Virus (“HCV”) treatments unreasonably restrict access to curative treatment, in violation of federal Medicaid law. These unreasonable restrictions on access to HCV treatment include: (1) requiring that beneficiaries have a Metavir Fibrosis Score1 of F3 or F4 before they can access curative medical treatments; (2) requiring that beneficiaries receive a prescription for the treatment from a liver specialist; and (3) requiring that beneficiaries abstain from drugs and alcohol for six months prior to treatment. We urge HCPF to take immediate steps to eliminate these unreasonable (and illegal) restrictions.

  1. The severity of liver damage due to HCV is measured by a scoring system. Liver disease is graded according to the level of liver scarring and assigned a Metavir Fibrosis Score (“fibrosis score”). A fibrosis score of F0 or F1 indicates no or minimal scarring; F2 is an intermediate stage of fibrosis; a score of F3 indicates severe fibrosis; F4 indicates cirrhosis. HCV is a chronic inflammatory condition. Lack of liver damage does not suggest that the individual does not have the disease (which can be confirmed by blood tests) or that the individual is not suffering other, extrahepatic symptoms of the disease. All the F score measures is liver damage, which is only one of multiple effects of the disease. See generally, Gill, Ghazinian, Manch, Gish, Hepatitis C virus as a systemic disease: reaching beyond the liver, HEPATOLOGY INTERNATIONAL, Vol. 9, No. 4 (2015).
  2. Center for Disease Control and Prevention, Hepatitis C Kills More Americans than Any Other Infectious Disease,
  3. See David Olinger, Ninety Percent of Colorado Residents with Hepatitis C Going Untreated, DENVER POST (May 18, 2016 8:22 AM),


Hepatitis C is a blood-borne infectious disease which, when left untreated, can cause liver damage, liver failure, liver cancer, and death. Even in the initial stages of the disease, individuals with HCV can experience serious symptoms, including fatigue, joint pain, depression, sore muscles, arthritis, mental changes, heart attacks, diabetes, nerve damage, jaundice, and various cancers. The Center for Disease Control and Prevention estimates that nearly 20,000 deaths were associated with HCV in 2014, making it the most deadly infectious disease in the United States.2 Approximately 70,000 Coloradoans suffer HCV infections.3 HCPF recently estimated that at least 9,000 Colorado Medicaid beneficiaries have HCV. 2

Until recently, the standard therapy for HCV consisted of a three-drug treatment regimen consisting of boceprevir, interferon, and ribavirin. At best, this course of treatment cured HCV in only 70% of patients, and it was often accompanied by significant adverse side effects such as bone pain, muscle pain, joint pain, anemia, insomnia, memory loss, anxiety, depression, nausea, liver failure, and death. In addition, this treatment regimen was lengthy, often requiring almost one year to complete. Because of the side effects and length of treatment, this HCV drug therapy was generally provided only to individuals with severe liver damage, as measured by a fibrosis score of F3 or F4.

Fortunately, in the past five years HCV treatments have advanced significantly. Beginning in 2011, the Food and Drug Administration (“FDA”) began approving new direct-acting antiviral (“DAA”) medications which, unlike the earlier HCV drugs, are capable of curing the disease via a short course of once-daily pills over the course of 8-12 weeks. These DAAs carry minimal side effects and are markedly more effective than the previous drugs, curing over 90% of patients. The FDA has designated DDAs as “breakthrough therapies,” a classification reserved for drugs that provide substantial improvement over existing therapies in treating serious or life-threatening conditions.

According to evidence-based, expert-developed guidelines published by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (“AASLD/IDSA Guidelines”), DAAs are now “recommended for all patients with chronic HCV infection,” with the narrow exception of patients “with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy.”4 These guidelines specifically urge early treatment of HCV, as in patients with fibrosis scores of F0, F1, and F2. In other words, the guidelines explicitly refute the idea that DAA drugs should be prescribed only to patients with severe liver damage, instead recommending that virtually all HCV patients receive DAA treatments regardless of their fibrosis score. The AASLD/IDSA Guidelines represent the professionally-accepted clinical standard of care for treatment of HCV.

4 American Association for the Study of Liver Diseases & Infectious Diseases Society of America, HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C, (emphasis added).

5 Centers for Medicare and Medicaid Services, Assuring Medicaid Beneficiaries Access to Hepatitis C (HCV) Drugs (Release No. 172), Nov. 5, 2015.

6 Id.

As a result of this consensus, the Centers for Medicare and Medicaid Services (“CMS”)—the federal agency responsible for administering Medicaid—issued Guidance on November 5, 2015, advising state Medicaid agencies that the new DAAs must be included in coverage of outpatient prescription drugs.5 CMS was clear as to the animating purpose of the Guidance: “CMS is concerned that some states are restricting access to DAA HCV drugs contrary to the statutory requirements in section 1927 of the Act by imposing conditions for coverage that may unreasonably restrict access to these drug.”6 Further, CMS warned states that any restrictions on access to DAAs “should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections.” Specifically, CMS identified three conditions which unreasonably restrict access to DAAs: (1) limiting treatment to beneficiaries with fibrosis scores of F3 and F4; (2) conditioning access to treatment on a period of abstinence from drug or alcohol abuse; and (3) requiring that DAAs be prescribed by, or in consultation with, specialists such as infectious disease specialists, gastroenterologists, or hepatologists. More than six months after receiving this Notice from CMS, Colorado Medicaid continues to enforce each of these three unreasonable restrictions on access to DAA medications.


Contrary to the AASLD/IDSA Guidelines and the CMS Notice, HCPF’s Prior Authorization Criteria for HCV treatments strictly—and illegally—restrict beneficiaries’ access to medically necessary care, namely DAA drugs. There are three restrictions that HCPF must rescind.

First, HCPF prevents Colorado Medicaid beneficiaries from obtaining curative HCV treatment 3 unless they have severe liver damage, as measured by a fibrosis score of F3 or F4. This restriction flatly contradicts the AASLD/IDSA Guidelines, which advise that virtually all chronic HCV patients, regardless of their fibrosis score, receive DAA treatment upon diagnosis. The HCPF policy has the bizarre effect of requiring eligible beneficiaries—who could be treated immediately with few to no adverse side effects—to wait until their disease causes irreparable liver damage before they can access curative treatment. While DAAs are extremely effective in curing HCV, the drugs cannot reverse liver scarring; thus, requiring beneficiaries to wait until their disease progresses results in serious, preventable, and permanent organ damage. Moreover, because HCV is communicable, delaying treatment not only harms the individual beneficiary’s health, but also endangers the health of their family and the general public. By requiring HCV patients to go without treatment, perhaps for years, Colorado Medicaid increases the risk that the disease will be transmitted to others.

Second, curative HCV treatment is denied under Colorado’s criteria if the beneficiary’s prescription is not issued by, or in conjunction with, an infectious disease specialist, gastroenterologist, or hepatologist. Because access to specialist care is limited, particularly in rural areas of Colorado, this requirement places an onerous burden on Medicaid beneficiaries. The AASLD/IDSA Guidelines label lack of access to specialists “a primary barrier to hepatitis C care.” Because DAAs require only a short course of treatment and involve few serious adverse side effects, the AASLD/IDSA Guidelines recommend relying on and expanding the role of primary care physicians in managing and treating HCV.

Third, HCPF’s Prior Authorization Criteria deny curative treatment to beneficiaries who have used alcohol, marijuana, or other drugs in any amount at any time during the six months prior to treatment. There is simply no medical justification for this policy. Drug and alcohol use has not been proven to decrease efficacy of DAA treatment for HCV. Further, the AASLD/IDSA Guidelines note that injection drug users have demonstrated adherence to DAA treatment regimens at rates comparable to individuals who do not use injection drugs, as well as low rates of reinfection. In fact, because HCV can be transmitted through injection drug use, the AASLD/IDSA Guidelines recommend treating individuals who use injection drugs to curb the spread of the disease. Not only is this restrictive policy unsupported by medical evidence, it also creates perverse public health outcomes. As the AASLD/IDSA Guidelines conclude, “there are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy. These requirements should be abandoned, because they create barriers to treatment, add unnecessary cost and effort, and potentially exclude populations that are likely to obtain substantial benefit from therapy.”

These three restrictive policies deny medically necessary HCV treatment to Medicaid beneficiaries, and thereby violate federal Medicaid law. Similar restrictions have been successfully challenged in Washington, where a federal district court recently enjoined the state Medicaid agency from enforcing its HCV treatment policy and ordered that HCV prescription drugs be provided to beneficiaries without regards to fibrosis score.7 Similar litigation is pending in Indiana. Medicaid agencies in a number of states, including Delaware, Florida, Massachusetts, and New York, have recently responded to legal and policy advocacy by rescinding their overly restrictive policies regarding access to HCV medications. Colorado must do the same.

7 See Order Granting Plaintiffs’ Motion for Preliminary Injunction, B.E. v. Teeter, No. C16-227-JCC (W.D. Wash. May 27, 2016), 2016 U.S. Dist. Lexis 70021 (W.D. Wash. May 27, 2016).

8 See, e.g., Alexis P. Chidi et al., Economic and Public Health Impacts of Policies Restricting Access to Hepatitis C Treatment for Medicaid Patients, 19 VALUE IN HEALTH 326 (2016) (concluding that expanding access to DAAs resulted in long-term cost savings ranging from $5,369 to $11,960 per patient).

Lifting the restrictions is the right thing to do, not only because it is legally required, but because this efficacious and curative treatment is indisputably medically necessary for the affected Colorado Medicaid enrollees. Moreover, providing full access to HCV treatments is the fiscally sound decision for Colorado Medicaid, because early treatment precludes expenses that would otherwise be incurred as a result of the disease’s progression.8 And, finally, lifting the restrictions avoids the need to resort to the courts. It would be better for all if HCPF did the right thing on its own initiative, and rescinded these unjustifiable 4 restrictions that impede access to medically necessary treatment, rather than have a federal court order it to do so.


Mark Silverstein Lawrence Treece
Legal Director Brownstein Hyatt Farber Schreck ACLU of Colorado In cooperation with the ACLU of Colorado

Kevin Costello
Director of Litigation Center for Health Law & Policy Innovation Harvard Law School

Hepatitis B and HIV combo may promote liver cancer


Liver cancer in Africans tends to occur between the ages of 30 and 40. But a study has found that it occurs at a significantly younger age in those infected with HIV and hepatitis B.

People who have both hepatitis B and HIV may have a greater chance of developing liver cancer at a young age, according to our new study.

Need for early diagnosis

The study, to be published shortly, involved patients from cancer units. The results showed that the age profile of liver cancer patients was affected by HIV. Liver cancer in Africans occurs at a young age: between the ages of 30 and 40 years. But we found that it occurs at a significantly younger age in those who are infected with HIV and hepatitis B.

Liver cancer is the third most common cause of death among the seven million people who die from cancer annually across the globe.


Another HCV treatment approved

Jul 25, 2016
– New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of VIEKIRA PAK® for adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection
– The approval marks another milestone in AbbVie’s ongoing commitment to therapeutic innovation for people living with GT1 HCV

NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for people with decompensated cirrhosis.

VIEKIRA XR is the first co-formulated three direct-acting antiviral (DAA) treatment for adult patients with GT1 HCV. VIEKIRA XR is given once-daily as three oral tablets and must be taken with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients. The approval is supported by Phase 3 clinical trials for VIEKIRA PAK which include data that demonstrated 100 percent sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95 percent SVR12 in GT1a patients when used with ribavirin for 12 or 24 weeks of therapy.