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Medicaid Restrictions, Opoid Replacement Therapy, African-Americans,
Depression/Comorbidities....is this legal? A lawsuit- "swift overturn in courts"
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one lawsuit could offer a cautionary tale......"any attempt to draw a line on an infectious disease will be met with a swift overturn in the courts", says Matt Salo, executive director of the National Association of Medicaid Directors.......http://www.yakimaherald.com/news/yhr/saturday/2363148-8/states-limit-medicaid-users-access-to-hepatitis-drug
State Medicaid programs are generally required to cover Food and Drug Administration-approved treatments regardless of price unless similar options are available
As states consider their Sovaldi coverage, one lawsuit could offer a cautionary tale. Three Arkansas patients suffering from cystic fibrosis filed a lawsuit last month claiming the state refused to cover a $300,000 drug because of its cost. Salo of the Medicaid directors group said he worries about the potential for similar lawsuits over hepatitis C coverage guidelines.
"When you have this public health mission coming out from CDC and other folks, any attempts to sort of draw a line to say, 'We will cure this person of an infection but not this person' ... any attempt to draw a line on an infectious disease will be met with a swift overturn in the courts," he said.
The treatment also allows patients to avoid expensive hospitalizations and liver transplants, which on average cost $577,000.
"The new policies are going to further restrict access to care for thousands of patients on the basis of no evidence,"
Groups representing employers, insurers and others who pay for health care have aggressively scrutinized Sovaldi's pricing. They warn that Sovaldi is a harbinger of a coming wave of expensive specialty medicines.
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Are restrictions legal? Here is the law on rebates. Medicaids receive a 23% discount, the VA 44%, these are negotiable upwards. In return the law says Medicaid is to provide drugs, there is no mention that allows restrictions. The law suggests to me providing treatment should be unfettered.
Section 1927 of the Social Security Act (actual text of the law establishing the Medicaid drug rebate program):
http://www.ssa.gov/OP_Home/ssact/title19/1927.htm
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OTP patients (Opoid Treatment Programs), ideal for new hepatitis C medication, put on bottom of list by payers
Alcoholism & Drug Abuse Weekly
http://www.alcoholismdrugabuseweekly.com/Article-Detail/otp-patients-ideal-for-new-hepatitis-c-medication-put-on-bottom-of-list-by-payers.aspx
"Sovaldi.....has a success rate better than 90 percent, and is ideal for use in opioid treatment programs (OTPs), yet payers are balking at covering it for patients who have a history of a substance use disorder".......[from Jules: below in this report are ALL the data so far made available on HCV treatment with both Abbvie's 3D interferon-free new 12 week therapy showing 97% SVR rate and Gilead's Sovaldi data in this patient population showing similarly high SVR rates]......a report Oregon Paper - last May by the Center for Evidence-Based Policy at Oregon Health and Science University, which was supported by state Medicaid directors, recommended excluding the use of Sovaldi in patients with alcohol or drug use within the past year......in New York State, 65% of OTP patients have chronic hepatitis C......Valerie King, research director at the OSHU center that issued the report, wrote us that the published Sovaldi studies excluded subjects with active substance misuse or the extent to which such people were included could not be determined, which is why the recommendation was made. NOT TRUE....Gilead: Methadone use was also permitted in Phase II and Phase III trials
Interview with Illinois Medicaid Medical Director Re: their new restrictions on Sovaldi Access - (08/08/14)....."They must have the most advanced stage of liver disease......restrictions.....can't have been abusing drugs or treated for alcohol or illicit drugs for 12 months prior to requesting Sovaldi...... nobody ever studied if Sovaldi could be safe or effective for such people......Why is it so bad to tell them they should be sober and take the drug in a dependable fashion? If someone is using a street drug such as heroin I can't be sure they are compliant taking Sovaldi. It's a total waste." Medicaid restrictions justifications like the Oregon paper & the Illinois Medicaid medical director appear to also be saying there is not adequate data for African-Americans either.
IAC: Abbvie 3D Regimen in HCV Genotype 1-Infected Patients on Methadone or Buprenorphine (07/21/14)
AASLD/2013: Virologic Response Rates to Sofosbuvir-Containing Regimens Are Similar in Patients With and Without Traditional Negative Predictive Factors: a Retrospective Analysis of Phase 3 Data
"An oral drug with few side effects and a 90-percent cure rate is now available to treat hepatitis C, which is prevalent in OTP patients, who are ideally suited for this medication......New York has a generous Medicaid benefit, but some states don't even pay for OTP treatment, much less HCV treatment. "That's the tragedy of our system," said Litwin. "These people are going to die, and society is okay with that." ......."This is something that's killing our people," said McCance-Katz......."That's part of the stigma, isn't it?" said Elinore McCance-Katz, M.D., chief medical officer for the Substance Abuse and Mental Health Services Administration (SAMHSA), which regulates OTPs.. "People who receive treatment in methadone programs are not relapsing," she said. "There's no reason to discriminate against them." But even if there were a relapse, that doesn't mean the patient shouldn't be treated for HCV, she said.
Matt Salo, NAMD executive director......need to at least take into consideration a variety of factors," he said. "Those factors may well include current drug use, in part because it may make adherence/compliance more difficult, but also because of the potential repercussions of successfully curing an individual only to have the risk of reinfection......We asked if he had any evidence that OTP patients or drug users are more likely to have a reinfection of HCV or be less compliant with medication. "I'm not sure that I have evidence on any of those things, per se," he said, but he pointed out that isn't NAMD's role......Valerie King, spokeswoman for the OHSU project, said that the published studies on Sovaldi "all excluded subjects with active substance misuse," and that is why the report concluded that these patients should not get the medication. She noted that there is no published research about using Sovaldi with naltrexone or buprenorphine.....Gilead. Methadone use was permitted in clinical trials, after the potential for drug interaction between Sovaldi and methadone was assessed in Phase I and it was found that the medications did not affect each other in terms of levels......based on the Sovaldi label, alcohol or other drug use is not a contraindication.....approximately 5-10 percent of patients in the Phase 3 studies self-reported this medical history, and there was no significant difference in [success] rates among these groups.....Virginia Medicaid formulary states that patients "must be evaluated for current history of substance abuse and alcohol with validated screening instruments" in order to get Sovaldi. "The prescriber can submit clinical rationale for treatment continuation, for positive tests that are false positives and not thought to be due to a relapse in alcohol or substance abuse," according to the formulary"
"Now we have this great treatment, but let's restrict it to people who are not actively using drugs - that is contrary to everything society should stand for," Alain H. Litwin, M.D., who helped develop the HCV screening and treatment programs at the Albert Einstein College of Medicine in New York City.......In New York state, 65 percent of OTP patients have chronic HCV, he said. "Other than addiction, hepatitis C is the leading chronic illness,"......Litwin cited a report issued in May by the Center for Evidence-Based Policy at Oregon Health and Science University (OHSU), supported by state Medicaid directors, that seeks to deter payments for Sovaldi, discrediting the trials and taking issue with the practice guidelines issued by the American Association for the Study of Liver Disease, which support the use of Sovaldi. The report singles out drug users as a group that should not be given the medication, saying that "patients with alcohol or drug use within the past year" should be excluded from treatment......At CODAC Behavioral Health Care based in Providence, Rhode Island.....85 percent of patients were infected with HCV; that is now down to 50 percent, largely as a result of the recent expansion of patients from 700 three years ago to 1,400 now......"The insurance companies aren't responsive when it comes to the request to use these new medications,"
July 28, 2014
By Alison Knopf
Sovaldi, approved by the Food and Drug Administration (FDA) last year for the treatment of chronic hepatitis C (HCV), has a success rate better than 90 percent, and is ideal for use in opioid treatment programs (OTPs), yet payers are balking at covering it for patients who have a history of a substance use disorder (SUD), ADAW has learned. This is despite any labeling that indicates it is not safe for these patients; in fact, in trials it was given concomitantly with methadone with patients in OTPs, and the FDA states it can be given concomitantly with methadone, with no dose adjustments.
Sovaldi (sofosbuvir) is the first oral medication for HCV that doesn't require interferon, an injected medication that has, for many patients, intolerable side effects, including nausea, fatigue and depression. Also last year, the FDA approved another oral medication for HCV: Olysio (simeprevir).
The problems with these medications are that they are costly: more than $60,000 for Olysio and more than $80,000 for Sovaldi. Treatment takes 12 to 24 weeks.
Now we have this great treatment, but let's restrict it to people who are not actively using drugs - that is contrary to everything society should stand for."
Alain H. Litwin, M.D.
Still, the morbidity and mortality associated with HCV, which can lead to cirrhosis, liver failure and death, call for the use of these medications, especially in OTPs, said Elinore McCance-Katz, M.D., chief medical officer for the Substance Abuse and Mental Health Services Administration (SAMHSA), which regulates OTPs.
"I've been waiting for these drugs for a long time," McCance-Katz, whose background is in infectious diseases, told ADAW last week. "This is an area that's very near and dear to my heart." Noting that people die from liver disease that is induced by HCV, she said that the first "Dear Colleague" letter she wrote to OTPs was about the need for testing for HCV. She just reissued that letter because the disease "is so important in terms of morbidity and mortality."
OTPs are uniquely able to provide HCV testing and treatment because they are already required to oversee medical care, she said. "Patients must have a physical exam, be seen by a doctor, and the OTP must make sure that patients get all the care that they need," she said.
Testing and treatment
It's not enough to simply do an antibody test for HCV; programs also need to test for viral load, said McCance-Katz. "Not everybody who shows a positive for ever being infected is still infected," she said. And then, it's essential to treat the HCV, if the infection is there, she said. "It's unfair to patients to tell them they are infected with HCV if there isn't anything that's being done on it," she said.
If patients have a viral load, they need to be referred to medical care, said McCance-Katz, adding that the care doesn't necessarily need to be provided in the OTP. "Another physician could do the workup," she said, adding, "not everybody with a viral load is going to be treated, because they may not be at a point where that is clinically indicated."
Hepatitis C is generally transmitted parenterally - via injection with infected needles, or a blood transfusion before 1992, when the supply was tested.
The FDA requires testing medications with methadone, and that was done for Sovaldi - another reason that OTP patients are uniquely suited to this medication, said McCance-Katz. There are no contraindications to giving both medications, and no dose adjustments are required.
Welcome from OTPs
OTPs are on the one hand delighted that they can offer this medication to their patients, but on the other hand cynical about whether payers will pay for it. "Over the next 10 to 20 years we can expect increased morbidity in terms of cirrhosis and liver cancer," said Alain H. Litwin, M.D., who helped develop the HCV screening and treatment programs at the Albert Einstein College of Medicine in New York City. "But this can be avoided with treatment." The Einstein OTP has treated 500 patients for HCV over the years, and Litwin is thrilled that Sovaldi is now available to these patients. "The time is now," he said. "There's always been excuses to wait - treatments aren't effective, the OTP population is too complicated, there are too many competing priorities." But now, with one pill a day, a 95 percent cure rate and very few side effects, there is no reason to back off treatment for what is a leading cause of death in OTP patients, he said.
Einstein has been treating patients with interferon, with injections given on site twice a week. Side effects are problematic. But the switch to Sovaldi is likely to be constrained by payers, he said.
OHSU-Medicaid report
In particular, Litwin cited a report issued in May by the Center for Evidence-Based Policy at Oregon Health and Science University (OHSU), supported by state Medicaid directors, that seeks to deter payments for Sovaldi, discrediting the trials and taking issue with the practice guidelines issued by the American Association for the Study of Liver Disease, which support the use of Sovaldi. The report singles out drug users as a group that should not be given the medication, saying that "patients with alcohol or drug use within the past year" should be excluded from treatment.
"Now we have this great treatment, but let's restrict it to people who are not actively using drugs - that is contrary to everything society should stand for," said Litwin. "It's unjust." In New York state, 65 percent of OTP patients have chronic HCV, he said. "Other than addiction, hepatitis C is the leading chronic illness," said Litwin. Einstein's model of care is group treatment - a shared medical visit in which everyone gets their medication. Now, with genotypes 2 and 3 of HCV, interferon-free is the best treatment, he said. The OTP could easily observe administration of the oral medication. About 30 percent of the OTP's patients have those genotypes and are getting Sovaldi, said Litwin. For genotype 3, Sovaldi must be taken for 24 weeks, at a cost of $168,000, said Litwin. "At some point, this does not become cost-effective," he said. "Everyone needs to contribute to this equation."
Hours on pre-authorization
At CODAC Behavioral Health Care based in Providence, Rhode Island, the OTP is spending hours on getting documentation together to get Sovaldi for HCV patients. At one point, 85 percent of patients were infected with HCV; that is now down to 50 percent, largely as a result of the recent expansion of patients from 700 three years ago to 1,400 now. The newer patients are "more savvy in terms of taking care of their health, and not sharing needles," said Diane Plante, CODAC nurse manager. "We do rapid HCV testing, and all patients who come back positive are sent to another clinic for viral load testing," said Plante. Depending on the genotype, patients get Sovaldi or Olysio; no patients get interferon due to the significant side effects, she said.
Clinically, everything is going well. But the problem is getting paid, said Plante. "We've prescribed and we're still muddling through the prior authorization process," she said. A nurse and an aide spend several hours per patient documenting the need for these medications, with private insurance companies and Medicaid alike, she said.
"The insurance companies aren't responsive when it comes to the request to use these new medications," said Michael Rizzi, CODAC president and CEO. "They want us to use old protocol first, which is throwing good money down the tube." The patient experience of using interferon "causes as much frustration as the disease" of HCV, he said.
Rizzi noted that $84,000, the cost of 12 weeks on Sovaldi, is much less than one acute hospitalization of a week in the ICU. "They're going to pay for it one way or another," he said of insurance companies and HCV treatment. He also thinks that patients in OTPs are being discriminated against if insurance companies think that everyone who is in recovery is a bad risk for reinfection.
"They wouldn't say to a guy who needed another bypass that he couldn't get it because he didn't change his diet," said Rizzi.
One concern is "warehousing" - that patients will be stuck using interferon until there are less expensive versions of Sovaldi on the market.
Medical discrimination
The National Association of Medicaid Directors (NAMD) circulated the OHSU report to state Medicaid directors, saying that the high cost of the medication "requires careful consideration of how to responsibly decide how to best use this new treatment option," especially considering that there are 3 million people with HCV. "Nobody is demonizing drug users and saying that they shouldn't be treated/cured," said Matt Salo, NAMD executive director, in an email to ADAW. "But the practical implications of administering a 12-week course of treatment that can cost between $84-140K need to at least take into consideration a variety of factors," he said. "Those factors may well include current drug use, in part because it may make adherence/compliance more difficult, but also because of the potential repercussions of successfully curing an individual only to have the risk of reinfection."
We asked if he had any evidence that OTP patients or drug users are more likely to have a reinfection of HCV or be less compliant with medication. "I'm not sure that I have evidence on any of those things, per se," he said, but he pointed out that isn't NAMD's role. "But we have heard (in a few states) that they've already spent more on Sovaldi in the first quarter of 2014 than they did for liver transplants in all of 2012 and 2013 combined."
"NAMD has no opinion on whether or not any individual or group of individuals should or shouldn't get treatment for anything," said Salo. "We do stand behind the ability of states (who have to make difficult decisions about this and many other things every day) to make those types of decisions, however."
Valerie King, spokeswoman for the OHSU project, said that the published studies on Sovaldi "all excluded subjects with active substance misuse," and that is why the report concluded that these patients should not get the medication. She noted that there is no published research about using Sovaldi with naltrexone or buprenorphine.
Gilead responds
The maker of Sovaldi, Foster City, Calif.-based Gilead Sciences, "disputes and strongly disagrees with the conclusions of the OHSU report, commissioned by the National Association of Medicaid Directors (NAMD), regarding the use of sofosbuvir for chronic hepatitis C," according to a spokeswoman for the company. "The report runs counter to the conclusions of regulatory authorities and expert professional groups that have licensed and endorsed sofosbuvir based on a well-designed and well-conducted clinical program demonstrating its ability to consistently deliver cure rates of over 90 percent."
Sovaldi has been studied in subjects who were taking methadone, and the success rates were comparable to overall outcomes, according to Gilead. Methadone use was permitted in clinical trials, after the potential for drug interaction between Sovaldi and methadone was assessed in Phase I and it was found that the medications did not affect each other in terms of levels.
Concerns with alcohol
Because alcohol accelerates the damage caused by HCV and leads to the more rapid development of cirrhosis, clinicians caution HCV patients to abstain from alcohol, the spokeswoman said. However, based on the Sovaldi label, alcohol or other drug use is not a contraindication, she said.
In the trials, HCV patients were counseled to discontinue alcohol use, the spokeswoman said. "Patients who were actively abusing alcohol were excluded from the clinical trials," she said. "However, a history of alcohol abuse or ongoing alcohol use was not exclusionary; approximately 5-10 percent of patients in the Phase 3 studies self-reported this medical history, and there was no significant difference in [success] rates among these groups."
Stigma
But OTPs are still concerned about patients not being able to afford the medication, especially if they pick up on the OHSU language.
For example, the Virginia Medicaid formulary states that patients "must be evaluated for current history of substance abuse and alcohol with validated screening instruments" in order to get Sovaldi. "The prescriber can submit clinical rationale for treatment continuation, for positive tests that are false positives and not thought to be due to a relapse in alcohol or substance abuse," according to the formulary.
New York has a generous Medicaid benefit, but some states don't even pay for OTP treatment, much less HCV treatment. "That's the tragedy of our system," said Litwin. "These people are going to die, and society is okay with that."
"That's part of the stigma, isn't it?" said McCance-Katz. "People who receive treatment in methadone programs are not relapsing," she said. "There's no reason to discriminate against them." But even if there were a relapse, that doesn't mean the patient shouldn't be treated for HCV, she said.
McCance-Katz added that patients in methadone treatment are being diligently monitored and therefore would be better candidates than other patients for Sovaldi. "If you are not in an OTP, they're probably not even going to be monitoring, not even doing drug screens," she said.
"This is something that's killing our people," said McCance-Katz. "I think OTPs are well-positioned to provide and to help to provide this care, and our patients deserve to have all of their issues that they bring to treatment addressed."
Gilead has established a patient assistance program to help patients with high copays or without insurance.
For the OHSU report, go to http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/med/upload/Sofosbuvir_for_HepatitisC_FINALDRAFT_6_12_2014.pdf.
Bottom Line...
An oral drug with few side effects and a 90-percent cure rate is now available to treat hepatitis C, which is prevalent in OTP patients, who are ideally suited for this medication. The hitch: It's too expensive.
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Medicaids Restrictions Based on Misleading Information: African-Americans/ Opoid Replacement (Methadone) Users SVR Rates, comorbidities
Jules Levin, NATAP
The medicaids that are imposing harsh & punitive restrictions to access for new HCV therapies are throwing up smokescreens to mislead the public, they claim the data/SVR rates are not good, studies haven't been conducted in drug users or African-Americans, but the real reason is they don't want to pay. In HIV they could never get away with this. Over $5 bill a year in spent on medicaid for HIV & $4.5 bill for medicare, and back when HAART first came out in 1996 they squawked as well, they didn't want to pay. The messaging by medicaid have been broadly distributed through the media & the public has eaten it up. But they have been sending out false & misleading information, particularly regarding the effectiveness of the SVR data from the new interferon-free regions, and regarding the effectiveness of the data in patient populations -
African-Americans and opoid users; they are trying to deny therapy, they are scapegoating patients who are African-American & former substance abusers - those on opoid replacement therapy, (methadone). A key restriction to therapy access that some medicaids particularly Illinois recently constructed is related to patients with a history of substance abuse (including of note IDUs and alcohol!). Illinois guidelines recently released said anyone with evidence of substance abuse in the last 12 months could not get HCV therapy & they said there isn't data to say these patients respond as well as patients who don't have substance abuse concerns, the absurdity of this is that injection drug use is the leading cause of HHCV-infection so they want to deny access to the most significant patient group based on false information, see the data below - African-Americans, those in opoid replacement programs and HCV/HIV coinfected have the same response rates as everyone else. In fact the Illinois Medicaid Medical Director said in an interview 1 week ago: "one-third of the population for which we were approving Sovaldi take drugs or alcohol, and nobody ever studied if Sovaldi could be safe or effective for such people.......So we could not see everybody getting a prescription, just because their own data says it's effective about 90% of the time. The previously used drugs were effective 75% to 80% of the time. There's an edge for Sovaldi, but is it effective for population we serve? We can't answer that today. Many of our patients have co-morbidities and take other meds. We did not find evidence that Gilead did research on that type of population." ....http://www.natap.org/2014/HCV/080814_07.htm. This week Vertex announced they are stopping distribution of telaprevir in the USA. No one wants to take boceprevir or telaprevir+Peg/Rbv, the phase 3 studies in treatment-naive patients showed 70% SVR rates for these combinations which were 24-48 weeks of therapy and WITH interferon in phase 3 studies but the side effects were difficult to tolerate, with the new therapies in the same treatment-naive patient populations showing 95-100% SVR rates without interferon for 12 weeks therapy, and the side effects are much better, no interferon!. Oregon questioned all the data related to Sovaldi saying the data is just not proven to be adequately convincing yet! Medicaids have alluded to that Sovaldi has not been studied adequately or at all in African-Americans or as mentioned above in ovoid replacement patient populations, and of course they are alluding the same is true for all the new DAAs, week, this is not true......
AASLD/2013: Virologic Response Rates to Sofosbuvir-Containing Regimens Are Similar in Patients With and Without Traditional Negative Predictive Factors: a Retrospective Analysis of Phase 3 Data - (11/13/13)...these were studies of Sofosbuvir/Rbv but below are more recently presented data at EASL in April of the phase 3 Sofosbuvir/Ledipasvir ION studies
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IAC: Abbvie 3D Regimen in HCV Genotype 1-Infected Patients on Methadone or Buprenorphine (07/21/14)
African-Americans
308 subjects (16%) in the ION studies were African American. Table 1 of each NEJM paper (attached) lists the demographic breakdown for the enrolled subjects.
Below is the SVR breakdown for African American subjects (all public info from the ION NEJM supplements also attached).
IAC: SAPPHIRE-II Subgroup Analysis: ABT-450/r/Ombitasvir (ABT-267), Dasabuvir (ABT-333), and Ribavirin Regimen Achieves High Sustained Virologic Response Rates 12 Weeks Post-treatment in Treatment-experienced Patients With Chronic HCV GT 1 Infection, Regardless of Baseline Characteristics - (07/25/14)
IAC: SAPPHIRE-I Subpopulation Analysis: ABT-450/r/Ombitasvir (ABT-267), Dasabuvir (ABT-333), and Ribavirin Regimen Achieves High Sustained Virologic Response Rates 12 Weeks Post-treatment in Treatment-naïve Patients With Chronic HCV GT 1 Infection, Regardless of Baseline Characteristics - (07/25/14)
IAC: TURQUOISE-I: SAFETY AND EFFICACY OF ABT-450/R/OMBITASVIR, DASABUVIR, AND RIBAVIRIN IN PATIENTS CO-INFECTED WITH HEPATITIS C AND HIV-1 (07/21/14)
IAC: High SVR12 With Sofosbuvir/Ribavirin in HCV/HIV-Coinfected: PHOTON-2 (07/21/14)
EASL: All Oral Fixed-Dose Combination Ledipasvir/Sofosbuvir With Or Without Ribavirin for 12 or 24 Weeks in Treatment-Naive Genotype 1 HCV-Infected Patients: the Phase 3 ION-1 Study - (04/14/14)
EASL: All Oral Fixed-Dose Combination Ledipasvir/Sofosbuvir With or Without Ribavirin for 12 or 24 Weeks in Treatment-Experienced Genotype 1 HCV-Infected Patients: The Phase 3 ION-2 Study - (04/14/14)
EASL: Ledipasvir/Sofosbuvir With and Without Ribavirin for 8 Weeks Compared to Ledipasvir/Sofosbuvir for 12 Weeks in Treatment-Naïve Noncirrhotic Genotype-1 HCV-Infected Patients: The Phase 3 ION-3 Study - (04/11/14)
NEJM publications, in the links you can find the full publications and the Supplementary Materials where the SVR rates by Race are provided, these tables above.
ION-1 Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection - (04/14/14)
ION-2 Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection - (04/14/14)
ION-3 Ledipasvir and Sofosbuvir for 8 or 12 Weeks for Chronic HCV without Cirrhosis - (04/11/14)
And here are the actual pdfs for the Supplementary Materials
EASL: TURQUOISE-II: SVR12 RATE OF 92-96% IN 380 HEPATITIS C VIRUS GENOTYPE 1-INFECTED ADULTS WITH COMPENSATED CIRRHOSIS TREATED WITH ABT-450/r/ABT-267 AND ABT-333 PLUS RIBAVIRIN - (04/14/14)
EASL: SAPPHIRE-I: PHASE 3 PLACEBO-CONTROLLED STUDY OF INTERFERON-FREE, 12-WEEK REGIMEN OF ABT-450/r/ABT-267, ABT-333, AND RIBAVIRIN IN 631 TREATMENT-NAïVE ADULTS WITH HEPATITIS C VIRUS GENOTYPE 1 - (04/11/14)
EASL: SAPPHIRE-II: PHASE 3 PLACEBO-CONTROLLED STUDY OF INTERFERON-FREE, 12-WEEK REGIMEN OF ABT-450/r/ABT-267, ABT-333, AND RIBAVIRIN IN 394 TREATMENT-EXPERIENCED ADULTS WITH HEPATITIS C VIRUS GENOTYPE 1 - (04/10/14)
TURQUOISE-II ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis - Phase 3 TURQUOISE-II - (04/14/14)
SAPPHIRE-I Treatment of HCV with ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin (in previously untreated patients with HCV genotype 1 infection and no cirrhosis) - (04/11/14)
SAPPHIRE-II Retreatment of HCV with ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin - (04/10/14) NEJM
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