Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog, the HCV drug pipeline, and for more information on HCV clinical trials
click here

Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.


Alan Franciscus

Editor-in-Chief

HCV Advocate



Showing posts with label achillion. Show all posts
Showing posts with label achillion. Show all posts

Friday, October 16, 2015

Achillion Announces That Janssen Has Initiated a Phase 2a Study to Evaluate the Combination of AL-335, Odalasvir (ACH-3102), and Simeprevir for the Treatment of Genotype 1 Chronic HCV

Once Daily Triple Direct-Acting Antiviral Regimen Will be Evaluated for Treatment Durations of Four, Six or Eight Weeks


NEW HAVEN, Conn., Oct. 16, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has initiated treatment in a phase 2a clinical trial to evaluate the safety, pharmacokinetics and efficacy of AL-335, odalasvir (also known as ACH-3102), and simeprevir in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection.
This phase 2a study is a randomized, open-label, three-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor, and simeprevir, an HCV NS3/4A protease inhibitor. Patients will be randomized to one of three treatment arms and receive once daily treatment for a duration of four, six or eight weeks. The primary objective of the study is to establish the safety of the treatment regimen with secondary endpoints consisting of pharmacokinetics, the proportion of subjects achieving sustained viral response (SVR), and the effect on the viral resistance profile after treatment. The study is expected to enroll approximately 60 patients across the three treatment arms.
As previously announced on May 19, 2015, Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir.
Further information about the study can be found at www.clinicaltrials.gov. Study identifier: NCT02569710.

Thursday, September 17, 2015

Achillion Reports 100% SVR12 From Second Cohort of Patients in the Previously-Completed Six Week Phase 2 Trial Evaluating Odalasvir (ACH-3102) and Sofosbuvir for Genotype 1 HCV ("Proxy Study")


- 100% SVR12 reported for all patients treated for six- (n=18) or eight-weeks (n=12) —
- Odalasvir (ACH-3102) is the subject of an exclusive, worldwide development and commercialization license granted to Janssen -

NEW HAVEN, Conn., Sept. 17, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced additional interim results from a Phase 2 study evaluating odalasvir (also known as ACH-3102), a NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for either six or eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection. Of the patients treated for six weeks in this cross-over cohort, 100 percent (n=6/6) remained HCV RNA undetectable twelve weeks after completing therapy (SVR12). Previously, Achillion reported results from this study including 100 percent SVR24 for the initial cohorts including 12 patients treated for eight weeks and 100 percent SVR24 for 12 patients treated for six weeks.

In May 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir, ACH-3422, and sovaprevir.

ACH-3102 - 017: Phase 2 pilot study evaluating six- and eight-weeks of treatment in combination with sofosbuvir for genotype 1 treatment-naïve HCV

Achillion conducted a Phase 2, open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of odalasvir and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study was determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were initially enrolled, including six observational patients (group 1). Twelve patients completed eight weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial. Ten of the 12 patients receiving eight weeks of treatment had genotype 1a HCV. At baseline, the median HCV RNA was 7.15 log10 (range 5.5 — 7.8 log10). Of the 12 patients, 100 percent achieved SVR24. Odalasvir and sofosbuvir were well tolerated with no significant adverse events, ECG findings, or lab abnormalities observed during treatment.

Following achievement of the pre-specified response rate of 100 percent, the six observational patients plus six additional patients (group 2) were enrolled and received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Median HCV RNA at baseline was 6.95 log10 (range 6.2 — 8.0 log10) and six patients had GT 1a HCV. Of the 12 patients, 100 percent achieved SVR24.

Six additional rollover patients (group 3), enrolled into the final cohort, also received six weeks of treatment consisting of 50 mg of odalasvir and 400 mg of sofosbuvir administered once daily. Baseline characteristics included five of six patients with genotype 1a HCV, four of six patients with non-CC IL28B (two patients with IL28B TT), and a median baseline HCV RNA of 6.32 log10 IU/ml (range 6.0 — 7.3 log10 IU/ml). In all, a total of 18 patients (group 2 and 3) received six weeks of treatment and all subjects, 100 percent, achieved SVR12.

About the Achillion Worldwide HCV Collaboration with Janssen

On May 19, 2015, Achillion announced it had granted Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir. A key objective of the collaboration is to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. Achillion announced on August 3, 2015 that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) had initiated a Phase 1 clinical trial to evaluate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 in healthy volunteers. Janssen previously stated its goal of initiating Phase 3 development with a triple regimen for HCV by early 2017.

About HCV

The hepatitis C virus (HCV) is one of the most common causes of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-quarters of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection.

About Achillion Pharmaceuticals

Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients' lives. Achillion believes that its scientific excellence, integrated capabilities and experienced team position it to successfully achieve its goal of advancing new products along the entire continuum from the bench to the patient. Achillion's pipeline is currently focused on small molecule therapeutics for infectious disease and complement-related diseases. www.achillion.com

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," "focus," "will," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: comply with its obligations under and otherwise maintain its collaboration agreement with Janssen on the agreed upon terms; demonstrate, either alone or through its collaborators, the requisite safety, efficacy and combinability of its drug candidates, and advance the preclinical and clinical development of its drug candidates under the timelines it projects in current and future clinical trials; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete effectively and successfully; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014, its quarterly report on Form 10-Q for the quarter ended June 30, 2015, and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.


Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
gschulman@achillion.com

Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com

Investors:
Tricia Truehart
The Trout Group, LLC
Tel. (646) 378-2953
ttruehart@troutgroup.com

Wednesday, May 20, 2015

Will the J&J Deal With Achillion Transform the Hep C Market?

As drug makers jockey for their share of the fast-growing hepatitis C market, the deal between Johnson & Johnson JNJ -0.35% and Achillion Pharmaceuticals ACHN -15.26% has Wall Street analysts rethinking forecasts.

The deal, which was announced late yesterday after a Twitter rumor had Gilead Sciences GILD -0.35% buying Achillion, calls for J&J to invest $225 million and assume responsibility for development costs. Ultimately, the value of the agreement could reach $1.1 billion, depending on milestones reached.

For J&J, the move may help reposition the company as a player in the hepatitis C market. And for Achillion, the collaboration provides a deep-pocketed partner for a company that some saw as a buyout target. But to what extent will this transform the hepatitis C market and what are the implications for the other drug makers? Here are what some of the wags are saying…

Read more...

Tuesday, May 19, 2015

Achillion Enters Into Worldwide Collaboration for Hepatitis C With Janssen

- Transactions include up to $1.1 billion in potential development, regulatory and sales milestone payments and a separate equity investment -
- Achillion eligible for tieredroyalties between mid-teens and low-twenties on future worldwide sales -
- Janssen responsible for all development costs within the collaboration and all subsequent costs related to commercialization of the assets -
- Conference call scheduled for today at 5:00 p.m. ET -

NEW HAVEN, Conn., May 19, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.

"We are excited to collaborate with Janssen for the worldwide development of our HCV assets in combination with their HCV portfolio. We believe that Janssen's renowned expertise in HCV development and commercialization enables a synergistic opportunity to rapidly advance our combined HCV assets toward the market while simultaneously achieving an optimized treatment regimen for all HCV patients," said Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "Furthermore, we believe that their investment in Achillion through Johnson & Johnson Innovation - JJDC allows us to maximize the value from our HCV portfolio and also positions us to become a leader in complement factor D inhibition, applying our broad platform to a wide number of complement-related diseases. We believe this strategy provides an ideal scenario to create further value for our shareholders."

Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.

A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.

Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation - JJDC, Inc. will invest $225 million in Achillion and, in return, receive approximately 18.4 million newly issued, unregistered shares of Achillion at a price of $12.25 per share.

The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.

Centerview Partners acted as exclusive financial advisor to Achillion. Leerink Partners also advised the Company. WilmerHale acted as legal counsel for Achillion in connection with the transactions.

Conference Call
Achillion will host a conference call and simultaneous webcast on Tuesday, May 19, 2015 at 5:00 p.m. Eastern time. To participate in the conference call, please dial (866) 205-4820 in the U.S. or (419) 386-0004 for international callers. A live audio webcast of the call will be accessible at http://www.achillion.com or http://ir.achillion.com. Please connect to Achillion's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

A replay of the webcast will be available for 30 days on www.achillion.com. Alternatively, a replay of the conference call will be available starting at 8:00 p.m. Eastern time on May 19, 2015, through 11:59 p.m. Eastern time on May 25, 2015 by dialing (855) 859-2056 or (404) 537-3406. The replay passcode is 51773113.

Read the rest of this press release here: http://ir.achillion.com/releasedetail.cfm?releaseid=913980

Monday, March 2, 2015

HCV Drugs —Alan Franciscus, Editor-in-Chief

In this month’s column, there is more good news about drugs in development.  Achillion is developing a potential treatment for genotype 1 that could shorten treatment time to 6 weeks.  However, there is also some disappointing news from the Food and Drug Administration (FDA)—they are rescinding the “breakthrough therapy designation” for hepatitis C drugs.  Other news which is also disappointing is that the ‘one-shot’ cure for hepatitis C does not look as if it is going to pan out.  Finally, data released from a small trial with sofosbuvir, pegylated interferon and ribavirin to treat genotype 2 and 3 shows that it may help cure some people with genotype 3 and advanced liver disease.
 
Achillion
Achillion has had HCV drugs in development for almost as long as the HCV Advocate has been reporting on HCV inhibitors.  Their latest drug and clinical trial—ACH-3102—combined with sofosbuvir (brand name Sovaldi)—was given to 12 HCV genotype 1 treatment-naïve patients for 6 weeks.  One hundred percent (12 of 12 patients) achieved SVR 12 (virologic cure).  Achillion is exploring additional trials with their other HCV inhibitors and perhaps shorter treatment durations (4 and 6 weeks).  Don’t pin all your hopes on this though—there were only 12 patients in the trial.  The combination should be studied in more people and the theory of treating for 4 or 6 weeks needs to be tested.  However, it is worth keeping an eye on.

FDA
The FDA is rescinding its “breakthrough therapy designation status” from Bristol-Myers Squibb for Daclatasvir and Merck for its combination of elbasvir (MK-8742) and grazoprevir (MK-5712). “Breakthrough therapy designation status” is given to drug(s) that demonstrate a substantial improvement over existing therapies.  Now that we have drugs that can cure over 90% of people with genotype 1 the newer drugs are unlikely to improve the cure rates.  The standard time it takes the FDA to review an application for approval is about 10 months.  Based on this it is unlikely that any new HCV drugs will be approved until 2016—at least for genotypes 1, 2 and 4.  This is unfortunate because it limits treatment choices for patients, and it affects the price of drugs already on the market.  What about genotype 3?  There is clearly a need for better therapies with shorter treatment durations.

Regulus
We have been following an on-going study of RG-101 as a possible treatment for genotype 1 that would require only one shot—yes you read that right – a possible one-shot treatment.  In a small study (2 mg/kg) dose, it was reported that 6 of 14 patients were undetectable 57 days after receiving the shot.  However, unfortunately, after 12 weeks that number dropped to only 4 patients.  Regulus started another study at a higher dose of RG-101 (4 mg/kg), but even at the higher dose the interim results (9 of 14 patients undetectable 57 days post-shot) cure rates were not as high as the current standard of care.

There is also the possibility that the single shot can be given in combination with 4 weeks of antiviral pills.  No side effect profile was given—an important issue since the current therapy has a low side effect profile.

Sofosbuvir/PEG/RBV
Current standard of care (SOC) treatment for genotypes 2 and 3 is the combination of sofosbuvir plus ribavirin.  The cure rates in the Phase 3 clinical trials of treatment-experienced patients with cirrhosis included:
  • Genotype 2 = 88% (12 weeks)
  • Genotype 3 = 60%  (24 weeks)
While the genotype 2 cure rates are impressive the genotype 3 rates were less than optimal and a 24-week course of treatment is a considerable period of time and expense.  Additional therapies are needed, but in this case perhaps interferon may be an option.
The current phase 2 study included 47 treatment-experienced patients—23 genotype 2 patients (14 with cirrhosis); 24 genotype 3 patients (12 with cirrhosis).  Treatment duration was 12 weeks.  The treatment was sofosbuvir, pegylated interferon (PEG) and ribavirin.
 
Genotype 2:  Cure rates = 93% (without cirrhosis); 96% (with cirrhosis).
The cure rates for genotype 2 were similar to the cure rates seen with sofosbuvir plus ribavirin—needless to say there is no need (or desire) to include PEG.
Genotype 3:  Cure rates = 83% with and without cirrhosis.
Clearly, much higher cure rates than 24 weeks of sofosbuvir plus ribavirin (without PEG).
There were 4 patients who had 5 serious side effects mostly related to interferon and ribavirin.
Adding pegylated interferon, however, may be an alternate therapy for genotype 3.  This regime is listed in the Guidance documents of the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) for those who can tolerate 12 weeks of PEG therapy.

There are many therapies in development to treat genotype 3 (BMS, Gilead, Merck).  I hope that the FDA will recognize the need for newer therapies for genotype 3 that produce higher cure rates—especially for treatment-experienced patients with cirrhosis—that have fewer side effects and grant them “breakthrough therapy” designation.  That part of the articles about Merck and BMS losing their “breakthrough designation” status was not that clear.


http://hcvadvocate.org/news/newsLetter/2015/advocate0315.html#1

Tuesday, February 17, 2015

Could This Be The Biggest Advance in Hepatitis C since Gilead Sciences' Sovaldi?

Tiny biotech stock Achillion Pharmaceuticals (NASDAQ: ACHN ) reported what could be pretty big news for hepatitis C patients this week. The clinical stage biotechnology company released data showing that combining its ACH-3102 with Gilead Sciences' (NASDAQ: GILD ) Sovaldi achieved 100% cure rates in as little as six weeks of treatment. The success of that combination is prompting Achillion to launch a study of the two drugs over an even shorter 4-week dosing period. If that study pans out, it could be the biggest advance in hepatitis C treatment since Sovaldi won approval in 2013.

Read more....

Tuesday, February 10, 2015

UPDATED: Buoyed by 6-week hep C data, Achillion sets out to test even faster cure

While Regulus was getting dinged this morning following some careful scrutiny of its latest hep C data, Achillion came out on top with new trial results which demonstrated that a combination of its NS5A inhibitor and Gilead's Sovaldi triggered a 6-week cure among all of the patients in a small study. And now researchers are using the data to set the stage to see if the results can be replicated even faster in a 4-week trial.

Investigators found that 50 mg of ACH-3102 and 400 mg of sofosbuvir did the trick for 12 out of 12 treatment-naive genotype 1 patients. CEO Milind Deshpande touted the results as the shortest duration, highest response results yet seen. He added: "Given the exceptional profile of ACH-3102, we will now be evaluating four- and six-week treatment durations that leverage all of our HCV assets including ACH-3102, ACH-3422, and sovaprevir."

Achillion is still looking to enter a fast-crowding marketplace. Competing drugs from Gilead and AbbVie have forced out earlier standard remedies with oral combos that are much easier to tolerate and much more likely to provide a lasting cure. The goal now is to find ways to do it quicker and with less expense, providing an opening for some of the companies still in the hunt.


Read more...

Monday, February 9, 2015

Achillion Achieves 100% SVR12 in Phase 2 Trial Evaluating 6-Week Combination Treatment With ACH-3102

- Achillion achieves 100% SVR12 in six-week regimen with combination of ACH-3102 and sofosbuvir for treatment-naïve genotype 1 HCV -
- Achillion to initiate 4-week treatment regimens based on the strength of ACH-3102 antiviral data -

NEW HAVEN, Conn., Feb. 9, 2015 (GLOBE NEWSWIRE) --Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced updated interim results from the ongoing interferon-free, ribavirin-free, Phase 2 study to evaluate the efficacy, safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after completion of therapy. One hundred percent of patients (12/12) in the six-week treatment duration arm achieved SVR12, which included patients with high baseline viral load.

"The ability to further shorten treatment duration to only six weeks and maintain excellent SVR12 rates remains the goal for clinicians and patients, and I am pleased that these Phase 2 results support that goal. The profile of ACH-3102, represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV," commented Professor Edward Gane, M.D., Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and Lead Investigator in the Phase 2 study of ACH-3102 and sofosbuvir and the ACH-3422 nucleotide inhibitor program.

Dr. Milind Deshpande, President and Chief Executive Officer of Achillion, commented, "Our goal is to deliver short duration, widely accessible treatments to all HCV patients. We believe that these results with ACH-3102 represent the shortest duration and highest response achieved to date with any two-drug, direct-acting antiviral regimen for HCV. Given the exceptional profile of ACH-3102, we will now be evaluating four- and six-week treatment durations that leverage all of our HCV assets including ACH-3102, ACH-3422, and sovaprevir."

Overview of Phase 2 Proxy Study Design and Top-line Results
This ongoing study is a Phase 2 open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight- and six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, once daily, in treatment-naïve genotype 1 HCV-infected patients. Initially, eighteen patients were enrolled, including six observational patients, into an eight-week treatment cohort.

Following the achievement of 100 percent SVR12 (12/12) in the eight-week cohort, the six-week treatment cohort was initiated. In all, eighteen patients were enrolled, including twelve active and six observational patients. Mean baseline HCV RNA viral load was 10 million (7 log10) IU/ml, range 2 million (6.23 log10) - 97 million (7.99 log10) IU/ml, including seven patients with baseline HCV RNA viral load exceeding 6 million (6.78 log10) IU/ml. Of the 12 active patients enrolled, seven patients were genotype 1a and five were genotype 1b.

Twelve weeks after the completion of therapy, 100 percent (12/12) achieved SVR12, independent of baseline viral load, gender, and IL28B status, in the six-week treatment arm. Additionally, one hundred percent of patients (12/12) in the eight-week treatment duration arm have achieved SVR24. The combination of ACH-3102 and sofosbuvir was well-tolerated with no serious adverse events, no discontinuations due to adverse events, and no clinically significant laboratory or ECG abnormalities.
"The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports our belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration," commented Dr. David Apelian, Executive Vice President of Clinical Development and Chief Medical Officer at Achillion. "We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program."

Read complete press release here...