48-Week Efficacy Comparison of Lexiva/Ritonavir QD vs. Nelfinavir BID in Therapy-Naive HIV+ Patients: Results Published in AIDS Research Triangle Park, NC, July 8, 2004 -- The protease inhibitor (PI) LEXIVA(R) (fosamprenavir calcium) dosed with ritonavir (LEXIVA/r) once-daily (QD) as part of a
<i>-56% of prior treatment null responder patients achieved SVR with a
48-week telaprevir-based regimen-</i>
<br />
<i>-97% of prior treatment relapsers and 55% of prior treatment partial
responders achieved SVR with 24-week or 48-week telaprevir-based
regimens-</i>
<br />
<i>-17% of people achieved SVR with pegylated-interferon and ribavirin
alone in the control arm-</i>
<br />
<i>-Safety and tolerability results were consistent with prior Phase 3
studies-</i>
<br />
<i>-Completion of rolling New Drug Application submission on track for
the fourth quarter 2010-</i>
<br />
<i><b>-Majority of patients treated with telaprevir received a 24-week
regimen-</b></i>
<br />
<i><b>-6.9% and 7.7% treatment discontinuation rates due to adverse
events in 12- and 8-week telaprevir-based treatment arms -- lower than
previous telaprevir trials-</b></i>
<br />
<i><b>-First Phase 3 trial results for a direct acting antiviral therapy
in hepatitis C-</b></i>
<br />
-Approximately 8,500 people in the U.S. are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S.
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
-Data provide proof-of-concept for use of VX-661 to further enhance CFTR function in people taking KALYDECO who have the F508del mutation and another mutation known to respond to KALYDECO alone- -Statistically significant improvements in lung function, as well as decreases in sweat chloride,
- After seven days of once-daily dosing with 200 mg of ALS-2200, genotype 1 patients with cirrhosis had a median 4.08 log 10 reduction in HCV RNA; among people with genotypes 3 or 4, there was a median 4.65 log 10 reduction in HCV RNA - - Data are consistent with previously reported ALS-2200
– If granted Marketing Authorization, people ages 12 and older in Europe who have one F508del mutation and one minimal function mutation will for the first time be able to benefit from a medicine that treats the underlying cause of the disease – – People 12 years of age and older who have two
