MEXICO CITY, Aug. 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK)
announced that a retrospective analysis of six clinical trials found that
anti-HIV regimens containing EPZICOM (abacavir + lamivudine) were effective in
treatment-naive patients regardless of baseline viral loads. One of the trials
analyzed was a large study comparing treatment with regimens containing
EPZICOM versus regimens containing Truvada(R) (tenofovir DF + emtricitabine)
in treatment-naive patients with both high and low baseline viral loads. The
analysis was presented today at the 17th International AIDS Conference in
Mexico City, Mexico.
GSK examined six clinical trials with 2,940 treatment-naive patients on
regimens containing either EPZICOM or its individual components over 48 weeks
of treatment, including the HEAT study, a head-to-head clinical trial
comparing EPZICOM to Truvada. Patients were analyzed according to baseline
viral load (<100,000c/mL being low and greater than or equal to 100,000c/mL
being high) and efficacy was determined by time to virologic failure. The
definition of virologic failure was similar to that utilized in the ACTG 5202
study. At 48 weeks, 87-95% of all patients in the analysis did not meet the
definition for virologic failure. An additional retrospective analysis of the
HEAT study found similar results in both EPZICOM- and Truvada-containing
regimens regardless of baseline viral load.
The analysis was conducted after interim data from a single, ongoing study
by the AIDS Clinical Trials Group (ACTG 5202) found results inconsistent with
previous experience with EPZICOM. A routine review of ACTG 5202 by the data
safety monitoring board (DSMB) found that although both the EPZICOM and
Truvada treatment arms were effective in reducing HIV viral load, a
statistically higher rate of protocol-defined virologic failure and
protocol-defined safety endpoints were seen in patients with high screening
viral loads in the EPZICOM-treatment arm. The rates of HIV viral load
reduction with EPZICOM in the high viral load arm were lower than what has
been reported in existing clinical data.
Following these findings, the DSMB recommended unblinding patients
receiving EPZICOM in the high viral load arm. Affected patients were notified
of the results by the physicians and provided the option to stay on EPZICOM if
the patient was having success with the regimen. The DSMB recommended that
study participants with lower screening viral loads continue on their assigned
blinded regimen and be followed in the study without change. The ACTG 5202
trial is ongoing and patients in the high viral load arm have the option to
continue in the study, whereas those in the lower viral load group continue in
the trial and remain blinded to their regimens.
"GlaxoSmithKline carefully considers any new information on our medicines
and we are working closely with ACTG to understand why our analyses found
conflicting results," said John Pottage, M.D., Vice President Global Clinical
Development at GlaxoSmithKline. "This analysis, based on similar criteria to
that utilized in ACTG 5202, demonstrates that EPZICOM continues to be an
effective treatment option for treatment-naive patients. As always, physicians
must consider each patient's individual health and treatment history when
making treatment decisions."
Study Analysis Explained
GSK's retrospective analysis included 48-week data from six clinical
trials in 2,940 treatment-naive HIV patients. Patients were analyzed based on
baseline HIV viral load (<100,000c/mL and greater than or equal to
100,000c/mL) with a primary efficacy endpoint of time to virologic failure
measured using Kaplan-Meier analysis. Virologic failure was defined as
confirmed viral load greater than or equal to 1,000c/mL at or after 16 weeks
and before 24 weeks, or viral load greater than or equal to 200c/mL at or
after 24 weeks. These are similar to the virologic failure criteria used in
ACTG 5202 to assess the impact of screening viral load on virologic response.
The six clinical trials included in the analysis were CNA30024, CNA30021,
ESS30009, SHARE, KLEAN and HEAT. The analysis examined EPZICOM-containing
regimens in each study and the Truvada-containing regimens in HEAT. Among all
patients receiving EPZICOM in the six clinical trial analysis, 87-95% did not
experience virologic failure by 48 weeks of treatment. In the HEAT study
87-90% of patients in both the EPZICOM and Truvada arms did not experience
virologic failure by 48 weeks, regardless of baseline viral load (<100,000 and
greater than or equal to 100,000c/mL).
A safety analysis was also conducted in the HEAT study using the ACTG 5202
safety endpoint criteria. The safety endpoint was defined as time to onset of
first grade 3 or 4 sign, symptom, or lab toxicity at least 1 grade higher than
baseline, as used in ACTG 5202. In both treatment arms of the HEAT trial, 15%
of patients had drug-related Grade 3-4 adverse events. Safety data from the
HEAT analysis also found that both EPZICOM- and Truvada-containing regimens
were generally well-tolerated with few treatment discontinuations due to
adverse events, (19% with Epzicom and 24% with Truvada).
Important Information about EPZICOM
EPZICOM, in combination with other antiretroviral agents, is indicated for
the treatment of HIV-1 infection in adults.
EPZICOM is one of 3 medicines containing abacavir. Before starting
EPZICOM, your healthcare professional will review your medical history in
order to avoid the use of abacavir if you have experienced an allergic
reaction to abacavir in the past.
In one study, more patients had a severe hypersensitivity reaction in the
abacavir once-daily group than in the abacavir twice-daily group.
EPZICOM should not be used as part of a triple-nucleoside regimen.
EPZICOM does not cure HIV infection/AIDS or prevent passing HIV to others.
Important Safety Information
EPZICOM contains abacavir, which is also contained in ZIAGEN(R) (abacavir
sulfate) and TRIZIVIR(R) (abacavir sulfate, lamivudine, and zidovudine).
Patients taking EPZICOM may have a serious allergic reaction (hypersensitivity
reaction) that can cause death.
If you get a symptom from 2 or more of the following groups while taking
EPZICOM, stop taking EPZICOM and call your doctor right away:
1. Fever
2. Rash
3. Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
4. Generally ill feeling, extreme tiredness, or achiness
5. Shortness of breath, cough, or sore throat
Carefully read the Warning Card that your pharmacist gives you and carry
it with you at all times.
If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM or
any other abacavir-containing medicine (ZIAGEN, TRIZIVIR) again. If you take
EPZICOM or any other abacavir-containing medicine again after you have had an
allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may
include very low blood pressure or death.
If you stop EPZICOM for any other reason, even for a few days, and you are
not allergic to EPZICOM, talk with your healthcare professional before taking
it again. Taking EPZICOM again can cause a serious or life-threatening
reaction, even if you never had an allergic reaction before. If your
healthcare professional tells you that you can take EPZICOM again, start
taking it when you are around medical help or people who can call a doctor if
you need one.
A build up of lactic acid in the blood and an enlarged liver, including
fatal cases, have been reported.
Do not take EPZICOM if your liver does not function normally.
Some patients infected with both hepatitis B virus (HBV) and HIV have
worsening of hepatitis after stopping lamivudine (a component of EPZICOM).
Discuss any change in treatment with your doctor. If you have both HBV and HIV
and stop treatment with EPZICOM, you should be closely monitored by your
doctor for at least several months.
Worsening of liver disease (sometimes resulting in death) has occurred in
patients infected with both HIV and hepatitis C virus who are taking anti-HIV
medicines and are also being treated for hepatitis C with interferon with or
without ribavirin. If you are taking EPZICOM as well as interferon with or
without ribavirin and you experience side effects, be sure to tell your doctor.
When you start taking HIV medicines, your immune system may get stronger
and could begin to fight infections that have been hidden in your body, such
as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after
starting your HIV medicines, be sure to tell your doctor.
Changes in body fat may occur in some patients taking antiretroviral
therapy. These changes may include an increased amount of fat in the upper
back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from
the legs, arms, and face may also occur. The cause and long-term health
effects of these conditions are not known at this time.
The most common side effects seen with the drugs in EPZICOM dosed
once-daily were allergic reaction, trouble sleeping, depression, headache,
tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal
dreams, and anxiety. Most of the side effects do not cause people to stop
taking EPZICOM.
For additional important information about EPZICOM please visit
www.epzicom.com
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and an industry leader in HIV research
and therapies. The company is engaged in basic research programs designed to
investigate new targets to treat HIV. For full information on GSK's HIV
medications, please visit www.treatHIV.com.
Enquiries:
US Media enquiries: Marc Meachem (919) 483 2839
Mary Anne Rhyne (919) 483 2839
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the company' s
Annual Report on Form 20-F for 2007.
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