Monday, March 30, 2015

Scientists Publish An Anti-Alzeheimer's Diet

An Anti-Alzheimer's Diet Developed?

FRIDAY, March 27, 2015 (HealthDay News) -- Scientists say they've developed an anti-Alzheimer's diet.

While it couldn't prove cause-and-effect, the new study found that adults who rigorously followed the so-called MIND diet faced a 53 percent lower risk for Alzheimer's, the most common type of dementia. Those sticking to the diet just "moderately well" saw their Alzheimer's risk drop by roughly 35 percent.

"Often, people who eat healthier also participate in other healthy lifestyle behavior, but the MIND diet afforded protection [against Alzheimer's] whether or not other healthy behaviors or health conditions were present," said study author Martha Clare Morris, a nutritional epidemiologist at the Rush University Medical Center and the Rush Alzheimer's Disease Center in Chicago.

In a previous study, higher concordance to the MIND diet, a hybrid Mediterranean-Dietary Approaches to Stop Hypertension diet, was associated with slower cognitive decline. In this study we related these three dietary patterns to incident Alzheimer's disease (AD). (read more here)

Research Article in Press: MIND diet associated with reduced incidence of Alzheimer's disease

Methods

We investigated the diet-AD relations in a prospective study of 923 participants, ages 58 to 98 years, followed on average 4.5 years. Diet was assessed by a semiquantitative food frequency questionnaire.

Results

In adjusted proportional hazards models, the second (hazards ratio or HR = 0.65, 95% confidence interval or CI 0.44, 0.98) and highest tertiles (HR = 0.47, 95% CI 0.26, 0.76) of MIND diet scores had lower rates of AD versus tertile 1, whereas only the third tertiles of the DASH (HR = 0.61, 95% CI 0.38, 0.97) and Mediterranean (HR = 0.46, 95% CI 0.26, 0.79) diets were associated with lower AD rates.

Conclusion

High adherence to all three diets may reduce AD risk. Moderate adherence to the MIND diet may also decrease AD risk.

DOI: http://dx.doi.org/10.1016/j.jalz.2014.11.009

2015 Alzheimer's disease facts and figures

This report discusses the public health impact of Alzheimer's disease (AD), including incidence and prevalence, mortality rates, costs of care and the overall effect on caregivers and society. It also examines the challenges encountered by health care providers when disclosing an AD diagnosis to patients and caregivers. 

An estimated 5.3 million Americans have AD; 5.1 million are age ≥65 years, and approximately 200,000 are age <65 years and have younger onset AD. By mid-century, the number of people living with AD in the United States is projected to grow by nearly 10 million, fueled in large part by the aging baby boom generation. 

Today, someone in the country develops AD every 67 seconds. By 2050, one new case of AD is expected to develop every 33 seconds, resulting in nearly 1 million new cases per year, and the estimated prevalence is expected to range from 11 million to 16 million. In 2013, official death certificates recorded 84,767 deaths from AD, making AD the sixth leading cause of death in the United States and the fifth leading cause of death in Americans age ≥65 years. Between 2000 and 2013, deaths resulting from heart disease, stroke and prostate cancer decreased 14%, 23% and 11%, respectively, whereas deaths from AD increased 71%. The actual number of deaths to which AD contributes (or deaths with AD) is likely much larger than the number of deaths from AD recorded on death certificates. In 2015, an estimated 700,000 Americans age ≥65 years will die with AD, and many of them will die from complications caused by AD. 

In 2014, more than 15 million family members and other unpaid caregivers provided an estimated 17.9 billion hours of care to people with AD and other dementias, a contribution valued at more than $217 billion. Average per-person Medicare payments for services to beneficiaries age ≥65 years with AD and other dementias are more than two and a half times as great as payments for all beneficiaries without these conditions, and Medicaid payments are 19 times as great. Total payments in 2015 for health care, long-term care and hospice services for people age ≥65 years with dementia are expected to be $226 billion. 

Among people with a diagnosis of AD or another dementia, fewer than half report having been told of the diagnosis by their health care provider. Though the benefits of a prompt, clear and accurate disclosure of an AD diagnosis are recognized by the medical profession, improvements to the disclosure process are needed. These improvements may require stronger support systems for health care providers and their patients. (download the article here >>)

Angelina's big surgery and anti-Alzheimer's diet

Saturday, March 28, 2015

Confronting Hereditary Breast and Ovarian Cancer

Confronting Hereditary Breast and Ovarian Cancer: Identify Your Risk, Understand Your Options, Change Your Destiny

"Be informed. Be empowered. Be well."

If you are concerned that the cancer in your family is hereditary, you face difficult choices. Should you have a blood test that may reveal whether you have a high likelihood of disease? Do you preemptively treat a disease that may never develop? How do you make decisions now that will affect the rest of your life? This helpful, informative guide answers your questions as you confront hereditary breast and ovarian cancer.

Developed by Facing Our Risk of Cancer Empowered (FORCE), the nation’s only nonprofit organization dedicated to supporting families affected by hereditary breast and ovarian cancer, this book stands alone among breast and ovarian cancer resources. Equal parts health guide and memoir, it defines complex issues facing previvors and survivors and provides solutions with a fresh, authoritative voice.

Written by three passionate advocates for the hereditary cancer community who are themselves breast cancer survivors, Confronting Hereditary Breast and Ovarian Cancer dispels myths and misinformation and presents practical risk-reducing alternatives and decision-making tools. Including information about genetic counseling and testing, preventive surgery, and fertility and family planning, as well as explanations of health insurance coverage and laws protecting genetic privacy, this resource tackles head-on the challenges of living in a high-risk body.

Confronting hereditary cancer is a complex, confusing, and highly individual journey. With its unique combination of the latest research, expert advice, and compelling personal stories, this book gives previvors, survivors, and their family members the guidance they need to face the unique challenges of hereditary cancer.



Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

Breast Cancer Death Rate: 34% Down

American Cancer Society Infographic

Findings from the Breast Cancer Facts & Figures 2013-2014 highlighting women 40 and older who've had a mammogram.

Every year over 200,000 American women are diagnosed with breast cancer. American Cancer Society screening guidelines for the early detection of breast cancer vary depending on a woman's age and risk, and include mammography and clinical breast examination (CBE).

Read more here >>


Baseline Awareness Athletic Crew Socks (Kids and Adult Sizes)

Tamoxifen hot flashes, mastectomy, reconstruction, breast cancer etiquette, Frankenboobs, bras with special attachments—Margaret Lesh shares all in her funny, heartfelt collection of essays, anecdotes, and life lessons from the perspective of a two-time breast cancer survivor. She’ll tell you when it’s okay to play the cancer card, what you should take to the hospital, and gives suggestions on how to cope in those dark moments of the soul. With practical tips sprinkled throughout, LET ME GET THIS OFF MY CHEST explores how breast cancer changed her outlook on life, offering honest insights, humor, and sensitivity as she looks for the silver lining in a not-so-great situation. Whether you are a woman diagnosed with breast cancer or whether you know someone with breast cancer, this book was written for you.

Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat

The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure.

 But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society.

From "designer" babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth.

Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments.

Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate.

The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health. Fran Hawthorne (New York, NY) is a senior contributing editor of Institutional Investor and has connections deep within the business and finance communities. Hawthorne has been covering healthcare and business for more than twenty years for such publications as Fortune, BusinessWeek, and Crain's New York Business.


Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

Thursday, March 26, 2015

Phase 2 Liberian Ebola Vaccine Clinical Trial: Test Vaccine Seems to Be SAFE

Two experimental Ebola vaccines appear to be safe based on evaluation in more than 600 people in Liberia who participated in the first stage of thePartnership for Research on Ebola Vaccines in Liberia (PREVAIL) Phase 2/3 clinical trial, according to interim findings from an independent Data and Safety Monitoring Board review. Based on these findings, the study, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, may now advance to Phase 3 testing.
 National Institutes of Health (NIH) - Turning Discovery Into Health
“We are grateful to the Liberian people who volunteered for this important clinical trial and encouraged by the study results seen with the two investigational Ebola vaccine candidates,” said NIAID Director Anthony S. Fauci, M.D. “Now we must move forward to adapt and expand the study so that ultimately we can determine whether these experimental vaccines can protect against Ebola virus disease and therefore be used in future Ebola outbreaks.”
The PREVAIL trial, which began on Feb. 2, 2015 in Monrovia, Liberia, is testing the safety and efficacy of the cAd3-EBOZ candidate vaccine co-developed by NIAID scientists and GlaxoSmithKline, and the VSV-ZEBOV candidate vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corporation and Merck. Volunteers are assigned at random to receive a single injection of the NIAID/GSK (cAd3-EBOZ) vaccine, the VSV-ZEBOV vaccine, or a placebo (saline) injection. The trial is also double-blinded, meaning that neither study subjects nor staff know whether a vaccine or placebo was administered. A randomized, double-blind, placebo-controlled trial is considered the “gold standard” in clinical research. (read more here >>

Liberia kicks off clinical trial for Ebola vaccines as outbreak ebbs 

http://passfda.com/buying-medicines-from-outside-the-us-looks-can-be-deceiving/



Wednesday, March 25, 2015

Full Story on Germanwings Crash

Germanwings Crash from NBC News


Read full story on Germanwings crash: http://nbcnews.to/1Bq4240
Posted by NBC News on Wednesday, March 25, 2015




Why Isn't There an AIDS Vaccine Yet?

An HIV "epidemic" fueled by needle-sharing opiate addicts has infected at least 72 people in one southern Indiana county as Gov. Mike Pence prepares to declare a public health emergency in that community, Pence said Wednesday evening. (read more here >>) NBC News


The outbreak's swift acceleration in Scott County — beginning with seven known HIV-positive patients in January — has prompted the Centers for Disease Control and Prevention to deploy a team of investigators to test residents and to help control further spread of the virus.


Tuesday, March 24, 2015

AHRQ Report Assesses Therapies for Menopause

 Agency for Healthcare Research and Quality

A new comparative effectiveness review from AHRQ examined the benefits and harms of treatments for menopause, including prescription, nonprescription and complementary therapies. 

The report assesses treatments and therapies for the symptoms of menopause, specifically hot flashes, sleep disturbance, psychologic symptoms, urogenital atrophy and sexual function. 

It evaluated a number of treatments, including the use of hormonal therapies (estrogen, alone or with progestogen or androgen), selective serotonin reuptake inhibitors and eszocpiclone. 

Both improvement in menopausal symptoms and adverse events were evaluated. The title of the review is  “Menopausal Symptoms: Comparative Effectiveness of Therapies.”


 

Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

FDA approved revisions to the Epivir (lamivudine) and Ziagen (abacavir sulfate) labels

On March 23, 2015, FDA approved revisions to the Epivir (lamivudine) and Ziagen (abacavir sulfate) labels to each provide for once-daily dosing in pediatric patients 3 months of age and older in combination with other antiretroviral agents for the treatment of HIV-1 infection. The specific changes to each label are summarized below.
 Epivir (lamivudine)
Section 2 DOSAGE AND ADMINISTRATION was updated as follows:
2.2          Pediatric Patients
The recommended oral dose of EPIVIR oral solution in HIV 1-infected pediatric patients aged 3 months and older is 4 mg per kg twice daily or 8 mg per kg once daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment with oral solution [see Clinical Pharmacology (12.3)].
EPIVIR is also available as a scored tablet for HIV 1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing EPIVIR tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow EPIVIR tablets, the oral solution formulation should be prescribed. The recommended oral dosage of EPIVIR tablets for HIV 1-infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for EPIVIR Scored (150-mg) Tablets in Pediatric Patients

Once-daily Dosing Regimena
Twice-daily Dosing Regimen Using Scored 150‑mg Tablet
Weight
(kg)
AM Dose
PM Dose
Total Daily Dose
14 to <20
1 tablet (150 mg)
½ tablet (75 mg)
½ tablet (75 mg)
150 mg
³20 to <25
1½ tablets (225 mg)
½ tablet (75 mg)
1 tablet (150 mg)
225 mg
³25
2 tablets (300 mg)b
1 tablet (150 mg)
1 tablet (150 mg)
300 mg
a  Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies (14.2)].
b  Patients may alternatively take one 300-mg tablet, which is not scored.


Section 6 ADVERSE REACTIONS was updated to include results from trial COL105677 as follows:
Pediatric Subjects Once-daily vs Twice-daily Dosing (COL105677)
The safety of once-daily compared with twice-daily dosing of EPIVIR was assessed in the ARROW trial. Primary safety assessment in the ARROW trial was based on Grade 3 and Grade 4 adverse events. The frequency of Grade 3 and 4 adverse events was similar among subjects randomized to once-daily dosing compared with subjects randomized to twice-daily dosing. One event of Grade 4 hepatitis in the once-daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator.
Section 12 CLINICAL PHARMACOLOGY was updated to include the pharmacokinetic data for once daily dosing.
Pediatric Patients: The pharmacokinetics of lamivudine have been studied after either single or repeat doses of EPIVIR in 210 pediatric subjects. Pediatric subjects receiving lamivudine oral solution according to the recommended dosage regimen achieved approximately 25% lower plasma concentrations of lamivudine compared with HIV‑1‑infected adults. Pediatric subjects receiving lamivudine oral tablets achieved plasma concentrations comparable to or slightly higher than those observed in adults. The absolute bioavailability of both EPIVIR tablets and oral solution are lower in children than adults. The relative bioavailability of EPIVIR oral solution is approximately 40% lower than tablets containing lamivudine in pediatric subjects despite no difference in adults. The mechanisms for the diminished absolute bioavailability of lamivudine and relative bioavailability of lamivudine solution are unknown.
The pharmacokinetics of lamivudine dosed once daily in HIV‑1-infected pediatric subjects aged 3 months through 12 years was evaluated in 3 trials (PENTA-15 [n = 17], PENTA 13 [n = 19], and ARROW PK [n = 35]). All 3 trials were 2-period, crossover, open-label pharmacokinetic trials of twice- versus once-daily dosing of abacavir and lamivudine. These 3 trials demonstrated that once-daily dosing provides similar AUC0-24 to twice-daily dosing of lamivudine at the same total daily dose when comparing the dosing regimens within the same formulation (i.e., either the oral solution or the tablet formulation). The mean Cmax was approximately 80% to 90% higher with lamivudine once-daily dosing compared with twice-daily dosing.

Table 8. Pharmacokinetic Parameters (Geometric Mean [95% CI]) after Repeat Dosing of Lamivudine in 3 Pediatric Trials

Trial
(Number of Subjects)

ARROW PK
(n = 35)
PENTA-13
(n = 19)
PENTA-15
(n = 17)a
Age Range
3-12 years
2-12 years
3-36 months
Formulation
Tablet
Solution and Tabletb
Solution
Parameter
Once Daily
Twice Daily
Once Daily
Twice Daily
Once Daily
Twice Daily
Cmax(mcg/mL)
3.17
(2.76, 3.64)
1.80
(1.59, 2.04)
2.09
(1.80, 2.42)
1.11
(0.96, 1.29)
1.87
(1.65, 2.13)
1.05
(0.88, 1.26)
AUC(0-24)(mcg·h/mL)
13.0
(11.4, 14.9)
12.0
(10.7, 13.4)
9.80
(8.64, 11.1)
8.88
(7.67, 10.3)
8.66
(7.46, 10.1)
9.48
(7.89, 11.4)
a  N = 16 for PENTA-15 Cmax.
b   Five subjects in PENTA-13 received lamivudine tablets.
  
Section 14 CLINICAL STUDIES was updated with results from trial COL105677
Once-daily Dosing
ARROW (COL105677) was a 5-year randomized, multicenter trial whichevaluated multiple aspects of clinical management of HIV-1 infection in pediatric subjects. HIV–1-infected, treatment-naïve subjects aged 3 months to 17 years were enrolled and treated with a first-line regimen containing EPIVIR and abacavir, dosed twice daily according to World Health Organization recommendations. After a minimum of 36 weeks on treatment, subjects were given the option to participate in Randomization 3 of the ARROW trial, comparing the safety and efficacy of once-daily dosing with twice-daily dosing of EPIVIR and abacavir, in combination with a third antiretroviral drug, for an additional 96 weeks. Of the 1,206 original ARROW subjects, 669 participated in Randomization 3. Virologic suppression was not a requirement for participation: at baseline for Randomization 3 (following a minimum of 36 weeks of twice-daily treatment), 75% of subjects in the twice-daily cohort were virologically suppressed, compared with 71% of subjects in the once-daily cohort.
The proportion of subjects with HIV-1 RNA of less than 80 copies per mL through 96 weeks is shown in Table 12. The differences between virologic responses in the two treatment arms were comparable across baseline characteristics for gender and age.
Table 12. Virologic Outcome of Randomized Treatment at Week 96a (ARROW Randomization 3)
Outcome
EPIVIR plus Abacavir
Twice-daily Dosing
(n = 333)
EPIVIR plus Abacavir
Once-daily Dosing
(n = 336)
HIV-1 RNA <80 copies/mLb
70%
67%
HIV-1 RNA ≥80 copies/mLc
28%
31%
No virologic data


Discontinued due to adverse event or death
1%
<1%
Discontinued study for otherreasonsd
0%
<1%
Missing data during window but on study
1%
1%
a   Analyses were based on the last observed viral load data within the Week 96 window.
b   Predicted difference (95% CI) of response rate is -4.5% (-11% to 2%) at Week 96.
c  Includes subjects who discontinued due to lack or loss of efficacy or for reasons other than an adverse event or death, and had a viral load value of greater than or equal to 80 copies per mL, or subjects who had a switch in background regimen that was not permitted by the protocol.
d   Other includes reasons such as withdrew consent, loss to follow-up, etc. and the last available HIV-1 RNA less than 80 copies per mL (or missing).

Ziagen (abacavir sulfate)

Section 2 DOSAGE AND ADMINISTRATION was updated as follows:
2.2          Pediatric Patients
The recommended oral dose of ZIAGEN oral solution in HIV 1 infected pediatric patients aged 3 months and older is 8 mg per kg twice daily or 16 mg per kg once-daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents.
ZIAGEN is also available as a scored tablet for HIV 1 infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing ZIAGEN tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow ZIAGEN tablets, the oral solution formulation should be prescribed. The recommended oral dosage of ZIAGEN tablets for HIV 1 infected pediatric patients is presented in Table 1.
Table 1. Dosing Recommendations for ZIAGEN Scored Tablets in Pediatric Patients
Weight (kg)
Once-daily Dosing Regimena
Twice-daily Dosing Regimen
AM Dose
PM Dose
Total Daily Dose
14 to <20
1 tablet (300 mg)
½ tablet (150 mg)
½ tablet (150 mg)
300 mg
³20 to <25
1½ tablets (450 mg)
½ tablet (150 mg)
1 tablet (300 mg)
450 mg
³25
2 tablets (600 mg)
1 tablet (300 mg)
1 tablet (300 mg)
600 mg
a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once daily dosing after 36 weeks of treatment [see Clinical Studies (14.2)].

Section 6 ADVERSE REACTIONS was updated to include results from trial COL105677 as follows:
Pediatric Subjects Once-daily vs Twice-daily Dosing (COL105677)
The safety of once-daily compared with twice-daily dosing of EPIVIR was assessed in the ARROW trial. Primary safety assessment in the ARROW trial was based on Grade 3 and Grade 4 adverse events. The frequency of Grade 3 and 4 adverse events was similar among subjects randomized to once-daily dosing compared with subjects randomized to twice-daily dosing. One event of Grade 4 hepatitis in the once-daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator.
Section 12 CLINICAL PHARMACOLOGY was updated to include the pharmacokinetic data for once daily dosing. Pediatric Patients: The pharmacokinetics of abacavir have been studied after either single or repeat doses of ZIAGEN in 169 pediatric subjects. Subjects receiving abacavir oral solution according to the recommended dosage regimen achieved plasma concentrations of abacavir similar to adults. Subjects receiving abacavir oral tablets achieved higher plasma concentrations of abacavir than subjects receiving oral solution.
The pharmacokinetics of abacavir dosed once daily in HIV 1-infected pediatric subjects aged 3 months through 12 years was evaluated in 3 trials (PENTA 13 [n = 14], PENTA 15 [n = 18], and ARROW [n = 36]). All 3 trials were 2-period, crossover, open-label pharmacokinetic trials of twice- versus once-daily dosing of abacavir and lamivudine. For the oral solution as well as the tablet formulation, these 3 trials demonstrated that once-daily dosing provides comparable AUC0-24 to twice-daily dosing of abacavir at the same total daily dose. The mean Cmax was approximately 1.6- to 2.3-fold higher with abacavir once-daily dosing compared with twice-daily dosing.
Section 14 CLINICAL STUDIES was updated with results from trial COL105677
Once-daily Dosing
ARROW (COL105677) was a 5-year randomized, multicenter trial which evaluated multiple aspects of clinical management of HIV-1 infection in pediatric subjects. HIV-1–infected, treatment-naïve subjects aged 3 months to 17 years were enrolled and treated with a first-line regimen containing ZIAGEN and lamivudine, dosed twice daily according to World Health Organization recommendations. After a minimum of 36 weeks of treatment, subjects were given the option to participate in Randomization 3 of the ARROW trial, comparing the safety and efficacy of once-daily dosing with twice-daily dosing of ZIAGEN and lamivudine, in combination with a third antiretroviral drug, for an additional 96 weeks. Of the 1,206 original ARROW subjects, 669 participated in Randomization 3. Virologic suppression was not a requirement for participation at baseline for Randomization 3 (following a minimum of 36 weeks of twice-daily treatment), 75% of subjects in the twice-daily cohort were virologically suppressed compared with 71% of subjects in the once-daily cohort.
The proportions of subjects with HIV-1 RNA less than 80 copies per mL through 96 weeks are shown in Table 11. The differences between virologic responses in the two treatment arms were comparable across baseline characteristics for gender and age.
Table 11. Virologic Outcome of Randomized Treatment at Week 96a (ARROW Randomization 3)
Outcome
ZIAGEN plus Lamivudine
Twice-daily Dosing
(n = 333)
ZIAGEN plus Lamivudine
Once-daily Dosing
(n = 336)
HIV-1 RNA <80 copies/mLb
70%
67%
HIV-1 RNA ≥80 copies/mLc
28%
31%
No virologic data


Discontinued due to adverse event or death
1%
<1%
Discontinued study for otherreasonsd
0%
<1%
Missing data during window but on study
1%
1%

a      Analyses were based on the last observed viral load data within the Week 96 window.
b      Predicted difference (95% CI) of response rate is -4.5% (-11% to 2%) at Week 96.
c      Includes subjects who discontinued due to lack or loss of efficacy or for reasons other than an adverse event or death, and had a viral load value of greater than or equal to 80 copies per mL, or subjects who had a switch in background regimen that was not permitted by the protocol.
d      Other includes reasons such as withdrew consent, loss to follow-up, etc. and the last available HIV-1 RNA less than 80 copies per mL (or missing).
Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).