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The new Norvir is a tablet. Unlike the previous soft-gel capsules, the tablets must be taken with food and, like the capsules, must be swallowed whole, not crushed, chewed, or broken.
The most significant difference between the capsules and the new tablets is that the tablets do not have to be refrigerated. This is of particular importance to homeless people with limited access -- if any -- to refrigerators, and to resource-poor countries where many patients may also have difficulty accessing refrigeration. The tablets use a heat-stable formulation called Meltrex that allows them to be stored at room temperature.
Though both the capsules and the tablets contain 100 mg of Norvir, they are not bioequivalent. When taken with food, the blood concentration of the tablets is higher. This may lead to greater side effects. Norvir is known for its gastrointestinal side effects, particularly diarrhea, and for increasing triglyceride levels. The capsules will remain available.
Norvir's manufacturer, Abbott Laboratories, reported that the new tablets will have the same wholesale acquisition (WAC) price as the capsules. Abbott also launched a Norvir co-pay support program that is now available. The co-pay program will be available for all formulations of Norvir. Once an individual has paid $25 in co-pays, the program covers up to $75 per month in co-pays for the first 12 months. Restrictions apply. Individuals can request the co-pay card from their health care provider, and will soon be able to print the card from the website. Visit www.norvir.com.
People with HIV taking a protease inhibitor drug combination, who have a viral load of more than 1,000 copies per ml, are invited to apply for study A5241. The study from the AIDS Clinical Trials Group (ACTG) will use drug resistance tests to determine what new medications should work best for these individuals and provide them with that optimized therapy.
ACTG will see if people going on a new drug regimen can have treatment success without taking nucleoside medications (also known as NRTIs). Usually, nucleosides are included in HIV treatment. With so many new and powerful HIV drugs on the market, however, nucleosides may no longer be necessary. Not taking nucleosides would decrease the risk of side effects and lower the number of pills patients need to take.
Among the medications that will be made available through the study is Isentress (raltegravir), and participants may not have ever taken a medication from its drug class, called integrase inhibitors.
A5241 is called the OPTIONS Study, for "Optimized Treatment that Includes or Omits NRTIs." ACTG is a division of the National Institutes of Health. The OPTIONS Study is taking place at more than 50 clinics around the country. For details or a study site near you, visit www.aactg.org. In Chicago, call Rush University Medical Center at (312) 942-5865.
Chicago is one of the sites for a new study from the HIV Vaccine Trial Network, HVTN 505. The study is now enrolling HIV-negative men who are circumcised and between the ages of 18 and 45. They cannot get HIV from the vaccine and will receive financial compensation for their participation. This is a randomized study -- the men will be given the vaccine being studied or a placebo (fake drug). In addition, the men will receive information on how to lower their risk of acquiring HIV. For more information, call (800) 575-5758 or (312) 413-5897, e-mail email@example.com, or visit www.hopetakesaction.org for a list of study sites around the country.
Invirase, an HIV protease inhibitor drug, must be taken with a booster dose of Norvir to achieve adequate blood levels. The federal agency cautions that "Patients should not stop taking their prescribed antiviral medications. Patients who are concerned about possible risks associated with using Invirase and Norvir should talk to their healthcare professional."
The FDA does not yet know the extent of the potential side effect or its clinical implications (in other words, whether people will require medical care). The agency noted that some people may be at increased risk of developing an abnormal heart rhythm.
"The changes to the electrical activity of the heart possibly associated with these drugs, known as prolonged QT or PR intervals, can be seen on an electrocardiogram (EKG)," the report continued. "A prolonged QT interval can increase the risk for abnormal heart rhythms, including a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heartbeat to slow or even stop; this is known as heart block and can affect how fast the heart is able to beat."
The report noted that "The FDA's analysis of these data is ongoing. However, healthcare professionals should be aware of this potential risk for changes to the electrical activity of the heart. Invirase and Norvir should not be used in patients already taking medications known to cause QT interval prolongation such as Class IA (such as quinidine) or Class III (such as amiodarone) antiarrhythmic drugs; or in patients with a history of QT interval prolongation."
In addition, medical providers should not prescribe Invirase to patients with cardiomyopathy, ischemic heart disease, pre-existing conduction system disease, or underlying structural heart disease.
The following is taken from a March 17 press release from the American Civil Liberties Union (ACLU).
The Mississippi Department of Corrections (MDOC) has agreed to end the segregation of prisoners with HIV, a longstanding discriminatory policy that has prevented prisoners from accessing key resources that facilitate their successful transition back into the community.
The decision by Mississippi's corrections commissioner Christopher Epps, prompted by recent advocacy by the ACLU and Human Rights Watch, leaves Alabama and South Carolina as the only states that segregate prisoners based on their HIV status. Epps made the decision ahead of a forthcoming report by the ACLU and Human Rights Watch analyzing the harmful impact segregation policies have had in the three states.
"Commissioner Epps deserves a tremendous amount of credit for making this courageous decision to replace a policy based on irrational HIV prejudice with a policy based on science, sound correctional practice, and respect for human rights," said Margaret Winter, Associate Director of the ACLU National Prison Project. "The remaining segregation policies in South Carolina and Alabama are remnants of the early days of the HIV epidemic and continue to stigmatize prisoners and inflict them and their families with a tremendous amount of needless suffering."
Since 1987, MDOC has performed mandatory HIV tests on all prisoners entering the state prison system, and has permanently housed all male prisoners who test positive in a segregated unit at the Mississippi State Penitentiary, the state's highest security prison. As a result, prisoners with HIV have been faced with unjustified isolation, exclusion, and marginalization, and low-custody prisoners have been forced unnecessarily to serve their sentences in more violent, more expensive prisons.
The change in policy will enable prisoners with HIV to participate in jobs, training programs, and other services to which they were previously denied access because of their HIV status and which are designed to prepare prisoners for a productive return to society.
Additionally, HIV-positive prisoners will no longer be assigned to a segregated HIV unit, which resulted in the public disclosure of their HIV status and left them at risk of being ostracized and subjected to hostility and violence at the hands of other prisoners.
"Prisoners with HIV were often forced to live in cruel, inhumane, and degrading conditions, and we're delighted that Mississippi has changed its policy," said Megan McLemore, health researcher at Human Rights Watch. "Integrating prisoners with HIV is the norm across the United States and MDOC deserves significant credit for making this decision."
There will be compensation for qualifying participants. The survey consists of a face-to-face meeting lasting about two hours. "This is a groundbreaking study, the first of its kind!" reads the announcement. "Your input will have far-reaching effects that will help us learn how to better serve women who are living with HIV/AIDS." For more information, call toll-free at (877) 737-4758, e-mail firstname.lastname@example.org, or visit www.hhrstrategies.org.
Spanish researchers looked to see how people with HIV did during the recent H1N1 flu epidemic (the so-called swine flu). In short, not bad.
In a clinic in Barcelona, 56 positive patients with H1N1 were compared to HIV-negative patients with H1N1.
The groups had similar symptoms. Interestingly, the HIV-negative people had more cases of pneumonia and respiratory failure. But when the researchers looked at only the people without a co-morbidity (another illness, such as hepatitis), there was no difference.
Also interesting is that the HIV-positive patients recovered sooner. That might be because people with HIV were more likely to be treated for H1N1. HIV-positive people overall were more likely to receive Tamiflu than HIV-negative people (95% compared to 71%). For those without a co-morbidity, the same was true (94% compared to 40%).
The rate of antibiotic use was similar between the two groups (half), but for the folks without a co-morbidity, the HIV-positive people were just shy of having a significantly higher rate of getting antibiotics.
Fortunately, there was no change in viral load or CD4 T-cell count for the people with HIV in the four to six weeks after their H1N1 diagnosis.
Of the five positive patients with pneumonia and respiratory failure, smoking and a history of injection drug use were risk factors for these illnesses.
The report was presented in February at the Conference on Retroviruses and Opportunitistic Infections (see page 18 for more news from CROI).
In February, GlaxoSmithKline (GSK) issued a Dear Healthcare Professional Letter on this label change to its HIV protease inhibitor drug. The new information shouldn't surprise anyone. As the letter points out, increases in lipid levels (cholesterol and triglycerides) are a known risk factor of this class of drugs. Monitoring lipid levels is important when using a protease inhibitor.
GSK pointed to a report from the French Hospital Database on HIV which showed an association between exposure to Lexiva and an increased risk of heart attack. (The same was true for the protease inhibitor Kaletra and for the nucleoside drug Ziagen.)
The letter explains that heart attacks are a recognized risk for the protease inhibitor drug class, possibly related to the risk of increased lipid levels. Providers are advised to help patients with modifiable cardiovascular risk factors such as diabetes, smoking, and high blood pressure. In addition, elevated lipid levels should be treated appropriately for the individual patient. Moreover, "Prescribers are reminded that HIV infection itself has been associated with lipid disorders and ische-mic heart disease."
See the 2009 French report at www.retroconference.org. The abstract, #43LB, is entitled "Impact of Specific NRTI and PI Exposure on the Risk of Myocardial Infarction: A Case-Control Study Nested within FHDH ANRS C04."
More than 850 people in 10 states are currently on ADAP waiting lists to access HIV/AIDS drugs, and more states are joining the ranks, according to the Fair Pricing Coalition (FPC).
The following is from the coalition:
This situation will not improve anytime soon -- certainly not until the new Health Care Reform Legislation is fully implemented -- unless we act now! AIDS Drug Assistance Programs (ADAPs) are at the center of a perfect storm, brought on by the economic meltdown, federal and state budget shortfalls, and continuing escalation of drug prices. The number of people who rely on ADAPs for their medications grew an unprecedented 80% each month in FY2009.
Join the Fair Pricing Coalition in calling on all HIV drug companies to do their part to help solve this crisis by:
The FPC is seeking organizational and individual endorsements of an open letter to the drug companies in anticipation of upcoming negotiations with ADAPs in May. To sign on and read the full letter, please go to www.hivresearchcatalystforum.org/action.
Note: There is a separate ADAP emergency funding sign-on that is still open for signatures (contact rclary@projectinform to sign on to the emergency funding letter).
The Fair Pricing Coalition is an ad hoc group of community-based activists who work on drug pricing issues with pharmaceutical companies in the field of HIV/AIDS and hepatitis. The FPC focuses on the impact of drug pricing on patients, public and private payers, and providers. The core group meets with and coordinates discussions over pricing with individual pharmaceutical companies. A much larger group of AIDS and hepatitis organizations and concerned individuals participate in the FPC through consensus statements and petitions.
In March, the FDA approved the use of Viread (tenofovir) in patients ages 12 to 18 who weigh more than 77 pounds. Viread is also available in the top-selling combination pills Truvada (Viread plus Emtriva) and Atripla (Viread and Emtriva plus Sustiva). Interestingly, the small study of 45 patients taking Viread and 42 taking placebos (sugar pills) did not find a difference in effectiveness (suppressed viral load) between the two groups. According to the FDA announcement, a subgroup analysis suggests that the lack of difference in virologic response may be due to differences in baseline drug resistance for these highly treatment-experienced adolescents. The FDA said that despite the disappointing results, the safety and pharmacokinetic data is similar to that seen in adults and supports approval for patients in this age range. Also, increased bone turnover was seen in the participants taking Viread, and the report noted that, "Although the effect of supplementation with calcium and vitamin D was not studied, such supplementation may be beneficial for all patients. If bone abnormalities are suspected, then appropriate consultation should be obtained."