•  NEW ANTIRETROVIRALS: ATRIPLA, TMC114

FDA Approves First Once-Daily, Single-Pill HAART Regimen
The U.S. Food and Drug Administration has granted approval for a once-daily, single-pill HAART regimen consisting of 600 mg efavirenz (Sustiva, Stocrin) + 200 mg emtricitabine (FTC, Emtriva) + 300 mg tenofovir (Viread). The new medication, which will be marketed under the brand name Atripla, is the first approved in the United States that combines antiretrovirals from two different drug classes. When distribution begins later this month, Atripla will sell at the same price as efavirenz and tenofovir/FTC (Truvada) sold separately. Click Here


U.S. Approves TMC114 for Treatment-Experienced Patients
The U.S. Food and Drug Administration (FDA) has granted approval for TMC114 (darunavir, Prezista), a protease inhibitor indicated for the treatment of multidrug-resistant, HIV-infected patients. The twice-daily drug, which must be coadministered with ritonavir (Norvir), is the first HIV antiretroviral to receive U.S. approval since tipranavir (Aptivus) was approved in June 2005. Twenty-four-week data from the POWER studies showed that 70% of treatment-experienced patients receiving an optimized HAART regimen that included the FDA-approved dose of 600 mg TMC114 + 100 mg ritonavir twice-daily experienced a viral load reduction of at least 1 log or greater, compared to 21% of control patients. The approval of TMC114 makes it the 26th antiretroviral medication or fixed-dose combination approved by the FDA. Click Here


Exclusive Interview: Cal Cohen, M.D., Provides an Insider's Look at TMC114
Cal Cohen, M.D., M.S., one of the lead researchers involved in the phase 2 and 3 clinical trials of TMC114 (darunavir, Prezista), talked with The Body PRO about some of the key questions surrounding this new HIV medication: Why should clinicians be excited about TMC114? What adverse effects are associated with the drug? How is TMC114 likely to impact the treatment of multidrug-resistant patients? Download a podcast of our 18-minute interview or read the transcript! Click Here


A Drug Pricing Victory: TMC114 Priced Well Below Recent Antiretrovirals
To the pleasant surprise of AIDS treatment advocates, Tibotec Therapeutics has agreed to set the price of TMC114 (darunavir, Prezista) well below that of some recently approved antiretrovirals. Although still quite expensive at $6.25 per pill ($25 per day/$9,000 per year), TMC 114 will cost nearly half the price of enfuvirtide (T-20, Fuzeon) and well below the price of tipranavir (Aptivus), a protease inhibitor that was approved last year. "This was exactly the kind of bold move sought by the community," says the patient advocacy group Project Inform, which led a nationwide push to ensure a fair price for TMC114. "It isn't often that Project Inform or other advocacy organizations call for [the] support of [a] drug company, but we must be fair. When they act in a socially responsible manner by responding to community needs, we need to reinforce that behavior." Click Here


Many Questions Remain About TMC114, Treatment Advocate Notes
"Development of [TMC114 (darunavir, Prezista)] was spectacularly fast," writes HIV treatment advocate Rob Camp of Treatment Action Group. Although HIV antiretrovirals tend to be approved quickly relative to drugs for other diseases, TMC114 shot through the pipeline faster than most, leaving a number of unanswered questions about the drug's efficacy and long-term safety. Although there are a great number of advantages to TMC114, Camp says, there is a lack of study data on many important issues. In this detailed review, he presents some of the questions that still remain about TMC114's optimal dose, benefits in women, potential drug interactions and long-term adverse effects, and a more accurate sense of how specific drug-resistance mutations will impact TMC114's antiretroviral activity. Many of these issues are, in fact, receiving attention in ongoing studies. Click Here

•  HIV TREATMENT & PATIENT CARE

Black Box Warning for Tipranavir: Possibility of Intracranial Hemorrhage
The U.S. Food and Drug Administration (FDA) has issued a "Dear Healthcare Provider" letter warning about the potential for intracranial hemorrhage events in HIV-infected patients receiving the protease inhibitor tipranavir (Aptivus) coadministered with ritonavir (Norvir). Of 6,840 HIV-infected patients receiving tipranavir + ritonavir in clinical trials, 13 experienced a total of 14 intracranial hemorrhage events, resulting in eight deaths, the letter states. The letter notes that no general pattern of abnormal coagulation parameters has been observed in patients receiving tipranavir, thus making it unnecessary to routinely measure coagulation parameters in tipranavir patients. However, the letter advises that tipranavir + ritonavir "should be used with caution in patients who may be at risk for increased bleeding from trauma, surgery or other medical conditions, or who are receiving medications known to increase the risk of bleeding, such as antiplatelet agents or anticoagulants." Click Here


Tipranavir First-Line Treatment Study Terminated
Tipranavir (Aptivus) is an effective option for many HIV treatment-experienced patients, but the early termination of an industry-sponsored study makes it doubtful that tipranavir will be utilized in treatment-naive patients. The multinational study of 558 treatment-naive patients aimed to assess the non-inferiority of tipranavir + ritonavir (Norvir) versus lopinavir/ritonavir (Kaletra) when used as part of an initial HAART regimen. The trial was closed after a higher rate of liver enzyme elevations was discovered in the 500 mg tipranavir/200 mg ritonavir arm compared to other study arms, and after a lower-dose arm -- 500 mg tipranavir/100 mg ritonavir -- failed to achieve non-inferiority compared to lopinavir/ritonavir at 60 weeks. Click Here


Los Angeles Times Examines HIV Nonprogressor Studies, Research Difficulties
Many of the United States' top researchers focusing on HIV nonprogressors (or "elite controllers") were interviewed for a recent Los Angeles Times report on the phenomenon. According to the Times, nonprogressors are exceedingly rare, accounting for an estimated .33% of the HIV-infected U.S. population. "I would say we still don't have the faintest idea why these people are doing as well as they are," Bruce Walker, director of Partners AIDS Research Center at Massachusetts General Hospital, said. "Achieving the state that these guys have reached in their bodies -- if we could do that through some intervention, we would solve the AIDS epidemic." Walker and his research team at Massachusetts General Hospital have enrolled 176 HIV nonprogressors from across the country to participate in a new study. "Basically, we want to recruit every single one of these people in the [U.S.]," Walker said, adding, "We have to have a large enough sample to begin to see patterns in this population." Click Here

Clinicians caring for patients who may qualify for enrollment in Walker et al's study can visit this Web page for more information.


Updated U.S. Perinatal HIV Treatment Guidelines Released
The U.S. health department has revised its recommendations on the treatment of pregnant, HIV-infected women in the United States. The most notable changes include a recommendation that resistance testing be provided to all pregnant women not currently receiving antiretrovirals, as well as all pregnant women receiving antiretroviral therapy who are 1) experiencing virologic failure or 2) experiencing suboptimal viral suppression on an initial regimen. These recommendations dovetail with recently updated U.S. HIV treatment guidelines for all adults and adolescents, which also urge more widespread use of resistance testing. The revised perinatal guidelines also advise against the use of single-dose nevirapine (Viramune) in pregnant women who are already receiving HAART. Click Here


Early Trials Ongoing for Maturation Inhibitor PA-457
PA-457 is one drug in a new class of antiretrovirals, maturation inhibitors, which could be used to suppress strains of HIV that have become resistant to current treatments. Recent in vitro experiments have indicated that PA-457 disrupts the formation of HIV's capsid protein, the conical shield that stores and protects the RNA essential to HIV replication. PA-457 binds to the capsid protein at a critical juncture when it is clipped apart from the structural gag protein and assembled into a cone. PA-457 stops the capsid from being clipped, leaving the sphere permeable, the RNA exposed and HIV unable to infect human cells. A full report on this research was published in the June 2006 issue of the Journal of Virology. Click Here


Double-Boosted PI Regimen Appears Effective in Multidrug-Resistant Patients: 15-Day Study
A double-boosted protease inhibitor (PI) regimen consisting of atazanavir (Reyataz) + lopinavir/ritonavir (Kaletra) may provide a safe and effective option for HIV-infected patients with multidrug resistance, according to the results of a small, short-term study published in the May 12 issue of AIDS. The 15-day, 16-patient study by Esteban Ribera and colleagues from Hospital Universitari Vall d'Hebron in Barcelona, Spain, found that atazanavir + lopinavir/ritonavir appears to have excellent antiretroviral activity without causing any adverse effects severe enough to cause treatment discontinuation. Click Here

•  HIV/HAART-RELATED COMPLICATIONS

Didanosine, Stavudine May Increase Hepatic Steatosis Risk in HIV/HCV-Coinfected Patients
HIV/hepatitis C (HCV)-coinfected patients have a much higher risk of developing hepatic steatosis if they are receiving didanosine (ddI, Videx) or stavudine (d4T, Zerit), according to the results of a 183-patient, U.S. study published in the Aug. 1 issue of Clinical Infectious Diseases. Barbara McGovern and colleagues found that HIV/HCV-coinfected patients who were taking the dideoxynucleoside analogs didanosine or stavudine were five times more likely to develop hepatic steatosis than patients who were not taking any drugs in the NRTI class. Click Here

In an accompanying editorial, Marija Zeremski and Andrew H. Talal write that McGovern et al's findings, when considered alongside earlier research, provide enough evidence to suggest that the "D drugs" didanosine and stavudine "should be used cautiously" in HIV/HCV-coinfected patients.


HAART, Avoidance of Cigarettes Greatly Reduce Pneumonia Risk for HIV-Infected Women
Bacterial pneumonia remains a major health risk for HIV-infected women, especially those with a CD4+ cell count below 200 -- but HAART, pneumonia prophylaxis and a cigarette-free lifestyle can go a long way toward eliminating the danger, according to a study by Albert Einstein College of Medicine researchers. The study confirmed earlier research that found bacterial pneumonia rates were higher among HIV-infected women before the HAART era began. In the modern treatment era, researchers found that the risk of bacterial pneumonia dropped by 3% for each month women received pneumonia prophylaxis, and by another 8% for each month they received HAART. The study, which appears in the July 1 issue of Clinical Infectious Diseases, also noted that HIV-infected women who smoked cigarettes were more than twice as likely to develop bacterial pneumonia than HIV-infected women who did not smoke. Click Here


Obesity Lowers HCV Treatment Success
Obese patients receiving treatment for chronic hepatitis C (HCV) infection may be more likely to achieve better results if the abnormalities associated with excessive fat tissue are corrected first, according to a study published in the May 25 issue of Hepatology. Obesity is considered a metabolic condition, not merely a matter of being very overweight, according to Michael R. Charlton, of the Mayo Clinic, and colleagues. In HCV-infected patients, obesity is associated with inflammation and insulin resistance, a prediabetic abnormality involving blood sugar. Obese HCV-infected patients may also have steatosis, fatty liver disease; liver scarring; fibrosis progression; and a poor response to the standard HCV treatments interferon and ribavirin. A key step to improving treatment response is weight loss aimed at reducing fat tissue, the researchers said. In addition, treatment with diabetes drugs such as metformin and pioglitazone might help reverse disease progression, according to the report. Administering higher doses of combination drug therapy (determined by body mass index instead of weight) for an extended period of time could help offset the decreased drug response. Click Here

•  HIV TRANSMISSION/TESTING

MSM Often Avoid HIV Testing Even if They Feel Symptoms, Survey Finds
Within a month of HIV infection, many individuals experience flu-like symptoms. However, a recent survey at a clinic in Seattle, Wash., of 150 HIV-uninfected men who have sex with men (MSM) found that the majority are unaware that these are potential symptoms of HIV. The survey also noted that even if MSM understand the possible symptoms of HIV, once they actually begin to experience them, they usually do not get tested for HIV. Joanne Stekler and colleagues from the University of Washington-Seattle said that the findings demonstrate how critical it is that health officials better educate MSM about the symptoms of HIV and the importance of routine HIV testing. Click Here


HIV-Infected Persons in U.S. South Often Victims of Abuse
A history of sexual or physical abuse is common among HIV-infected people in the southern United States -- regardless of their gender or sexual preference, say Kathryn Whetten, of Duke University, and colleagues. In a study of HIV-infected people receiving HIV treatment in five southern states, Whetten et al found that at least 50% reported experiencing sexual abuse or severe physical abuse at some point in their lives -- and that about 25% (men and women alike) had been sexually abused before their 13th birthday. The study appears in the June 2006 issue of the American Journal of Public Health. Experts believe that a history of abuse makes individuals more likely to develop HIV risk behaviors, and may make HIV-infected people less likely to adhere to antiretroviral treatment. Click Here


Rapid HIV Test Increases Diagnoses: Study
Experts have been saying it for years, and a massive new study has proven it: Where rapid HIV tests are available (instead of conventional, slower tests), people are more likely to get tested. In 2003, the U.S. Centers for Disease Control and Prevention (CDC) launched a plan to distribute nearly 800,000 rapid HIV tests to communities and prisons throughout the country. In a detailed report on the plan's success, published in the June 23 issue of Morbidity and Mortality Weekly Report, CDC researchers confirmed that people are more likely to seek testing if there is a quick and easy way to do so. The report added that the CDC's rapid-test distribution plan may have helped increase HIV diagnoses among people who would otherwise never have learned about their status. Studies show that nearly one-third of individuals who undergo conventional HIV testing (which takes about two weeks) never return for their results, but that if test results are available within a half hour, people are more likely to wait for them. Click Here


Support in the U.S. Growing for "Routine" HIV Testing
National HIV Testing Day on June 27 coincided with a U.S. Centers for Disease Control and Prevention (CDC) proposal to make HIV testing a routine part of patient health care. National AIDS advocacy groups, however, have mixed views about how that campaign should be put into practice. Some advocates are concerned about the CDC's call to relax pre- and post-test counseling and written consent requirements, which was made to accommodate the schedules of overworked nurses and doctors. "Clearly, the key is to get to the high-risk populations," said Rebecca Haag, executive director of AIDS Action, which supports routine HIV testing with some limitations. "The problem with routine testing is that many of the people in high-risk groups may not be in routine health care." Click Here


Point/Counterpoint: What Is the Significance of the Georgia Prison Report?
A recent U.S. Centers for Disease Control and Prevention report found that approximately 91% of HIV-infected men incarcerated in Georgia's prisons last fall had been infected with the virus before they were imprisoned, shattering commonly held assumptions regarding the transmission of HIV within prison systems. In this article, Joseph Paris, M.D., and Madie LaMarre, M.N., A.P.R.N., B.C., debate the implications of these study results for HIV prevention efforts in U.S. prisons. Click Here

•  HIV-RELATED POLICY/ADVOCACY IN THE UNITED STATES

New Calif. Ruling: Withholding Sexual History Can Be Grounds for Lawsuits Involving HIV Transmission
The California Supreme Court on July 3 narrowly ruled that an HIV-infected woman can sue the sexual partner from whom she contracted the virus, even if the man did not know he was HIV infected at the time, the New York Times reports. A California law makes it a felony, punishable by up to eight years in prison, to knowingly expose or infect an unaware person to HIV. The law also allows a person's HIV status to be disclosed if the person is the subject of a criminal investigation for committing this crime. In the court's 4-3 majority opinion, Justice Marvin Baxter wrote that "negligent transmission of HIV does not depend solely on actual knowledge of HIV infection" but also if the person "has reason to know" he or she might be living with the virus. The ruling defined "reason to know" as when there is cause for a "reasonably intelligent" person "to infer he or she is infected with the virus or that infection is so highly probable that his or her conduct would be predicated on that assumption." One of the dissenting judges warned that the court's decision "potentially licenses invasions into sexual privacy of all sexually active Californians and may even invite abuse of the judicial process." Click Here


Gates, Buffett Get Serious About Charity; Global Anti-HIV Efforts May Benefit
When Bill Gates, one of the richest men in the world, announces plans to leave his day job at Microsoft in order to focus on spreading health care and education to the world's poor, there is reason to rejoice. When Gates and his wife Melinda specifically cite the creation of effective microbicides and an AIDS vaccine as two of their primary goals, it's hard to blame the HIV community for cheering. And when Gates is joined by another multibillionaire, Warren Buffett -- who has pledged to give some $30 billion to Gates' foundation -- it's enough to make one hope that perhaps the tragic inequalities in the world may finally be comprehensively addressed by people who demand results. Click Here

Since the announcements by Gates and Buffett, the U.S. media has exploded with coverage, comments and editorials. As David Leonhart wrote in the New York Times: While Buffett could have used his mountains of cash to form his own university or create a new foundation, thus "engag[ing] in a little competitive philanthropy," he "made the point that giving away money should be more about results than ego."

To read many more editorials and opinion pieces about Gates' and Buffett's announcements, click here. For a more detailed recap of those announcements, click here.

•  HIV NEWS & VIEWS

AIDS at 25: A Sober Perspective From Howard Grossman, M.D.
"Death was a constant companion in 1995," recalls Howard Grossman, head of the American Academy of HIV Medicine. One day that year, in the span of a few hours, Grossman lost two of his patients, as well as one of his best friends. Not long after that, HAART entered the HIV treatment universe, and everything changed: "In my practice alone in 1995 there were 37 deaths. In 1996 it dropped to 10, in 1997 to four and in 1998 to zero," he says. But despite this miraculous advance, the HIV epidemic in the United States today is far from a bed of roses, Grossman writes. "We've still lost a lot of patients since 1995. … Their deaths must serve as another reminder that, for all our success, AIDS has not gone away." Click Here


XVI International AIDS Conference Announces Program, Including Prominent Leaders and Scientists
The XVI International AIDS Conference, to be held Aug. 13 to Aug. 18 in Toronto, Canada, will feature a number of prominent non-clinical speakers, including former U.S. President Clinton, former President of Ireland Mary Robinson, Crown Princess Mette-Marti of Norway, Bill and Melinda Gates and actor Richard Gere. The conference will highlight scientific advances, as well as current policy issues among political, scientific and community leaders. Although in recent years the International AIDS Conference has grown relatively light on major scientific breakthroughs, it remains the largest international gathering of HIV/AIDS activists, prevention and treatment experts, physicians and researchers; about 20,000 participants are expected to attend, and the conference will feature more than 400 sessions, meetings and workshops. Click Here

The XVI International AIDS Conference program is now available online.

•  HIV OUTSIDE THE UNITED STATES

AIDS Is Leading Cause of Death in Caribbean, UNAIDS Report Says
AIDS-related illnesses are the leading cause of mortality for people ages 15 to 44 in the Caribbean, according to a new UNAIDS report. Accounting for 27,000 deaths in 2005, the Caribbean is still one of the regions of the world most affected by HIV, second only to Africa. UNAIDS estimates that 330,000 HIV-infected people were living in the Caribbean at the end of 2005, and that fewer than one in four people who needed antiretrovirals were receiving them. Still, the news is not all grim: While countries like Guyana are in the grips of a serious epidemic, the Bahamas, Barbados, the Dominican Republic and Haiti are all showing signs of slowing the spread of HIV. Click Here


HIV Prevalence in Tijuana Rising Rapidly, Researcher Says
As many as one out of every 125 adults in Tijuana, Mexico, has HIV -- three times the rate of the rest of the country, according to University of California-San Diego (UCSD) researcher Steffanie Strathdee. In a recent interview (which you can listen to online), Strathdee said that since the 1990s, HIV rates among injection drug users in Tijuana have tripled and HIV rates among female sex workers have increased nearly tenfold. Strathdee attributes much of this increase to Tijuana's location on a major drug-trafficking route and its poor, marginalized migrant population. In an attempt to curb the upward trend of HIV, UCSD has donated a customized van to serve as a mobile testing and prevention clinic in neighborhoods with high levels of drug use and sex work. Click Here

To listen to an MP3 of this interview, click here.