Note: This study was also published in the CDC's February 4 Mortality and Morbidity Weekly Report, or MMWR, along with an editorial. Visit www.cdc.gov/mmwr.
The study surveyed 31 African American women living with HIV and 101 who were HIV-negative. Unfortunately, these are small numbers. But the information was tantalizing. (A total of 208 black women were diagnosed with HIV, but not all were surveyed for various reasons, for example, because they declined to participate or had been diagnosed in another state.)
Of special concern was the higher risk of HIV in women with a history of genital herpes. (Herpes can lead to ulcers, or breaks in the skin. This makes it easier to become infected with HIV. Other sexually transmitted diseases are also associated with an increased risk of HIV, in part because of the lack of condom use.)
CDC researcher Dr. Lisa Fitzpatrick (who is herself African American) said during her presentation that, "Despite a high incidence of unprotected sex, most of the women did not perceive a high risk of HIV." Of the positive women, 18 (58%) said they "believed they were unlikely/very unlikely to contract HIV," vs. 72 (71%) of the HIV-negative women.
Compared to the HIV-negative women, the positive women were more likely to:
Other high-risk factors included a financial dependence on men, a sense of invincibility, low self-esteem and use of alcohol or drugs. Again, the numbers are small, but the findings are in keeping with the results of other research.
The positive women were less likely to talk about sex and behavioral history with their partners. Therefore, Dr. Fitzpatrick said such "discussion appears to be protective." (One HIV specialist described it as "women who are strong enough" to have these discussions with their partners.)
Dr. Fitzpatrick said it's hard to make recommendations with only having surveyed 31 positive women, but it seems that some ideas would be good to follow up on. Encourage a delay in sexual debut (first time having sex), introduce HIV prevention at earlier ages, enhance communication between sexual partners, integrate HIV testing and treatment into healthcare and address socioeconomic challenges.
The report noted that, "The HIV epidemic in the United States increasingly affects black, heterosexual women in the South. In North Carolina, trends in HIV prevalence among women mirror national trends in the U.S. epidemic, where black women represent 72% of new cases of HIV infection among women. In 2003, the HIV infection rate for black women in North Carolina was 14 times higher than that for white women."
After eight weeks, triglycerides were down 26% in the fish oil group vs. up 1% in the placebo group. Triglycerides had normalized for 22% of the treatment group vs. 7% of the placebo group.
Everyone was then given the fish oil capsules for another eight weeks. The previously treated group maintained their decreased triglyceride levels and 21% of the placebo group now saw a decrease.
The researchers said that Maxepa "could represent a potential option for first line therapy for ART [HIV drug]-associated hypertriglyceridemia because of its efficacy, good tolerance, and absence of drug interactions." Everyone was also given a diet to follow before the study, plus nutritional counseling during the study.
Other doctors and patients, however, talked about how unpleasant taking fish oil capsules can be (don't burp). They also said that translating one gram into 100 mg available in the stores might make for a whole lot of capsules to take.
They found that switching patients from a nucleoside-containing drug regimen to one without nucleosides significantly improved arms and legs after one year. On the other hand, there was also an increase in blood lipids (triglycerides and cholesterol). The study participants were all switched to Kaletra and Sustiva, which are known to raise lipid levels. Trunk fat (stomach area) stayed the same.
The researchers reported, "These results provide additional evidence that NRTI [nucleoside drugs] are important in progressive appendicular fat loss that characterizes HIV-lipoatrophy. The switch to a NRTI-sparing regimen represents a therapeutic option for patients with lipoatrophy." They also noted that the potential side effects of a switch need to be taken into consideration.
British researchers took a more specific look at nucleosides. They switched patients taking either of the two thymidine nucleosides (AZT, or Retrovir, and Zerit) to the nucleosides Ziagen or Viread. At one year's time, both drugs lead to "similar, significant increases in limb fat." Presenter Dr. Graeme Moyle, of the Royal Free Hospital in London, said, "This is very encouraging for patients."
The report added that, "While both [drugs] maintain virological suppression [undetectable viral load -- study participants started with less than 50 copies], [Viread] is associated with fewer treatment discontinuations and greater improvements in lipid parameters than [Ziagen]." The discontinuations were three persons on Viread (6%) and eight persons on Ziagen (15%, including three with a hypersensitivity reaction). Viread was associated with a greater improvement in cholesterol levels, due to a decrease in LDL ("bad" cholesterol).
Dr. Moyle noted that Ziagen had already been found to improve the recovery of peripheral fat, which had made it the "standard of care" for treatment of lipoatrophy.
Both studies measured fat by using DEXA (dual-energy x-ray absorptiometry).
Another AACTG study did find improvements in stomach fat when switching people from a thymidine drug to Ziagen or to change their entire combination to Kaletra and Viramune. (Neither drug is a nucleoside -- Kaletra is a protease inhibitor and Viramune is a non-nucleoside.) Limb fat only improved, by 8%, in the Kaletra/Viramune group. Presenter Dr. Robert Murphy, of Northwestern University, said the 8% was a visible improvement to patients. He noted that the CT scans taken of the thighs, however, were very difficult to get, and are not available in clinics. He said DEXA is probably easier to use.
At a press conference, researcher Dr. Peter Reiss, of the HIV Monitoring Foundation at the University of Amsterdam, pointed out that "prevention is better, since reversal of lipoatrophy is only partial."
In a press conference, however, one of the researchers noted that control of other risk factors (such as diet and lack of exercise) helps to counteract risk from therapy. Dr. Jens Lundgren, of the Copenhagen HIV Program in Denmark, also said that, "As patients get older, it's increasingly important to modify risks."
As doctors continually point out, the benefits of therapy need to be remembered. "Whatever risks we talk about needs to be put in perspective with the extraordinary benefit of treatment," he reminded everyone.
The study reported that, "The relative increase in risk appears similar in men and women, and in older and younger subjects. Dyslipidemia [lipid abnormalities] explained part but not all of the association of combined ART with risk of myocardial infarction [heart attack]."
In her presentation to the conference, Dr. Wafaa El-Sadr, of Harlem Hospital and Columbia University, said, "It's important to monitor carefully patients with identifiable risk and lower those risks." She added that, "The proportion of people who are smoking is amazing [47%]. An effective intervention is important."
Instead, it was the "C" in the country's famous "ABC" prevention program -- condoms -- plus "D" for deaths, that lowered the prevalence. There was no increase in either the rate of abstinence ("A") nor "B" for "be faithful" if you're having sex, but there was for the use of condoms. Furthermore, deaths from HIV/AIDS outnumbered new infections, which lowered the number of people living with the virus.
The researchers also found that newly infected people, not knowing that they were infected and being highly infectious, were driving the infection rate. They called this "E" for epidemiology. They also suggested another letter to the ABC equation, "F," not for failure, but for "future." Would future roll-out of HIV therapy lead to the "treatment optimism" noted in the developed countries, where people report being less afraid of becoming infected because of drug availability? What about condom and prevention fatigue?
At a conference forum, Stephen Gange put the New York case into perspective against the research conducted through MACS (the Multicenter AIDS Cohort Study) and WIHS (the Women's Intragency HIV Study). He pointed out that the studies gather the medical evidence against which infections can be measured -- such as the risk of progression to AIDS.
"Cohort studies remain a vital tool for [putting new reports into] context, and further study -- with the continued dedication of their participants -- will continue to do so." Gange works with the analysis center for both cohorts, as well as the Johns Hopkins Bloomberg School of Public Health.
It's not always easy to stay in a study -- hats off to the MACS men and WIHS women for their dedication.
In preliminary 24 weeks results, a little more than half of the patients (56%) had less than 50 viral load. Seventy-six percent of them had less than 400. This was despite advanced HIV disease. Study participants were given Retrovir, Epivir (perhaps in their combined formulation, Combivir -- not stated) and Viread. Dr. Mutuluuza said these results were comparable to those seen in a U.K. study using protease inhibitor or non-nucleoside drug combos.
One African American researcher noted that, "This is an indicator that their decisions are more wise than we might think based on our experience." In this case, triple nuke therapy has been largely discredited in wealthier countries. Adding Retrovir to such combinations, however, has been found to be key to their success, while some triple-nuke combos are definitely to be avoided (for example, Epivir, Ziagen and Viread).
Twelve infants were treated within a few months of birth, for up to six years. Most were given a protease inhibitor-based drug combination. Eight had undetectable viral load (less than 50). The infants had started with a medium baseline viral load of 668,000. The researchers reported that, "Early HAART limits sequence diversity and divergence in pol and env [HIV proteins]."
They did. (Note: previous data has shown that African Americans stop their HIV therapy sooner than do whites.)
Of the patients who started a Sustiva-based combination after January 1, 2000, African Americans were twice as likely to discontinue Sustiva. This was even after taking into account age, sex, history of injection drug use, and other drugs in the combination, as well as T-cell count and viral load when starting treatment.
The probability of discontinuing the drug within the first year of therapy was 32% for African Americans vs. 16% for whites. The majority of the discontinuations in both groups were for reasons other than adverse events.
Of 218 African Americans who started Sustiva, 92 (42%) stopped taking it. This compared to 65 white patients who started Sustiva, of which 15 (23%) stopped taking it.
Black people were also less likely to have undetectable viral load (less than 400 copies). At six months, 56% of African Americans on Sustiva had less than 400 viral load, compared to 72% of the whites. At one year, 66% of the African Americans had less than 400, compared to 82% of the whites.