POSITIVELY AWARE NOVEMBER/DECEMBER 2010
Briefly
reported by Enid Vázquez
New drug application for TMC278
HIV-negative women, HIV-positive men
New drug application for TMC278
Tibotec Pharmaceuticals submitted a New Drug Application (NDA) in late July to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an HIV non-nucleoside reverse transcriptase inhibitor (see page 42). TMC278 continued to show good results in data presented at the International AIDS Society Conference held in Vienna in July. Results from two large Phase 3 studies found TMC278 to be non-inferior to the kingpin Sustiva. These are 48-week results from 1,368 study participants. They started out with a median (half above, half below) viral load of 100,000 and T-cells of 256. Tibotec also has a non-nucleoside medication, Intelence (etravirine), currently on the market.
HIV-negative women, HIV-positive men
What treatments do HIV-negative women prefer when trying to conceive a child with an HIV-positive male partner? The Bay Area Perinatal AIDS Center (BAPAC) wants to know. BAPAC, run out of the University of California, San Francisco, has an online survey for HIV-negative women who desire to have a baby with an HIV-positive male partner. “Millions of HIV positive men and women are living long and productive lives in the United States,” writes Dr. Deborah Cohan, BAPAC’s medical director. “Many HIV positive men with HIV negative partners would like to become parents but are concerned about the risks of HIV transmission to their partners if they have unprotected sex in order to conceive a child.” Together with Dr. Nena Barnhart, she composed a survey of options available to learn what couples prefer. “We hope this information will be useful in educating couples, physicians, policy-makers, and advocates for the HIV positive community in addressing this important issue,” she writes. To take the survey, visit www.surveymonkey.com/s/D5YQ77L. Only one survey can be filled out per computer. For questions, call Dr. Cohan at (415) 206-3658.
A Canadian study of HIV-positive women found that they felt they were being negatively judged by their medical providers for their desire to have children. “Physicians may be following out-of-date guidelines created in the late 1980s recommending that HIV-positive women shouldn’t plan a family, which could explain this perceived stigmatization by these women,” said lead author Anne Wagner, a PhD student at Ryerson University in Toronto, in a university press release. Said study co-author Trevor Hart in the same release, “There need to be more efforts to make physicians aware of the practically nil chance of HIV-positive women transmitting HIV to their newborns as long as the women are continuing to receive appropriate medical treatment. There also needs to be continuing medical education to reduce the stigma perceived by HIV-positive women, which will improve their mental health and well-being.”
Ryerson researchers surveyed 159 women. More than half of them were from African or Caribbean countries, and they perceived more stigma than the women from Canada, who nevertheless also experienced negative attitudes. Both groups of women, however, said their family and friends did not play a significant role in the stigma they perceived over their desire to have children. The study was published in the June issue of Archives of Women’s Mental Health.
In a separate study, researchers from Johns Hopkins University interviewed HIV-positive women about whether or not they had discussed pregnancy with a medical provider. Of 181 women, two-thirds had what the researchers called a “generalized” discussion about pregnancy and a third had a “personalized” conversation, two-thirds of the conversations being initiated by the women. Moreover, these women reported a higher level of unmet reproductive counseling needs (56% vs. 23% for the women with a generalized discussion). The researchers reported, “A significant proportion of HIV-infected women want to talk about reproductive plans with their HIV provider; however, many have not. HIV care providers and gynecologists can address their unmet communication needs by discussing reproductive plans with all women of childbearing age so that preconception counseling can be provided when appropriate. Providers will miss opportunities to help women safely plan pregnancy if they only discuss reproductive plans with younger patients.” The study was published in the June issue of AIDS Patient Care and STDs.
Children make the switch from Kaletra to Viramune
Good news for children’s HIV therapy: researchers found that children could successfully switch from taking Kaletra (lopinavir/ritonavir) to taking Viramune (nevirapine) for HIV therapy. That’s good because the Kaletra formulation taken primarily by children, the liquid formula, has an incredibly nasty taste. Moreover, Kaletra is associated with metabolic dysfunctions, such as increases in cholesterol and trigly-cerides. On the other hand, the problem with Viramune is that it’s widely used to prevent HIV transmission from mother to child and the development of drug resistance has been seen in both moms and infants. For this reason, Viramune has generally been avoided in HIV-positive infants who had been exposed to the drug.
In the September 8 issue of JAMA (Journal of the American Medical Association), the researchers wrote, “Protease inhibitor-based therapy [such as Kaletra] is recommended for infants infected with [HIV] who were exposed to nevirapine for prevention of mother-to-child HIV transmission. However, there are limitations of continuing PI-based therapy indefinitely and reuse of nevirapine has many advantages.”
The study looked at 195 Viramune-exposed children in Johannesburg who started HIV treatment before they were two years old and had a viral load of less than 400 copies per mL for at least three months. Half the children were switched from Kaletra to Viramune. After one year, the children switched to Viramune were more likely to have achieved an undetectable viral load (less than 50 copies per mL) and had a greater increase in their CD4+ T-cell counts. The differences were statistically significant. However, the children who were switched were also more likely to have a viral load over 1,000 copies compared to those kept on Kaletra. This was associated with greater age, inadequate adherence, and drug resistance in the child’s virus, all of which can presumably be related to an older child’s greater ability to thwart forced medication.
Ironically, all the children were taking a background regimen of Epivir, a very tolerable medication, and Zerit, a drug so toxic that it’s rarely taken in the U.S. today. This is due to differences in poorer regions of the world, such as a lower cost for Zerit (and fixed dose combinations of Zerit with Epivir, as well as the two of them with Viramune, that are not available in the U.S.). Better drugs commonly used in wealthier countries may not yet be available or affordable in poorer areas.
Abbott hit with patent challenge over Norvir
A New York City public interest group, the Public Patent Foundation (PubPat), has challenged eight patents on the widely used HIV/AIDS protease inhibitor drug Norvir (ritonavir). PubPat has called on the U.S. Patent and Trademark Office to hold a “formal reexamination of a string of awards made between 1996 and 2008.”
PubPat claims that Norvir’s maker, Abbott Laboratories, is “attempting to maintain an improper monopoly.” In extensive documents filed on August 26, PubPat asks the Patent Office to “declare the patents invalid because they fail to describe a new invention and are causing significant public harm.” PubPat goes on to say, “The ritonavir patents inflate the cost of therapy for HIV/AIDS patients and restrict research on related drug possibilities.”
Abbott has been challenged before over HIV/AIDS therapy. In 2003, a group of consumers sued the company and tried to overturn its patents on Norvir after Abbott raised the price, boosting the patient’s cost from roughly $1.71 a day to $8.57 a day. Abbott fought the suit for years, but finally agreed to settle in 2008 by distributing $10 million to patient support groups.
Lynda Dee of the Fair Pricing Coalition, which advocates with the pharmaceutical industry regarding the price of HIV and hepatitis drugs, commented, “While I wish PubPat well, I doubt they will be successful. We tried a similar tactic years ago based on monopoly and access issues, but were unsuccessful. We had members of Congress on our side and a real concerted effort of community activists, healthcare providers, and even a few labor unions. If we weren’t successful then, when Abbott first took the unconscionable Norvir price hike based on these same issues, I doubt that PubPat will be successful today when the price of at least the old Norvir formulation costs pennies compared to the original cost, as a result of rebates mandated by the new healthcare reform legislation. But, of course, big corporations have U.S. Supreme Court Justice Scalia on their side. Recent court decisions by Scalia make cases based on a monopoly theory virtually impossible to win.”
—SUE SALTMARSH, FROM PA E-NEWS