The new year promises notable highs and lows for HIVers. While our divine diviners see no new drugs popping OUT of the pipeline, there are plenty of promising pills IN it. And with President Bush up for re-election, “A” for abstinence is IN, while “A” for access to drugs is, sadly, OUT. The prognosis? Iffy. The treatment? Raise a glass to life—that’s always IN.
IN: Once-daily regimens, which “make people’s lives much easier,” says Jules Levin of the National AIDS Treatment Advocacy Project (www.natap.org.) “This is where every drug company is going.”
OUT: The “d” drugs. “Clearly, they’ve hit bottom” due to nasty side effects, says University of Cincinnati’s Judith Feinberg, MD. Bye-bye, d4T’s lipoatrophy and lactic acidosis, and—especially when ddI and d4T are taken together—pancreatitis and peripheral neuropathy.
IN: Searching for improved salvage therapy for through-the-treatment-mill HIVers with mucho resistance. “The patients who are doing fabulous are on all kinds of combos,” Feinberg says. “But for those who aren’t, you scratch your head.”
OUT: Triple-nuke regimens, given the sorry solo acts last year by Trizivir (AZT/3TC/Ziagen) and once-daily 3TC/Ziagen/Viread, according to treatment advocate Tim Horn. Survey says: Too weak to knock out HIV. But some docs will keep them alive for folks with low viral loads.
New drugs are only IN rehearsal but not ready to debut, so 2004 looks much drier than 2003, when a record four new HIV meds popped OUT of the pipeline.
IN the wings: Two nukes in one, for easier adherence. First Ziagen will unite with 3TC, while Viread and Emtriva will come together as one. Once the latter gets the nod (early 2005), “This will really give Combivir a run for its money,” Feinberg says.
IN expanded access: Tipranavir, the salvage-therapy hopeful.
IN FDA trials: TNX-355, a brand-new entry in the brand-new class of entry inhibitor.
IN wider use: The new PI Lexiva, approved at the end of 2003 (see “New Med on the Shelf”).
IN: Results from a study of the hormone DHEA as an immune modulator, slowing HIV by pumping up immune cells rather than attacking the virus itself, reports Donald Abrams, MD, of UCSF’s Positive Health Program.
IN: Individually tailored treatment, says Kathryn Anastos, MD, of the Women’s Interagency HIV Study (WIHS), “before start[ing] therapy, based on things like pre-existing risks for diabetes or heart disease.” Anastos anticipates new WIHS data on bone loss, cardio, lipo, cervical disease and how CD4 levels relate to treatment success in women.
IN: Abrams’ expanded study of pot-smoking for neuropathy pain—a small pilot study gave encouraging results (see “Safe Spliffs” POZ, December 2003).
So far out they’re IN: Oyster mushrooms, a gourmet item, being studied to see if they can reduce blood fat levels raised by power PI Kaletra.
IN: New hep C drugs. Some “will look good enough to go into Phase II trials,” says Jules Levin, “and two or three will move into trials in people,” including HCV protease inhibitor VX-950. Plus, a head-to-head trial of which hep C treatment, Pegasys or Peg-Intron, is more effective and better tolerated.
IN: Hep Cers acting up: “The grassroots are just beginning to organize,” on issues of hepatitis C treatment and awareness, says Levin, himself a longtime agitator.
OUT: Hep C treatment for used-to-be-hip-to-hep celeb and advocate Pamela Anderson. She announced late in ’03 that she’s decided not to take interferon and expects to die of hep C in 10 years or “maybe 15, if I’m lucky.”
IN: Desperate need for AIDS $$$. Fred Dillon, policy director at the San Francisco AIDS Foundation, says, “If there aren’t more resources, people will die because they don’t have access to drugs.”
OUT: AIDS $$$. American Academy of HIV Medicine head Scott Hitt, MD, blames it on state and federal budget crises and the increased pressure for funds that will come from the CDC’s push to test more people. And “We’re confronting for the first time in many years flat funding for Ryan White,” warns Christine Lubinski of the HIV Medicine Association—so planning for 2005’s Ryan White Care Act reauthorization should be IN in ’04.
IN: Pressing Congress to pass the Early Treatment for HIV ACT to allow HIVers to be covered by Medicaid before they develop AIDS. Agitate: www.projinf.org/org/etha.html.
IN: A World Health Organization plan to provide new three-in-one combo pills to 3 million people. These fixed-dose combos—three drugs from three companies—are “the most affordable and effective option” for poor countries, Health GAP’s Sharonann Lynch says.
IN: HIV. Feinberg says, “there are lots of little pieces of data showing that HIV infection is increasing,” especially among young gay and bi men. But guess what’s...
OUT: Condoms (if you listen to the Vatican and Bush administration), and look what’s...
IN: The CDC’s Prevention for Positives plan, which will divert bucks from existing outreach programs and add up to “empty words” without more funding for care, says prevention expert Thomas Coates, PhD.
ON THE FENCE: As the 2004 presidential race accelerates, candidates will surely speechify on the domestic healthcare crisis, especially ballooning drug prices and numbers of uninsured. So far they’ve barely mentioned AIDS—but, Hitt notes, “they haven’t been hit very hard yet by activists.” And dare we hope that Bush will be OUT in 2004?