The Department of Health and Human Services (DHHS) has once again revised the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. This most recent version of the Guidelines was updated October 6, 2005 and released for publication May 4, 2006. A “living” document that provides guidelines but is not a mandate for treating HIV, the Guidelines are constantly updated to reflect recent clinical findings and current knowledge in HIV medication issues. The most significant changes in this 2006 update include HIV genotype resistance testing prior to initiation of antiretroviral therapy in people with acute or chronic HIV infection. Previously, the Guidelines only recommended resistance testing in the chronically infected. This change reflects the understanding that more people are becoming infected with resistant HIV strains and an initial genotype test can help to guide treatment decisions, making initial therapy cost effective.

In light of the hubbub over the stopping of the SMART treatment interruption trial, and more disappointing results with other treatment interruption studies, recommendations have been added in this revision, with discussions over the risks and benefits of planned long term treatment interruption in chronically infected people with suppressed virus. Information on the management of people with hepatitis B and HIV co-infection have also been updated.

The Guidelines represent the consensus opinion of the Panel on Clinical Practices for Treatment of HIV, which consists of leading researchers, clinicians, DHHS participants and community members. They reflect the most up-to-date information representing a “standard of care” for treatment of HIV in the U.S. This is the latest revision since the Guidelines were created in 1998. Visit http://AIDSinfo.nih.gov.

In the first joint company marketing of an HIV therapy, Gilead Sciences and Bristol-Myers Squibb announced the FDA filing of their once-daily tablet that combines Truvada (Emtriva plus Viread) and Sustiva. The collaboration of two competing pharmaceutical giants in the HIV field is unprecedented. Bioequivalence and the initiation of stability studies has been completed, paving the way for NDA (New Drug Application) submission with the FDA. The new once-daily tablet includes 600 mg of Sustiva, 200 mg of Emtriva and 300 mg of Viread, all three of which are drugs that block the reverse transcriptase enzyme that is necessary for HIV replication.

Both companies will share marketing and publicity for the new product as well as support for promotion. In a joint company press release both companies “will receive revenues from future net sales at percentages relative to the contribution represented by their individual products that comprise the once-daily single tablet regimen.” Each individual drug will continue to be available separately. The new fixed-dosed combination should be available within a few months.

Pfizer and Monogram Biosciences have entered into a collaborative agreement to make Monogram’s HIV co-receptor tropism assay globally available for patient use. The test is used to determine the path taken by a patient’s HIV to attach to his or her CD4 cells. In a new wave of science and technology, the development of therapies that target the CCR5 co-receptor on CD4 cells by Pfizer and other companies has led to the need for an assay to determine which co-receptor is most prevalent and therefore the best target for the appropriate antagonists. About 80–85% of people newly diagnosed with HIV have dominant CCR5 tropic virus. The number drops to 50-60% in those who have been on HIV therapy, and even lower for those with advanced disease.

Since the companies really “need” each other for their own interests, Pfizer has invested 25 million dollars in Monogram. The implications of providing tropism assay tests have not been validated, but if these drugs become approved (Pfizer’s maraviroc being the most likely first candidate, expected to be approved next year), the test will probably be widely used in order to determine the best use of the drug.

The Fair Pricing Coalition has initiated a new sign-on letter demanding that Tibotec’s new HIV protease inhibitor (PI) Prezista, previously known as TMC-114/darunavir, which is nearing the final approval stages, be cost neutral to Abbott’s Kaletra—its biggest competitor. This is not your normal AIDS drug pricing demand, because Tibotec’s new protease inhibitor represents an improvement over current therapies, as it appears to work well against PI-resistant strains. It also comes along in a time of higher drug costs, a crisis in healthcare, and growing competition from other HIV drug companies.

A Senate health committee approved legislation to reauthorize funding for AIDS services through 2011. The Ryan White CARE Act, the largest federally funded AIDS services legislation of over 2 billion dollars annually, expired in September 2005 when legislators could not agree on its terms. The current form of the legislation has received bipartisan support, but still has to pass through the Senate and be signed by the president before it is enacted. The reauthorization process has been tenuous as other versions of the bill have been less than generous. This version is peeling back the layers of AIDS services in a less threatening way, but the writing is basically on the wall that federal funding for AIDS care as we once knew it is all but over.

This latest version of the bill settled compromises on several key cutback proposals by conservative Senator Tom Coburn (R-OK), which would have limited services even more than the current bill proposes. This version is the lesser of two evils in the latest of our current administration’s efforts to thwart AIDS care in the U.S.

The new legislation increases the number of cities receiving funding from 51 to 76 and creates a tier system for those cities based on AIDS cases. New funding distribution formulas are still being negotiated at press time. One of the significant changes in funding is that 75% of services be allocated for “core medical services,” which will leave the categories of transportation and case management in jeopardy.

Activists are decrying the changes because the support services negatively affected by the new legislation enable people to access the “core medical services.” One person living with HIV exclaimed at a recent Chicago Ryan White community forum, “It’s like robbing Peter to pay Paul.” Final votes for passage into law should be in August 2006.

The International Rectal Microbicide Working Group (IRMWG) issued a report during the Microbicides 2006 conference in Cape Town, South Africa, held in April. “Rectal Microbicides: Investments and Advocacy” is the first-ever report tracking rectal microbicide research and development expenditures. The group reported that, “Similar to a vaginal microbicide, a rectal microbicide may be formulated as a gel, cream or lubricant and would provide protection against HIV and other sexually transmitted infections (STIs) in the absence of a condom during anal intercourse. Studies show that up to 30% of the heterosexual population in many cultures engages in anal intercourse, making the development of a safe, effective rectal microbicide a desperately needed new prevention option for women, males who have sex with males, and gay men around the world.” According to the report, funding for rectal microbicide research totaled US$34 million between 2000 and 2006, showing an increase from US$2 million in 2000. The U.S. public sector contributed 97.4% of these funds.

A medication used as an opiate substitute, buprenorphine, has been related to a drug interaction with the HIV drugs Reyataz and Norvir. Doctors reported three cases in the March 21 issue of AIDS. One patient reported “daytime sleepiness” and “reduced mental function,” a second reported feeling “doped out” and a third complained of dizziness and a feeling of being high. All side effects were controlled with dose adjustments. Buprenorphine is sold under the brand name Subutex, or combined with naloxone and sold under the name Suboxone. Its great advantage is that it can be prescribed by any doctor (training is required), and its withdrawal is mild to moderate and can usually be managed without the use of drugs. —EV

The U.S. Centers for Disease Control and Prevention (CDC) has expanded its research into the prevention of HIV using HIV medication. The study uses the HIV drug Viread to see if it prevents infection due to sexual exposure. It will now also test the HIV drug Truvada, which is a two-in-one pill combo of Viread and Emtriva. Recently reported results with monkeys found Truvada to be even more effective than Viread alone. Viread is being tested in Atlanta and San Francisco for prevention in men who have sex with men (MSM), and the CDC will add a third U.S. city (not yet identified) to study the use of Truvada for prevention among MSM.—EV