CROI 2012 Preview: Which Studies Are Most Likely to Make Waves

Benjamin Young, M.D., Ph.D.

Like Capistrano sparrows, HIV researchers and clinicians from around the world return to North America at the end of each winter for the Conference on Retroviruses and Opportunistic Infections (CROI). Known as one of the highest-quality scientific meetings on HIV and its complications, the 19th edition will be held next week in Seattle, Wash.

For me, it's been a couple of years since my last attendance, but CROI is a place to catch up with the latest in HIV basic science, the newest clinical medicine and new drugs. It's where I learn about new treatment strategies, clinical trials and the HIV drug pipeline. It's also a place to catch up with mentors and old friends.

This year, I'm anticipating learning about advances in several major thematic areas. Here are a few of the many presentations that I'm looking forward to hearing more about. Let's hope that the rain stays away.

New Therapies/Strategies

The current HIV pipeline looks rich, with several new drugs and coformulations in advance-stage clinical development.

• "Quad" vs. efavirenz/tenofovir/emtricitabine in naive patients. Gilead's newest coformulated single-tablet regimen of tenofovir/emtricitabine/cobicistat/elvitegravir could be the first once-daily, integrase inhibitor-based regimen. The presentation will show key data from a pivotal trial that compares Quad to the industry standard efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC, Atripla) and provide further information about the new pharmacokinetic boosting agent, cobicistat.
• Dolutegravir (SPRING-1 at 96 weeks). Ninety-six week data from the phase 2 SPRING-1 clinical trial will be shown in a late-breaker presentation on Tuesday, March 6. This study compared GlaxoSmithKline's new integrase inhibitor, dolutegravir, to efavirenz (EFV, Sustiva, Stocrin) in first-line antiretroviral treatment. Earlier published 48-week data showed the non-inferiority of dolutegravir.
• GS-7340 (tenofovir prodrug). GS-7340 is a prodrug of the widely used tenofovir (TDF, Viread). It is postulated to have better efficacy and less toxicity. The March 7 presentation will discuss the results comparing GS-7340 to tenofovir in a 10-day monotherapy trial.
• Symposium on viral latency and reservoirs. If there's a hope for a treatment-focused cure, it will involve a better understanding of, and strategy for, dealing with latently infected cells and special anatomic (or pharmacologic) reservoirs. (This symposium will take place on March 7.)

HIV Prevention

This was perhaps the hottest subject area last year, when a number of studies showcased the important role of antiretrovirals in the prevention of new HIV infections. Whether it's the reduction of viral load in HIV-infected individuals, pre-exposure prophylaxis (PrEP) or microbicides, these are among the many sure-to-be discussed sessions.

• Opening session by investigators from CAPRISA (South Africa) prevention studies (Monday, March 5).
• Plenary session by Dr. Wafaa El-Sadr on antiretrovirals as prevention of HIV transmission (Tuesday, March 6).
• Oral abstract session on PrEP, topical microbicides and circumcision (Tuesday, March 6).
• Symposium on antiretrovirals for prevention (Tuesday, March 6).
• Plenary session on the elimination of mother-to-child transmission of HIV.

Non-AIDS Complications

A long-emerging theme; as our patients live longer and better on HIV treatments, there's a growing concern about their long-term health. Among these hot-button topics are issues related to neurocognitive health, osteoporosis and malignancy; all will be highlighted in interesting presentations.

• Themed discussions on neurocognitive impairment (Wednesday, March 7).
• Oral session on metabolic complications (Wednesday, March 7), including late-breaker presentations on:
  • Pulmonary function.
  • The effects of switching antiretroviral therapy on bone health.
• Late-breaker presentation on treatment of anal intraepithelial neoplasia (Thursday, March 8).
• Symposium on HIV complications, including talks on aging, bone and cognitive health (Thursday, March 8).

Hepatitis

If the HIV drug discovery pipeline is hot, then the hepatitis antiviral pipeline is white hot. The first two direct-acting agents were approved by the U.S. Food and Drug Administration last year, with dozens more in the pipeline. Data on these drugs are sorely missing regarding the treatment of HIV/HCV-coinfected persons; the session on Tuesday, March 6, will provide key information. Meanwhile, long-term data on treatment of hepatitis B with tenofovir will be looked at with interest for the many patients (especially in South Asia) who are living with this virus.

• Oral abstract session on breakthroughs in hepatitis (Tuesday, March 6), including:
  • Emerging information about the use of direct-acting antivirals (boceprevir [Victrelis] and telapravir [Incivek]) in HIV/HCV-coinfected persons.
  • Long-term treatment of HIV/HBV-coinfected persons with tenofovir.
• Themed discussion on the predictors of responses to HCV treatment (Tuesday, March 6).
• Symposium on advances in viral hepatitis treatment (Tuesday, March 6).

Look for more of our CROI 2012 coverage at TheBodyPRO.com in the days to come.