People who have the life-threatening infections that are the hallmark of AIDS are often excluded from the initial round of clinical trials of AIDS drugs. Therefore, the effectiveness of some anti-HIV drugs in this population may not be well documented. To try to assess the impact of efavirenz (Sustiva, Stocrin) on AIDS, researchers in Barcelona, Spain, reviewed the hospital records of 92 subjects who had symptoms of AIDS and who used this drug. Their results suggest that the non-nuke efavirenz, when used as part of combination therapy, can be useful for some people with AIDS.

Study details

Researchers found data on 92 subjects who used efavirenz in combination with two nukes (nucleoside analogues) as follows:

• 3TC (lamivudine, Epivir) and d4T (stavudine, Zerit)
• AZT (Retrovir) and 3TC

Researchers examined medical records between July 1999 and November 2001. Here is the profile of the 92 subjects before they began to take efavirenz:

• 17% female, 83% male
• average CD4+ count – 32 cells
• average viral load – 350,000 copies
• average time from diagnosis of AIDS to starting efavirenz-based therapy – one month

Results – Changes in lab tests

The response to therapy was generally good with about 70% of subjects achieving a CD4+ count of at least 100 cells. About 70% of subjects also were able to suppress their viral load below the 50 copy mark.

Results – Survival

There were three deaths during the study period from the following causes:

• wasting
• liver failure due to hepatitis C
• lung cancer

Because highly active antiretroviral therapy (HAART) can cause the immune system to respond to previously quiet infections — something called the "immune restoration syndrome" — sometimes HAART users develop reactivated infections. This occurred for the following three AIDS-related illnesses in the numbers of subjects indicated:

• shingles – four cases
• CMV retinitis – one case
• tuberculosis (TB) – one case

Results — Complications affected by efavirenz

The benefit of HAART becomes clear when PHAs who had been experiencing hard-to-treat complications begin to stabilize or improve when they begin HAART, as in the following:

• parasite-related diarrhea (Cryptosporidiosis) – five cases
• Kaposi's sarcoma (KS) – four cases
• PML (progressive multifocal leukoencephalopathy) – one case

Only two subjects stopped taking efavirenz because of side effects, which were not described in the researchers' report.

All in all, this study shows that efavirenz-based combination therapy is useful in people with symptoms of AIDS who also have low CD4+ cell counts.

REFERENCE

Arribas JR, Pulido F, Miró JM, et al. "High effectiveness of efavirenz-based HAART in HIV-1 infected patients with less than 100 CD4 cells/uL and opportunistic diseases. The EFAVIP-2 study (Efavirenz in very immunosuppressed patients)". XIV International AIDS Conference, July 7-12, 2002, Barcelona. Poster TuPeB4444.

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