Monotherapy, clean needles, and more.

by Enid Vázquez

Kaletra by itself

Dr. Joseph Gathe, Jr. and colleagues from a Houston clinic updated the results of their small study placing people on Kaletra monotherapy. How exciting—one drug (three capsules twice a day), instead of the two, three or four drug combinations that the general public inaccurately refers to as a “cocktail.” The group presented 48-week data on using the HIV protease inhibitor by itself.

Of 30 persons put on Kaletra and no other HIV drug, 20 were still on it 48 weeks later. All of them maintained undetectable viral load (less than 400 copies). The majority of them (18) had less than 50 viral load. This was their first HIV therapy.

The mean T-cell increase (half of the people had more and half had less) was 317. (Half of the participants started out with less than 169 T-cells and more than 262,000 viral load.)

What happened to the other 10 folks? Two had “virologic failure,” but came back down to undetectable after adding Epivir and Viread.

For the rest, two were lost to follow-up; two did not take the Kaletra or did not take it correctly (they were non-adherent); one was deported and one developed hepatitis B (this is a viral infection and has nothing to do with medication). Information was not provided on the other persons.

Dr. Gathe reported no significant toxicity or drug resistance in the patients.

For a previous report on this study, see the November/December 2003 News Briefs.

More Kaletra monotherapy

There was more good news on using Kaletra by itself.

In continuing efforts to simplify HIV drug treatment, Dr. Gerald Pierone, Jr. (an HIV specialist in Vero Beach, Florida) and his colleagues at the AIDS Research & Treatment Center of the Treasure Coast conducted another study on the revolutionary therapy. They found that most people were able to maintain their undetectable viral load with the Kaletra monotherapy.

The 18 people enrolled in this tiny study were on triple combination therapy with either Sustiva or Viramune. They continued to take their two “background” drugs during the first two weeks they switched the Sustiva or the Viramune for Kaletra, and then continued to take only the Kaletra.

Of the 14 who were still taking Kaletra monotherapy at the time of this report, 13 had less than 75 copies viral load (as they did before). These people ranged from four to 24 weeks on Kaletra (the study will run for 48 weeks).

Three of the participants had dropped Kaletra due to diarrhea (at weeks 2, 4 and 8). Another person was switched back to their original therapy and viral load results are not in yet. This person had a viral load increase to 1,067.

Two persons developed diabetes, which is sometimes seen with the use of protease inhibitors. Both had pre-existing blood sugar problems, and both had the diabetes under control and were continuing with the Kaletra monotherapy. Three participants also needed to be put on medication for increased triglyceride levels (fat in the blood).

The report noted that, “This is one of the first prospective [planned] studies showing effectiveness and tolerability of simplification to [Kaletra] monotherapy.”

Previously…

In a previous study, Dr. Pierone and colleagues reported that of 15 people put on Kaletra monotherapy for a variety of reasons, 12 remained on it for a mean of 82 weeks (for a range of 57 to 122 weeks), and of those 12, eleven had less than 75 viral load.

Of the four persons who were put on Kaletra monotherapy for simplification alone (the HIV therapy they were taking was already working well), all four were in the study for 57 to 60 weeks at the time of the report, with a T-cell increase ranging from 68 to 213.

The other 11 persons were given Kaletra monotherapy for “salvage” purposes (eight due to detectable viral load, or virologic failure, and three due to adverse events with their therapy). Of these 11, seven had less than 75 viral load for a range of 8 to 122 weeks (with a mean of 92 weeks, meaning that half of them had less than 92 weeks on monotherapy and half had more). They had a mean increase of 209 T-cells.

Four of the salvage participants, however, did not maintain a viral load under 400 copies. Two of them had a high level of non-adherence. One was undetectable at first, but then had a viral load increase up to 587 at 32 weeks, and was later lost to follow-up upon incarceration. The fourth continued on monotherapy for 60 weeks despite a low but detectable viral load (ranging from 600 to 2,000).

Of the 12 persons continuing on therapy, nine had to be given lipid lowering drugs.

This previous report from Treasure Coast was presented at the 9th European AIDS Conference (EAC), held in Warsaw in October 2003.

More Kaletra alone

Meanwhile in L.A., at Tower ID Medical Associates, doctors were also simplifying patients to Kaletra monotherapy. Of the men on the study out to 24 weeks (the number of men was not given), all still had less than 75 viral load. Four of them had experienced viral blips (small increases), which ranged from 150 to 387. (One of the participants had two blips in the six months.)

The 18 men enrolled had been undetectable for at least nine months at the time the study began. They were either on a Kaletra combination or had Kaletra added to their HIV therapy for two weeks. All other HIV medications were then dropped except for the Kaletra.

Trizivir for adherence

Italian researchers reported that patients with adherence problems did well when switching to Trizivir (which is a triple combination HIV therapy in one pill, taken twice a day).

The researchers surveyed 70 patients who had taken HIV therapy for about a year, finding that 25 had problems with their regimen due to its pill burden. These patients did not have drug resistance based on a genotype test, and were switched to Trizivir.

Of the 16 who started the study with more than 50 copies viral load (half of them had more than 25,000), all were under 50 copies out to 120 weeks. The seven participants who started out with less than 50 remained there. Two persons experienced a viral load blip (at less than 450 copies) at weeks 72 and 80.

The report concluded that, “Switching to a regimen of [Retrovir, Epivir and Ziagen—the three drugs which make up Trizivir] appears to be safe and effective in patients with difficulties in maintaining adherence.” (U.S. treatment guidelines do not recommend Trizivir as a sole therapy for people with high viral load.)

Life expectancy cut short

AIDS is cutting the life expectancy in countries around the world. So says the United Nations Development Program. UNDP estimated that in seven sub-Saharan African countries, the life expectancy is now less than 40 years. These countries are Central African Republic, Lesotho, Mozambique, Swaziland, Malawi, Zambia and Zimbabwe. The lowest figure was for Zambia—32 years. For the United States, life expectancy was 77 years. The report was based on data gathered as of 2002.

Youth and women

In announcing conference programs on youth and women, the International AIDS Society (IAS), organizers of the international conference, listed several reasons why these groups are of concern. The following is from an IAS press release.

Why focus on youth?

• Of the estimated 14,000 new HIV infections that occur each day worldwide, about half are among young people aged 15-24. This amounts to one infection approximately every 12 seconds.

• More than a third of all people living with HIV/AIDS globally are under the age of 25.

• Young people are particularly vulnerable to HIV infection and frequently carry the burden of caring for family members living with HIV/AIDS.

• Stigma and discrimination can be particularly damaging to young people at a time when they are trying to consolidate their identity and establish their place in the world.

Ensuring access for women:

• For a long time, AIDS was seen as affecting mainly men. Today, women account for half of the 40 million people living with HIV worldwide. In Africa, 60% of people living with HIV are women.

• Young women aged 15-24 are 2.5 times more likely to be infected than young men. In some southern African countries, for example, girls aged 15-19 are infected at rates as much as seven times higher than boys.

• In India as well, the HIV/AIDS epidemic is increasingly affecting women, with about 25% of all HIV infections occurring in women.

• In wealthier countries, incidence of mother-to-child transmission of HIV has plummeted as a result of widespread use of antiretroviral drugs by pregnant women and by their infants. But these proven strategies are not yet as readily available in the developing world.

Women are vulnerable to HIV for many reasons, including inadequate knowledge about HIV/AIDS, lack of access to sexual health and educational services, inability to negotiate safer sex due to gender discrimination and imbalances of power, and a lack of female-controlled HIV prevention methods such as microbicides. Poverty can also fuel HIV transmission as women engage in unsafe sex in exchange for money, housing, food or education.

Pharmacy needles

Sure, illicit drug users can now buy syringes from the pharmacy in most states, but how well does this system work?

Researchers found racial differences to access. They sent out what they called racially “visual” black, white and Latino purchasers. They visited 38 pharmacies in three different cities in Rhode Island.

Six of the pharmacies visited (16%, or almost one out of five) presented barriers to access. The barriers were the unavailability of the syringes or sale only in boxes of 100, which resulted in lack of access due to high cost.

None of the six pharmacies gave the same story to purchasers, and five of them told different things depending on the purchaser’s race. For example, in two of these pharmacies, a black man was told that there were no syringes available for sale at all, while the other purchasers were told that syringes were available only in boxes of 100.

The researchers, from Brown University and Harvard Medical Center, reported that while pharmacies differed in the minimum amount of syringes they would sell, the cost of the syringes was about the same in each store, with a price range from 15 cents to $6.49 per syringe.

In their conclusion, the researchers noted that access to clean needles is arbitrary despite state law. They urged that people look at how a state law is being implemented before evaluating how effective it is at decreasing the rate of HIV infections.

Blacks and Latinos

Dallas researchers wrote that because blacks and Latinos are underrepresented in clinical trials, there’s little data showing whether or not they do as well as whites on HIV therapy.

The group looked at the Parkland [Health and Hospital System] HIV Database. They looked at 653 people of color (438 African American and 215 Latinos) whose first therapy was Combivir with either Sustiva, Viramune, Viracept, or Ziagen.

HIV treatment results were the same as found with white patients in clinical trials. Treatment with a combination of Sustiva and Combivir gave people the greatest amount of time before treatment failure, 2.3 years. (This compared to less than one year with Viracept, 1.1 with Ziagen and 1.2 with Viramune.) Failure was defined as two consecutive viral loads above 400 or not having gone down to below 400 in the first place.

HIV-positive doctors

Columbia University researchers conducted in-depth interviews with 40 HIV-positive doctors. They reported that “many HIV-positive MDs found it hard to ‘practice what they preach’ concerning adherence to treatment, safer sex, substance use and accessing mental health services. They became more aware of the difficulty of ‘sticking to a schedule,’ and became ‘less hard on patients’: less likely to chastise or lecture them. They struggled with whether and how to ‘come out’ and/or ‘go public.’ Desires arose to do so for educational or political reasons, but could backfire, as these MDs were not protected by the Americans with Disabilities Act. …Disclosures to parents were hard among gay MDs who tried to succeed professionally; and a few tried to commit suicide. Some felt burnt-out due to over-identifying with their patients.”

For many, fear of discrimination led to feeling “stuck” in their jobs. Disclosure often forced retirement. “Many missed work, but felt they could not return because of loss of disability. Some transitioned to research or administration, but clinical work was ‘all consuming.’ Others volunteered, which buffered self-esteem.”

HIV and menopause

The Women’s Interagency HIV Study (WIHS) reported that “menopausal women are more likely to correctly assess their menopausal status than are their [health care] providers, especially if they are HIV-positive. Providers may be attributing amenorrhea [the absence of periods] in their HIV-positive patients to causes other than menopause.”

HIV-positive women correctly identified themselves as being menopausal 57.7% of the time, while their doctors identified it 37% of the time. In a group of 272 HIV-negative women, menopause was self-identified 69.2% of the time, compared to 50% of the time by their doctors.

Menopause was defined as having a FSH level (follicle stimulating hormone) equal to or above 40 mIU/ml. Pre-menopause was defined as a FSH level above 25.

Women longterm non-progressors

Of 101 HIV-positive women receiving care at the Miriam Immunology Center in Rhode Island by 1989, 5% became longterm non-progressors. These five women never once had T-cells drop below 500 during a period of 15 to 21 years. Nor did they ever have a viral load above 1,400. They have never experienced an opportunistic infection (one that preys on a weak immune system) and they remain in excellent health.

Two of the women are white, two are African American and one is Latina. Four of them acquired HIV through injection drug use and one through sex. The Brown Medical School researchers reported no differences in these women from the others in terms of baseline health or demographics.

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