Effective use of pre-exposure prophylaxis (PrEP) Among stimulant users with multiple condomless sex partners: a longitudinal study of men who have sex with men in Los Angeles.

PrEP's potential benefit for men who have sex with men (MSM) who use stimulants may be limited by adherence or prescriber willingness to recommend PrEP due to concerns of non-compliance. Using data from PATH-PrEP, a 48-week study evaluating PrEP for MSM in Los Angeles, we modeled an interaction between stimulant use and condomless sex with multiple partners (CAS-MP) on prevention-effective dried blood spot tenofovir-diphosphate concentrations. At week 4, participants reporting stimulant use and CAS-MP had a decreased odds of prevention-effective adherence compared to non-stimulant use and non-CAS-MP (AOR 0.15, 95% CI 0.04-0.57). From week 4-48, participants reporting stimulant use and CAS-MP had increased odds of prevention-effective adherence (AOR 1.06 per week, 95%CI 1.01-1.12). Participants reporting CAS-MP without stimulant use had no significant change in prevention-effective adherence (AOR 0.99 per week, 95%CI 0.96-1.02). Stimulant use moderated the association of CAS-MP on prevention-effective PrEP adherence over time.

Increasing Urban African American Women's Readiness for Pre-exposure Prophylaxis: A Pilot Study of the Women Prepping for PrEp Plus Program (WP3+).

BACKGROUND: African American women are disproportionately at risk for HIV infection. To increase women's readiness to consider taking pre-exposure prophylaxis (PrEP), we conducted a pilot study of Women Prepping for PrEP Plus (WP3+). Adapted from an evidence-based HIV risk reduction intervention for African American couples who are HIV-serodiscordant, WP3+ is a group-based culturally congruent program designed for African American women without HIV. METHODS: Women were screened for eligibility; if eligible, they were invited to participate in the four-session WP3+ group. Participants completed surveys at baseline (n = 47) and post-implementation (n = 28); surveys assessed demographics, HIV and PrEP knowledge, depression and posttraumatic stress (PTS) symptoms, substance use, sexual risk behaviors, health care-related discrimination, and social support. In a process evaluation, a subset of women completed qualitative interviews at baseline (n = 35) and post-implementation (n = 18); the interviews were designed to converge with (e.g., on HIV and PrEP knowledge) and expand upon (e.g., unmeasured perceived impacts of WP3+) quantitative measures. To triangulate with the quantitative data, deductive qualitative analysis concentrated on women's knowledge and awareness of PrEP and HIV, their relationship dynamics and challenges, and their considerations (e.g., barriers, facilitators) related to taking PrEP; inductive analysis focused on women's experiences in the intervention. RESULTS: Participants in the WP3+ intervention reported: improved proportion of condom use in the past 90 days (p < .01) and in a typical week (p < .05); reduced PTS symptoms (p < .05); increased HIV knowledge (p < .0001) and awareness of PrEP (p < .001); and greater consideration of using PrEP (p < .001). In interviews, participants expressed not only increased knowledge but also appreciation for learning how to protect themselves against HIV, communicate with their partners, and take charge of their health, and they expressed greater receptiveness to using PrEP as a result of the knowledge and skills they gained. CONCLUSIONS: The WP3+ pilot study demonstrated preliminary efficacy and acceptability as an HIV-prevention program for African American women. A controlled trial is needed to confirm its efficacy for increasing PrEP use among African American women.

Proprotein convertase subtisilin/kexin 9 levels decline with hepatitis C virus therapy in people with HIV/hepatitis C virus and correlate with inflammation.

BACKGROUND: Proprotein convertase subtisilin/kexin 9 (PCSK9) raises low-density lipoprotein cholesterol (LDL-C) levels and is associated with inflammation, which is elevated in HIV and hepatitis C virus (HCV) infection. We compared PCSK9 levels in people with co-occurring HIV and HCV (HIV/HCV) vs. HIV alone, and evaluated the impact of HCV direct-acting antiviral (DAA) therapy on PCSK9. DESIGN: A prospective, observational cohort study. METHODS: Thirty-five adults with HIV/HCV and 37 with HIV alone were evaluated, all with HIV virologic suppression and without documented cardiovascular disease. Circulating PCSK9 and inflammatory biomarkers were measured at baseline and following HCV treatment or at week 52 (for HIV alone) and compared using Wilcoxon tests and Spearman correlations. RESULTS: At baseline, PCSK9 trended higher in HIV/HCV vs. HIV alone (307 vs. 284 ng/ml, P  = 0.06). Twenty-nine participants with HIV/HCV completed DAA therapy with sustained virologic response. PCSK9 declined from baseline to posttreatment 1 (median 7.3 weeks after end of therapy [EOT]) and posttreatment 2 (median 43.5 weeks after EOT), reaching levels similar to HIV alone; median within-person reduction was -60.5 ng/ml ( P  = 0.003) and -55.6 ng/ml ( P  = 0.02), respectively. Decline in PCSK9 correlated with decline in soluble (s)E-selectin and sCD163 ( r  = 0.64, P  = 0.002; r  = 0.58, P  = 0.008, respectively), but not with changes in LDL-C or other biomarkers. No significant change in PCSK9 occurred in the HIV alone group over 52 weeks. CONCLUSION: PCSK9 declined with DAA therapy in participants with HIV/HCV, correlating with declines in several inflammatory biomarkers but not LDL-C. Elevated PCSK9 with HCV may be linked to particular HCV-associated inflammatory pathways more so than cholesterol homeostasis.

A comparison of MSM stigma, HIV stigma and depression in HIV-positive Latino and African American men who have sex with men (MSM).

Little research has examined differences in HIV stigma versus MSM stigma and the role of these stigmas in depression for HIV-positive Latino and African American men who have sex with men (MSM), subgroups disproportionately impacted by HIV in the US. MSM stigma, HIV stigma, depression, stress and social support were examined among HIV-positive Latino (n = 100) and African American (n = 99) MSM patients at five HIV clinics in Los Angeles County, California. In multiple regression models, Latino MSM had higher HIV stigma scores (p = 0.002) but lower MSM stigma scores (p < 0.001) compared to African American MSM. General support and stress were associated with HIV stigma (p < 0.001), but not MSM stigma. Both HIV stigma (p < 0.0001) and MSM stigma (p < 0.0001) were associated with depression. These data underscore the differences in experienced stigma for Latino and African American MSM and can be used to shape effective stigma reduction programs and behavioral counseling.

HIV testing practices among black primary care physicians in the United States.

BACKGROUND: The Centers for Disease Control and Prevention recommends routine HIV testing in all healthcare settings, but it is unclear how consistently physicians adopt the recommendation. Making the most of each interaction between black physicians and their patients is extremely important to address the HIV health disparities that disproportionately afflict the black community. The goal of this survey-based study was to evaluate the perceptions and practices of black, primary care physicians regarding HIV testing. METHODS: A physician survey was administered at the 2010 National Medical Association Annual Convention, via online physician panels, and by email. Physician eligibility criteria: black race; practicing at least 1 year in the US; practice comprised of at least 60% adults and 20% black patients. Contingency tables and ordinary least squares regression were used for comparisons and statistical analyses. A Chi-square test compared percentages of physicians who gave a particular response and a t-test compared the means of values provided by physicians. RESULTS: Physicians over-estimated HIV prevalence and believed that HIV is a crisis in the black community, yet reported that only 34% of patients were HIV tested in the past year. Physicians reported that 67% of those patients tested did so due to a physician recommendation. Physicians who were younger, female, obstetricians/gynecologists, and had a higher proportion of black, low-socioeconomic status, and Medicaid patients reported higher testing rates. Most testing was risk-based rather than routine, and three of the five most commonly reported barriers to testing were related to disease stigma and perceived value judgments. Physicians reported that in-office patient informational materials, increased media attention, additional education and training on HIV testing, government mandates requiring routine testing, and accurate pre-packed tests would most help them test more frequently for HIV. CONCLUSIONS: In this sample of black, primary care physicians, HIV testing practices differed according to physician characteristics and practice demographics, and overall reported testing rates were low. More physician education and training around testing guidelines is needed to enable more routine testing, treatment, and long-term management of patients with HIV.

An exploratory study to characterize the HIV testing-to-care continuum to improve outcomes for Black and Latinx residents of South Los Angeles.

BACKGROUND: South Los Angeles (SPA6), with mostly Black (27.4%) and Latinx (68.2%) residents, has the second highest rates of new HIV diagnoses (31 per 100,000) in Los Angeles County. However, there is limited understanding of the HIV testing-to-care continuum among newly diagnosed in this setting. METHODS: We conducted an exploratory study that analyzed de-identified data, including demographic characteristics and biomedical outcomes, from the electronic medical records of individuals newly diagnosed with HIV from 2016-2020 at the only public safety-net, county-run health department HIV clinic in SPA 6. We used Pearson Chi-square and Fisher's Exact test to explore associations with HIV outcomes and a Kaplan-Meier survival curve to assess the time to linkage to care. RESULTS: A total of 281 patients were identified. The majority (74.1%) presented with a baseline CD4 <500, many of which presented with a CD4<200 (39.2%). We found twice as many newly diagnosed Black individuals in our study population (48.2%) when compared to LAC (23%), despite only accounting for 27.4% of residents in SPA 6. The majority were linked to care within 30 days of positive test and prescribed anti-retroviral therapy. Viral suppression (59.8%) and undetectable VL (52.6%) were achieved within the year following diagnosis, with 9.3% lost to follow-up. Of those who became virally suppressed, 20.7% experienced viral rebound within the year following diagnosis. CONCLUSION: The large proportion of patients with a baseline CD4 <500 raises concerns about late diagnoses. Despite high rates of linkage to care and ART prescription, achievement of sustained viral suppression remains low with high rates of viral rebound. Longitudinal studies are needed to understand the barriers to early testing, retention in care, and treatment adherence to develop strategies and interventions with community organizations that respond to the unique needs of people living with HIV in South Los Angeles.

Do social support, stress, disclosure and stigma influence retention in HIV care for Latino and African American men who have sex with men and women?

Limited research has examined the role that social support, stress, stigma and HIV disclosure play in retention in HIV care for African Americans and Latinos. Among 398 Latino and African American men who have sex with men (MSM) and women, the major predictor of retention in HIV care was disclosure of HIV status to more social network members (OR = 1.5; 95% CI: 1.1, 1.9). Among those who had disclosed (n = 334), female gender (OR = 1.8, 95% CI: 1.1, 3.1) and disclosure of HIV status to more network members (OR = 1.5, 95% CI: 1.1, 1.9) was associated with retention in HIV care. General stress was associated with retention in care (OR = 1.2; 95% CI: 1.1, 1.3) for African American MSM who had disclosed. More MSM-stigma was associated with poorer retention (OR = 0.9; 95% CI: 0.8, 0.9) for Latino MSM. Interventions that help patients safely disclose their HIV status to more social network members may improve HIV care retention as would social network counseling for Latino MSM to reduce MSM-stigma.

A youth-focused case management intervention to engage and retain young gay men of color in HIV care.

HIV-positive Latino and African-American young men who have sex with men (YMSM) have low rates of engagement and retention in HIV care. An evaluation of a youth-focused case management intervention (YCM) designed to improve retention in HIV care is presented. HIV-positive Latino and African-American YMSM, ages 18-24, who were newly diagnosed with HIV or in intermittent HIV care, were enrolled into a psychosocial case management intervention administered by Bachelor-level peer case managers at two HIV clinics in Los Angeles County, California. Participants met weekly with a case manager for the first two months and monthly for the next 22 months. Retention in HIV primary care at three and six months of follow-up was evaluated as were factors associated with retention in care. From April 2006 to April 2009, 61 HIV-positive participants were enrolled into the intervention (54% African-American, 46% Latino; mean age 21 years). At the time of enrollment into the intervention, 78% of the YMSM had a critical or immediate need for stable housing, nutrition support, substance abuse treatment, or mental health services. Among intervention participants (n=61), 90% were retained in primary HIV care at three months and 70% at six months. Among those who had previously been in intermittent care (n=33), the proportion attending all HIV primary care visits in the previous six months increased from 7% to 73% following participation in the intervention (p<0.0001). Retention in HIV care at six months was associated with increased number of intervention visits (p=0.05), more hours in the intervention (p=0.02), and prescription of HAART. These data highlight the critical needs of HIV-positive African-American and Latino YMSM and demonstrate that a clinic-based YCM can be effective in stabilizing hard-to-reach clients and retaining them in consistent HIV care.

Social support, stress and social network characteristics among HIV-positive Latino and African American women and men who have sex with men.

Social support and stress have been poorly characterized for persons with HIV, particularly for racial/ethnic minorities. To address this gap, data on general and HIV-specific support and stress and social network characteristics were collected for 399 African American and Latino women and men who have sex with men (MSM) in Los Angeles County. African American (mean = 41; SD = 17) and Latina (mean = 40; SD = 19) women reported the highest general support. Stress was also highest for Latina women (mean = 18; SD = 11) and higher compared to Latino and African American MSM. African American and Latina women reported receiving most of their social support and stress from family members, while African American and Latino MSM received their support and stress from friends and providers. Finally, Latina and African American women disclosed their HIV status to more network members and received more HIV-specific support compared to MSM. Interventions are needed to help Latino and African American MSM enhance their support networks to manage a stigmatized illness.

Barriers to Testing for Sexually Transmitted Infections among HIV-Serodiscordant Couples: The Influence of Discrimination.

Objectives: African Americans face challenges in accessing services for sexually transmitted infections (STIs). From 2012-2016, the EBAN II intervention was funded by the NIH to test the effectiveness of implementing a culturally congruent, evidence-based HIV/AIDS prevention program in Los Angeles and Oakland, California. This study examined the impact of personal characteristics and experiences of discrimination on the likelihood of being tested for STIs. Methods: Participants (N=91) completed a baseline survey. Descriptive statistics were used to test for differences between those who did and did not obtain STI testing. Factors included HIV serostatus, sociodemographic variables, STI history, the presence of outside partners, and discrimination experiences. Multiple logistic regressions were conducted for men and women separately. Results: Participants with no recent experiences of discrimination were more than 3 (3.4) times more likely to obtain a baseline STI test than those who reported discrimination experiences. HIV-positive women with no recent experiences of discrimination were 11 times more likely than those with reports of recent discrimination to obtain STI tests. Conclusions: It is often women who are the gatekeepers for health seeking in families and the same may be for these couples. Experiences of discrimination may impede STI testing, and heighten several health risks, particularly among HIV-positive African American women in HIV-serodiscordant relationships. Addressing the impact of discrimination experiences may be important for STI prevention and treatment efforts in interventions promoting health care utilization.

PrEP Nonadherence, White Coat Dosing, and HIV Risk Among a Cohort of MSM.

Among a cohort of men who have sex with men in a pre-exposure prophylaxis (PrEP) adherence trial, syphilis requiring treatment was associated with white coat dosing (increased PrEP adherence immediately preceding study visits) when compared with participants with optimal drug concentrations. The findings highlight the need for identifying and reducing barriers to PrEP adherence.

Results from the post-exposure prophylaxis pilot program (P-QUAD) demonstration project in Los Angeles County.

Post-exposure prophylaxis (PEP) is a promising but under-utilized strategy for HIV prevention in high-risk populations. Between March 2010 and June 2011, two community-based clinics in Los Angeles County provided PEP in a pilot program to 267 unique individuals. Courses were primarily dispensed to men who have sex with men (84%) and consisted overwhelmingly of a three-drug antiretroviral therapy regimen containing two nucleoside reverse transcriptase inhibitors and either an integrase inhibitor (raltegravir) or a boosted protease inhibitor (lopinavir/ritonavir). Approximately 64% of all PEP courses were followed for at least 12 weeks, and seven individuals seroconverted. Of the seven seroconversions, six had subsequent re-exposure. The low rate of PEP failure calls for expanded funding for PEP in other jurisdictions.

Reaching lost-to-care populations.

Identification of patients who are at high risk for human immunodeficiency virus (HIV) infection can lead to reduced frequencies of high-risk behaviors, provision of timely care for infected individuals, and decreased transmission of HIV. The HIV-associated outreach programs at the OASIS Clinic of the King-Harbor/Drew University complex (Los Angeles, CA) has 3 components: a traditional partner-notification (i.e., contact-tracing) component, a focused-intervention component through which clients are given incentives to bring in persons they feel are at high risk for HIV infection, and an outreach component targeting hard-to-reach populations. These interventions are highly effective in identifying individuals early during the course of their disease, when initiation of antiretroviral therapy is most effective. The partner-services program at the OASIS Clinic has been particularly useful in identifying partners of HIV-positive women, whereas the focused-intervention program is most useful for identifying gay men who are unaware of their positive HIV serostatus. Successful targeted outreach programs can identify many individuals who would not otherwise be aware of their HIV infection, but the programs also require more clinicians to manage these patients.

Factors influencing the acceptance of changes in antiretroviral therapy among HIV-1-infected patients.

Physicians routinely consider modifying antiretroviral therapy (ART) regimen for their patients with HIV. Little is known about the factors associated with patients' willingness to accept providers' recommended ART changes. This multicenter prospective observational study examined factors associated with willingness to accept ART changes recommended by their providers among HIV-infected adults from six urban outpatient HIV clinics. Patients were surveyed using the Patient Attitudes about Altering Antiretroviral Therapy Survey questionnaire (PAAARTS). Factors associated with willingness to accept ART changes were assessed using a multivariate generalized estimating equation (GEE) model to account for correlated responses. The Classification and Regression Trees (CART) analysis was also performed to determine subgroups of patients with higher acceptance of change. 216 of 289 patients (75%) definitely accepted recommended changes. Odds for acceptance were 3.2, 2.3, and 2.8 times higher for patients with higher attitudes and beliefs about ART (p < 0.01; 95% confidence interval [CI] = 1.59, 6.52), patients who rated their provider's care as excellent (p < 0.05; 95% CI = 1.07, 4.78), and non-Hispanic patients (p < 0.05; 95% CI 1.03, 7.57), respectively. CART analysis showed similar results and identified that when patients had less positive attitude about ART, acceptance rates were higher for non-Hispanic patients with higher assessments of their patient-provider communication. While most patients accepted providers' recommendation for ART changes, this willingness was influenced by both patients' attitudes and beliefs about ART and their assessment of either the effectiveness of patient-provider communication or their rating of providers' care. ART acceptance rates among Hispanic patients were lower.

Project Engage: Snowball Sampling and Direct Recruitment to Identify and Link Hard-to-Reach HIV-Infected Persons Who Are Out of Care.

INTRODUCTION: Innovative strategies are needed to identify and link hard-to-find persons living with HIV (PLWH) who are out of care (OOC). Project Engage, a health department-based project in Los Angeles County, used a mixed-methods approach to locate and provide linkage for PLWH who have limited contact with HIV medical and nonmedical services. METHODS: Incentivized social network recruitment (SNR) and direct recruitment (DR) was used to identify eligible OOC alters for a linkage intervention that included HIV clinic selection, appointment and transportation support, reminder calls/texts, and clinic navigation. RESULTS: Between 2012 and 2015, 112 alters were identified using SNR (n = 74) and DR (n = 38). Most alters were male (80%), African American (38%), and gay (60%). Sizable percentages were homeless (78%), had engaged in sex work (32%) in the previous 6 months, had injected drugs (47%), were incarcerated in the previous 12 months (50%), and had only received HIV care during the previous 5 years while incarcerated (24%). SNR alters were more likely than DR alters to be African American, uninsured, unemployed, homeless, sex workers, injection drug users, recently incarcerated, and have unmet service needs. Alters linked to care within 3 (69%), 4-6 (5%), and 7-12 months (8%), and 72% were retained at 6-12 months. The percent virally suppressed increased (27% vs. 41%) and the median viral load decreased (P = 0.003) between linkage and follow-up at 6-12 months. DISCUSSION: The alternative approaches presented were effective at locating marginalized HIV-positive persons who are OOC for linkage and retention. The SNR approach was most successful at identifying alters with serious social challenges and gaps in needed medical/ancillary services.

Plasma Tenofovir Levels to Support Adherence to TDF/FTC Preexposure Prophylaxis for HIV Prevention in MSM in Los Angeles, California.

BACKGROUND: Tenofovir disoproxil fumarate/emtricitabine preexposure prophylaxis (PrEP) is effective against HIV acquisition when taken as prescribed. Strategies that identify and intervene with those challenged by adherence to daily medication are needed. SETTING: PATH-PrEP was an open-label single-arm interventional cohort study conducted at 2 community-based clinical sites in Los Angeles, CA. METHODS: We enrolled self-identified men who have sex with men and transgender women ≥18 years of age at an elevated risk of HIV acquisition. Participants received a postexposure prophylaxis (PEP)-based or PrEP-based HIV prevention package for at least 48 weeks. Plasma tenofovir levels from each PrEP visit assessed as below the limit of quantitation (<10 ng/mL) triggered increased adherence support. RESULTS: Three hundred one participants enrolled. Forty-eight-week retention in the PrEP cohort was 75.1%. Biomarker evidence of PrEP adherence consistent with ≥4 doses per week at weeks 4, 12, 24, 36, and 48 was found in 83.1%, 83.4%, 75.7%, 71.6%, and 65.5% of participants, respectively; younger and African American participants were less likely to have protective drug levels. Most of those with suboptimal adherence had adherence improvement after brief intervention. One seroconversion occurred in a participant who discontinued PrEP. Nearly half (46.4%) of participants were diagnosed with at least 1 incident sexually transmitted infection during 48 weeks of study follow-up. CONCLUSIONS AND RELEVANCE: PrEP was acceptable and well tolerated in a diverse population of men who have sex with men in Los Angeles. A brief intervention triggered from biomarkers of poor adherence was associated with improved adherence. Drug level monitoring has the potential to allow targeting of additional adherence support to those struggling with daily tablet adherence.

Optimizing treatment for African Americans and Latinos with HIV/AIDS.

HIV/AIDS is a disease that has a disproportionate negative impact on the African-American and Latino communities when compared with the general population. African Americans account for more than 50% of new AIDS cases, though they comprise only 12% of the general population. More than one-third of AIDS-related deaths in the United States have been among African Americans. Many factors contribute to the HIV/AIDS healthcare disparities seen in the African-American and Latino communities. These factors include medical issues (such as resistance to antiretroviral therapy, toxicities of medications and hepatitis-C coinfection) and social factors (such as a lack of faith in the healthcare system, cultural circumstances and poor access to healthcare services). Healthcare providers can take steps to improve HIV care for African Americans and Latinos. Distrust of the medical establishment can be addressed by increasing the number of culturally sensitive healthcare providers. Communication is the first step toward establishing the trust of patients and minimizing the devastating effects of perceived institutional bias that may lead many HIV patients to be diagnosed late in the course of the disease. Medical and cultural issues faced by African Americans and Latinos should also be addressed in treatment guidelines. When healthcare providers take steps to overcome the medical and cultural issues facing African Americans and Latinos, HIV patients will have access to more effective disease management.

Optimizing care for African-American HIV-positive patients.

The African-American community has been disproportionately affected HIV/AIDS, as noted by higher reported rates of HIV infection, higher proportion of AIDS cases, and more deaths caused by complications of AIDS than whites and other ethnic groups. In addition, epidemiologic trends suggest that African Americans with HIV infection are more often diagnosed later in the course of HIV disease than whites. Numerous reasons account for this disparity, including the lack of perception of risk and knowledge about HIV transmission as well as a delays in HIV testing and diagnosis in the African-American community. Understanding the important considerations in the management of HIV infection in the African-American patient may create awareness among health care professionals and broaden the knowledge of HIV-infected patients within the African-American community.

Nevirapine plus efavirenz plus didanosine: a simple, safe, and effective once-daily regimen for patients with HIV infection.

Conventional highly active antiretroviral therapy (HAART) regimens used to treat human immunodeficiency virus (HIV) infection typically use nucleoside reverse transcriptase inhibitors (NRTIs) and either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). Because PI-based regimens are associated with significant long-term toxicity and adherence difficulty, there is a need for novel regimens that maximize combination treatment options. This 12-month, observational, cohort study evaluated the efficacy, safety, and tolerability of a novel three-drug HAART regimen. Drug treatment consisted of nevirapine (NVP), efavirenz (EFV), and didanosine (ddl). Twenty-six treatment-naive and -experienced HIV-1+ men and women were included in the study. Assessment consisted of CD4+ cell count, plasma HIV-1 RNA load, and adverse effects of study medications. After one year of therapy, 11/12 treatment-naive subjects (92%) and 8/9 treatment-experienced subjects (89%) had viral loads < 400 copies/mL. Both groups also had an excellent immune response. At one year, there was a mean increase of 438 CD4+ cells/mm3 among treatment-naive subjects and 367 cells/mm3 among treatment-experienced subjects. Treatment-limiting adverse effects occurred in 3/15 treatment-naive (20%) and 2/11 treatment-experienced (18%) subjects. These preliminary data suggest that the combination of NVP, EFV, and ddl is simple, safe, and effective.