Improving adherence to antiretroviral therapy.

Antiretroviral therapy (ART) has transformed HIV infection into a treatable, chronic condition. However, the need to continue treatment for decades rather than years, calls for a long-term perspective of ART. Adherence to the regimen is essential for successful treatment and sustained viral control. Studies have indicated that at least 95% adherence to ART regimens is optimal. It has been demonstrated that a 10% higher level of adherence results in a 21% reduction in disease progression. The various factors affecting success of ART are social aspects like motivation to begin therapy, ability to adhere to therapy, lifestyle pattern, financial support, family support, pros and cons of starting therapy and pharmacological aspects like tolerability of the regimen, availability of the drugs. Also, the regimen's pill burden, dosing frequency, food requirements, convenience, toxicity and drug interaction profile compared with other regimens are to be considered before starting ART. The lack of trust between clinician and patient, active drug and alcohol use, active mental illness (e.g. depression), lack of patient education and inability of patients to identify their medications, lack of reliable access to primary medical care or medication are considered to be predictors of inadequate adherence. Interventions at various levels, viz. patient level, medication level, healthcare level and community level, boost adherence and overall outcome of ART.

An open study to evaluate the efficacy and safety of tazarotene gel (0.1%) in acne vulgaris.

BACKGROUND: Tazarotene is a new third generation topical acetylenic retinoid. The present study was conducted to evaluate the efficacy and safety of tazarotene gel (0.1%) in Indian patients of acne vulgaris. METHODS: The present study was a prospective, open, multicentric, phase III trial. The duration of study was 14 weeks, including a 12-week active treatment period, preceded by a 2-week washout phase. Patients applied 0.1% tazarotene gel as a thin film over the affected area once daily in the evening. The efficacy was evaluated by analyzing changes in the number of facial acne lesions and patient's and physicians' global assessment. The efficacy parameters were assessed at baseline, visits 2, 4, 8, and 12 weeks. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. RESULTS: A total of 126 patients in 6 centers completed the study. At the end of the 8th and 12th weeks, the mean number of inflammatory lesions reduced by 70.6% and 86.1%, non-inflammatory lesions by 81.5% and 92%, and total lesion count 75.6% and 88.8% respectively from baseline. Also, 90.7% and 93.6% of total study cases showed complete to moderate clearance of acne lesions according to physicians at the end of the 8th and 12th weeks. CONCLUSIONS: This study confirms the efficacy and safety of tazarotene gel (0.1%) in Indian patients of acne vulgaris.

Evaluation of the efficacy, safety and tolerability of Tacrolimus ointment in Indian patients of moderate to severe atopic dermatitis: a multicentric, open label, phase III study.

AIM OF STUDY: Tacrolimus, a topical immunomodulator, has been introduced as a new treatment for moderate to severe atopic dermatitis. The present study was conducted to evaluate the efficacy, safety and tolerability of Tacrolimus ointment in patients of atopic dermatitis in an Indian setting. METHODS: The present study was a prospective, open, multicentric, Phase III trial.The duration of study was 5 weeks, including a 3-week active treatment period, preceded by a 1-week washout phase and followed by a 1-week follow-up phase. Patients diagnosed to be suffering from moderate to severe atopic dermatitis as per the Rajka and Langeland criteria were treated with Tacrolimus ointment 0.03% twice daily. Efficacy was assessed by modified Eczema Area Sensitivity Index (mEASI) score, patient's and physician's global assessment. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. RESULTS: There was a statistically significant decrease in the modified Eczema Area Sensitivity Index (mEASI) score (P< 0.05). Patient's and Physician's global evaluation of treatment was complete resolution to very good improvement in most of the patients. The laboratory values were within normal limits. The drug was well tolerated. CONCLUSIONS: This study confirms the efficacy and safety of Tacrolimus ointment 0.03% in Indian patients of moderate to severe atopic dermatitis.

Efficacy and safety of butenafine in superficial dermatophytoses (tinea pedis, tinea cruris, tinea corporis).

Superficial dermatophytoses of skin are very common infections seen in clinical practice. Besides topical imidazoles, triazoles and allylamines, topical butenafine (a benzylamine derivative) is a novel agent with broad antifungal activity. One hundred and eleven patients with tinea infections were enrolled in this multicentric, randomised, single-blind non-comparative study, which involved application of butenafine (1%) cream in tinea pedis (4 weeks) and tinea cruris and tinea corporis (2 weeks) cases. The results showed that butenafine causes rapid resolution of signs and symptoms (erythema itching, burning, crusting, scaling, etc), with good patient and physician acceptability of treatment. The broader spectrum fungicidal activity and better drug retention in superficial skin layers may be responsible for this beneficial effect.

Evaluation of safety and efficacy of ketoconazole 2% and zinc pyrithione 1% shampoo in patients with moderate to severe dandruff--a postmarketing study.

A postmarketing study was conducted on 236 patients from 23 centres suffering from moderate to severe dandruff with a combination of ketoconazole and zinc pyrithione (1%) for a duration of 4 weeks with 2 weeks further follow-up. Scoring of dandruff was done on a 0-10 scale for each of the 6 regions of scalp at each week up to 6 weeks. The results indicate that there was a consistent improvement in dandruff scores over the treatment period and a reduction of > 90% was seen for all areas of scalp individually as well as collectively as compared to baseline. The treatment also showed significant improvement in other signs and symptoms such as erythema and itching, with a highly favourable adverse event profile. The overall assessment for global improvement by investigators showed good-excellent results with high acceptability amongst the patient population for the treatment. A combination shampoo of ketoconazole (2%) and zinc pyrithione (1%) offers a safe and effective option in the treatment of dandruff.

Cyclospora infection in acquired immunodeficiency syndrome.

BACKGROUND: Diarrhea is a common clinical manifestation of human immunodeficiency virus (HIV) infection. The important protozoan pathogens causing diarrhea include cryptosporidium, microsporidium, Isospora belli and cyclospora besides giardia lamblia and entamoeba histolytica. OBJECTIVE: The objective of the present study was to determine the incidence of cyclospora (a coccidian protozoan) infection in HIV infected patients. METHODOLOGY: Faecal smears were stained by modified acid fast staining method to demonstrate oocysts of cyclospora. RESULTS: Out of 334 faecal specimens which were studied, cyclospora were identified in 22 cases (6.6 percent); and in 50 percent of the patients, there was a mixed infection with another protozoan parasite namely cryptosporidium. CONCLUSION: Identification of this parasite is important because cyclosporiasis can be treated with trimethoprim-sulfamethoxazole. Outbreaks of cyclospora infection have been linked to waterborne transmission. Though adequately chlorinated water is free of coliforms, it can still contain cyclospora.

Cryptosporidium, isospora and strongyloides in AIDS.

BACKGROUND: Diarrhoea is a common presentation in patients with AIDS. It occurs due to a number of parasites which are seldom seen in immunocompetent hosts. METHODS: Between January 1993 and July 1994, faecal specimens from 77 patients with AIDS presenting with diarrhoea of more than a month's duration were examined by direct wet mount microscopy of saline and iodine preparations and by the modified Ziehl-Neelsen stain. RESULTS: Cryptosporidium, Isospora and Strongyloides stercoralis alone or in combination were present in 29 of the 77 patients. CONCLUSION: The presence of these parasites highlights their pathogenic potential for immunocompromised patients with AIDS. Diarrhoea due to Isosporais responsive to treatment, hence their identification has therapeutic implications as well.